HIV Infections
Conditions
Keywords
Antiretroviral therapy, HIV infections, cabotegravir, rilpivirine, long-acting intramuscular injection,
Brief summary
Chronic human immunodeficiency virus (HIV) infection in adults continues to be characterized by increased development of resistant virus, increased transmission of resistant virus and issues associated with the long-term toxicity of anti-retroviral therapy (ART), despite advances in development of new ART, which provides extensive insight in management of HIV-infected individuals. Cabotegravir (CAB) is a potent integrase inhibitor (INI) and rilpivirine (RPV) is a potent non-nucleoside reverse transcriptase inhibitor (NNRTI). A two-drug regimen (DR)with CAB plus RPV long acting (LA) product offers many potential advantages over daily oral regimens including better tolerability, improved compliance, adherence, less likely to develop resistance, and overall treatment satisfaction in virologically suppressed subjects. This is a single-arm, open-label, multicenter, short term facilitation study to evaluate the effect of an implementation strategy on the degree of acceptability, appropriateness, feasibility, fidelity and sustainability of clinical practices to deliver the CAB+RPV LA regimen to HIV infected subjects and to also measure subject satisfaction by recording timeliness of visits, length of visit and their education. Approximately 135 subjects will be enrolled in the study and the total duration of the study will be approximately 52-weeks.
Interventions
DRUGCAB LA+RPV LA
Subjects will receive one tablet of CAB 30 milligram(mg) + RPV 25 mg once daily from Day 1 for 1 month. During month 1, subjects will receive 600 mg of CAB LA injection+ 900 mg of RPV LA injection. Following Month 1, subjects will receive 400mg of CAB LA + 600mg of RPV LA at each subsequent injection.
Sponsors
ViiV Healthcare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Be able to understand and comply with protocol requirements, instructions, and restrictions; * Understand the long-term commitment to the study and be likely to complete the study as planned; * Be considered appropriate candidates for participation in an investigative clinical trial with oral and intramuscularly injectable medications (e.g., no active substance use disorder, acute major organ disease, or planned long-term work assignments out of the country, etc.). All Participants eligible for enrolment in the study must meet all of the following criteria: * Aged 18 years or older at the time of signing the informed consent. * HIV-1 infected and must be on an active highly active antiretroviral therapy (HAART) (2 or 3 drug) regimen for at least 6 months prior to Screening. Any prior switch, defined as a change of a single drug or multiple drugs simultaneously, must have occurred due to tolerability/safety, access to medications, or convenience/simplification, and must NOT have been done for treatment failure (HIV-1 RNA \>=200 c/mL). Acceptable stable ARV regimens prior to Screening include 2 NRTIs plus: • INI (either the initial or second Combination antiretroviral therapy (cART) regimen) * NNRTI (either the initial or second cART regimen) * Boosted prediction interval (PI) (or atazanavir \[ATV\] unboosted) (must be either the initial cART regimen or one historical within class switch is permitted due to safety/tolerability) * Any suppressed participants on a triple ART regimen for at least 6 months who had their regimen switched to a 2DR of dolutegravir (DTG)/RPV \- Documented evidence of at least two plasma HIV-1 RNA measurements \<50 c/mL in the 12 months prior to Screening: at least one within 6 months prior to Screening; * Plasma HIV-1 RNA \<50 c/mL at Screening; * A female participant is eligible to participate if she is not pregnant (as confirmed by a negative urine human chorionic gonadotrophin (hCG) test at screen and at Day 1), not lactating, and at least one of the following conditions applies: 1. Non-reproductive potential defined as: * Pre-menopausal females with one of the following: * Documented tubal ligation * Documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion * Hysterectomy * Documented Bilateral Oophorectomy * Postmenopausal defined as 12 months of spontaneous amenorrhea \[in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) and estradiol levels consistent with menopause (refer to laboratory reference ranges for confirmatory levels)\]. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment. b. Reproductive potential and agrees to follow one of the options listed in the Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) from 30 days prior to the first dose of study medication, throughout the study, and for at least 30 days after discontinuation of all oral study medications and for at least 52 weeks after discontinuation of CAB LA and RPV LA. The investigator is responsible for ensuring that participants understand how to properly use these methods of contraception. \- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the consent form and in this protocol. Eligible participants or their legal guardians (and next of kin when locally required), must sign a written Informed Consent Form before any protocol-specified assessments are conducted. Enrolment of participants who are unable to provide direct informed consent is optional and will be based on local legal/regulatory requirements and site feasibility to conduct protocol procedures.
Exclusion criteria
* Within 6 months prior to Screening, plasma HIV-1 RNA measurement \>=50 c/mL; * During the previous 12 months, any confirmed HIV-1 RNA measurement \>=200 c/mL Exclusionary medical conditions * Women who are pregnant, breastfeeding, or plan to become pregnant or breastfeed during the study * Any evidence of a current Center for Disease Control and Prevention (CDC) Stage 3 disease, except cutaneous Kaposi's sarcoma not requiring systemic therapy, and Cluster of Differentiation (CD4+) counts \<200 cells/microliter are not exclusionary * Any pre-existing physical or mental condition (including substance use disorder) which, in the opinion of the Investigator, may interfere with the participant's ability to comply with the dosing schedule and/or protocol evaluations or which may compromise the safety of the participant. * Participants determined by the Investigator to have a high risk of seizures, including participants with an unstable or poorly controlled seizure disorder. A participant with a prior history of seizure may be considered for enrolment if the Investigator believes the risk of seizure recurrence is low. * Participants who, in the investigator's judgment, pose a significant suicide risk. Participant's recent history of suicidal behavior and/or suicidal ideation should be considered when evaluating for suicide risk. * The participant has a tattoo or other dermatological condition overlying the gluteus region which may interfere with interpretation of injection site reactions. * Evidence of Hepatitis B virus (HBV) infection based on the results of testing for Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (anti-HBc), Hepatitis B surface antibody (anti-HBs) and HBV Deoxyribonucleic acid (DNA) as follows: * Participants positive for HBsAg are excluded; * Participants negative for anti-HBs but positive for anti-HBc (negative HBsAg status) and positive for HBV DNA are excluded Note: Participants positive for anti-HBc (negative HBsAg status) and positive for anti-HBs (past and/or current evidence) are immune to HBV and are not excluded. * Participants who are anticipated to require HCV treatment within 12 months must be excluded. Asymptomatic individuals with chronic hepatitis C virus (HCV) infection will not be excluded; investigators must carefully assess if therapy specific for HCV infection is required. (HCV treatment on study may be permitted, following consultation and approval of the direct acting antiviral (DAA) drug based therapy being considered with the medical monitor). * Participants with HCV co-infection will be allowed entry into this study if: * Liver enzymes meet entry criteria * HCV Disease has undergone appropriate work-up, and is not advanced. Additional information (where available) on participants with HCV coinfection at screening should include results from any liver biopsy, Fibroscan, ultrasound, or other fibrosis evaluation, history of cirrhosis or other decompensated liver disease, prior treatment, and timing/plan for HCV treatment. * In the event that recent biopsy or imaging data is not available or inconclusive, the Fib-4 score will be used to verify eligibility * Fib-4 score \>3.25 is exclusionary * Fib-4 scores 1.45 - 3.25 requires Medical Monitor consultation Fibrosis 4 Score Formula: (Age x AST) / (Platelets x ( sqr \[ ALT \]) * Unstable liver disease (as defined by any of the following: presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice or cirrhosis), known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per investigator assessment). * History of liver cirrhosis with or without hepatitis viral co-infection. * Ongoing or clinically relevant pancreatitis. * Clinically significant cardiovascular disease, as defined by history/evidence of congestive heart failure, symptomatic arrhythmia, angina/ischemia, coronary artery bypass grafting (CABG) surgery or percutaneous transluminal coronary angioplasty (PTCA) or any clinically significant cardiac disease. * Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical intraepithelial neoplasia; other localized malignancies require agreement between the investigator and the Study medical monitor for inclusion of the participant prior to inclusion. * Any condition which, in the opinion of the Investigator, may interfere with the absorption, distribution, metabolism or excretion of the study drugs or render the participant unable to receive study medication. * History or presence of allergy or intolerance to the study drugs or their components or drugs of their class. * Current or anticipated need for chronic anti-coagulation with the exception of the use of low dose acetylsalicylic acid (\<=325 milligram (mg) per day) or hereditary coagulation and platelet disorders such as haemophilia or Von Willebrand Disease. * Corrected QT interval (QTc \[Bazett\]) \>450 milli second (msec) or QTc (Bazett) \>480 msec for subjects with bundle branch block). Exclusionary Laboratory Values or Clinical Assessments (a single repeat to determine eligibility is allowed). * Any evidence of primary resistance based on the presence of any major known INI or NNRTI resistance-associated mutation, except for K103N, (International acquired immune deficiency syndrome \[AIDS\] Society \[IAS\]-USA) by any historical resistance test result. * ALT \>=5 × Upper Limit Normal (ULN) or ALT \>=3xULN and bilirubin \>=1.5xULN (with \>35% direct bilirubin) over the last 6 months. * Any verified Grade 4 laboratory abnormality. A single repeat test is allowed during the Screening phase to verify a result. * Participant has estimated creatinine clearance \<50 mL/min/1.73meter\^2 via the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation. Concomitant Medications * Exposure to an experimental drug or experimental vaccine within either 28 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to Day 1 of this study; * Treatment with any of the following agents within 28 days of Day 1: * radiation therapy; * cytotoxic chemotherapeutic agents; * tuberculosis therapy with the exception of isoniazid (isonicotinylhydrazid \[INH\]); * anti-coagulation agents; * Immunomodulators that alter immune responses such as chronic systemic corticosteroids, interleukins, or interferons. Note: Participants using short-term (e.g. \<=21 days) systemic corticosteroid treatment; topical, inhaled and intranasal corticosteroids are eligible for enrolment. * Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening. * Use of medications which are associated with Torsade de Pointes must be discussed with the Medical Monitor to determine eligibility. * Subjects receiving any prohibited medication and who are unwilling or unable to switch to an alternate medication. Note: Any prohibited medications that decrease CAB or RPV concentrations should be discontinued for a minimum of four weeks or a minimum of three half-lives (whichever is longer) prior to the first dose and any other prohibited medications should be discontinued for a minimum of two weeks or a minimum of three half-lives (whichever is longer) prior to the first dose.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline for FIM Total Score in Staff Study Participants at Month 12 | Baseline and Month 12 | FIM is a four item survey that assessed the feasibility of an implementation process. The staff study participants were asked to indicate how much they agreed or disagreed with each of the 4 items in the FIM based on their current experiences with implementing the CAB + RPV injection treatment on a five point rating scale (1=completely disagree to 5=completely agree). The FIM total score ranges from 1 to 5 with 1 indicating the least feasibility and 5 the most feasibility. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value. |
| Change From Baseline in IAM Score in Participants With HIV Infection at Month 12 | Baseline and Month 12 | IAM is a four item survey that assessed the appropriateness of an implementation process. The participants were asked to indicate how much they agreed or disagreed with each of the 4 items in the IAM based on their current experiences with implementing the CAB + RPV injection treatment on a five point rating scale (1=completely disagree to 5=completely agree). The IAM total score ranges from 1 to 5 with 1 indicating the least appropriateness and 5 the most appropriateness. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value. |
| Change From Baseline in Feasibility of Intervention Measure (FIM) Total Score in Staff Study Participants at Month 4 | Baseline and Month 4 | FIM is a four item survey that assessed the feasibility of an implementation process. The staff study participants were asked to indicate how much they agreed or disagreed with each of the 4 items in the FIM based on their current experiences with implementing the CAB + RPV injection treatment on a five point rating scale (1=completely disagree to 5=completely agree). The FIM total score ranges from 1 to 5 with 1 indicating the least feasibility and 5 the most feasibility. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value. |
| Change From Baseline in the Acceptability of Intervention Measure (AIM) Total Score in Staff Study Participants at Month 4 | Baseline and Month 4 | AIM is a four item survey that assessed the acceptability of an implementation process. The staff study participants were asked to indicate how much they agreed or disagreed with each of the 4 items in the AIM based on their current experiences with implementing the CAB + RPV injection treatment on a five point rating scale (1=completely disagree to 5=completely agree). The AIM total score ranges from 1 to 5 with 1 indicating the least acceptability and 5 the most acceptability. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value. |
| Change From Baseline in AIM Total Score in Staff Study Participants at Month 12 | Baseline and Month 12 | AIM is a four item survey that assessed the acceptability of an implementation process. The staff study participants were asked to indicate how much they agreed or disagreed with each of the 4 items in the AIM based on their current experiences with implementing the CAB + RPV injection treatment on a five point rating scale (1=completely disagree to 5=completely agree). The AIM total score ranges from 1 to 5 with 1 indicating the least acceptability and 5 the most acceptability. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value. |
| Change From Baseline in AIM Total Score in Participants With HIV Infection at Month 4 | Baseline and Month 4 | AIM is a four item survey that assessed the acceptability of an implementation process. The participants were asked about their impressions of the CAB LA + RPV LA injection treatment for treating HIV on a five point rating scale (1=completely disagree to 5=completely agree). The AIM total score ranges from 1 to 5 with 1 indicating the least acceptability and 5 the most acceptability. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value. |
| Change From Baseline in AIM Total Score in Participants With HIV Infection at Month 12 | Baseline and Month 12 | AIM is a four item survey that assessed the acceptability of an implementation process. The participants were asked about their impressions of the CAB LA + RPV LA injection treatment for treating HIV on a five point rating scale (1=completely disagree to 5=completely agree). The AIM total score ranges from 1 to 5 with 1 indicating the least acceptability and 5 the most acceptability. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value. |
| Change From Baseline in Intervention Appropriateness Measure (IAM) Score in Staff Study Participants at Month 4 | Baseline and Month 4 | IAM is a four item survey that assessed the appropriateness of an implementation process. The staff study participants were asked to indicate how much they agreed or disagreed with each of the 4 items in the IAM based on their current experiences with implementing the CAB + RPV injection treatment on a five point rating scale (1=completely disagree to 5=completely agree). The IAM total score ranges from 1 to 5 with 1 indicating the least appropriateness and 5 the most appropriateness. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value. |
| Change From Baseline in IAM Score in Staff Study Participants at Month 12 | Baseline and Month 12 | IAM is a four item survey that assessed the appropriateness of an implementation process. The staff study participants were asked to indicate how much they agreed or disagreed with each of the 4 items in the IAM based on their current experiences with implementing the CAB + RPV injection treatment on a five point rating scale (1=completely disagree to 5=completely agree). The IAM total score ranges from 1 to 5 with 1 indicating the least appropriateness and 5 the most appropriateness. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value. |
| Change From Baseline in IAM Score in Participants With HIV Infection at Month 4 | Baseline and Month 4 | IAM is a four item survey that assessed the appropriateness of an implementation process. The participants were asked to indicate how much they agreed or disagreed with each of the 4 items in the IAM based on their current experiences with implementing the CAB + RPV injection treatment on a five point rating scale (1=completely disagree to 5=completely agree). The IAM total score ranges from 1 to 5 with 1 indicating the least appropriateness and 5 the most appropriateness. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Staff Study Participants Using Support Materials/Toolkit at Month 4 | At Month 4 | Number of staff study participants using support materials/toolkit at Month 4 was assessed by variables: Not used, Used similar resource, used the support materials/toolkit. The support materials/toolkit consisted of website for clinical staff, video on giving CAB + RPV LA, how to use new packaging card, study factsheet for healthcare providers, consultation aid, reminder e-application, reminder SMS/text, face-to-face training by healthcare staff, facilitation group calls, web-based (WB) treatment planner, WB health clinic capacity planning tool, injection flashcards, website for participants, what to expect factsheet for participants, handbook, FAQ chatbot, trial guide app, video-what to expect and hot and cold packs. |
| Number of Staff Study Participants Using Support Materials/Toolkit at Month 12 | At Month 12 | Number of staff study participants using support materials/toolkit at Month 12 was assessed by variables: Not used, Used similar resource, used the support materials/toolkit. The support materials/toolkit consisted of website for clinical staff, video on giving CAB + RPV LA, how to use new packaging card, study factsheet for healthcare providers, consultation aid, reminder e-application, reminder SMS/text, face-to-face training by healthcare staff, facilitation group calls, web-based (WB) treatment planner, WB health clinic capacity planning tool, injection flashcards, website for participants, what to expect factsheet for participants, handbook, FAQ chatbot, trial guide app, video-what to expect and hot and cold packs. |
| Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | At Month 4 | Participants with HIV infection were asked about their utilization of each element of the support materials/toolkit and were asked to categorize it as Extremely helpful (EH) Very helpful (VH), Somewhat helpful (SH), A little helpful (ALH), Not at all helpful (NAAH), did not receive (DNR), Received but did not use (RBDNU) and missing. Not Applicable (NA) in the data means participants were not offered the response option. The support materials/toolkit consisted of information and resources, hot and cold pack, written materials, website for participants, video, verbal information, reminder calls, reminder text messages, reminder app, peer group information session and appointments outside work time. Percentage of participants with the rating on helpfulness for each toolkit resources is presented. |
| Number of Participants Receiving Injections Within Target Window at Month 4 | At Month 4 | Number of participants receiving injections within target window at Month 4 is presented. The target window is +/- 7 days from the target injection visit date. |
| Number of Participants Receiving Injections Within Target Window at Month 12 | At Month 12 | Number of participants receiving injections within target window at Month 12 is presented. The target window is +/- 7 days from the target injection visit date. |
| Implementation Sustainability Assessed in Staff Study Participants Using Program Sustainability Assessment Tool (PSAT) Scores | At Month 12 | Implementation sustainability in staff study participants was assessed using PSAT tool that evaluated capability of clinics to maintain processes developed to administer CAB+RPV injection in routine clinical settings after study conclusion.It consisted of 6 domains(1.Environmental support,2.Organizational capacity,3.Program evaluation,4.Program adaptation,5.Communications and 6.Strategic planning).Each domain consisted of 5 items,each assessed using 7-point numerical rating scale:1=to not extent at all,7=to a very great extent and an eighth not applicable/not able to answer response(NA).Score ranges for total domain scores are 5 to 35 for each of 6 domains(5 items in each domain on 1 to 7 scale).Numeric response to each item within specific domain is summed to produce a total domain score then mean domain score is calculated(excluding any NA responses).Higher scores indicate better outcome(higher endorsement/more positive impressions by staff-study with sustainability survey concepts) |
| HIV Treatment Satisfaction Questionnaire Status Version (HIV-TSQs) Scores at Month 1 | At Month 1 | Participant satisfaction was measured using the validated HIV Treatment Satisfaction Questionnaire (HIV-TSQ), status version (HIV-TSQs), which measured satisfaction with the treatment used in the previous few weeks. HIVTSQs total treatment satisfaction score was computed with 1-11 items. Each item was scored from 0 (least satisfied) to 6 (most satisfied). Items 1-11 were summed to produce score with possible range of 0 to 66. Higher the score, greater improvement in satisfaction with treatment; lower score, greater the deterioration in satisfaction with treatment. |
| HIV-TSQs Scores at Month 4 | At Month 4 | Participant satisfaction was measured using the validated HIV Treatment Satisfaction Questionnaire (HIV-TSQ), status version (HIV-TSQs), which measured satisfaction with the treatment used in the previous few weeks. HIVTSQs total treatment satisfaction score was computed with 1-11 items. Each item was scored from 0 (least satisfied) to 6 (most satisfied). Items 1-11 were summed to produce score with possible range of 0 to 66. Higher the score, greater improvement in satisfaction with treatment; lower score, greater the deterioration in satisfaction with treatment. |
| HIV-TSQs Scores at Month 12 | At Month 12 | Participant satisfaction was measured using the validated HIV Treatment Satisfaction Questionnaire (HIV-TSQ), status version (HIV-TSQs), which measured satisfaction with the treatment used in the previous few weeks. HIVTSQs total treatment satisfaction score was computed with 1-11 items. Each item was scored from 0 (least satisfied) to 6 (most satisfied). Items 1-11 were summed to produce score with possible range of 0 to 66. Higher the score, greater improvement in satisfaction with treatment; lower score, greater the deterioration in satisfaction with treatment. |
| Number of Participants With Reported Acceptability of the Amount of Time Spent in the Clinic for Each Injection Visit | At Month 12 | The results for participant reported acceptability of the amount of time spent in the clinic for each injection visit is presented. Participants were asked to rate the acceptability of the amount of time spent in the clinic for each injection visit as extremely acceptable, very acceptable, somewhat acceptable, a little acceptable and not at all acceptable. |
| Number of Participants With the Reported Time Spent in Clinic/Practice for Each Injection Visit | At Month 12 | Number of participants with the reported time spent in clinic/practice for each injection visit is presented. |
| Number of Participants With Extent of Knowledge About the CAB + RPV LA Treatment | At Month 12 | Participants were asked to rate how knowledgeable they feel about the CAB LA + RPV LA treatment as extremely knowledgeable, very knowledgeable, somewhat knowledgeable, a little knowledgeable and not at all knowledgeable. |
| Length of Participant Visit | At Months 1, 5 and 11 | Length of visit was calculated by subtracting the arrival time (Lead time \[actual start time of appointment - arrival time\] + process time \[actual end time of appointment - actual start time of appointment\]) from actual end time of appointment. |
| Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) Less Than (<)50 Copies/Milliliter (c/mL) by Modified Food and Drug Administration (FDA) Snapshot Algorithm | Month 1, Month 2, Month 4, Month 6, Month 8, Month 10 and Month 12 | Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with plasma HIV-1 RNA \<50 c/mL (virologic success) was evaluated using the modified Food and Drug Administration (FDA) snapshot algorithm with Coronavirus Disease 2019 (COVID-19) related missing value imputed using the last observation carried forward (LOCF) approach. |
| Percentage of Participants With Plasma HIV-1 RNA <50 c/mL - Observed Case | Months 1, Month 2, Month 4, Month 6, Month 8, Month 10, Month 12, Month 13, Month 15, Month 16, Month 18, Month 19, Month 21, Month 22, Month 24, Month 25, Month 27, Month 28 and Month 30 | Plasma samples were collected for quantitative analysis of HIV-1 RNA. The percentage value presented has been rounded off. |
| Percentage of Participants With Confirmed Virologic Failure (CVF) | Up to 30 months | Plasma samples were collected for quantitative analysis of HIV-1 RNA. The CVF is defined as rebound as indicated by two consecutive plasma HIV-1 RNA levels greater than or equal to (\>=)200 copies/mL after prior suppression to \<200 copies/mL. |
| Number of Participants With Treatment Emergent Genotypic Resistance to CAB and RPV | Up to 30 months | Plasma samples were collected for drug resistance testing. Number of participants who met CVF criteria (two consecutive plasma HIV-1 RNA levels \>=200 copies/mL after prior suppression to \<200 copies/mL) with emergent genotypic resistance is summarized. |
| Number of Participants With Treatment Emergent Phenotypic Resistance to CAB and RPV | Up to 30 months | Plasma samples were collected for drug resistance testing. Number of participants who met CVF criteria (two consecutive plasma HIV-1 RNA levels \>=200 copies/mL after prior suppression to \<200 copies/mL) with emergent phenotypic resistance is summarized. |
| Absolute Values of Hematology Parameter: RBC Count | Up to Month 12 | Blood samples were collected to analyze the hematology parameter: RBC count. |
| Number of Participants With Serious Adverse Events (SAEs) and Common (>=5 Percent [%]) Non-serious Adverse Events (Non-SAEs) | Up to 30 months | An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose may result in death or is life-threatening or requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity or is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment or is associated with liver injury and impaired liver function. Number of participants with any SAE and common (\>=5%) non-SAEs are presented. Adverse events which were not serious have been considered as non-serious adverse events. |
| Percentage of Participants Who Discontinue Treatment or Withdraw From Study Due to AEs Over Time | Up to 30 months | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Percentage of participants with adverse events leading to study treatment or study withdrawal has been presented. The percentage value presented has been rounded off. |
| Number of Participants With Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Up to Month 12 | Blood samples were collected for the analysis of following hematology parameters: leukocytes, neutrophils and platelets. The parameters were graded according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) toxicity scale from Grade 1 to 4, where Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). Higher the grade, more severe the symptoms. |
| Number of Participants With Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study | Up to 30 months | Blood samples were collected for the analysis of following hematology parameters: hemoglobin, leukocytes, neutrophils and platelets. The parameters were graded according to the DAIDS toxicity scale from Grade 1 to 4, where Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). Higher the grade, more severe the symptoms. |
| Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Up to Month 12 | Blood samples were collected up to the Month 12 visit for the analysis of clinical chemistry parameters: alanine aminotransferase (ALT), alkaline phosphate (ALP), aspartate aminotransferase (AST), bilirubin, carbon dioxide (CO2), creatine kinase (CK), creatinine, direct bilirubin, glucose, lipase, phosphate, potassium and sodium. Any abnormality in clinical chemistry parameters were evaluated according to the DAIDS toxicity scale From Grade 1 to 4: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). Higher the grade, more severe the symptoms. |
| Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study | Up to 30 months | Blood samples were collected for the analysis of clinical chemistry parameters: ALT, ALP, AST, bilirubin, CO2, CK, creatinine, direct bilirubin, Glomerular filtration rate (GFR) from Creatinine (Creat) Adjusted (Adj) using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI), GFR From Creat Adj for body surface area (BSA), glucose, lipase, phosphate, potassium and sodium. Any abnormality in clinical chemistry parameters were evaluated according to the DAIDS toxicity scale From Grade 1 to 4: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). Higher the grade, more severe the symptoms. |
| Absolute Values of the Hematology Parameters: Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count | Up to Month 12 | Blood samples were collected for the analysis of hematology parameters including platelet count, WBC count, basophil count, eosinophil count, lymphocyte count, monocyte count and neutrophil count. |
| Number of Participants With Urinalysis Result of Potential Clinical Importance | Up to Month 12 | Urine samples were collected to analyze the urine parameters: Protein, occult blood or glucose. Potential clinical importance is defined as an increase in protein (dipstick) or occult blood (dipstick) post-Baseline relative to Baseline. Number of participants with results of potential clinical importance in any of the urine parameters is presented. |
| Number of Participants With Urinalysis Result of Potential Clinical Importance Through End of Study | Up to 30 months | Urine samples were collected to analyze the urine parameters: Protein, occult blood or glucose. Potential clinical importance is defined as an increase in protein (dipstick) or occult blood (dipstick) post-Baseline relative to Baseline. Number of participants with results of potential clinical importance in any of the urine parameters is presented. |
| Number of Participants With Injection Site Reactions (ISRs) Over Time | Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 | Local tolerability was measured by injection site reaction (ISR), for example; bruise at the site of injection and/or itching, pain, blistering or skin damage. ISRs were assigned to the most recent planned injection visit prior to/on the onset date of the ISR. Number of participants with ISRs by each assigned injection visit is presented. |
| Number of Participants With Injection Site Reactions (ISRs) Over Time From Month 13 to Month 30 | Months 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29 and 30 | Local tolerability was measured by injection site reaction (ISR), for example; bruise at the site of injection and/or itching, pain, blistering or skin damage. ISRs were assigned to the most recent planned injection visit prior to/on the onset date of the ISR. Number of participants with ISRs by each assigned injection visit is presented. |
| Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count | Baseline and up to Month 12 | Blood samples were collected to analyze the hematology parameters: Platelet count, WBC count, Basophil count, Eosinophil count, Lymphocyte count, Monocyte count and Neutrophil count. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value. |
| Change From Baseline in Hematology Parameter: Red Blood Cell (RBC) Count | Baseline and up to Month 12 | Blood samples were collected to analyze the hematology parameter: RBC count. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value. |
| Change From Baseline in Hematology Parameter: Hemoglobin | Baseline and up to Month 12 | Blood samples were collected to analyze the hematology parameter: Hemoglobin. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value. |
| Change From Baseline in Hematology Parameter: Hematocrit | Baseline and up to Month 12 | Blood samples were collected to analyze the hematology parameter: Hematocrit (fraction of 1). Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value. |
| Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume (MCV) | Baseline and up to Month 12 | Blood samples were collected to analyze the hematology parameter: Erythrocytes MCV. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value. |
| Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30 | Baseline and Months 15, 18, 21, 24, 27, 30 | Blood samples were collected to analyze the hematology parameters: Platelet count, WBC count, Basophil count, Eosinophil count, Lymphocyte count, Monocyte count and Neutrophil count. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value. |
| Change From Baseline in Hematology Parameter-Red Blood Cell (RBC) Count From Month 15 to Month 30 | Baseline and Months 15, 18, 21, 24, 27, 30 | Blood samples were collected to analyze the hematology parameter: RBC count. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value. |
| Change From Baseline in Hematology Parameter-Hemoglobin From Month 15 to Month 30 | Baseline and Months 15, 18, 21, 24, 27, 30 | Blood samples were collected to analyze the hematology parameter: Hemoglobin. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value. |
| Change From Baseline in Hematology Parameter-Hematocrit From Month 15 to Month 30 | Baseline and Months 15, 18, 21, 24, 27, 30 | Blood samples were collected to analyze the hematology parameter: Hematocrit (fraction of 1). Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value. |
| Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Volume (MCV) From Month 15 to Month 30 | Baseline and Months 15, 18, 21, 24, 27, 30 | Blood samples were collected to analyze the hematology parameter: Erythrocytes MCV. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value. |
| Absolute Values of Hematology Parameter: Hemoglobin | Up to Month 12 | Blood samples were collected to analyze the hematology parameter: Hemoglobin |
| Absolute Values of Hematology Parameter: Hematocrit | Up to Month 12 | Blood samples were collected to analyze the hematology parameter: Hematocrit (fraction of 1) |
| Absolute Values of Hematology Parameter: Erythrocytes MCV | Up to Month 12 | Blood samples were collected to analyze the hematology parameter: Erythrocytes MCV. |
| Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30 | Months 15, 18, 21, 24, 27, 30 | Blood samples were collected for the analysis of hematology parameters including platelet count, WBC count, basophil count, eosinophil count, lymphocyte count, monocyte count and neutrophil count. |
| Absolute Values of Hematology Parameter-RBC Count From Month 15 to Month 30 | Months 15, 18, 21, 24, 27, 30 | Blood samples were collected to analyze the hematology parameter: RBC count. |
| Absolute Values of Hematology Parameter-Hemoglobin From Month 15 to Month 30 | Months 15, 18, 21, 24, 27, 30 | Blood samples were collected to analyze the hematology parameter: Hemoglobin. |
| Absolute Values of Hematology Parameter-Hematocrit From Month 15 to Month 30 | Months 15, 18, 21, 24, 27, 30 | Blood samples were collected to analyze the hematology parameter: Hematocrit (fraction of 1). |
| Absolute Values of Hematology Parameter-Erythrocytes MCV From Month 15 to Month 30 | Months 15, 18, 21, 24, 27, 30 | Blood samples were collected to analyze the hematology parameter: Erythrocytes MCV. |
| Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate | Baseline and up to Month 12 | Blood samples were collected to analyze the chemistry parameters: Sodium, potassium, carbon dioxide, chloride, glucose, urea and phosphate. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value. |
| Change From Baseline in Clinical Laboratory Parameters: Creatinine and Bilirubin | Baseline and up to Month 12 | Blood samples were collected to analyze the chemistry parameters: Creatinine and Bilirubin. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value. |
| Change From Baseline in Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase | Baseline and up to Month 12 | Blood samples were collected to analyze the chemistry parameters: ALT, AST, ALP and creatine kinase. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value. |
| Change From Baseline in Clinical Laboratory Parameter: Glomerular Filtration Rate (GFR) From Creatinine Adjusted for Body Surface Area (BSA) | Baseline and up to Month 12 | Blood samples were collected from participants at indicated time points to analyze the clinical chemistry parameter: GFR from creatinine adjusted for BSA. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value. |
| Change From Baseline in Clinical Laboratory Parameter: Lipase | Baseline and up to Month 12 | Blood samples were collected for the analysis of clinical chemistry parameter: Lipase. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. |
| Change From Baseline in Clinical Laboratory Parameter: Albumin | Baseline and up to Month 12 | Blood samples were collected for the analysis of clinical chemistry parameter: Albumin. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. |
| Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Baseline and Months 15, 18, 21, 24, 27, 30 | Blood samples were collected to analyze the chemistry parameters: Sodium, potassium, carbon dioxide, chloride, glucose, urea and phosphate. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value. |
| Change From Baseline in Clinical Laboratory Parameters: Creatinine and Bilirubin From Month 15 to Month 30 | Baseline and Months 15, 18, 21, 24, 27, 30 | Blood samples were collected to analyze the chemistry parameters: Creatinine and Bilirubin. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value. |
| Change From Baseline in Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30 | Baseline and Months 15, 18, 21, 24, 27, 30 | Blood samples were collected to analyze the chemistry parameters: ALT, AST, ALP and creatine kinase. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value. |
| Change From Baseline in Clinical Laboratory Parameter-glomerular Filtration Rate (GFR) From Creatinine Adjusted for Body Surface Area (BSA) From Month 15 to Month 30 | Baseline and Months 15, 18, 21, 24, 27, 30 | Blood samples were collected from participants at indicated time points to analyze the clinical chemistry parameter: GFR from creatinine adjusted for BSA. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value. |
| Change From Baseline in Clinical Laboratory Parameter- Lipase From Month 15 to Month 30 | Baseline and Months 15, 18, 21, 24, 27, 30 | Blood samples were collected for the analysis of clinical chemistry parameter: Lipase. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. |
| Change From Baseline in Clinical Laboratory Parameter-Albumin From Month 15 to Month 30 | Baseline and Months 15, 18, 21, 24, 27, 30 | Blood samples were collected for the analysis of clinical chemistry parameter-Albumin. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. |
| Absolute Values of Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate | Up to Month 12 | Blood samples were collected to analyze the chemistry parameters: Sodium, potassium, carbon dioxide, chloride, glucose, urea and phosphate. |
| Absolute Values of Clinical Laboratory Parameters: Creatinine and Bilirubin | Up to Month 12 | Blood samples were collected to analyze the chemistry parameters: Creatinine and Bilirubin. |
| Absolute Values of Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase | Up to Month 12 | Blood samples were collected to analyze the chemistry parameters: ALT, AST, ALP and creatine kinase. |
| Absolute Values of Clinical Laboratory Parameter: Glomerular Filtration Rate (GFR) From Creatinine Adjusted for Body Surface Area (BSA) | Up to Month 12 | Blood samples were collected from participants to analyze the clinical chemistry parameter: GFR from Creatinine adjusted for BSA |
| Absolute Values of Clinical Laboratory Parameter: Lipase | Up to Month 12 | Blood samples were collected for the analysis of clinical chemistry parameter: Lipase. |
| Absolute Values of Clinical Laboratory Parameter: Albumin | Up to Month 12 | Blood samples were collected for the analysis of clinical chemistry parameter: Albumin. |
| Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Months 15, 18, 21, 24, 27, 30 | Blood samples were collected to analyze the chemistry parameters: Sodium, potassium, carbon dioxide, chloride, glucose, urea and phosphate. |
| Absolute Values of Clinical Laboratory Parameters: Creatinine and Bilirubin From Month 15 to Month 30 | Months 15, 18, 21, 24, 27, 30 | Blood samples were collected to analyze the chemistry parameters: Creatinine and Bilirubin. |
| Absolute Values of Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30 | Months 15, 18, 21, 24, 27, 30 | Blood samples were collected to analyze the chemistry parameters: ALT, AST, ALP and creatine kinase. |
| Absolute Values of Clinical Laboratory Parameter-glomerular Filtration Rate (GFR) From Creatinine Adjusted for Body Surface Area (BSA) From Month 15 to Month 30 | Months 15, 18, 21, 24, 27, 30 | Blood samples were collected from participants to analyze the clinical chemistry parameter: GFR from Creatinine adjusted for BSA. |
| Absolute Values of Clinical Laboratory Parameter-Albumin From Month 15 to Month 30 | Months 15, 18, 21, 24, 27, 30 | Blood samples were collected for the analysis of clinical chemistry parameter-Albumin. |
| Absolute Values of Clinical Laboratory Parameter-Lipase From Month 15 to Month 30 | Months 15, 18, 21, 24, 27, 30 | Blood samples were collected for the analysis of clinical chemistry parameter-Lipase. |
| Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | At Month 4 | The helpfulness of the toolkit resources was identified using a 19-item survey and the helpfulness of the resources were rated on a five point scale where 1=Extremely helpful (EH), 2=Very helpful (VH), 3=Somewhat helpful (SH), 4=A little helpful (ALH) and 5=Not at all helpful (NAAH). Not Applicable (NA) in the categories mean response was not offered. The toolkit resources consisted of website for clinical staff, video on giving CAB + RPV LA, how to use new packaging card, study factsheet for healthcare providers, consultation aid, reminder e-application, reminder SMS/text, face-to-face training by healthcare staff, facilitation group calls, web-based (WB) treatment planner, WB health clinic capacity planning tool, injection flashcards, website for participants, what to expect factsheet, handbook, FAQ chatbot, trial guide app, video-what to expect and hot and cold packs. The number of participants with the rating on helpfulness for each toolkit resources at Month 4 is presented. |
| Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | At Month 12 | The helpfulness of the toolkit resources was identified using a 19-item survey and the helpfulness of the resources were rated on a five point scale where 1=Extremely helpful (EH), 2=Very helpful (VH), 3=Somewhat helpful (SH), 4=A little helpful (ALH) and 5=Not at all helpful (NAAH). Not Applicable (NA) in the categories mean response was not offered. The toolkit resources consisted of website for clinical staff, video on giving CAB + RPV LA, how to use new packaging card, study factsheet for healthcare providers, consultation aid, reminder e-application, reminder SMS/text, face-to-face training by healthcare staff, facilitation group calls, WB treatment planner, WB health clinic capacity planning tool, injection flashcards, website for participants, what to expect factsheet for participants, handbook, FAQ chatbot, trial guide app, video-what to expect and hot and cold packs. The number of participants with the rating on helpfulness for each toolkit resources at Month 12 is presented. |
| Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants | Baseline and Month 4 | BIM is a 23-item survey which assessed barriers (that is, difficulties and challenges) to successful implementation of the CAB LA + RPV LA injection treatment in the study clinic/practices. For each item, providers were asked to rate how much they agreed or disagreed that the issue is a barrier based on their experiences with implementing the CAB + RPV treatment on a five point rating scale (1=completely disagree to 5=completely agree). It is presented as fewer perceived barriers (FPB)=all negative change in scores from Baseline, some perceived barriers (SPB)=change in score of 0 from Baseline, and greater/more perceived barriers (MPB)=all positive change in scores from Baseline. |
| Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants | Baseline and Month 12 | BIM is a 23-item survey which assessed barriers (i.e., difficulties and challenges) to successful implementation of the CAB LA + RPV LA injection treatment in the study clinic/practices. For each item, providers were asked to rate how much they agreed or disagreed that the issue is a barrier based on their experiences with implementing the CAB + RPV treatment on a five point rating scale (1=completely disagree to 5=completely agree). It is presented as fewer perceived barriers (FPB)=all negative change in scores from Baseline, some perceived barriers (SPB)=change in score of 0 from Baseline, and greater/more perceived barriers (MPB)=all positive change in scores from Baseline. |
| Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | At Month 12 | The helpfulness of the toolkit resources was identified using a 19-item survey and the helpfulness of the resources were rated on a five point scale where 1=Extremely helpful (EH), 2=Very helpful (VH), 3=Somewhat helpful (SH), 4=A little helpful (ALH) and 5=Not at all helpful (NAAH). Categories for did not receive (DNR) and recevied but did not use (RBDNU) were presented as well. Not Applicable (NA) in the data means participants were not offered the response option. The toolkit resources consisted of information and resources, hot and cold pack, written materials, website for participants, video, verbal information, reminder calls, reminder text messages, reminder app, peer group information session and appointments outside work time. The number of participants with the rating on helpfulness for each toolkit resources is presented. |
| Number of Participants With HIV Reporting Barriers to CAB LA + RPV LA Injection Treatment at Month 12 | At Month 12 | Participants were asked to report any factors that were interfering with their ability to get the monthly CAB LA + RPV LA injection treatment. Number of participants along with the reasons for interference in ability to get CAB LA + RPV LA is presented. |
| Number of Barriers Assessed Among Clinics Using Short-term Facilitation | Up to 6 months | The barriers were analyzed using semi-structured interviews from the validated consolidated framework for implementation research (CFIR) across 7 calls. An implementation science approach was used to understand the barriers for participants with HIV for delivering CAB + RPV LA within an interventional clinical trial where the CAB + RPV LA regimen was delivered to HIV infected, virologically-suppressed participants. |
| Number of Facilitators Assessed Among Clinics Using Short-term Facilitation | Up to 6 months | The facilitators were analyzed using semi-structured interviews from the validated CFIR across 7 calls. An implementation science approach was used to understand the facilitators for participants with HIV for delivering CAB + RPV LA within an interventional clinical trial where the CAB + RPV LA regimen was delivered to HIV infected, virologically-suppressed participants. |
| Number of Best Practices Assessed Among Clinics Using Short-term Facilitation | Up to 6 months | The best practices were analyzed using short-term facilitation calls. An implementation science approach was used to understand the best practices for participants with HIV for delivering CAB + RPV LA within an interventional clinical trial where the CAB + RPV LA regimen was delivered to HIV infected, virologically-suppressed participants. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Urinalysis Parameters: Urine Albumin to Creatinine Ratio | Baseline and up to Month 12 | Urine samples were not planned to be collected for the analysis of urine albumin to creatinine ratio. The results for this outcome measure will never be posted. |
| Change From Baseline in Urinalysis Parameters: Urine Phosphate | Baseline and up to Month 12 | Urine samples were not planned to be collected for the analysis of urine phosphate. The results for this outcome measure will never be posted. |
| Change From Baseline in Urinalysis Parameters: Urine Protein to Creatinine Ratio | Baseline and up to Month 12 | Urine samples were not planned to be collected for the analysis of urine protein to creatinine ratio. The results for this outcome measure will never be posted. |
Countries
United States
Participant flow
Recruitment details
Total 115 participants were enrolled in study and received study treatment. The 24 study staff population(HIV care providers,nurses/staff performing CAB+LA injections administrators/clinic managers)is not considered participants in the study and were not counted in the enrollment number nor reported in any modules that are considered for enrolled participants as study staff didn't have to complete the informed consent process and did not receive oral lead-in medication or CAB+RPV LA injections.
Pre-assignment details
Study staff participants only provided input through the completion of surveys, semi-structured interviews and facilitation calls. Participant flow, Baseline characteristics or adverse events for study staff participants were not collected because it was not required per study design.
Participants by arm
| Arm | Count |
|---|---|
| Participants With HIV Infection In the Intervention Phase, participants with Human immunodeficiency virus (HIV) infection received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB long-acting (LA) + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until Month 12. Participants continued CAB LA + RPV LA IM injection from Month 13 in the Extension Phase until it is commercially available. Participants were followed up for an additional 52 weeks if they discontinue the study treatment (after receiving at least 1 dose of CAB LA and /or RPV LA) and have started an alternative antiretroviral therapy (ART). | 115 |
| Total | 115 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Extension Phase (From Months 13 to 30) | Adverse Event | 2 |
| Extension Phase (From Months 13 to 30) | Lost to Follow-up | 1 |
| Extension Phase (From Months 13 to 30) | Protocol Violation | 1 |
| Extension Phase (From Months 13 to 30) | Withdrawal by Subject | 2 |
| Intervention Phase (Up to Month 12) | Adverse Event | 5 |
| Intervention Phase (Up to Month 12) | Physician Decision | 1 |
| Intervention Phase (Up to Month 12) | Protocol Violation | 3 |
| Intervention Phase (Up to Month 12) | Withdrawal by Subject | 4 |
| Long-term Follow-up Phase(Up to Week 52) | Lost to Follow-up | 1 |
| Long-term Follow-up Phase(Up to Week 52) | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Participants With HIV Infection |
|---|---|
| Age, Continuous | 38.8 Years STANDARD_DEVIATION 11.71 |
| Race/Ethnicity, Customized American Indian or Alaskan native | 5 Participants |
| Race/Ethnicity, Customized Black or African American | 42 Participants |
| Race/Ethnicity, Customized Black or African American and White | 2 Participants |
| Race/Ethnicity, Customized White-White/Caucasian/European heritage | 66 Participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 99 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 115 |
| other Total, other adverse events | 101 / 115 |
| serious Total, serious adverse events | 9 / 115 |
Outcome results
Primary
Change From Baseline for FIM Total Score in Staff Study Participants at Month 12
FIM is a four item survey that assessed the feasibility of an implementation process. The staff study participants were asked to indicate how much they agreed or disagreed with each of the 4 items in the FIM based on their current experiences with implementing the CAB + RPV injection treatment on a five point rating scale (1=completely disagree to 5=completely agree). The FIM total score ranges from 1 to 5 with 1 indicating the least feasibility and 5 the most feasibility. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Time frame: Baseline and Month 12
Population: All staff study participants population. Only those staff study participants who completed the survey were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Staff Study Participants | Change From Baseline for FIM Total Score in Staff Study Participants at Month 12 | 0.07 Scores on a scale | Standard Deviation 0.69 |
Primary
Change From Baseline in AIM Total Score in Participants With HIV Infection at Month 12
AIM is a four item survey that assessed the acceptability of an implementation process. The participants were asked about their impressions of the CAB LA + RPV LA injection treatment for treating HIV on a five point rating scale (1=completely disagree to 5=completely agree). The AIM total score ranges from 1 to 5 with 1 indicating the least acceptability and 5 the most acceptability. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Time frame: Baseline and Month 12
Population: Safety population. Only those participants who completed the survey were included in the analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Staff Study Participants | Change From Baseline in AIM Total Score in Participants With HIV Infection at Month 12 | 0.19 Scores on a scale | Standard Deviation 0.52 |
Primary
Change From Baseline in AIM Total Score in Participants With HIV Infection at Month 4
AIM is a four item survey that assessed the acceptability of an implementation process. The participants were asked about their impressions of the CAB LA + RPV LA injection treatment for treating HIV on a five point rating scale (1=completely disagree to 5=completely agree). The AIM total score ranges from 1 to 5 with 1 indicating the least acceptability and 5 the most acceptability. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Time frame: Baseline and Month 4
Population: Safety population consisted of all participants who were enrolled and received atleast one dose of CAB LA + RPV LA. Only those participants who completed the survey were included in the analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Staff Study Participants | Change From Baseline in AIM Total Score in Participants With HIV Infection at Month 4 | 0.03 Scores on a scale | Standard Deviation 0.74 |
Primary
Change From Baseline in AIM Total Score in Staff Study Participants at Month 12
AIM is a four item survey that assessed the acceptability of an implementation process. The staff study participants were asked to indicate how much they agreed or disagreed with each of the 4 items in the AIM based on their current experiences with implementing the CAB + RPV injection treatment on a five point rating scale (1=completely disagree to 5=completely agree). The AIM total score ranges from 1 to 5 with 1 indicating the least acceptability and 5 the most acceptability. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Time frame: Baseline and Month 12
Population: All staff study participants population. Only those staff study participants who completed the survey were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Staff Study Participants | Change From Baseline in AIM Total Score in Staff Study Participants at Month 12 | 0.02 Scores on a scale | Standard Deviation 0.52 |
Primary
Change From Baseline in Feasibility of Intervention Measure (FIM) Total Score in Staff Study Participants at Month 4
FIM is a four item survey that assessed the feasibility of an implementation process. The staff study participants were asked to indicate how much they agreed or disagreed with each of the 4 items in the FIM based on their current experiences with implementing the CAB + RPV injection treatment on a five point rating scale (1=completely disagree to 5=completely agree). The FIM total score ranges from 1 to 5 with 1 indicating the least feasibility and 5 the most feasibility. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Time frame: Baseline and Month 4
Population: All staff study participants Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Staff Study Participants | Change From Baseline in Feasibility of Intervention Measure (FIM) Total Score in Staff Study Participants at Month 4 | -0.02 Scores on a scale | Standard Deviation 0.63 |
Primary
Change From Baseline in IAM Score in Participants With HIV Infection at Month 12
IAM is a four item survey that assessed the appropriateness of an implementation process. The participants were asked to indicate how much they agreed or disagreed with each of the 4 items in the IAM based on their current experiences with implementing the CAB + RPV injection treatment on a five point rating scale (1=completely disagree to 5=completely agree). The IAM total score ranges from 1 to 5 with 1 indicating the least appropriateness and 5 the most appropriateness. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Time frame: Baseline and Month 12
Population: Safety population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Staff Study Participants | Change From Baseline in IAM Score in Participants With HIV Infection at Month 12 | 0.19 Scores on a scale | Standard Deviation 0.58 |
Primary
Change From Baseline in IAM Score in Participants With HIV Infection at Month 4
IAM is a four item survey that assessed the appropriateness of an implementation process. The participants were asked to indicate how much they agreed or disagreed with each of the 4 items in the IAM based on their current experiences with implementing the CAB + RPV injection treatment on a five point rating scale (1=completely disagree to 5=completely agree). The IAM total score ranges from 1 to 5 with 1 indicating the least appropriateness and 5 the most appropriateness. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Time frame: Baseline and Month 4
Population: Safety population. Only those participants who completed the survey were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Staff Study Participants | Change From Baseline in IAM Score in Participants With HIV Infection at Month 4 | 0.05 Scores on a scale | Standard Deviation 0.78 |
Primary
Change From Baseline in IAM Score in Staff Study Participants at Month 12
IAM is a four item survey that assessed the appropriateness of an implementation process. The staff study participants were asked to indicate how much they agreed or disagreed with each of the 4 items in the IAM based on their current experiences with implementing the CAB + RPV injection treatment on a five point rating scale (1=completely disagree to 5=completely agree). The IAM total score ranges from 1 to 5 with 1 indicating the least appropriateness and 5 the most appropriateness. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Time frame: Baseline and Month 12
Population: All Staff study participant population. Only those staff study participants who completed the survey were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Staff Study Participants | Change From Baseline in IAM Score in Staff Study Participants at Month 12 | 0.10 Scores on a scale | Standard Deviation 0.43 |
Primary
Change From Baseline in Intervention Appropriateness Measure (IAM) Score in Staff Study Participants at Month 4
IAM is a four item survey that assessed the appropriateness of an implementation process. The staff study participants were asked to indicate how much they agreed or disagreed with each of the 4 items in the IAM based on their current experiences with implementing the CAB + RPV injection treatment on a five point rating scale (1=completely disagree to 5=completely agree). The IAM total score ranges from 1 to 5 with 1 indicating the least appropriateness and 5 the most appropriateness. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Time frame: Baseline and Month 4
Population: All Staff study participants population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Staff Study Participants | Change From Baseline in Intervention Appropriateness Measure (IAM) Score in Staff Study Participants at Month 4 | -0.03 Scores on a scale | Standard Deviation 0.5 |
Primary
Change From Baseline in the Acceptability of Intervention Measure (AIM) Total Score in Staff Study Participants at Month 4
AIM is a four item survey that assessed the acceptability of an implementation process. The staff study participants were asked to indicate how much they agreed or disagreed with each of the 4 items in the AIM based on their current experiences with implementing the CAB + RPV injection treatment on a five point rating scale (1=completely disagree to 5=completely agree). The AIM total score ranges from 1 to 5 with 1 indicating the least acceptability and 5 the most acceptability. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Time frame: Baseline and Month 4
Population: All Staff study participants Population comprised of HIV care providers (HCPs), nurses/staff performing CAB+RPV LA injections and administrators/clinic managers at each investigational site.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Staff Study Participants | Change From Baseline in the Acceptability of Intervention Measure (AIM) Total Score in Staff Study Participants at Month 4 | 0.00 Scores on a scale | Standard Deviation 0.42 |
Secondary
Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Blood samples were collected to analyze the chemistry parameters: Sodium, potassium, carbon dioxide, chloride, glucose, urea and phosphate.
Time frame: Months 15, 18, 21, 24, 27, 30
Population: Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Staff Study Participants | Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Sodium, Month 15, n=99 | 139.3 Millimoles per liter | Standard Deviation 1.81 |
| Staff Study Participants | Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Sodium, Month 18, n=97 | 139.3 Millimoles per liter | Standard Deviation 1.92 |
| Staff Study Participants | Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Sodium, Month 21, n=75 | 139.0 Millimoles per liter | Standard Deviation 1.89 |
| Staff Study Participants | Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Sodium, Month 24, n=35 | 138.7 Millimoles per liter | Standard Deviation 1.87 |
| Staff Study Participants | Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Sodium, Month 27, n=8 | 138.1 Millimoles per liter | Standard Deviation 1.36 |
| Staff Study Participants | Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Sodium, Month 30, n=1 | 137.0 Millimoles per liter | — |
| Staff Study Participants | Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Potassium, Month 15, n=99 | 4.15 Millimoles per liter | Standard Deviation 0.366 |
| Staff Study Participants | Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Potassium, Month 18, n=97 | 4.16 Millimoles per liter | Standard Deviation 0.34 |
| Staff Study Participants | Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Potassium, Month 21, n=75 | 4.08 Millimoles per liter | Standard Deviation 0.313 |
| Staff Study Participants | Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Potassium, Month 24, n=35 | 4.02 Millimoles per liter | Standard Deviation 0.308 |
| Staff Study Participants | Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Potassium, Month 27, n=8 | 3.94 Millimoles per liter | Standard Deviation 0.119 |
| Staff Study Participants | Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Potassium, Month 30,n=1 | 4.10 Millimoles per liter | — |
| Staff Study Participants | Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Carbon dioxide, Month 15, n=99 | 23.8 Millimoles per liter | Standard Deviation 2.18 |
| Staff Study Participants | Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Carbon dioxide, Month 18, n=97 | 24.1 Millimoles per liter | Standard Deviation 2.11 |
| Staff Study Participants | Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Carbon dioxide, Month 21, n=75 | 23.8 Millimoles per liter | Standard Deviation 2.24 |
| Staff Study Participants | Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Carbon dioxide, Month 24, n=35 | 23.8 Millimoles per liter | Standard Deviation 2.09 |
| Staff Study Participants | Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Carbon dioxide, Month 27, n=8 | 23.5 Millimoles per liter | Standard Deviation 2.27 |
| Staff Study Participants | Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Carbon dioxide, Month 30, n=1 | 24.0 Millimoles per liter | — |
| Staff Study Participants | Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Chloride, Month 15, n=99 | 103.1 Millimoles per liter | Standard Deviation 2.29 |
| Staff Study Participants | Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Chloride, Month 18, n=97 | 103.0 Millimoles per liter | Standard Deviation 2.37 |
| Staff Study Participants | Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Chloride, Month 21, n=75 | 102.6 Millimoles per liter | Standard Deviation 2.24 |
| Staff Study Participants | Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Chloride, Month 24, n=35 | 102.9 Millimoles per liter | Standard Deviation 2.18 |
| Staff Study Participants | Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Chloride, Month 27, n=8 | 103.0 Millimoles per liter | Standard Deviation 1.85 |
| Staff Study Participants | Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Chloride, Month 30, n=1 | 101.0 Millimoles per liter | — |
| Staff Study Participants | Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Glucose, Month 15, n=99 | 5.72 Millimoles per liter | Standard Deviation 2.344 |
| Staff Study Participants | Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Glucose, Month 18, n=97 | 5.89 Millimoles per liter | Standard Deviation 3.089 |
| Staff Study Participants | Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Glucose, Month 21, n=75 | 5.86 Millimoles per liter | Standard Deviation 2.382 |
| Staff Study Participants | Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Glucose, Month 24, n=35 | 6.14 Millimoles per liter | Standard Deviation 3.294 |
| Staff Study Participants | Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Glucose, Month 27, n=8 | 5.33 Millimoles per liter | Standard Deviation 0.654 |
| Staff Study Participants | Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Glucose, Month 30, n=1 | 4.40 Millimoles per liter | — |
| Staff Study Participants | Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Urea; Month 15, n=99 | 4.81 Millimoles per liter | Standard Deviation 1.362 |
| Staff Study Participants | Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Urea; Month 18, n=97 | 4.96 Millimoles per liter | Standard Deviation 1.413 |
| Staff Study Participants | Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Urea; Month 21, n=75 | 4.94 Millimoles per liter | Standard Deviation 1.529 |
| Staff Study Participants | Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Urea; Month 24, n=35 | 4.79 Millimoles per liter | Standard Deviation 1.313 |
| Staff Study Participants | Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Urea; Month 27 , n=8 | 5.69 Millimoles per liter | Standard Deviation 1.668 |
| Staff Study Participants | Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Urea; Month 30, n=1 | 5.00 Millimoles per liter | — |
| Staff Study Participants | Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Phosphate; Month 15, n=99 | 1.091 Millimoles per liter | Standard Deviation 0.1919 |
| Staff Study Participants | Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Phosphate; Month 18, n=97 | 1.079 Millimoles per liter | Standard Deviation 0.1844 |
| Staff Study Participants | Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Phosphate; Month 21, n=75 | 1.083 Millimoles per liter | Standard Deviation 0.1848 |
| Staff Study Participants | Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Phosphate; Month 24, n=35 | 1.091 Millimoles per liter | Standard Deviation 0.1574 |
| Staff Study Participants | Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Phosphate; Month 27, n=8 | 1.119 Millimoles per liter | Standard Deviation 0.1252 |
| Staff Study Participants | Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Phosphate; Month 30, n=1 | 1.300 Millimoles per liter | — |
Secondary
Absolute Values of Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate
Blood samples were collected to analyze the chemistry parameters: Sodium, potassium, carbon dioxide, chloride, glucose, urea and phosphate.
Time frame: Up to Month 12
Population: Safety population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Staff Study Participants | Absolute Values of Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate | Sodium | 139.7 Millimoles per liter | Standard Deviation 1.67 |
| Staff Study Participants | Absolute Values of Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate | Potassium | 4.15 Millimoles per liter | Standard Deviation 0.309 |
| Staff Study Participants | Absolute Values of Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate | Carbon dioxide | 23.1 Millimoles per liter | Standard Deviation 2.02 |
| Staff Study Participants | Absolute Values of Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate | Chloride | 103.8 Millimoles per liter | Standard Deviation 2.18 |
| Staff Study Participants | Absolute Values of Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate | Glucose | 5.26 Millimoles per liter | Standard Deviation 1.425 |
| Staff Study Participants | Absolute Values of Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate | Urea | 5.08 Millimoles per liter | Standard Deviation 1.588 |
| Staff Study Participants | Absolute Values of Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate | Phosphate | 1.087 Millimoles per liter | Standard Deviation 0.1687 |
Secondary
Absolute Values of Clinical Laboratory Parameter: Albumin
Blood samples were collected for the analysis of clinical chemistry parameter: Albumin.
Time frame: Up to Month 12
Population: Safety Population. Only those participants with data available at the indicated time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Staff Study Participants | Absolute Values of Clinical Laboratory Parameter: Albumin | 44.7 Grams per liter | Standard Deviation 2.74 |
Secondary
Absolute Values of Clinical Laboratory Parameter-Albumin From Month 15 to Month 30
Blood samples were collected for the analysis of clinical chemistry parameter-Albumin.
Time frame: Months 15, 18, 21, 24, 27, 30
Population: Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Staff Study Participants | Absolute Values of Clinical Laboratory Parameter-Albumin From Month 15 to Month 30 | Month 15, n=99 | 44.5 Grams per liter | Standard Deviation 3.02 |
| Staff Study Participants | Absolute Values of Clinical Laboratory Parameter-Albumin From Month 15 to Month 30 | Month 18, n=97 | 44.3 Grams per liter | Standard Deviation 2.71 |
| Staff Study Participants | Absolute Values of Clinical Laboratory Parameter-Albumin From Month 15 to Month 30 | Month 21, n=75 | 44.1 Grams per liter | Standard Deviation 2.49 |
| Staff Study Participants | Absolute Values of Clinical Laboratory Parameter-Albumin From Month 15 to Month 30 | Month 24, n=35 | 43.7 Grams per liter | Standard Deviation 3.05 |
| Staff Study Participants | Absolute Values of Clinical Laboratory Parameter-Albumin From Month 15 to Month 30 | Month 27, n=8 | 43.8 Grams per liter | Standard Deviation 2.82 |
| Staff Study Participants | Absolute Values of Clinical Laboratory Parameter-Albumin From Month 15 to Month 30 | Month 30, n=1 | 39.0 Grams per liter | — |
Secondary
Absolute Values of Clinical Laboratory Parameter: Glomerular Filtration Rate (GFR) From Creatinine Adjusted for Body Surface Area (BSA)
Blood samples were collected from participants to analyze the clinical chemistry parameter: GFR from Creatinine adjusted for BSA
Time frame: Up to Month 12
Population: Safety Population. Only those participants with data available at the indicated time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Staff Study Participants | Absolute Values of Clinical Laboratory Parameter: Glomerular Filtration Rate (GFR) From Creatinine Adjusted for Body Surface Area (BSA) | 1.60853 Milliliters/seconds/1.73 meter square | Standard Deviation 0.305979 |
Secondary
Absolute Values of Clinical Laboratory Parameter-glomerular Filtration Rate (GFR) From Creatinine Adjusted for Body Surface Area (BSA) From Month 15 to Month 30
Blood samples were collected from participants to analyze the clinical chemistry parameter: GFR from Creatinine adjusted for BSA.
Time frame: Months 15, 18, 21, 24, 27, 30
Population: Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Staff Study Participants | Absolute Values of Clinical Laboratory Parameter-glomerular Filtration Rate (GFR) From Creatinine Adjusted for Body Surface Area (BSA) From Month 15 to Month 30 | Month 15, n=99 | 1.62074 Milliliters/seconds/1.73 meter square | Standard Deviation 0.285224 |
| Staff Study Participants | Absolute Values of Clinical Laboratory Parameter-glomerular Filtration Rate (GFR) From Creatinine Adjusted for Body Surface Area (BSA) From Month 15 to Month 30 | Month 18, n=93 | 1.51293 Milliliters/seconds/1.73 meter square | Standard Deviation 0.27555 |
| Staff Study Participants | Absolute Values of Clinical Laboratory Parameter-glomerular Filtration Rate (GFR) From Creatinine Adjusted for Body Surface Area (BSA) From Month 15 to Month 30 | Month 21, n=75 | 1.58759 Milliliters/seconds/1.73 meter square | Standard Deviation 0.293326 |
| Staff Study Participants | Absolute Values of Clinical Laboratory Parameter-glomerular Filtration Rate (GFR) From Creatinine Adjusted for Body Surface Area (BSA) From Month 15 to Month 30 | Month 24, n=35 | 1.61813 Milliliters/seconds/1.73 meter square | Standard Deviation 0.292292 |
| Staff Study Participants | Absolute Values of Clinical Laboratory Parameter-glomerular Filtration Rate (GFR) From Creatinine Adjusted for Body Surface Area (BSA) From Month 15 to Month 30 | Month 27, n=7 | 1.68813 Milliliters/seconds/1.73 meter square | Standard Deviation 0.18751 |
| Staff Study Participants | Absolute Values of Clinical Laboratory Parameter-glomerular Filtration Rate (GFR) From Creatinine Adjusted for Body Surface Area (BSA) From Month 15 to Month 30 | Month 30, n=1 | 1.81670 Milliliters/seconds/1.73 meter square | — |
Secondary
Absolute Values of Clinical Laboratory Parameter: Lipase
Blood samples were collected for the analysis of clinical chemistry parameter: Lipase.
Time frame: Up to Month 12
Population: Safety Population. Only those participants with data available at the indicated time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Staff Study Participants | Absolute Values of Clinical Laboratory Parameter: Lipase | 31.6 Units per liter | Standard Deviation 25.92 |
Secondary
Absolute Values of Clinical Laboratory Parameter-Lipase From Month 15 to Month 30
Blood samples were collected for the analysis of clinical chemistry parameter-Lipase.
Time frame: Months 15, 18, 21, 24, 27, 30
Population: Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Staff Study Participants | Absolute Values of Clinical Laboratory Parameter-Lipase From Month 15 to Month 30 | Month 15, n=99 | 36.0 Units per liter | Standard Deviation 33.52 |
| Staff Study Participants | Absolute Values of Clinical Laboratory Parameter-Lipase From Month 15 to Month 30 | Month 18, n=93 | 35.0 Units per liter | Standard Deviation 30.44 |
| Staff Study Participants | Absolute Values of Clinical Laboratory Parameter-Lipase From Month 15 to Month 30 | Month 21, n=75 | 34.5 Units per liter | Standard Deviation 33.39 |
| Staff Study Participants | Absolute Values of Clinical Laboratory Parameter-Lipase From Month 15 to Month 30 | Month 24, n=35 | 34.6 Units per liter | Standard Deviation 26.3 |
| Staff Study Participants | Absolute Values of Clinical Laboratory Parameter-Lipase From Month 15 to Month 30 | Month 27, n=8 | 38.6 Units per liter | Standard Deviation 30.26 |
| Staff Study Participants | Absolute Values of Clinical Laboratory Parameter-Lipase From Month 15 to Month 30 | Month 30, n=1 | 35.0 Units per liter | — |
Secondary
Absolute Values of Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase
Blood samples were collected to analyze the chemistry parameters: ALT, AST, ALP and creatine kinase.
Time frame: Up to Month 12
Population: Safety Population. Only those participants with data available at the indicated time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Staff Study Participants | Absolute Values of Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase | ALT | 24.6 International units per liter | Standard Deviation 17.52 |
| Staff Study Participants | Absolute Values of Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase | AST | 21.7 International units per liter | Standard Deviation 14.31 |
| Staff Study Participants | Absolute Values of Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase | ALP | 69.0 International units per liter | Standard Deviation 19.42 |
| Staff Study Participants | Absolute Values of Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase | Creatine kinase | 181.4 International units per liter | Standard Deviation 153.58 |
Secondary
Absolute Values of Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30
Blood samples were collected to analyze the chemistry parameters: ALT, AST, ALP and creatine kinase.
Time frame: Months 15, 18, 21, 24, 27, 30
Population: Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Staff Study Participants | Absolute Values of Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30 | ALT, Month 15, n=99 | 27.9 International units per liter | Standard Deviation 23.06 |
| Staff Study Participants | Absolute Values of Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30 | ALT, Month 18, n=97 | 26.4 International units per liter | Standard Deviation 16.91 |
| Staff Study Participants | Absolute Values of Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30 | ALT, Month 21, n=75 | 26.2 International units per liter | Standard Deviation 23.02 |
| Staff Study Participants | Absolute Values of Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30 | ALT, Month 24, n=35 | 24.1 International units per liter | Standard Deviation 12.23 |
| Staff Study Participants | Absolute Values of Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30 | ALT, Month 27, n=8 | 24.1 International units per liter | Standard Deviation 8.03 |
| Staff Study Participants | Absolute Values of Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30 | ALT, Month 30 n=1 | 17.0 International units per liter | — |
| Staff Study Participants | Absolute Values of Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30 | ALP, Month 15, n=99 | 66.3 International units per liter | Standard Deviation 19.77 |
| Staff Study Participants | Absolute Values of Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30 | ALP, Month 18, n=97 | 67.5 International units per liter | Standard Deviation 22.26 |
| Staff Study Participants | Absolute Values of Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30 | ALP, Month 21, n=75 | 68.3 International units per liter | Standard Deviation 21.1 |
| Staff Study Participants | Absolute Values of Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30 | ALP, Month 24, n=35 | 65.9 International units per liter | Standard Deviation 18.86 |
| Staff Study Participants | Absolute Values of Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30 | ALP, Month 27, n=8 | 76.9 International units per liter | Standard Deviation 15.25 |
| Staff Study Participants | Absolute Values of Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30 | ALP, Month 30, n=1 | 70.0 International units per liter | — |
| Staff Study Participants | Absolute Values of Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30 | AST, Month 15, n=99 | 22.4 International units per liter | Standard Deviation 10.72 |
| Staff Study Participants | Absolute Values of Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30 | AST, Month 18, n=97 | 25.2 International units per liter | Standard Deviation 27.55 |
| Staff Study Participants | Absolute Values of Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30 | AST, Month 21, n=75 | 21.7 International units per liter | Standard Deviation 8.73 |
| Staff Study Participants | Absolute Values of Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30 | AST, Month 24, n=35 | 19.8 International units per liter | Standard Deviation 5.57 |
| Staff Study Participants | Absolute Values of Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30 | AST, Month 27, n=8 | 20.5 International units per liter | Standard Deviation 5.32 |
| Staff Study Participants | Absolute Values of Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30 | AST, Month 30, n=1 | 14.0 International units per liter | — |
| Staff Study Participants | Absolute Values of Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30 | Creatine Kinase, Month 15, n=99 | 178.6 International units per liter | Standard Deviation 198.96 |
| Staff Study Participants | Absolute Values of Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30 | Creatine Kinase, Month 18, n=97 | 338.4 International units per liter | Standard Deviation 1050.63 |
| Staff Study Participants | Absolute Values of Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30 | Creatine Kinase, Month 21, n=75 | 226.9 International units per liter | Standard Deviation 374.26 |
| Staff Study Participants | Absolute Values of Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30 | Creatine Kinase, Month 24, n=35 | 151.9 International units per liter | Standard Deviation 70.67 |
| Staff Study Participants | Absolute Values of Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30 | Creatine Kinase, Month 27, n=8 | 251.9 International units per liter | Standard Deviation 139.79 |
| Staff Study Participants | Absolute Values of Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30 | Creatine Kinase, Month 30, n=1 | 165.0 International units per liter | — |
Secondary
Absolute Values of Clinical Laboratory Parameters: Creatinine and Bilirubin
Blood samples were collected to analyze the chemistry parameters: Creatinine and Bilirubin.
Time frame: Up to Month 12
Population: Safety Population. Only those participants with data available at the indicated time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Staff Study Participants | Absolute Values of Clinical Laboratory Parameters: Creatinine and Bilirubin | Creatinine | 89.10 Micromoles per liter | Standard Deviation 15.229 |
| Staff Study Participants | Absolute Values of Clinical Laboratory Parameters: Creatinine and Bilirubin | Bilirubin | 10.0 Micromoles per liter | Standard Deviation 5.1 |
Secondary
Absolute Values of Clinical Laboratory Parameters: Creatinine and Bilirubin From Month 15 to Month 30
Blood samples were collected to analyze the chemistry parameters: Creatinine and Bilirubin.
Time frame: Months 15, 18, 21, 24, 27, 30
Population: Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Staff Study Participants | Absolute Values of Clinical Laboratory Parameters: Creatinine and Bilirubin From Month 15 to Month 30 | Creatinine, Month 15, n=99 | 88.50 Micromoles per liter | Standard Deviation 13.908 |
| Staff Study Participants | Absolute Values of Clinical Laboratory Parameters: Creatinine and Bilirubin From Month 15 to Month 30 | Creatinine, Month 18, n=97 | 94.26 Micromoles per liter | Standard Deviation 12.797 |
| Staff Study Participants | Absolute Values of Clinical Laboratory Parameters: Creatinine and Bilirubin From Month 15 to Month 30 | Creatinine, Month 21, n=75 | 88.09 Micromoles per liter | Standard Deviation 14.41 |
| Staff Study Participants | Absolute Values of Clinical Laboratory Parameters: Creatinine and Bilirubin From Month 15 to Month 30 | Creatinine, Month 24, n=35 | 87.77 Micromoles per liter | Standard Deviation 14.39 |
| Staff Study Participants | Absolute Values of Clinical Laboratory Parameters: Creatinine and Bilirubin From Month 15 to Month 30 | Creatinine, Month 27, n=8 | 88.85 Micromoles per liter | Standard Deviation 12.854 |
| Staff Study Participants | Absolute Values of Clinical Laboratory Parameters: Creatinine and Bilirubin From Month 15 to Month 30 | Creatinine, Month 30, n=1 | 91.90 Micromoles per liter | — |
| Staff Study Participants | Absolute Values of Clinical Laboratory Parameters: Creatinine and Bilirubin From Month 15 to Month 30 | Bilirubin, Month 15, n=99 | 9.9 Micromoles per liter | Standard Deviation 4.67 |
| Staff Study Participants | Absolute Values of Clinical Laboratory Parameters: Creatinine and Bilirubin From Month 15 to Month 30 | Bilirubin, Month 18, n=97 | 9.5 Micromoles per liter | Standard Deviation 4.69 |
| Staff Study Participants | Absolute Values of Clinical Laboratory Parameters: Creatinine and Bilirubin From Month 15 to Month 30 | Bilirubin, Month 21 n=75 | 10.7 Micromoles per liter | Standard Deviation 5.49 |
| Staff Study Participants | Absolute Values of Clinical Laboratory Parameters: Creatinine and Bilirubin From Month 15 to Month 30 | Bilirubin, Month 24, n=35 | 10.9 Micromoles per liter | Standard Deviation 6.69 |
| Staff Study Participants | Absolute Values of Clinical Laboratory Parameters: Creatinine and Bilirubin From Month 15 to Month 30 | Bilirubin, Month 27 n=8 | 8.5 Micromoles per liter | Standard Deviation 4.38 |
| Staff Study Participants | Absolute Values of Clinical Laboratory Parameters: Creatinine and Bilirubin From Month 15 to Month 30 | Bilirubin, Month 30, n=1 | 4.0 Micromoles per liter | — |
Secondary
Absolute Values of Hematology Parameter: Erythrocytes MCV
Blood samples were collected to analyze the hematology parameter: Erythrocytes MCV.
Time frame: Up to Month 12
Population: Safety population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Staff Study Participants | Absolute Values of Hematology Parameter: Erythrocytes MCV | 92.37 Femtoliter | Standard Deviation 5.546 |
Secondary
Absolute Values of Hematology Parameter-Erythrocytes MCV From Month 15 to Month 30
Blood samples were collected to analyze the hematology parameter: Erythrocytes MCV.
Time frame: Months 15, 18, 21, 24, 27, 30
Population: Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Staff Study Participants | Absolute Values of Hematology Parameter-Erythrocytes MCV From Month 15 to Month 30 | Month 15, n=99 | 90.16 Femtoliter | Standard Deviation 5.138 |
| Staff Study Participants | Absolute Values of Hematology Parameter-Erythrocytes MCV From Month 15 to Month 30 | Month 18, n=97 | 89.64 Femtoliter | Standard Deviation 5.048 |
| Staff Study Participants | Absolute Values of Hematology Parameter-Erythrocytes MCV From Month 15 to Month 30 | Month 21, n=75 | 90.39 Femtoliter | Standard Deviation 5.533 |
| Staff Study Participants | Absolute Values of Hematology Parameter-Erythrocytes MCV From Month 15 to Month 30 | Month 24, n=35 | 89.74 Femtoliter | Standard Deviation 5.468 |
| Staff Study Participants | Absolute Values of Hematology Parameter-Erythrocytes MCV From Month 15 to Month 30 | Month 27, n=8 | 85.75 Femtoliter | Standard Deviation 4.652 |
| Staff Study Participants | Absolute Values of Hematology Parameter-Erythrocytes MCV From Month 15 to Month 30 | Month 30, n=1 | 78.00 Femtoliter | — |
Secondary
Absolute Values of Hematology Parameter: Hematocrit
Blood samples were collected to analyze the hematology parameter: Hematocrit (fraction of 1)
Time frame: Up to Month 12
Population: Safety population. Only those participants with data available at the specified data points were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Staff Study Participants | Absolute Values of Hematology Parameter: Hematocrit | 0.4445 Percentage of red blood cells in blood | Standard Deviation 0.03412 |
Secondary
Absolute Values of Hematology Parameter-Hematocrit From Month 15 to Month 30
Blood samples were collected to analyze the hematology parameter: Hematocrit (fraction of 1).
Time frame: Months 15, 18, 21, 24, 27, 30
Population: Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Staff Study Participants | Absolute Values of Hematology Parameter-Hematocrit From Month 15 to Month 30 | Month 15, n=99 | 0.4341 Percentage of red blood cells in blood | Standard Deviation 0.03251 |
| Staff Study Participants | Absolute Values of Hematology Parameter-Hematocrit From Month 15 to Month 30 | Month 18, n=97 | 0.4335 Percentage of red blood cells in blood | Standard Deviation 0.04229 |
| Staff Study Participants | Absolute Values of Hematology Parameter-Hematocrit From Month 15 to Month 30 | Month 21, n=75 | 0.4349 Percentage of red blood cells in blood | Standard Deviation 0.03472 |
| Staff Study Participants | Absolute Values of Hematology Parameter-Hematocrit From Month 15 to Month 30 | Month 24, n=35 | 0.4377 Percentage of red blood cells in blood | Standard Deviation 0.03484 |
| Staff Study Participants | Absolute Values of Hematology Parameter-Hematocrit From Month 15 to Month 30 | Month 27, n=8 | 0.4183 Percentage of red blood cells in blood | Standard Deviation 0.05263 |
| Staff Study Participants | Absolute Values of Hematology Parameter-Hematocrit From Month 15 to Month 30 | Month 30, n=1 | 0.3960 Percentage of red blood cells in blood | — |
Secondary
Absolute Values of Hematology Parameter: Hemoglobin
Blood samples were collected to analyze the hematology parameter: Hemoglobin
Time frame: Up to Month 12
Population: Safety population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Staff Study Participants | Absolute Values of Hematology Parameter: Hemoglobin | 145.19 Grams per liter | Standard Deviation 11.121 |
Secondary
Absolute Values of Hematology Parameter-Hemoglobin From Month 15 to Month 30
Blood samples were collected to analyze the hematology parameter: Hemoglobin.
Time frame: Months 15, 18, 21, 24, 27, 30
Population: Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Staff Study Participants | Absolute Values of Hematology Parameter-Hemoglobin From Month 15 to Month 30 | Month 15, n=99 | 145.84 Grams per liter | Standard Deviation 10.827 |
| Staff Study Participants | Absolute Values of Hematology Parameter-Hemoglobin From Month 15 to Month 30 | Month 18, n=97 | 146.08 Grams per liter | Standard Deviation 14.021 |
| Staff Study Participants | Absolute Values of Hematology Parameter-Hemoglobin From Month 15 to Month 30 | Month 21, n=75 | 144.52 Grams per liter | Standard Deviation 11.781 |
| Staff Study Participants | Absolute Values of Hematology Parameter-Hemoglobin From Month 15 to Month 30 | Month 24, n=35 | 144.46 Grams per liter | Standard Deviation 11.559 |
| Staff Study Participants | Absolute Values of Hematology Parameter-Hemoglobin From Month 15 to Month 30 | Month 27, n=8 | 138.25 Grams per liter | Standard Deviation 18.344 |
| Staff Study Participants | Absolute Values of Hematology Parameter-Hemoglobin From Month 15 to Month 30 | Month 30, n=1 | 130.00 Grams per liter | — |
Secondary
Absolute Values of Hematology Parameter: RBC Count
Blood samples were collected to analyze the hematology parameter: RBC count.
Time frame: Up to Month 12
Population: Safety population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Staff Study Participants | Absolute Values of Hematology Parameter: RBC Count | 4.84 10^12 cells per liter | Standard Deviation 0.504 |
Secondary
Absolute Values of Hematology Parameter-RBC Count From Month 15 to Month 30
Blood samples were collected to analyze the hematology parameter: RBC count.
Time frame: Months 15, 18, 21, 24, 27, 30
Population: Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Staff Study Participants | Absolute Values of Hematology Parameter-RBC Count From Month 15 to Month 30 | Month 15, n=99 | 4.85 10^12 cells per liter | Standard Deviation 0.482 |
| Staff Study Participants | Absolute Values of Hematology Parameter-RBC Count From Month 15 to Month 30 | Month 18, n=97 | 4.85 10^12 cells per liter | Standard Deviation 0.534 |
| Staff Study Participants | Absolute Values of Hematology Parameter-RBC Count From Month 15 to Month 30 | Month 21, n=75 | 4.84 10^12 cells per liter | Standard Deviation 0.474 |
| Staff Study Participants | Absolute Values of Hematology Parameter-RBC Count From Month 15 to Month 30 | Month 24, n=35 | 4.90 10^12 cells per liter | Standard Deviation 0.513 |
| Staff Study Participants | Absolute Values of Hematology Parameter-RBC Count From Month 15 to Month 30 | Month 27, n=8 | 4.88 10^12 cells per liter | Standard Deviation 0.557 |
| Staff Study Participants | Absolute Values of Hematology Parameter-RBC Count From Month 15 to Month 30 | Month 30, n=1 | 5.10 10^12 cells per liter | — |
Secondary
Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30
Blood samples were collected for the analysis of hematology parameters including platelet count, WBC count, basophil count, eosinophil count, lymphocyte count, monocyte count and neutrophil count.
Time frame: Months 15, 18, 21, 24, 27, 30
Population: Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Staff Study Participants | Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30 | Platelet count, Month 15, n=99 | 245.56 10^9 cells per Liter | Standard Deviation 62.285 |
| Staff Study Participants | Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30 | Platelet count, Month 18, n=97 | 250.99 10^9 cells per Liter | Standard Deviation 68.61 |
| Staff Study Participants | Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30 | Platelet count, Month 21, n=75 | 247.04 10^9 cells per Liter | Standard Deviation 50.792 |
| Staff Study Participants | Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30 | Platelet count, Month 24, n=35 | 245.43 10^9 cells per Liter | Standard Deviation 54.199 |
| Staff Study Participants | Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30 | Platelet count, Month 27, n=8 | 271.63 10^9 cells per Liter | Standard Deviation 81.512 |
| Staff Study Participants | Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30 | Platelet count, Month 30, n=1 | 417.00 10^9 cells per Liter | — |
| Staff Study Participants | Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30 | WBC count, Month 15, n=99 | 6.21 10^9 cells per Liter | Standard Deviation 1.983 |
| Staff Study Participants | Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30 | WBC count, Month 18, n=97 | 5.79 10^9 cells per Liter | Standard Deviation 1.748 |
| Staff Study Participants | Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30 | WBC count, Month 21, n=75 | 5.92 10^9 cells per Liter | Standard Deviation 1.626 |
| Staff Study Participants | Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30 | WBC count, Month 24, n=35 | 5.75 10^9 cells per Liter | Standard Deviation 1.377 |
| Staff Study Participants | Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30 | WBC count, Month 27, n=8 | 6.55 10^9 cells per Liter | Standard Deviation 1.787 |
| Staff Study Participants | Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30 | WBC count, Month 30, n=1 | 12.30 10^9 cells per Liter | — |
| Staff Study Participants | Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30 | Basophil count, Month 15, n=99 | 0.045 10^9 cells per Liter | Standard Deviation 0.0255 |
| Staff Study Participants | Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30 | Basophil count, Month 18, n=97 | 0.044 10^9 cells per Liter | Standard Deviation 0.0344 |
| Staff Study Participants | Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30 | Basophil count, Month 21, n=75 | 0.037 10^9 cells per Liter | Standard Deviation 0.0222 |
| Staff Study Participants | Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30 | Basophil count, Month 24, n=35 | 0.033 10^9 cells per Liter | Standard Deviation 0.0214 |
| Staff Study Participants | Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30 | Basophil count, Month 27, n=8 | 0.039 10^9 cells per Liter | Standard Deviation 0.021 |
| Staff Study Participants | Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30 | Basophil count, Month 30, n=1 | 0.090 10^9 cells per Liter | — |
| Staff Study Participants | Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30 | Eosinophil count, Month 15, n=99 | 0.163 10^9 cells per Liter | Standard Deviation 0.1238 |
| Staff Study Participants | Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30 | Eosinophil count, Month 18, n=97 | 0.151 10^9 cells per Liter | Standard Deviation 0.1052 |
| Staff Study Participants | Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30 | Eosinophil count, Month 21, n=75 | 0.141 10^9 cells per Liter | Standard Deviation 0.1085 |
| Staff Study Participants | Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30 | Eosinophil count, Month 24, n=35 | 0.143 10^9 cells per Liter | Standard Deviation 0.1366 |
| Staff Study Participants | Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30 | Eosinophil count, Month 27, n=8 | 0.090 10^9 cells per Liter | Standard Deviation 0.0366 |
| Staff Study Participants | Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30 | Eosinophil count, Month 30, n=1 | 0.090 10^9 cells per Liter | — |
| Staff Study Participants | Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30 | Lymphocyte count, Month 15, n=99 | 2.1271 10^9 cells per Liter | Standard Deviation 0.61543 |
| Staff Study Participants | Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30 | Lymphocyte count, Month 18, n=97 | 2.0999 10^9 cells per Liter | Standard Deviation 0.74371 |
| Staff Study Participants | Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30 | Lymphocyte count, Month 21, n=75 | 2.0521 10^9 cells per Liter | Standard Deviation 0.58855 |
| Staff Study Participants | Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30 | Lymphocyte count, Month 24, n=35 | 1.9229 10^9 cells per Liter | Standard Deviation 0.53307 |
| Staff Study Participants | Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30 | Lymphocyte count, Month 27, n=8 | 2.1350 10^9 cells per Liter | Standard Deviation 0.6337 |
| Staff Study Participants | Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30 | Lymphocyte count, Month 30, n=1 | 1.9100 10^9 cells per Liter | — |
| Staff Study Participants | Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30 | Monocyte count, Month 15, n=99 | 0.451 10^9 cells per Liter | Standard Deviation 0.1617 |
| Staff Study Participants | Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30 | Monocyte count, Month 18, n=97 | 0.444 10^9 cells per Liter | Standard Deviation 0.2301 |
| Staff Study Participants | Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30 | Monocyte count, Month 21, n=75 | 0.423 10^9 cells per Liter | Standard Deviation 0.1379 |
| Staff Study Participants | Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30 | Monocyte count, Month 24, n=35 | 0.388 10^9 cells per Liter | Standard Deviation 0.0859 |
| Staff Study Participants | Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30 | Monocyte count, Month 27, n=8 | 0.396 10^9 cells per Liter | Standard Deviation 0.164 |
| Staff Study Participants | Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30 | Monocyte count, Month 30, n=1 | 0.540 10^9 cells per Liter | — |
| Staff Study Participants | Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30 | Neutrophil count, Month 15, n=99 | 3.423 10^9 cells per Liter | Standard Deviation 1.6355 |
| Staff Study Participants | Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30 | Neutrophil count, Month 18, n=97 | 3.056 10^9 cells per Liter | Standard Deviation 1.3502 |
| Staff Study Participants | Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30 | Neutrophil count, Month 21, n=75 | 3.275 10^9 cells per Liter | Standard Deviation 1.2803 |
| Staff Study Participants | Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30 | Neutrophil count, Month 24, n=35 | 3.273 10^9 cells per Liter | Standard Deviation 1.1311 |
| Staff Study Participants | Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30 | Neutrophil count, Month 27, n=8 | 3.906 10^9 cells per Liter | Standard Deviation 1.643 |
| Staff Study Participants | Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30 | Neutrophil count, Month 30, n=1 | 9.640 10^9 cells per Liter | — |
Secondary
Absolute Values of the Hematology Parameters: Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count
Blood samples were collected for the analysis of hematology parameters including platelet count, WBC count, basophil count, eosinophil count, lymphocyte count, monocyte count and neutrophil count.
Time frame: Up to Month 12
Population: Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Staff Study Participants | Absolute Values of the Hematology Parameters: Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count | Platelet count, n=100 | 238.78 10^9 cells per liter | Standard Deviation 56.321 |
| Staff Study Participants | Absolute Values of the Hematology Parameters: Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count | WBC count, n=101 | 5.81 10^9 cells per liter | Standard Deviation 1.606 |
| Staff Study Participants | Absolute Values of the Hematology Parameters: Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count | Basophil count, n=101 | 0.042 10^9 cells per liter | Standard Deviation 0.0239 |
| Staff Study Participants | Absolute Values of the Hematology Parameters: Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count | Eosinophil count, n=101 | 0.160 10^9 cells per liter | Standard Deviation 0.1305 |
| Staff Study Participants | Absolute Values of the Hematology Parameters: Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count | Lymphocyte count, n=101 | 1.9528 10^9 cells per liter | Standard Deviation 0.58037 |
| Staff Study Participants | Absolute Values of the Hematology Parameters: Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count | Monocyte count, n=101 | 0.388 10^9 cells per liter | Standard Deviation 0.1352 |
| Staff Study Participants | Absolute Values of the Hematology Parameters: Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count | Neutrophil count, n=101 | 3.269 10^9 cells per liter | Standard Deviation 1.3055 |
Secondary
Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate
Blood samples were collected to analyze the chemistry parameters: Sodium, potassium, carbon dioxide, chloride, glucose, urea and phosphate. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Time frame: Baseline and up to Month 12
Population: Safety population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Staff Study Participants | Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate | Sodium | 0.2 Millimoles per liter | Standard Deviation 2 |
| Staff Study Participants | Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate | Potassium | 0.02 Millimoles per liter | Standard Deviation 0.295 |
| Staff Study Participants | Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate | Carbon dioxide | -0.0 Millimoles per liter | Standard Deviation 2.2 |
| Staff Study Participants | Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate | Chloride | -0.8 Millimoles per liter | Standard Deviation 2.34 |
| Staff Study Participants | Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate | Glucose | -0.37 Millimoles per liter | Standard Deviation 1.636 |
| Staff Study Participants | Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate | Urea | 0.13 Millimoles per liter | Standard Deviation 1.324 |
| Staff Study Participants | Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate | Phosphate | -0.005 Millimoles per liter | Standard Deviation 0.1853 |
Secondary
Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Blood samples were collected to analyze the chemistry parameters: Sodium, potassium, carbon dioxide, chloride, glucose, urea and phosphate. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Time frame: Baseline and Months 15, 18, 21, 24, 27, 30
Population: Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Staff Study Participants | Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Sodium, Month 15, n=99 | -0.2 Millimoles per liter | Standard Deviation 1.93 |
| Staff Study Participants | Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Sodium, Month 18, n=97 | -0.2 Millimoles per liter | Standard Deviation 1.78 |
| Staff Study Participants | Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Sodium, Month 21, n=75 | -0.6 Millimoles per liter | Standard Deviation 1.97 |
| Staff Study Participants | Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Sodium, Month 24, n=35 | -0.9 Millimoles per liter | Standard Deviation 2.39 |
| Staff Study Participants | Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Sodium, Month 27, n=8 | -1.1 Millimoles per liter | Standard Deviation 2.03 |
| Staff Study Participants | Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Sodium, Month 30, n=1 | -2.0 Millimoles per liter | — |
| Staff Study Participants | Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Potassium, Month 15, n=99 | 0.02 Millimoles per liter | Standard Deviation 0.325 |
| Staff Study Participants | Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Potassium, Month 18, n=97 | 0.03 Millimoles per liter | Standard Deviation 0.315 |
| Staff Study Participants | Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Potassium, Month 21, n=75 | -0.05 Millimoles per liter | Standard Deviation 0.321 |
| Staff Study Participants | Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Potassium, Month 24, n=35 | -0.10 Millimoles per liter | Standard Deviation 0.335 |
| Staff Study Participants | Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Potassium, Month 27, n=8 | -0.13 Millimoles per liter | Standard Deviation 0.271 |
| Staff Study Participants | Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Potassium, Month 30,n=1 | 0.40 Millimoles per liter | — |
| Staff Study Participants | Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Carbon dioxide, Month 15, n=99 | 0.7 Millimoles per liter | Standard Deviation 2.1 |
| Staff Study Participants | Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Carbon dioxide, Month 18, n=97 | 1.0 Millimoles per liter | Standard Deviation 2.26 |
| Staff Study Participants | Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Carbon dioxide, Month 21, n=75 | 0.6 Millimoles per liter | Standard Deviation 1.86 |
| Staff Study Participants | Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Carbon dioxide, Month 24, n=35 | 0.3 Millimoles per liter | Standard Deviation 2.09 |
| Staff Study Participants | Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Carbon dioxide, Month 27, n=8 | 0.4 Millimoles per liter | Standard Deviation 2.72 |
| Staff Study Participants | Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Carbon dioxide, Month 30, n=1 | 2.0 Millimoles per liter | — |
| Staff Study Participants | Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Chloride, Month 15, n=99 | -1.5 Millimoles per liter | Standard Deviation 2.29 |
| Staff Study Participants | Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Chloride, Month 18, n=97 | -1.6 Millimoles per liter | Standard Deviation 2.31 |
| Staff Study Participants | Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Chloride, Month 21, n=75 | -2.2 Millimoles per liter | Standard Deviation 2.3 |
| Staff Study Participants | Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Chloride, Month 24, n=35 | -1.8 Millimoles per liter | Standard Deviation 2.21 |
| Staff Study Participants | Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Chloride, Month 27, n=8 | -1.3 Millimoles per liter | Standard Deviation 1.58 |
| Staff Study Participants | Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Chloride, Month 30, n=1 | -3.0 Millimoles per liter | — |
| Staff Study Participants | Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Glucose, Month 15, n=99 | 0.05 Millimoles per liter | Standard Deviation 1.907 |
| Staff Study Participants | Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Glucose, Month 18, n=97 | 0.22 Millimoles per liter | Standard Deviation 2.804 |
| Staff Study Participants | Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Glucose, Month 21, n=75 | 0.24 Millimoles per liter | Standard Deviation 2.033 |
| Staff Study Participants | Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Glucose, Month 24, n=35 | 0.42 Millimoles per liter | Standard Deviation 2.546 |
| Staff Study Participants | Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Glucose, Month 27, n=8 | -0.30 Millimoles per liter | Standard Deviation 1.278 |
| Staff Study Participants | Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Glucose, Month 30, n=1 | -0.30 Millimoles per liter | — |
| Staff Study Participants | Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Urea; Month 15, n=99 | -0.15 Millimoles per liter | Standard Deviation 1.157 |
| Staff Study Participants | Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Urea; Month 18, n=97 | 0.04 Millimoles per liter | Standard Deviation 1.364 |
| Staff Study Participants | Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Urea; Month 21, n=75 | -0.06 Millimoles per liter | Standard Deviation 1.271 |
| Staff Study Participants | Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Urea; Month 24, n=35 | 0.04 Millimoles per liter | Standard Deviation 1.114 |
| Staff Study Participants | Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Urea; Month 27 , n=8 | 0.63 Millimoles per liter | Standard Deviation 1.458 |
| Staff Study Participants | Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Urea; Month 30, n=1 | 1.00 Millimoles per liter | — |
| Staff Study Participants | Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Phosphate; Month 15, n=99 | 0.006 Millimoles per liter | Standard Deviation 0.2069 |
| Staff Study Participants | Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Phosphate; Month 18, n=97 | -0.007 Millimoles per liter | Standard Deviation 0.2015 |
| Staff Study Participants | Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Phosphate; Month 21, n=75 | 0.001 Millimoles per liter | Standard Deviation 0.194 |
| Staff Study Participants | Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Phosphate; Month 24, n=35 | -0.009 Millimoles per liter | Standard Deviation 0.2248 |
| Staff Study Participants | Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Phosphate; Month 27, n=8 | 0.031 Millimoles per liter | Standard Deviation 0.212 |
| Staff Study Participants | Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Phosphate; Month 30, n=1 | 0.350 Millimoles per liter | — |
Secondary
Change From Baseline in Clinical Laboratory Parameter: Albumin
Blood samples were collected for the analysis of clinical chemistry parameter: Albumin. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Time frame: Baseline and up to Month 12
Population: Safety Population. Only those participants with data available at the indicated time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Staff Study Participants | Change From Baseline in Clinical Laboratory Parameter: Albumin | 0.2 Grams per liter | Standard Deviation 2.54 |
Secondary
Change From Baseline in Clinical Laboratory Parameter-Albumin From Month 15 to Month 30
Blood samples were collected for the analysis of clinical chemistry parameter-Albumin. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Time frame: Baseline and Months 15, 18, 21, 24, 27, 30
Population: Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Staff Study Participants | Change From Baseline in Clinical Laboratory Parameter-Albumin From Month 15 to Month 30 | Month 15, n=99 | -0.0 Grams per liter | Standard Deviation 2.63 |
| Staff Study Participants | Change From Baseline in Clinical Laboratory Parameter-Albumin From Month 15 to Month 30 | Month 18, n=97 | -0.2 Grams per liter | Standard Deviation 2.75 |
| Staff Study Participants | Change From Baseline in Clinical Laboratory Parameter-Albumin From Month 15 to Month 30 | Month 21, n=75 | -0.3 Grams per liter | Standard Deviation 2.16 |
| Staff Study Participants | Change From Baseline in Clinical Laboratory Parameter-Albumin From Month 15 to Month 30 | Month 24, n=35 | -0.5 Grams per liter | Standard Deviation 2.09 |
| Staff Study Participants | Change From Baseline in Clinical Laboratory Parameter-Albumin From Month 15 to Month 30 | Month 27, n=8 | 0.0 Grams per liter | Standard Deviation 1.85 |
| Staff Study Participants | Change From Baseline in Clinical Laboratory Parameter-Albumin From Month 15 to Month 30 | Month 30, n=1 | 0.0 Grams per liter | — |
Secondary
Change From Baseline in Clinical Laboratory Parameter: Glomerular Filtration Rate (GFR) From Creatinine Adjusted for Body Surface Area (BSA)
Blood samples were collected from participants at indicated time points to analyze the clinical chemistry parameter: GFR from creatinine adjusted for BSA. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Time frame: Baseline and up to Month 12
Population: Safety Population. Only those participants with data available at the indicated time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Staff Study Participants | Change From Baseline in Clinical Laboratory Parameter: Glomerular Filtration Rate (GFR) From Creatinine Adjusted for Body Surface Area (BSA) | 0.00520 Milliliters/seconds/1.73 meter square | Standard Deviation 0.221404 |
Secondary
Change From Baseline in Clinical Laboratory Parameter-glomerular Filtration Rate (GFR) From Creatinine Adjusted for Body Surface Area (BSA) From Month 15 to Month 30
Blood samples were collected from participants at indicated time points to analyze the clinical chemistry parameter: GFR from creatinine adjusted for BSA. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Time frame: Baseline and Months 15, 18, 21, 24, 27, 30
Population: Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Staff Study Participants | Change From Baseline in Clinical Laboratory Parameter-glomerular Filtration Rate (GFR) From Creatinine Adjusted for Body Surface Area (BSA) From Month 15 to Month 30 | Month 15, n=99 | 0.03216 Milliliters/seconds/1.73 meter square | Standard Deviation 0.210193 |
| Staff Study Participants | Change From Baseline in Clinical Laboratory Parameter-glomerular Filtration Rate (GFR) From Creatinine Adjusted for Body Surface Area (BSA) From Month 15 to Month 30 | Month 18, n=93 | -0.09140 Milliliters/seconds/1.73 meter square | Standard Deviation 0.190551 |
| Staff Study Participants | Change From Baseline in Clinical Laboratory Parameter-glomerular Filtration Rate (GFR) From Creatinine Adjusted for Body Surface Area (BSA) From Month 15 to Month 30 | Month 21, n=75 | 0.02044 Milliliters/seconds/1.73 meter square | Standard Deviation 0.203936 |
| Staff Study Participants | Change From Baseline in Clinical Laboratory Parameter-glomerular Filtration Rate (GFR) From Creatinine Adjusted for Body Surface Area (BSA) From Month 15 to Month 30 | Month 24, n=35 | 0.07667 Milliliters/seconds/1.73 meter square | Standard Deviation 0.252677 |
| Staff Study Participants | Change From Baseline in Clinical Laboratory Parameter-glomerular Filtration Rate (GFR) From Creatinine Adjusted for Body Surface Area (BSA) From Month 15 to Month 30 | Month 27, n=7 | 0.06905 Milliliters/seconds/1.73 meter square | Standard Deviation 0.173056 |
| Staff Study Participants | Change From Baseline in Clinical Laboratory Parameter-glomerular Filtration Rate (GFR) From Creatinine Adjusted for Body Surface Area (BSA) From Month 15 to Month 30 | Month 30, n=1 | 0.20000 Milliliters/seconds/1.73 meter square | — |
Secondary
Change From Baseline in Clinical Laboratory Parameter: Lipase
Blood samples were collected for the analysis of clinical chemistry parameter: Lipase. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Time frame: Baseline and up to Month 12
Population: Safety Population. Only those participants with data available at the indicated time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Staff Study Participants | Change From Baseline in Clinical Laboratory Parameter: Lipase | -2.3 Units per liter | Standard Deviation 21.54 |
Secondary
Change From Baseline in Clinical Laboratory Parameter- Lipase From Month 15 to Month 30
Blood samples were collected for the analysis of clinical chemistry parameter: Lipase. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Time frame: Baseline and Months 15, 18, 21, 24, 27, 30
Population: Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Staff Study Participants | Change From Baseline in Clinical Laboratory Parameter- Lipase From Month 15 to Month 30 | Month 15, n=99 | 2.2 Units per liter | Standard Deviation 32.47 |
| Staff Study Participants | Change From Baseline in Clinical Laboratory Parameter- Lipase From Month 15 to Month 30 | Month 18, n=93 | 0.9 Units per liter | Standard Deviation 31.03 |
| Staff Study Participants | Change From Baseline in Clinical Laboratory Parameter- Lipase From Month 15 to Month 30 | Month 21, n=75 | -1.3 Units per liter | Standard Deviation 29.74 |
| Staff Study Participants | Change From Baseline in Clinical Laboratory Parameter- Lipase From Month 15 to Month 30 | Month 24, n=35 | -9.9 Units per liter | Standard Deviation 53.42 |
| Staff Study Participants | Change From Baseline in Clinical Laboratory Parameter- Lipase From Month 15 to Month 30 | Month 27, n=8 | 5.9 Units per liter | Standard Deviation 23.43 |
| Staff Study Participants | Change From Baseline in Clinical Laboratory Parameter- Lipase From Month 15 to Month 30 | Month 30, n=1 | 2.0 Units per liter | — |
Secondary
Change From Baseline in Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase
Blood samples were collected to analyze the chemistry parameters: ALT, AST, ALP and creatine kinase. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Time frame: Baseline and up to Month 12
Population: Safety Population. Only those participants with data available at the indicated time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Staff Study Participants | Change From Baseline in Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase | ALT | 1.1 International units per liter | Standard Deviation 14.17 |
| Staff Study Participants | Change From Baseline in Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase | AST | 0.5 International units per liter | Standard Deviation 11.59 |
| Staff Study Participants | Change From Baseline in Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase | ALP | 0.3 International units per liter | Standard Deviation 12.27 |
| Staff Study Participants | Change From Baseline in Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase | Creatine kinase | -29.1 International units per liter | Standard Deviation 278.65 |
Secondary
Change From Baseline in Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30
Blood samples were collected to analyze the chemistry parameters: ALT, AST, ALP and creatine kinase. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Time frame: Baseline and Months 15, 18, 21, 24, 27, 30
Population: Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Staff Study Participants | Change From Baseline in Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30 | ALT, Month 15, n=99 | 4.0 International units per liter | Standard Deviation 20.92 |
| Staff Study Participants | Change From Baseline in Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30 | ALT, Month 18, n=97 | 2.9 International units per liter | Standard Deviation 14.96 |
| Staff Study Participants | Change From Baseline in Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30 | ALT, Month 21, n=75 | 3.1 International units per liter | Standard Deviation 23.81 |
| Staff Study Participants | Change From Baseline in Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30 | ALT, Month 24, n=35 | -0.2 International units per liter | Standard Deviation 12.35 |
| Staff Study Participants | Change From Baseline in Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30 | ALT, Month 27, n=8 | 1.6 International units per liter | Standard Deviation 16.16 |
| Staff Study Participants | Change From Baseline in Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30 | ALT, Month 30 n=1 | -2.0 International units per liter | — |
| Staff Study Participants | Change From Baseline in Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30 | ALP, Month 15, n=99 | -2.1 International units per liter | Standard Deviation 13.62 |
| Staff Study Participants | Change From Baseline in Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30 | ALP, Month 18, n=97 | -0.8 International units per liter | Standard Deviation 14.45 |
| Staff Study Participants | Change From Baseline in Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30 | ALP, Month 21, n=75 | -0.2 International units per liter | Standard Deviation 13.61 |
| Staff Study Participants | Change From Baseline in Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30 | ALP, Month 24, n=35 | 0.1 International units per liter | Standard Deviation 10.35 |
| Staff Study Participants | Change From Baseline in Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30 | ALP, Month 27, n=8 | 5.5 International units per liter | Standard Deviation 12.32 |
| Staff Study Participants | Change From Baseline in Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30 | ALP, Month 30, n=1 | -9.0 International units per liter | — |
| Staff Study Participants | Change From Baseline in Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30 | AST, Month 15, n=99 | 1.2 International units per liter | Standard Deviation 9.63 |
| Staff Study Participants | Change From Baseline in Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30 | AST, Month 18, n=97 | 4.1 International units per liter | Standard Deviation 26.52 |
| Staff Study Participants | Change From Baseline in Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30 | AST, Month 21, n=75 | 1.4 International units per liter | Standard Deviation 8.8 |
| Staff Study Participants | Change From Baseline in Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30 | AST, Month 24, n=35 | -0.5 International units per liter | Standard Deviation 5.54 |
| Staff Study Participants | Change From Baseline in Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30 | AST, Month 27, n=8 | 1.6 International units per liter | Standard Deviation 9.65 |
| Staff Study Participants | Change From Baseline in Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30 | AST, Month 30, n=1 | -1.0 International units per liter | — |
| Staff Study Participants | Change From Baseline in Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30 | Creatine Kinase, Month 15, n=99 | -25.0 International units per liter | Standard Deviation 306.57 |
| Staff Study Participants | Change From Baseline in Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30 | Creatine Kinase, Month 18, n=97 | 132.5 International units per liter | Standard Deviation 1053.02 |
| Staff Study Participants | Change From Baseline in Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30 | Creatine Kinase, Month 21, n=75 | 28.0 International units per liter | Standard Deviation 454.78 |
| Staff Study Participants | Change From Baseline in Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30 | Creatine Kinase, Month 24, n=35 | -61.7 International units per liter | Standard Deviation 376.27 |
| Staff Study Participants | Change From Baseline in Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30 | Creatine Kinase, Month 27, n=8 | 70.8 International units per liter | Standard Deviation 107.32 |
| Staff Study Participants | Change From Baseline in Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30 | Creatine Kinase, Month 30, n=1 | -8.0 International units per liter | — |
Secondary
Change From Baseline in Clinical Laboratory Parameters: Creatinine and Bilirubin
Blood samples were collected to analyze the chemistry parameters: Creatinine and Bilirubin. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Time frame: Baseline and up to Month 12
Population: Safety Population. Only those participants with data available at the indicated time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Staff Study Participants | Change From Baseline in Clinical Laboratory Parameters: Creatinine and Bilirubin | Creatinine | -1.59 Micromoles per liter | Standard Deviation 14.736 |
| Staff Study Participants | Change From Baseline in Clinical Laboratory Parameters: Creatinine and Bilirubin | Bilirubin | 0.9 Micromoles per liter | Standard Deviation 4.24 |
Secondary
Change From Baseline in Clinical Laboratory Parameters: Creatinine and Bilirubin From Month 15 to Month 30
Blood samples were collected to analyze the chemistry parameters: Creatinine and Bilirubin. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Time frame: Baseline and Months 15, 18, 21, 24, 27, 30
Population: Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Staff Study Participants | Change From Baseline in Clinical Laboratory Parameters: Creatinine and Bilirubin From Month 15 to Month 30 | Creatinine, Month 15, n=99 | -2.73 Micromoles per liter | Standard Deviation 13.479 |
| Staff Study Participants | Change From Baseline in Clinical Laboratory Parameters: Creatinine and Bilirubin From Month 15 to Month 30 | Creatinine, Month 18, n=97 | 3.19 Micromoles per liter | Standard Deviation 12.588 |
| Staff Study Participants | Change From Baseline in Clinical Laboratory Parameters: Creatinine and Bilirubin From Month 15 to Month 30 | Creatinine, Month 21, n=75 | -2.92 Micromoles per liter | Standard Deviation 14.496 |
| Staff Study Participants | Change From Baseline in Clinical Laboratory Parameters: Creatinine and Bilirubin From Month 15 to Month 30 | Creatinine, Month 24, n=35 | -6.80 Micromoles per liter | Standard Deviation 16.452 |
| Staff Study Participants | Change From Baseline in Clinical Laboratory Parameters: Creatinine and Bilirubin From Month 15 to Month 30 | Creatinine, Month 27, n=8 | -6.95 Micromoles per liter | Standard Deviation 9.095 |
| Staff Study Participants | Change From Baseline in Clinical Laboratory Parameters: Creatinine and Bilirubin From Month 15 to Month 30 | Creatinine, Month 30, n=1 | -10.60 Micromoles per liter | — |
| Staff Study Participants | Change From Baseline in Clinical Laboratory Parameters: Creatinine and Bilirubin From Month 15 to Month 30 | Bilirubin, Month 15, n=99 | 0.7 Micromoles per liter | Standard Deviation 4.99 |
| Staff Study Participants | Change From Baseline in Clinical Laboratory Parameters: Creatinine and Bilirubin From Month 15 to Month 30 | Bilirubin, Month 18, n=97 | 0.4 Micromoles per liter | Standard Deviation 4.42 |
| Staff Study Participants | Change From Baseline in Clinical Laboratory Parameters: Creatinine and Bilirubin From Month 15 to Month 30 | Bilirubin, Month 21 n=75 | 1.7 Micromoles per liter | Standard Deviation 4.34 |
| Staff Study Participants | Change From Baseline in Clinical Laboratory Parameters: Creatinine and Bilirubin From Month 15 to Month 30 | Bilirubin, Month 24, n=35 | 1.9 Micromoles per liter | Standard Deviation 5.75 |
| Staff Study Participants | Change From Baseline in Clinical Laboratory Parameters: Creatinine and Bilirubin From Month 15 to Month 30 | Bilirubin, Month 27 n=8 | 0.8 Micromoles per liter | Standard Deviation 1.04 |
| Staff Study Participants | Change From Baseline in Clinical Laboratory Parameters: Creatinine and Bilirubin From Month 15 to Month 30 | Bilirubin, Month 30, n=1 | -4.0 Micromoles per liter | — |
Secondary
Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume (MCV)
Blood samples were collected to analyze the hematology parameter: Erythrocytes MCV. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Time frame: Baseline and up to Month 12
Population: Safety population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Staff Study Participants | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume (MCV) | -3.90 Femtoliter | Standard Deviation 2.961 |
Secondary
Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Volume (MCV) From Month 15 to Month 30
Blood samples were collected to analyze the hematology parameter: Erythrocytes MCV. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Time frame: Baseline and Months 15, 18, 21, 24, 27, 30
Population: Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Staff Study Participants | Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Volume (MCV) From Month 15 to Month 30 | Month 15, n=99 | -6.13 Femtoliter | Standard Deviation 2.724 |
| Staff Study Participants | Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Volume (MCV) From Month 15 to Month 30 | Month 18, n=97 | -6.64 Femtoliter | Standard Deviation 3.004 |
| Staff Study Participants | Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Volume (MCV) From Month 15 to Month 30 | Month 21, n=75 | -5.61 Femtoliter | Standard Deviation 3.413 |
| Staff Study Participants | Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Volume (MCV) From Month 15 to Month 30 | Month 24, n=35 | -5.37 Femtoliter | Standard Deviation 2.691 |
| Staff Study Participants | Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Volume (MCV) From Month 15 to Month 30 | Month 27, n=8 | -6.25 Femtoliter | Standard Deviation 3.77 |
| Staff Study Participants | Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Volume (MCV) From Month 15 to Month 30 | Month 30, n=1 | -7.00 Femtoliter | — |
Secondary
Change From Baseline in Hematology Parameter: Hematocrit
Blood samples were collected to analyze the hematology parameter: Hematocrit (fraction of 1). Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Time frame: Baseline and up to Month 12
Population: Safety population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Staff Study Participants | Change From Baseline in Hematology Parameter: Hematocrit | -0.0022 Percentage of red blood cells in blood | Standard Deviation 0.02554 |
Secondary
Change From Baseline in Hematology Parameter-Hematocrit From Month 15 to Month 30
Blood samples were collected to analyze the hematology parameter: Hematocrit (fraction of 1). Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Time frame: Baseline and Months 15, 18, 21, 24, 27, 30
Population: Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Staff Study Participants | Change From Baseline in Hematology Parameter-Hematocrit From Month 15 to Month 30 | Month 15, n=99 | -0.0133 Percentage of red blood cells in blood | Standard Deviation 0.02272 |
| Staff Study Participants | Change From Baseline in Hematology Parameter-Hematocrit From Month 15 to Month 30 | Month 18, n=97 | -0.0134 Percentage of red blood cells in blood | Standard Deviation 0.02963 |
| Staff Study Participants | Change From Baseline in Hematology Parameter-Hematocrit From Month 15 to Month 30 | Month 21, n=75 | -0.0091 Percentage of red blood cells in blood | Standard Deviation 0.02346 |
| Staff Study Participants | Change From Baseline in Hematology Parameter-Hematocrit From Month 15 to Month 30 | Month 24, n=35 | -0.0102 Percentage of red blood cells in blood | Standard Deviation 0.02364 |
| Staff Study Participants | Change From Baseline in Hematology Parameter-Hematocrit From Month 15 to Month 30 | Month 27, n=8 | -0.0166 Percentage of red blood cells in blood | Standard Deviation 0.01935 |
| Staff Study Participants | Change From Baseline in Hematology Parameter-Hematocrit From Month 15 to Month 30 | Month 30, n=1 | -0.0340 Percentage of red blood cells in blood | — |
Secondary
Change From Baseline in Hematology Parameter: Hemoglobin
Blood samples were collected to analyze the hematology parameter: Hemoglobin. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Time frame: Baseline and up to Month 12
Population: Safety population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Staff Study Participants | Change From Baseline in Hematology Parameter: Hemoglobin | -1.11 Grams per liter | Standard Deviation 7.221 |
Secondary
Change From Baseline in Hematology Parameter-Hemoglobin From Month 15 to Month 30
Blood samples were collected to analyze the hematology parameter: Hemoglobin. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Time frame: Baseline and Months 15, 18, 21, 24, 27, 30
Population: Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Staff Study Participants | Change From Baseline in Hematology Parameter-Hemoglobin From Month 15 to Month 30 | Month 15, n=99 | -0.71 Grams per liter | Standard Deviation 7.172 |
| Staff Study Participants | Change From Baseline in Hematology Parameter-Hemoglobin From Month 15 to Month 30 | Month 18, n=97 | -0.29 Grams per liter | Standard Deviation 9.92 |
| Staff Study Participants | Change From Baseline in Hematology Parameter-Hemoglobin From Month 15 to Month 30 | Month 21, n=75 | -1.09 Grams per liter | Standard Deviation 6.717 |
| Staff Study Participants | Change From Baseline in Hematology Parameter-Hemoglobin From Month 15 to Month 30 | Month 24, n=35 | -2.26 Grams per liter | Standard Deviation 7.636 |
| Staff Study Participants | Change From Baseline in Hematology Parameter-Hemoglobin From Month 15 to Month 30 | Month 27, n=8 | -3.25 Grams per liter | Standard Deviation 5.203 |
| Staff Study Participants | Change From Baseline in Hematology Parameter-Hemoglobin From Month 15 to Month 30 | Month 30, n=1 | -4.00 Grams per liter | — |
Secondary
Change From Baseline in Hematology Parameter: Red Blood Cell (RBC) Count
Blood samples were collected to analyze the hematology parameter: RBC count. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Time frame: Baseline and up to Month 12
Population: Safety population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Staff Study Participants | Change From Baseline in Hematology Parameter: Red Blood Cell (RBC) Count | 0.18 10^12 cells per liter | Standard Deviation 0.26 |
Secondary
Change From Baseline in Hematology Parameter-Red Blood Cell (RBC) Count From Month 15 to Month 30
Blood samples were collected to analyze the hematology parameter: RBC count. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Time frame: Baseline and Months 15, 18, 21, 24, 27, 30
Population: Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Staff Study Participants | Change From Baseline in Hematology Parameter-Red Blood Cell (RBC) Count From Month 15 to Month 30 | Month 15, n=99 | 0.17 10^12 cells per liter | Standard Deviation 0.245 |
| Staff Study Participants | Change From Baseline in Hematology Parameter-Red Blood Cell (RBC) Count From Month 15 to Month 30 | Month 18, n=97 | 0.19 10^12 cells per liter | Standard Deviation 0.313 |
| Staff Study Participants | Change From Baseline in Hematology Parameter-Red Blood Cell (RBC) Count From Month 15 to Month 30 | Month 21, n=75 | 0.19 10^12 cells per liter | Standard Deviation 0.248 |
| Staff Study Participants | Change From Baseline in Hematology Parameter-Red Blood Cell (RBC) Count From Month 15 to Month 30 | Month 24, n=35 | 0.16 10^12 cells per liter | Standard Deviation 0.274 |
| Staff Study Participants | Change From Baseline in Hematology Parameter-Red Blood Cell (RBC) Count From Month 15 to Month 30 | Month 27, n=8 | 0.14 10^12 cells per liter | Standard Deviation 0.267 |
| Staff Study Participants | Change From Baseline in Hematology Parameter-Red Blood Cell (RBC) Count From Month 15 to Month 30 | Month 30, n=1 | 0.10 10^12 cells per liter | — |
Secondary
Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count
Blood samples were collected to analyze the hematology parameters: Platelet count, WBC count, Basophil count, Eosinophil count, Lymphocyte count, Monocyte count and Neutrophil count. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Time frame: Baseline and up to Month 12
Population: Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Staff Study Participants | Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count | Platelet count, n=100 | -0.66 10^9 cells per Liter | Standard Deviation 33.512 |
| Staff Study Participants | Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count | WBC count, n=101 | 0.27 10^9 cells per Liter | Standard Deviation 1.412 |
| Staff Study Participants | Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count | Basophil count, n=101 | 0.006 10^9 cells per Liter | Standard Deviation 0.0232 |
| Staff Study Participants | Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count | Eosinophil count, n=101 | 0.018 10^9 cells per Liter | Standard Deviation 0.1632 |
| Staff Study Participants | Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count | Lymphocyte count, n=101 | -0.0005 10^9 cells per Liter | Standard Deviation 0.49237 |
| Staff Study Participants | Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count | Monocyte count, n=101 | 0.029 10^9 cells per Liter | Standard Deviation 0.1434 |
| Staff Study Participants | Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count | Neutrophil count, n=101 | 0.214 10^9 cells per Liter | Standard Deviation 1.1746 |
Secondary
Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30
Blood samples were collected to analyze the hematology parameters: Platelet count, WBC count, Basophil count, Eosinophil count, Lymphocyte count, Monocyte count and Neutrophil count. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Time frame: Baseline and Months 15, 18, 21, 24, 27, 30
Population: Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Staff Study Participants | Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30 | Platelet count, Month 15, n=98 | 5.47 10^9 cells per Liter | Standard Deviation 41.191 |
| Staff Study Participants | Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30 | Platelet count, Month 18, n=96 | 9.59 10^9 cells per Liter | Standard Deviation 57.934 |
| Staff Study Participants | Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30 | Platelet count, Month 21, n=75 | 8.07 10^9 cells per Liter | Standard Deviation 34.613 |
| Staff Study Participants | Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30 | Platelet count, Month 24, n=35 | 14.51 10^9 cells per Liter | Standard Deviation 24.923 |
| Staff Study Participants | Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30 | Platelet count, Month 27, n=8 | 31.13 10^9 cells per Liter | Standard Deviation 48.265 |
| Staff Study Participants | Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30 | Platelet count, Month 30, n=1 | 73.00 10^9 cells per Liter | — |
| Staff Study Participants | Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30 | WBC count, Month 15, n=99 | 0.66 10^9 cells per Liter | Standard Deviation 1.648 |
| Staff Study Participants | Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30 | WBC count, Month 18, n=97 | 0.23 10^9 cells per Liter | Standard Deviation 1.718 |
| Staff Study Participants | Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30 | WBC count, Month 21, n=75 | 0.30 10^9 cells per Liter | Standard Deviation 1.452 |
| Staff Study Participants | Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30 | WBC count, Month 24, n=35 | -0.04 10^9 cells per Liter | Standard Deviation 1.463 |
| Staff Study Participants | Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30 | WBC count, Month 27, n=8 | -0.05 10^9 cells per Liter | Standard Deviation 1.543 |
| Staff Study Participants | Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30 | WBC count, Month 30, n=1 | 0.40 10^9 cells per Liter | — |
| Staff Study Participants | Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30 | Basophil count, Month 15, n=99 | 0.009 10^9 cells per Liter | Standard Deviation 0.0292 |
| Staff Study Participants | Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30 | Basophil count, Month 18, n=97 | 0.008 10^9 cells per Liter | Standard Deviation 0.0374 |
| Staff Study Participants | Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30 | Basophil count, Month 21, n=75 | 0.001 10^9 cells per Liter | Standard Deviation 0.0243 |
| Staff Study Participants | Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30 | Basophil count, Month 24, n=35 | -0.002 10^9 cells per Liter | Standard Deviation 0.0268 |
| Staff Study Participants | Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30 | Basophil count, Month 27, n=8 | 0.010 10^9 cells per Liter | Standard Deviation 0.0351 |
| Staff Study Participants | Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30 | Basophil count, Month 30, n=1 | 0.060 10^9 cells per Liter | — |
| Staff Study Participants | Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30 | Eosinophil count, Month 15, n=99 | 0.019 10^9 cells per Liter | Standard Deviation 0.1623 |
| Staff Study Participants | Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30 | Eosinophil count, Month 18, n=97 | 0.008 10^9 cells per Liter | Standard Deviation 0.1609 |
| Staff Study Participants | Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30 | Eosinophil count, Month 21, n=75 | -0.001 10^9 cells per Liter | Standard Deviation 0.1683 |
| Staff Study Participants | Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30 | Eosinophil count, Month 24, n=35 | -0.033 10^9 cells per Liter | Standard Deviation 0.2489 |
| Staff Study Participants | Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30 | Eosinophil count, Month 27, n=8 | -0.060 10^9 cells per Liter | Standard Deviation 0.065 |
| Staff Study Participants | Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30 | Eosinophil count, Month 30, n=1 | 0.010 10^9 cells per Liter | — |
| Staff Study Participants | Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30 | Lymphocyte count, Month 15, n=99 | 0.1654 10^9 cells per Liter | Standard Deviation 0.53448 |
| Staff Study Participants | Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30 | Lymphocyte count, Month 18, n=97 | 0.1315 10^9 cells per Liter | Standard Deviation 0.71555 |
| Staff Study Participants | Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30 | Lymphocyte count, Month 21, n=75 | 0.0360 10^9 cells per Liter | Standard Deviation 0.51313 |
| Staff Study Participants | Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30 | Lymphocyte count, Month 24, n=35 | -0.1046 10^9 cells per Liter | Standard Deviation 0.50251 |
| Staff Study Participants | Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30 | Lymphocyte count, Month 27, n=8 | 0.0237 10^9 cells per Liter | Standard Deviation 0.47192 |
| Staff Study Participants | Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30 | Lymphocyte count, Month 30, n=1 | -0.2100 10^9 cells per Liter | — |
| Staff Study Participants | Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30 | Monocyte count, Month 15, n=99 | 0.091 10^9 cells per Liter | Standard Deviation 0.1707 |
| Staff Study Participants | Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30 | Monocyte count, Month 18, n=97 | 0.085 10^9 cells per Liter | Standard Deviation 0.2257 |
| Staff Study Participants | Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30 | Monocyte count, Month 21, n=75 | 0.048 10^9 cells per Liter | Standard Deviation 0.128 |
| Staff Study Participants | Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30 | Monocyte count, Month 24, n=35 | -0.009 10^9 cells per Liter | Standard Deviation 0.1228 |
| Staff Study Participants | Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30 | Monocyte count, Month 27, n=8 | -0.030 10^9 cells per Liter | Standard Deviation 0.1743 |
| Staff Study Participants | Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30 | Monocyte count, Month 30, n=1 | 0.110 10^9 cells per Liter | — |
| Staff Study Participants | Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30 | Neutrophil count, Month 15, n=99 | 0.365 10^9 cells per Liter | Standard Deviation 1.3448 |
| Staff Study Participants | Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30 | Neutrophil count, Month 18, n=97 | -0.007 10^9 cells per Liter | Standard Deviation 1.2956 |
| Staff Study Participants | Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30 | Neutrophil count, Month 21, n=75 | 0.211 10^9 cells per Liter | Standard Deviation 1.2534 |
| Staff Study Participants | Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30 | Neutrophil count, Month 24, n=35 | 0.109 10^9 cells per Liter | Standard Deviation 1.2653 |
| Staff Study Participants | Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30 | Neutrophil count, Month 27, n=8 | -0.003 10^9 cells per Liter | Standard Deviation 1.0602 |
| Staff Study Participants | Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30 | Neutrophil count, Month 30, n=1 | 0.350 10^9 cells per Liter | — |
Secondary
HIV Treatment Satisfaction Questionnaire Status Version (HIV-TSQs) Scores at Month 1
Participant satisfaction was measured using the validated HIV Treatment Satisfaction Questionnaire (HIV-TSQ), status version (HIV-TSQs), which measured satisfaction with the treatment used in the previous few weeks. HIVTSQs total treatment satisfaction score was computed with 1-11 items. Each item was scored from 0 (least satisfied) to 6 (most satisfied). Items 1-11 were summed to produce score with possible range of 0 to 66. Higher the score, greater improvement in satisfaction with treatment; lower score, greater the deterioration in satisfaction with treatment.
Time frame: At Month 1
Population: Safety population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Staff Study Participants | HIV Treatment Satisfaction Questionnaire Status Version (HIV-TSQs) Scores at Month 1 | 60.7 Scores on a scale | Standard Deviation 6.3 |
Secondary
HIV-TSQs Scores at Month 12
Participant satisfaction was measured using the validated HIV Treatment Satisfaction Questionnaire (HIV-TSQ), status version (HIV-TSQs), which measured satisfaction with the treatment used in the previous few weeks. HIVTSQs total treatment satisfaction score was computed with 1-11 items. Each item was scored from 0 (least satisfied) to 6 (most satisfied). Items 1-11 were summed to produce score with possible range of 0 to 66. Higher the score, greater improvement in satisfaction with treatment; lower score, greater the deterioration in satisfaction with treatment.
Time frame: At Month 12
Population: Safety population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Staff Study Participants | HIV-TSQs Scores at Month 12 | 63.30 Scores on a scale | Standard Deviation 3.81 |
Secondary
HIV-TSQs Scores at Month 4
Participant satisfaction was measured using the validated HIV Treatment Satisfaction Questionnaire (HIV-TSQ), status version (HIV-TSQs), which measured satisfaction with the treatment used in the previous few weeks. HIVTSQs total treatment satisfaction score was computed with 1-11 items. Each item was scored from 0 (least satisfied) to 6 (most satisfied). Items 1-11 were summed to produce score with possible range of 0 to 66. Higher the score, greater improvement in satisfaction with treatment; lower score, greater the deterioration in satisfaction with treatment.
Time frame: At Month 4
Population: Safety population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Staff Study Participants | HIV-TSQs Scores at Month 4 | 62.12 Scores on a scale | Standard Deviation 5.79 |
Secondary
Implementation Sustainability Assessed in Staff Study Participants Using Program Sustainability Assessment Tool (PSAT) Scores
Implementation sustainability in staff study participants was assessed using PSAT tool that evaluated capability of clinics to maintain processes developed to administer CAB+RPV injection in routine clinical settings after study conclusion.It consisted of 6 domains(1.Environmental support,2.Organizational capacity,3.Program evaluation,4.Program adaptation,5.Communications and 6.Strategic planning).Each domain consisted of 5 items,each assessed using 7-point numerical rating scale:1=to not extent at all,7=to a very great extent and an eighth not applicable/not able to answer response(NA).Score ranges for total domain scores are 5 to 35 for each of 6 domains(5 items in each domain on 1 to 7 scale).Numeric response to each item within specific domain is summed to produce a total domain score then mean domain score is calculated(excluding any NA responses).Higher scores indicate better outcome(higher endorsement/more positive impressions by staff-study with sustainability survey concepts)
Time frame: At Month 12
Population: All staff study participants population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Staff Study Participants | Implementation Sustainability Assessed in Staff Study Participants Using Program Sustainability Assessment Tool (PSAT) Scores | Environmental support | 5.82 Scores on a scale | Standard Deviation 0.2 |
| Staff Study Participants | Implementation Sustainability Assessed in Staff Study Participants Using Program Sustainability Assessment Tool (PSAT) Scores | Organizational capacity | 5.74 Scores on a scale | Standard Deviation 0.28 |
| Staff Study Participants | Implementation Sustainability Assessed in Staff Study Participants Using Program Sustainability Assessment Tool (PSAT) Scores | Program evaluation | 5.83 Scores on a scale | Standard Deviation 0.49 |
| Staff Study Participants | Implementation Sustainability Assessed in Staff Study Participants Using Program Sustainability Assessment Tool (PSAT) Scores | Program adaptation | 5.98 Scores on a scale | Standard Deviation 0.15 |
| Staff Study Participants | Implementation Sustainability Assessed in Staff Study Participants Using Program Sustainability Assessment Tool (PSAT) Scores | Communications | 6.09 Scores on a scale | Standard Deviation 0.06 |
| Staff Study Participants | Implementation Sustainability Assessed in Staff Study Participants Using Program Sustainability Assessment Tool (PSAT) Scores | Strategic planning | 5.50 Scores on a scale | Standard Deviation 0.34 |
Secondary
Length of Participant Visit
Length of visit was calculated by subtracting the arrival time (Lead time \[actual start time of appointment - arrival time\] + process time \[actual end time of appointment - actual start time of appointment\]) from actual end time of appointment.
Time frame: At Months 1, 5 and 11
Population: Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Staff Study Participants | Length of Participant Visit | At Month 1, n=109 | 63.4 Minutes | Standard Deviation 29.51 |
| Staff Study Participants | Length of Participant Visit | At Month 5, n=104 | 38.7 Minutes | Standard Deviation 19.91 |
| Staff Study Participants | Length of Participant Visit | At Month 11, n=100 | 36.3 Minutes | Standard Deviation 16.85 |
Secondary
Number of Barriers Assessed Among Clinics Using Short-term Facilitation
The barriers were analyzed using semi-structured interviews from the validated consolidated framework for implementation research (CFIR) across 7 calls. An implementation science approach was used to understand the barriers for participants with HIV for delivering CAB + RPV LA within an interventional clinical trial where the CAB + RPV LA regimen was delivered to HIV infected, virologically-suppressed participants.
Time frame: Up to 6 months
Population: Safety population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Staff Study Participants | Number of Barriers Assessed Among Clinics Using Short-term Facilitation | Facilitation call 1 | 5 Barriers |
| Staff Study Participants | Number of Barriers Assessed Among Clinics Using Short-term Facilitation | Facilitation call 2 | 3 Barriers |
| Staff Study Participants | Number of Barriers Assessed Among Clinics Using Short-term Facilitation | Facilitation call 3 | 7 Barriers |
| Staff Study Participants | Number of Barriers Assessed Among Clinics Using Short-term Facilitation | Facilitation call 4 | 6 Barriers |
| Staff Study Participants | Number of Barriers Assessed Among Clinics Using Short-term Facilitation | Facilitation call 5 | 4 Barriers |
| Staff Study Participants | Number of Barriers Assessed Among Clinics Using Short-term Facilitation | Facilitation call 6 | 7 Barriers |
| Staff Study Participants | Number of Barriers Assessed Among Clinics Using Short-term Facilitation | Facilitation call 7 | 3 Barriers |
Secondary
Number of Best Practices Assessed Among Clinics Using Short-term Facilitation
The best practices were analyzed using short-term facilitation calls. An implementation science approach was used to understand the best practices for participants with HIV for delivering CAB + RPV LA within an interventional clinical trial where the CAB + RPV LA regimen was delivered to HIV infected, virologically-suppressed participants.
Time frame: Up to 6 months
Population: Safety population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Staff Study Participants | Number of Best Practices Assessed Among Clinics Using Short-term Facilitation | Facilitation call 1 | 5 Best practices |
| Staff Study Participants | Number of Best Practices Assessed Among Clinics Using Short-term Facilitation | Facilitation call 2 | 2 Best practices |
| Staff Study Participants | Number of Best Practices Assessed Among Clinics Using Short-term Facilitation | Facilitation call 3 | 2 Best practices |
| Staff Study Participants | Number of Best Practices Assessed Among Clinics Using Short-term Facilitation | Facilitation call 4 | 5 Best practices |
| Staff Study Participants | Number of Best Practices Assessed Among Clinics Using Short-term Facilitation | Facilitation call 5 | 6 Best practices |
| Staff Study Participants | Number of Best Practices Assessed Among Clinics Using Short-term Facilitation | Facilitation call 6 | 6 Best practices |
| Staff Study Participants | Number of Best Practices Assessed Among Clinics Using Short-term Facilitation | Facilitation call 7 | 8 Best practices |
Secondary
Number of Facilitators Assessed Among Clinics Using Short-term Facilitation
The facilitators were analyzed using semi-structured interviews from the validated CFIR across 7 calls. An implementation science approach was used to understand the facilitators for participants with HIV for delivering CAB + RPV LA within an interventional clinical trial where the CAB + RPV LA regimen was delivered to HIV infected, virologically-suppressed participants.
Time frame: Up to 6 months
Population: Safety population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Staff Study Participants | Number of Facilitators Assessed Among Clinics Using Short-term Facilitation | Facilitation call 1 | 7 Facilitators |
| Staff Study Participants | Number of Facilitators Assessed Among Clinics Using Short-term Facilitation | Facilitation call 2 | 3 Facilitators |
| Staff Study Participants | Number of Facilitators Assessed Among Clinics Using Short-term Facilitation | Facilitation call 3 | 3 Facilitators |
| Staff Study Participants | Number of Facilitators Assessed Among Clinics Using Short-term Facilitation | Facilitation call 4 | 5 Facilitators |
| Staff Study Participants | Number of Facilitators Assessed Among Clinics Using Short-term Facilitation | Facilitation call 5 | 9 Facilitators |
| Staff Study Participants | Number of Facilitators Assessed Among Clinics Using Short-term Facilitation | Facilitation call 6 | 9 Facilitators |
| Staff Study Participants | Number of Facilitators Assessed Among Clinics Using Short-term Facilitation | Facilitation call 7 | 8 Facilitators |
Secondary
Number of Participants Receiving Injections Within Target Window at Month 12
Number of participants receiving injections within target window at Month 12 is presented. The target window is +/- 7 days from the target injection visit date.
Time frame: At Month 12
Population: Safety population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Staff Study Participants | Number of Participants Receiving Injections Within Target Window at Month 12 | 96 Participants |
Secondary
Number of Participants Receiving Injections Within Target Window at Month 4
Number of participants receiving injections within target window at Month 4 is presented. The target window is +/- 7 days from the target injection visit date.
Time frame: At Month 4
Population: Safety population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Staff Study Participants | Number of Participants Receiving Injections Within Target Window at Month 4 | 100 Participants |
Secondary
Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants
BIM is a 23-item survey which assessed barriers (that is, difficulties and challenges) to successful implementation of the CAB LA + RPV LA injection treatment in the study clinic/practices. For each item, providers were asked to rate how much they agreed or disagreed that the issue is a barrier based on their experiences with implementing the CAB + RPV treatment on a five point rating scale (1=completely disagree to 5=completely agree). It is presented as fewer perceived barriers (FPB)=all negative change in scores from Baseline, some perceived barriers (SPB)=change in score of 0 from Baseline, and greater/more perceived barriers (MPB)=all positive change in scores from Baseline.
Time frame: Baseline and Month 4
Population: All staff study participants population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Staff Study Participants | Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants | Interest in the new treatment, FPB | 15 Participants |
| Staff Study Participants | Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants | Interest in the new treatment, SPB | 6 Participants |
| Staff Study Participants | Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants | Interest in the new treatment, MPB | 3 Participants |
| Staff Study Participants | Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants | Incentives for clinical practice change, FPB | 15 Participants |
| Staff Study Participants | Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants | Incentives for clinical practice change, SPB | 3 Participants |
| Staff Study Participants | Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants | Incentives for clinical practice change, MPB | 6 Participants |
| Staff Study Participants | Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants | Ability to keep monthly appointments (apts), FPB | 14 Participants |
| Staff Study Participants | Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants | Ability to keep monthly appointments, SPB | 5 Participants |
| Staff Study Participants | Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants | Ability to keep monthly appointments, MPB | 5 Participants |
| Staff Study Participants | Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants | Failing due to missed doses/injection apts, FPB | 13 Participants |
| Staff Study Participants | Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants | Failing due to missed doses/injection apts, SPB | 9 Participants |
| Staff Study Participants | Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants | Failing due to missed doses/injection apts, MPB | 2 Participants |
| Staff Study Participants | Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants | Lack of familiarity with tools/resources, FPB | 13 Participants |
| Staff Study Participants | Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants | Lack of familiarity with tools/resources, SPB | 8 Participants |
| Staff Study Participants | Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants | Lack of familiarity with tools/resources, MPB | 3 Participants |
| Staff Study Participants | Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants | Transportation for monthly apts, FPB | 12 Participants |
| Staff Study Participants | Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants | Transportation for monthly apts, SPB | 10 Participants |
| Staff Study Participants | Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants | Transportation for monthly apts, MPB | 2 Participants |
| Staff Study Participants | Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants | Injection (Inj)/pain soreness, FPB | 12 Participants |
| Staff Study Participants | Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants | Injection/pain soreness, SPB | 10 Participants |
| Staff Study Participants | Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants | Injection/pain soreness, MPB | 2 Participants |
| Staff Study Participants | Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants | Rescheduling missed injections, FPB | 12 Participants |
| Staff Study Participants | Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants | Rescheduling missed injections, SPB | 9 Participants |
| Staff Study Participants | Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants | Rescheduling missed injections, MPB | 3 Participants |
| Staff Study Participants | Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants | Time for new method implementation CAB+RPV LA, FPB | 12 Participants |
| Staff Study Participants | Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants | Time for new method implementation CAB+RPV LA, SPB | 11 Participants |
| Staff Study Participants | Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants | Time for new method implementation CAB+RPV LA, MPB | 1 Participants |
| Staff Study Participants | Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants | Flagging/awareness of missed injection visits, FPB | 11 Participants |
| Staff Study Participants | Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants | Flagging/awareness of missed injection visits, SPB | 9 Participants |
| Staff Study Participants | Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants | Flagging/awareness of missed injection visits, MPB | 4 Participants |
| Staff Study Participants | Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants | Competing clinic priorities, FPB | 11 Participants |
| Staff Study Participants | Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants | Competing clinic priorities, SPB | 10 Participants |
| Staff Study Participants | Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants | Competing clinic priorities, MPB | 3 Participants |
| Staff Study Participants | Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants | Manage for inj visits with other care need, FPB | 10 Participants |
| Staff Study Participants | Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants | Manage for inj visits with other care need,SPB | 8 Participants |
| Staff Study Participants | Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants | Manage for inj visit with other care need, MPB | 6 Participants |
| Staff Study Participants | Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants | Transition from oral to injection treatment, FPB | 10 Participants |
| Staff Study Participants | Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants | Transition from oral to injection treatment, SPB | 13 Participants |
| Staff Study Participants | Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants | Transition from oral to injection treatment, MPB | 1 Participants |
| Staff Study Participants | Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants | Time to administer the injection, FPB | 10 Participants |
| Staff Study Participants | Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants | Time to administer the injection, SPB | 10 Participants |
| Staff Study Participants | Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants | Time to administer the injection, MPB | 4 Participants |
| Staff Study Participants | Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants | Number of exam rooms for injection, FPB | 9 Participants |
| Staff Study Participants | Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants | Number of exam rooms for injection, SPB | 9 Participants |
| Staff Study Participants | Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants | Number of exam rooms for injection, MPB | 6 Participants |
| Staff Study Participants | Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants | Staff resourcing for clinic flow, FPB | 9 Participants |
| Staff Study Participants | Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants | Staff resourcing for clinic flow, SPB | 8 Participants |
| Staff Study Participants | Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants | Staff resourcing for clinic flow, MPB | 7 Participants |
| Staff Study Participants | Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants | Staff buy-in, FPB | 9 Participants |
| Staff Study Participants | Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants | Staff buy-in, SPB | 13 Participants |
| Staff Study Participants | Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants | Staff buy-in, MPB | 2 Participants |
| Staff Study Participants | Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants | Staff preparation, FPB | 9 Participants |
| Staff Study Participants | Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants | Staff preparation, SPB | 13 Participants |
| Staff Study Participants | Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants | Staff preparation, MPB | 2 Participants |
| Staff Study Participants | Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants | Scheduling of apt reminders, FPB | 8 Participants |
| Staff Study Participants | Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants | Scheduling of apt reminders, SPB | 12 Participants |
| Staff Study Participants | Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants | Scheduling of apt reminders, MPB | 4 Participants |
| Staff Study Participants | Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants | Answering questions between visits, FPB | 7 Participants |
| Staff Study Participants | Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants | Answering questions between visits, SPB | 11 Participants |
| Staff Study Participants | Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants | Answering questions between visits, MPB | 6 Participants |
| Staff Study Participants | Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants | Scheduling of monthly apts, FPB | 7 Participants |
| Staff Study Participants | Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants | Scheduling of monthly apts, SPB | 13 Participants |
| Staff Study Participants | Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants | Scheduling of monthly apts, MPB | 4 Participants |
| Staff Study Participants | Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants | Leadership support, FPB | 6 Participants |
| Staff Study Participants | Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants | Leadership support, SPB | 14 Participants |
| Staff Study Participants | Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants | Leadership support, MPB | 4 Participants |
| Staff Study Participants | Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants | Storage/refrigeration, FPB | 5 Participants |
| Staff Study Participants | Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants | Storage/refrigeration, SPB | 11 Participants |
| Staff Study Participants | Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants | Storage/refrigeration, MPB | 8 Participants |
Secondary
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Blood samples were collected up to the Month 12 visit for the analysis of clinical chemistry parameters: alanine aminotransferase (ALT), alkaline phosphate (ALP), aspartate aminotransferase (AST), bilirubin, carbon dioxide (CO2), creatine kinase (CK), creatinine, direct bilirubin, glucose, lipase, phosphate, potassium and sodium. Any abnormality in clinical chemistry parameters were evaluated according to the DAIDS toxicity scale From Grade 1 to 4: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). Higher the grade, more severe the symptoms.
Time frame: Up to Month 12
Population: Safety population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Staff Study Participants | Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | AST, increase from Grade 1 to 4 | 8 Participants |
| Staff Study Participants | Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | AST, increase from Grade 2 to 4 | 4 Participants |
| Staff Study Participants | Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | AST, increase from Grade 3 to 4 | 0 Participants |
| Staff Study Participants | Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Bilirubin, increase from Grade 1 to 4 | 4 Participants |
| Staff Study Participants | Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Bilirubin, increase from Grade 2 to 4 | 1 Participants |
| Staff Study Participants | Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Bilirubin, increase from Grade 3 to 4 | 0 Participants |
| Staff Study Participants | Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | CO2, increase from Grade 1 to 4 | 16 Participants |
| Staff Study Participants | Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | CO2, increase from Grade 2 to 4 | 0 Participants |
| Staff Study Participants | Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | CO2, increase from Grade 3 to 4 | 0 Participants |
| Staff Study Participants | Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | CK, increase from Grade 1 to 4 | 11 Participants |
| Staff Study Participants | Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | CK, increase from Grade 2 to 4 | 4 Participants |
| Staff Study Participants | Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Creatinine, increase from Grade 1 to 4 | 2 Participants |
| Staff Study Participants | Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Creatinine, increase from Grade 2 to 4 | 1 Participants |
| Staff Study Participants | Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Creatinine, increase from Grade 3 to 4 | 0 Participants |
| Staff Study Participants | Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Direct bilirubin, increase from Grade 1 to 4 | 1 Participants |
| Staff Study Participants | Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Direct bilirubin, increase from Grade 2 to 4 | 1 Participants |
| Staff Study Participants | Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Direct bilirubin, increase from Grade 3 to 4 | 1 Participants |
| Staff Study Participants | Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Glucose, increase from Grade 1 to 4 | 18 Participants |
| Staff Study Participants | Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Glucose, increase from Grade 2 to 4 | 8 Participants |
| Staff Study Participants | Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Glucose, increase from Grade 3 to 4 | 0 Participants |
| Staff Study Participants | Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Lipase, increase from Grade 1 to 4 | 17 Participants |
| Staff Study Participants | Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Lipase, increase from Grade 2 to 4 | 11 Participants |
| Staff Study Participants | Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Lipase, increase from Grade 3 to 4 | 0 Participants |
| Staff Study Participants | Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Phosphate, increase from Grade 1 to 4 | 16 Participants |
| Staff Study Participants | Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Phosphate, increase from Grade 2 to 4 | 4 Participants |
| Staff Study Participants | Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Phosphate, increase from Grade 3 to 4 | 0 Participants |
| Staff Study Participants | Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Potassium, increase from Grade 1 to 4 | 4 Participants |
| Staff Study Participants | Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Potassium, increase from Grade 2 to 4 | 0 Participants |
| Staff Study Participants | Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Potassium, increase from Grade 3 to 4 | 0 Participants |
| Staff Study Participants | Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Sodium, increase from Grade 1 to 4 | 6 Participants |
| Staff Study Participants | Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Sodium, increase from Grade 2 to 4 | 0 Participants |
| Staff Study Participants | Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Sodium, increase from Grade 3 to 4 | 0 Participants |
| Staff Study Participants | Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | CK, increase from Grade 3 to 4 | 1 Participants |
| Staff Study Participants | Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | ALT, increase from Grade 1 to 4 | 15 Participants |
| Staff Study Participants | Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | ALT, increase from Grade 2 to 4 | 3 Participants |
| Staff Study Participants | Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | ALT, increase from Grade 3 to 4 | 0 Participants |
| Staff Study Participants | Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | ALP, increase from Grade 1 to 4 | 3 Participants |
| Staff Study Participants | Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | ALP, increase from Grade 2 to 4 | 0 Participants |
| Staff Study Participants | Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | ALP, increase from Grade 3 to 4 | 0 Participants |
Secondary
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study
Blood samples were collected for the analysis of clinical chemistry parameters: ALT, ALP, AST, bilirubin, CO2, CK, creatinine, direct bilirubin, Glomerular filtration rate (GFR) from Creatinine (Creat) Adjusted (Adj) using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI), GFR From Creat Adj for body surface area (BSA), glucose, lipase, phosphate, potassium and sodium. Any abnormality in clinical chemistry parameters were evaluated according to the DAIDS toxicity scale From Grade 1 to 4: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). Higher the grade, more severe the symptoms.
Time frame: Up to 30 months
Population: Safety population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Staff Study Participants | Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study | ALT, increase from Grade 1 to 4 | 24 Participants |
| Staff Study Participants | Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study | ALT, increase from Grade 2 to 4 | 6 Participants |
| Staff Study Participants | Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study | ALT, increase from Grade 3 to 4 | 0 Participants |
| Staff Study Participants | Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study | ALP, increase from Grade 1 to 4 | 3 Participants |
| Staff Study Participants | Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study | ALP, increase from Grade 2 to 4 | 0 Participants |
| Staff Study Participants | Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study | ALP, increase from Grade 3 to 4 | 0 Participants |
| Staff Study Participants | Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study | AST, increase from Grade 1 to 4 | 13 Participants |
| Staff Study Participants | Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study | AST, increase from Grade 2 to 4 | 5 Participants |
| Staff Study Participants | Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study | AST, increase from Grade 3 to 4 | 1 Participants |
| Staff Study Participants | Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study | Bilirubin, increase from Grade 1 to 4 | 6 Participants |
| Staff Study Participants | Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study | Bilirubin, increase from Grade 2 to 4 | 1 Participants |
| Staff Study Participants | Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study | Bilirubin, increase from Grade 3 to 4 | 0 Participants |
| Staff Study Participants | Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study | CO2, increase from Grade 1 to 4 | 18 Participants |
| Staff Study Participants | Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study | CO2, increase from Grade 2 to 4 | 0 Participants |
| Staff Study Participants | Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study | CO2, increase from Grade 3 to 4 | 0 Participants |
| Staff Study Participants | Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study | CK, increase from Grade 1 to 4 | 18 Participants |
| Staff Study Participants | Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study | CK, increase from Grade 2 to 4 | 9 Participants |
| Staff Study Participants | Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study | CK, increase from Grade 3 to 4 | 4 Participants |
| Staff Study Participants | Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study | Creatinine, increase from Grade 1 to 4 | 5 Participants |
| Staff Study Participants | Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study | Creatinine, increase from Grade 2 to 4 | 1 Participants |
| Staff Study Participants | Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study | Creatinine, increase from Grade 3 to 4 | 0 Participants |
| Staff Study Participants | Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study | Direct bilirubin, increase from Grade 1 to 4 | 1 Participants |
| Staff Study Participants | Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study | Direct bilirubin, increase from Grade 2 to 4 | 1 Participants |
| Staff Study Participants | Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study | Direct bilirubin, increase from Grade 3 to 4 | 1 Participants |
| Staff Study Participants | Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study | GFR From Creat Adj Using CKD-EPI increase from Grade 1 to 4 | 27 Participants |
| Staff Study Participants | Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study | GFR From Creat Adj Using CKD-EPI increase from Grade 2 to 4 | 27 Participants |
| Staff Study Participants | Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study | GFR From Creat Adj Using CKD-EPI increase from Grade 3 to 4 | 6 Participants |
| Staff Study Participants | Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study | GFR From Creat Adj for BSA increase from Grade 1 to 4 | 27 Participants |
| Staff Study Participants | Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study | GFR From Creat Adj for BSA increase from Grade 2 to 4 | 27 Participants |
| Staff Study Participants | Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study | GFR From Creat Adj for BSA increase from Grade 3 to 4 | 6 Participants |
| Staff Study Participants | Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study | Glucose, increase from Grade 1 to 4 | 26 Participants |
| Staff Study Participants | Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study | Glucose, increase from Grade 2 to 4 | 16 Participants |
| Staff Study Participants | Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study | Glucose, increase from Grade 3 to 4 | 2 Participants |
| Staff Study Participants | Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study | Lipase, increase from Grade 1 to 4 | 23 Participants |
| Staff Study Participants | Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study | Lipase, increase from Grade 2 to 4 | 16 Participants |
| Staff Study Participants | Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study | Lipase, increase from Grade 3 to 4 | 0 Participants |
| Staff Study Participants | Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study | Phosphate, increase from Grade 1 to 4 | 22 Participants |
| Staff Study Participants | Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study | Phosphate, increase from Grade 2 to 4 | 6 Participants |
| Staff Study Participants | Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study | Phosphate, increase from Grade 3 to 4 | 0 Participants |
| Staff Study Participants | Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study | Potassium, increase from Grade 1 to 4 | 4 Participants |
| Staff Study Participants | Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study | Potassium, increase from Grade 2 to 4 | 0 Participants |
| Staff Study Participants | Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study | Potassium, increase from Grade 3 to 4 | 0 Participants |
| Staff Study Participants | Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study | Sodium, increase from Grade 1 to 4 | 7 Participants |
| Staff Study Participants | Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study | Sodium, increase from Grade 2 to 4 | 0 Participants |
| Staff Study Participants | Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study | Sodium, increase from Grade 3 to 4 | 0 Participants |
Secondary
Number of Participants With Extent of Knowledge About the CAB + RPV LA Treatment
Participants were asked to rate how knowledgeable they feel about the CAB LA + RPV LA treatment as extremely knowledgeable, very knowledgeable, somewhat knowledgeable, a little knowledgeable and not at all knowledgeable.
Time frame: At Month 12
Population: Safety population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Staff Study Participants | Number of Participants With Extent of Knowledge About the CAB + RPV LA Treatment | Extremely knowledgeable | 34 Participants |
| Staff Study Participants | Number of Participants With Extent of Knowledge About the CAB + RPV LA Treatment | Very knowledgeable | 40 Participants |
| Staff Study Participants | Number of Participants With Extent of Knowledge About the CAB + RPV LA Treatment | Somewhat knowledgeable | 25 Participants |
| Staff Study Participants | Number of Participants With Extent of Knowledge About the CAB + RPV LA Treatment | A little knowledgeable | 2 Participants |
| Staff Study Participants | Number of Participants With Extent of Knowledge About the CAB + RPV LA Treatment | Not at all knowledgeable | 1 Participants |
Secondary
Number of Participants With Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Blood samples were collected for the analysis of following hematology parameters: leukocytes, neutrophils and platelets. The parameters were graded according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) toxicity scale from Grade 1 to 4, where Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). Higher the grade, more severe the symptoms.
Time frame: Up to Month 12
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Staff Study Participants | Number of Participants With Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Leukocytes, increase from Grade 1 to 4 | 5 Participants |
| Staff Study Participants | Number of Participants With Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Leukocytes, increase from Grade 2 to 4 | 2 Participants |
| Staff Study Participants | Number of Participants With Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Leukocytes, increase from Grade 3 to 4 | 1 Participants |
| Staff Study Participants | Number of Participants With Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Neutrophils, increase from Grade 1 to 4 | 8 Participants |
| Staff Study Participants | Number of Participants With Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Neutrophils, increase from Grade 2 to 4 | 3 Participants |
| Staff Study Participants | Number of Participants With Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Neutrophils, increase from Grade 3 to 4 | 1 Participants |
| Staff Study Participants | Number of Participants With Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Platelets, increase from Grade 1 to 4 | 1 Participants |
| Staff Study Participants | Number of Participants With Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Platelets, increase from Grade 2 to 4 | 0 Participants |
| Staff Study Participants | Number of Participants With Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Platelets, increase from Grade 3 to 4 | 0 Participants |
Secondary
Number of Participants With Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study
Blood samples were collected for the analysis of following hematology parameters: hemoglobin, leukocytes, neutrophils and platelets. The parameters were graded according to the DAIDS toxicity scale from Grade 1 to 4, where Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). Higher the grade, more severe the symptoms.
Time frame: Up to 30 months
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Staff Study Participants | Number of Participants With Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study | Hemoglobin, increase from Grades 1 to 4 | 1 Participants |
| Staff Study Participants | Number of Participants With Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study | Hemoglobin, increase from Grades 2 to 4 | 0 Participants |
| Staff Study Participants | Number of Participants With Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study | Hemoglobin, increase from Grades 3 to 4 | 0 Participants |
| Staff Study Participants | Number of Participants With Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study | Leukocytes, increase from Grade 1 to 4 | 6 Participants |
| Staff Study Participants | Number of Participants With Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study | Leukocytes, increase from Grade 2 to 4 | 2 Participants |
| Staff Study Participants | Number of Participants With Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study | Leukocytes, increase from Grade 3 to 4 | 1 Participants |
| Staff Study Participants | Number of Participants With Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study | Neutrophils, increase from Grade 1 to 4 | 9 Participants |
| Staff Study Participants | Number of Participants With Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study | Neutrophils, increase from Grade 2 to 4 | 4 Participants |
| Staff Study Participants | Number of Participants With Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study | Neutrophils, increase from Grade 3 to 4 | 2 Participants |
| Staff Study Participants | Number of Participants With Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study | Platelets, increase from Grade 1 to 4 | 2 Participants |
| Staff Study Participants | Number of Participants With Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study | Platelets, increase from Grade 2 to 4 | 0 Participants |
| Staff Study Participants | Number of Participants With Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study | Platelets, increase from Grade 3 to 4 | 0 Participants |
Secondary
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
The helpfulness of the toolkit resources was identified using a 19-item survey and the helpfulness of the resources were rated on a five point scale where 1=Extremely helpful (EH), 2=Very helpful (VH), 3=Somewhat helpful (SH), 4=A little helpful (ALH) and 5=Not at all helpful (NAAH). Categories for did not receive (DNR) and recevied but did not use (RBDNU) were presented as well. Not Applicable (NA) in the data means participants were not offered the response option. The toolkit resources consisted of information and resources, hot and cold pack, written materials, website for participants, video, verbal information, reminder calls, reminder text messages, reminder app, peer group information session and appointments outside work time. The number of participants with the rating on helpfulness for each toolkit resources is presented.
Time frame: At Month 12
Population: Safety population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Video, Missing | 1 Participants |
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Information and resources, EH | 50 Participants |
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Information and resources, VH | 40 Participants |
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Information and resources, SH | 4 Participants |
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Information and resources, ALH | 2 Participants |
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Information and resources, NAAH | 0 Participants |
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Information and resources, DNR | 6 Participants |
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Information and resources, RBDNU | 0 Participants |
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Information and resources, Missing | 0 Participants |
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Hot and cold pack, EH | 18 Participants |
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Hot and cold pack, VH | 20 Participants |
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Hot and cold pack, SH | 14 Participants |
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Hot and cold pack, ALH | 6 Participants |
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Hot and cold pack, NAAH | 8 Participants |
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Hot and cold pack, DNR | 9 Participants |
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Hot and cold pack, RBDNU | 27 Participants |
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Hot and cold pack, Missing | 0 Participants |
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Written materials, EH | 37 Participants |
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Written materials, VH | 37 Participants |
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Written materials, SH | 11 Participants |
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Written materials, ALH | 2 Participants |
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Written materials, NAAH | 0 Participants |
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Written materials, DNR | 1 Participants |
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Written materials, RBDNU | 14 Participants |
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Written materials, Missing | 0 Participants |
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Website for participants, EH | 25 Participants |
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Website for participants, VH | 28 Participants |
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Website for participants, SH | 11 Participants |
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Website for participants, ALH | 2 Participants |
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Website for participants, NAAH | 1 Participants |
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Website for participants, DNR | 4 Participants |
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Website for participants, RBDNU | 31 Participants |
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Website for participants, Missing | 0 Participants |
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Video, EH | 29 Participants |
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Video, VH | 38 Participants |
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Video, SH | 13 Participants |
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Video, ALH | 5 Participants |
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Video, NAAH | 1 Participants |
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Video, DNR | 9 Participants |
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Video, RBDNU | 6 Participants |
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Verbal information, EH | 69 Participants |
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Verbal information, VH | 31 Participants |
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Verbal information, SH | 2 Participants |
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Verbal information, ALH | 0 Participants |
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Verbal information, NAAH | 0 Participants |
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Verbal information, DNR | 0 Participants |
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Verbal information, RBDNU | 0 Participants |
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Verbal information, Missing | 0 Participants |
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Reminder calls, EH | 67 Participants |
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Reminder calls, VH | 24 Participants |
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Reminder calls, SH | 5 Participants |
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Reminder calls, ALH | 1 Participants |
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Reminder calls, NAAH | 1 Participants |
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Reminder calls, DNR | 4 Participants |
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Reminder calls, RBDNU | 0 Participants |
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Reminder calls, Missing | 0 Participants |
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Reminder text messages, EH | 63 Participants |
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Reminder text messages, VH | 19 Participants |
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Reminder text messages, SH | 4 Participants |
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Reminder text messages, ALH | 1 Participants |
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Reminder text messages, NAAH | 0 Participants |
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Reminder text messages, DNR | 15 Participants |
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Reminder text messages, RBDNU | 0 Participants |
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Reminder text messages, Missing | 0 Participants |
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Reminder app, EH | 26 Participants |
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Reminder app, VH | 14 Participants |
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Reminder app, SH | 3 Participants |
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Reminder app, ALH | 0 Participants |
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Reminder app, NAAH | 0 Participants |
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Reminder app, DNR | 28 Participants |
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Reminder app, RBDNU | 31 Participants |
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Reminder app, Missing | 0 Participants |
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Peer group informational (info) session, EH | 24 Participants |
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Peer group info session, VH | 27 Participants |
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Peer group info session, SH | 25 Participants |
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Peer group info session, ALH | 6 Participants |
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Peer group info session, NAAH | 20 Participants |
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Peer group info session, DNR | NA Participants |
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Peer group info session, RBDNU | NA Participants |
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Peer group info session, Missing | 0 Participants |
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Apts outside work time, EH | 63 Participants |
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Apts outside work time, VH | 22 Participants |
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Apts outside work time, SH | 13 Participants |
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Apts outside work time, ALH | 1 Participants |
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Apts outside work time, NAAH | 3 Participants |
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Apts outside work time, DNR | NA Participants |
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Apts outside work time, RBDNU | NA Participants |
| Staff Study Participants | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | Apts outside work time, Missing | 0 Participants |
Secondary
Number of Participants With HIV Reporting Barriers to CAB LA + RPV LA Injection Treatment at Month 12
Participants were asked to report any factors that were interfering with their ability to get the monthly CAB LA + RPV LA injection treatment. Number of participants along with the reasons for interference in ability to get CAB LA + RPV LA is presented.
Time frame: At Month 12
Population: Safety population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Staff Study Participants | Number of Participants With HIV Reporting Barriers to CAB LA + RPV LA Injection Treatment at Month 12 | Pain or soreness from the injection | 15 Participants |
| Staff Study Participants | Number of Participants With HIV Reporting Barriers to CAB LA + RPV LA Injection Treatment at Month 12 | Scheduling upcoming injection visits | 2 Participants |
| Staff Study Participants | Number of Participants With HIV Reporting Barriers to CAB LA + RPV LA Injection Treatment at Month 12 | Rescheduling missed injection visits | 1 Participants |
| Staff Study Participants | Number of Participants With HIV Reporting Barriers to CAB LA + RPV LA Injection Treatment at Month 12 | Forgetting appointment for the injection visits | 2 Participants |
| Staff Study Participants | Number of Participants With HIV Reporting Barriers to CAB LA + RPV LA Injection Treatment at Month 12 | Frequency of required visits to clinic for inj | 6 Participants |
| Staff Study Participants | Number of Participants With HIV Reporting Barriers to CAB LA + RPV LA Injection Treatment at Month 12 | Missing work too frequently for the injection | 7 Participants |
| Staff Study Participants | Number of Participants With HIV Reporting Barriers to CAB LA + RPV LA Injection Treatment at Month 12 | Transportation to clinic/practice for inj visit | 3 Participants |
| Staff Study Participants | Number of Participants With HIV Reporting Barriers to CAB LA + RPV LA Injection Treatment at Month 12 | Ease of parking at clinic/practice for inj visit | 4 Participants |
| Staff Study Participants | Number of Participants With HIV Reporting Barriers to CAB LA + RPV LA Injection Treatment at Month 12 | Limited clinic/practice hours for inj visits | 3 Participants |
| Staff Study Participants | Number of Participants With HIV Reporting Barriers to CAB LA + RPV LA Injection Treatment at Month 12 | Less privacy for inj visits than daily HIV medicine | 1 Participants |
| Staff Study Participants | Number of Participants With HIV Reporting Barriers to CAB LA + RPV LA Injection Treatment at Month 12 | Nothing is interfering with getting this treatment | 75 Participants |
Secondary
Number of Participants With Injection Site Reactions (ISRs) Over Time
Local tolerability was measured by injection site reaction (ISR), for example; bruise at the site of injection and/or itching, pain, blistering or skin damage. ISRs were assigned to the most recent planned injection visit prior to/on the onset date of the ISR. Number of participants with ISRs by each assigned injection visit is presented.
Time frame: Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12
Population: Safety population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Staff Study Participants | Number of Participants With Injection Site Reactions (ISRs) Over Time | Month 6 | 103 Participants |
| Staff Study Participants | Number of Participants With Injection Site Reactions (ISRs) Over Time | Month 7 | 103 Participants |
| Staff Study Participants | Number of Participants With Injection Site Reactions (ISRs) Over Time | Month 8 | 102 Participants |
| Staff Study Participants | Number of Participants With Injection Site Reactions (ISRs) Over Time | Month 1 | 109 Participants |
| Staff Study Participants | Number of Participants With Injection Site Reactions (ISRs) Over Time | Month 2 | 108 Participants |
| Staff Study Participants | Number of Participants With Injection Site Reactions (ISRs) Over Time | Month 3 | 106 Participants |
| Staff Study Participants | Number of Participants With Injection Site Reactions (ISRs) Over Time | Month 4 | 105 Participants |
| Staff Study Participants | Number of Participants With Injection Site Reactions (ISRs) Over Time | Month 5 | 104 Participants |
| Staff Study Participants | Number of Participants With Injection Site Reactions (ISRs) Over Time | Month 9 | 100 Participants |
| Staff Study Participants | Number of Participants With Injection Site Reactions (ISRs) Over Time | Month 10 | 100 Participants |
| Staff Study Participants | Number of Participants With Injection Site Reactions (ISRs) Over Time | Month 11 | 100 Participants |
| Staff Study Participants | Number of Participants With Injection Site Reactions (ISRs) Over Time | Month 12 | 101 Participants |
Secondary
Number of Participants With Injection Site Reactions (ISRs) Over Time From Month 13 to Month 30
Local tolerability was measured by injection site reaction (ISR), for example; bruise at the site of injection and/or itching, pain, blistering or skin damage. ISRs were assigned to the most recent planned injection visit prior to/on the onset date of the ISR. Number of participants with ISRs by each assigned injection visit is presented.
Time frame: Months 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29 and 30
Population: Safety population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Staff Study Participants | Number of Participants With Injection Site Reactions (ISRs) Over Time From Month 13 to Month 30 | Month 13 | 99 Participants |
| Staff Study Participants | Number of Participants With Injection Site Reactions (ISRs) Over Time From Month 13 to Month 30 | Month 14 | 99 Participants |
| Staff Study Participants | Number of Participants With Injection Site Reactions (ISRs) Over Time From Month 13 to Month 30 | Month 15 | 98 Participants |
| Staff Study Participants | Number of Participants With Injection Site Reactions (ISRs) Over Time From Month 13 to Month 30 | Month 16 | 96 Participants |
| Staff Study Participants | Number of Participants With Injection Site Reactions (ISRs) Over Time From Month 13 to Month 30 | Month 17 | 95 Participants |
| Staff Study Participants | Number of Participants With Injection Site Reactions (ISRs) Over Time From Month 13 to Month 30 | Month 18 | 97 Participants |
| Staff Study Participants | Number of Participants With Injection Site Reactions (ISRs) Over Time From Month 13 to Month 30 | Month 19 | 95 Participants |
| Staff Study Participants | Number of Participants With Injection Site Reactions (ISRs) Over Time From Month 13 to Month 30 | Month 20 | 86 Participants |
| Staff Study Participants | Number of Participants With Injection Site Reactions (ISRs) Over Time From Month 13 to Month 30 | Month 21 | 75 Participants |
| Staff Study Participants | Number of Participants With Injection Site Reactions (ISRs) Over Time From Month 13 to Month 30 | Month 22 | 65 Participants |
| Staff Study Participants | Number of Participants With Injection Site Reactions (ISRs) Over Time From Month 13 to Month 30 | Month 23 | 49 Participants |
| Staff Study Participants | Number of Participants With Injection Site Reactions (ISRs) Over Time From Month 13 to Month 30 | Month 24 | 35 Participants |
| Staff Study Participants | Number of Participants With Injection Site Reactions (ISRs) Over Time From Month 13 to Month 30 | Month 25 | 19 Participants |
| Staff Study Participants | Number of Participants With Injection Site Reactions (ISRs) Over Time From Month 13 to Month 30 | Month 26 | 11 Participants |
| Staff Study Participants | Number of Participants With Injection Site Reactions (ISRs) Over Time From Month 13 to Month 30 | Month 27 | 8 Participants |
| Staff Study Participants | Number of Participants With Injection Site Reactions (ISRs) Over Time From Month 13 to Month 30 | Month 28 | 7 Participants |
| Staff Study Participants | Number of Participants With Injection Site Reactions (ISRs) Over Time From Month 13 to Month 30 | Month 29 | 4 Participants |
| Staff Study Participants | Number of Participants With Injection Site Reactions (ISRs) Over Time From Month 13 to Month 30 | Month 30 | 1 Participants |
Secondary
Number of Participants With Reported Acceptability of the Amount of Time Spent in the Clinic for Each Injection Visit
The results for participant reported acceptability of the amount of time spent in the clinic for each injection visit is presented. Participants were asked to rate the acceptability of the amount of time spent in the clinic for each injection visit as extremely acceptable, very acceptable, somewhat acceptable, a little acceptable and not at all acceptable.
Time frame: At Month 12
Population: Safety population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Staff Study Participants | Number of Participants With Reported Acceptability of the Amount of Time Spent in the Clinic for Each Injection Visit | Extremely acceptable | 62 Participants |
| Staff Study Participants | Number of Participants With Reported Acceptability of the Amount of Time Spent in the Clinic for Each Injection Visit | Very acceptable | 33 Participants |
| Staff Study Participants | Number of Participants With Reported Acceptability of the Amount of Time Spent in the Clinic for Each Injection Visit | Somewhat acceptable | 7 Participants |
| Staff Study Participants | Number of Participants With Reported Acceptability of the Amount of Time Spent in the Clinic for Each Injection Visit | A little acceptable | 0 Participants |
| Staff Study Participants | Number of Participants With Reported Acceptability of the Amount of Time Spent in the Clinic for Each Injection Visit | Not at all acceptable | 0 Participants |
Secondary
Number of Participants With Serious Adverse Events (SAEs) and Common (>=5 Percent [%]) Non-serious Adverse Events (Non-SAEs)
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose may result in death or is life-threatening or requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity or is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment or is associated with liver injury and impaired liver function. Number of participants with any SAE and common (\>=5%) non-SAEs are presented. Adverse events which were not serious have been considered as non-serious adverse events.
Time frame: Up to 30 months
Population: Safety population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Staff Study Participants | Number of Participants With Serious Adverse Events (SAEs) and Common (>=5 Percent [%]) Non-serious Adverse Events (Non-SAEs) | Common (>=5%) non-SAEs | 101 Participants |
| Staff Study Participants | Number of Participants With Serious Adverse Events (SAEs) and Common (>=5 Percent [%]) Non-serious Adverse Events (Non-SAEs) | SAEs | 9 Participants |
Secondary
Number of Participants With the Reported Time Spent in Clinic/Practice for Each Injection Visit
Number of participants with the reported time spent in clinic/practice for each injection visit is presented.
Time frame: At Month 12
Population: Safety population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Staff Study Participants | Number of Participants With the Reported Time Spent in Clinic/Practice for Each Injection Visit | 1-15 minutes | 14 Participants |
| Staff Study Participants | Number of Participants With the Reported Time Spent in Clinic/Practice for Each Injection Visit | 16-30 minutes | 51 Participants |
| Staff Study Participants | Number of Participants With the Reported Time Spent in Clinic/Practice for Each Injection Visit | 31-45 minutes | 23 Participants |
| Staff Study Participants | Number of Participants With the Reported Time Spent in Clinic/Practice for Each Injection Visit | 46-60 minutes | 12 Participants |
| Staff Study Participants | Number of Participants With the Reported Time Spent in Clinic/Practice for Each Injection Visit | More than 60 minutes | 1 Participants |
Secondary
Number of Participants With Treatment Emergent Genotypic Resistance to CAB and RPV
Plasma samples were collected for drug resistance testing. Number of participants who met CVF criteria (two consecutive plasma HIV-1 RNA levels \>=200 copies/mL after prior suppression to \<200 copies/mL) with emergent genotypic resistance is summarized.
Time frame: Up to 30 months
Population: Safety population. Only participants with CVF were included in the analysis
Secondary
Number of Participants With Treatment Emergent Phenotypic Resistance to CAB and RPV
Plasma samples were collected for drug resistance testing. Number of participants who met CVF criteria (two consecutive plasma HIV-1 RNA levels \>=200 copies/mL after prior suppression to \<200 copies/mL) with emergent phenotypic resistance is summarized.
Time frame: Up to 30 months
Population: Safety population. Only participants with CVF were included in the analysis
Secondary
Number of Participants With Urinalysis Result of Potential Clinical Importance
Urine samples were collected to analyze the urine parameters: Protein, occult blood or glucose. Potential clinical importance is defined as an increase in protein (dipstick) or occult blood (dipstick) post-Baseline relative to Baseline. Number of participants with results of potential clinical importance in any of the urine parameters is presented.
Time frame: Up to Month 12
Population: Safety population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Staff Study Participants | Number of Participants With Urinalysis Result of Potential Clinical Importance | 8 Participants |
Secondary
Number of Participants With Urinalysis Result of Potential Clinical Importance Through End of Study
Urine samples were collected to analyze the urine parameters: Protein, occult blood or glucose. Potential clinical importance is defined as an increase in protein (dipstick) or occult blood (dipstick) post-Baseline relative to Baseline. Number of participants with results of potential clinical importance in any of the urine parameters is presented.
Time frame: Up to 30 months
Population: Safety population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Staff Study Participants | Number of Participants With Urinalysis Result of Potential Clinical Importance Through End of Study | 1 Participants |
Secondary
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
The helpfulness of the toolkit resources was identified using a 19-item survey and the helpfulness of the resources were rated on a five point scale where 1=Extremely helpful (EH), 2=Very helpful (VH), 3=Somewhat helpful (SH), 4=A little helpful (ALH) and 5=Not at all helpful (NAAH). Not Applicable (NA) in the categories mean response was not offered. The toolkit resources consisted of website for clinical staff, video on giving CAB + RPV LA, how to use new packaging card, study factsheet for healthcare providers, consultation aid, reminder e-application, reminder SMS/text, face-to-face training by healthcare staff, facilitation group calls, WB treatment planner, WB health clinic capacity planning tool, injection flashcards, website for participants, what to expect factsheet for participants, handbook, FAQ chatbot, trial guide app, video-what to expect and hot and cold packs. The number of participants with the rating on helpfulness for each toolkit resources at Month 12 is presented.
Time frame: At Month 12
Population: All staff study participants population. Only those staff study participants who completed the survey were included in the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | Website for clinical staff, EH | 2 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | Website for clinical staff, VH | 2 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | Website for clinical staff, SH | 6 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | Website for clinical staff, ALH | 0 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | Website for clinical staff, NAAH | 0 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | Website for clinical staff, NA | 13 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | Video on giving CAB + RPV LA injection, EH | 4 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | Video on giving CAB + RPV LA injection, VH | 6 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | Video on giving CAB + RPV LA injection, SH | 7 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | Video on giving CAB + RPV LA injection, ALH | 0 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | Video on giving CAB + RPV LA injection, NAAH | 0 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | Video on giving CAB + RPV LA injection, NA | 6 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | How to use new packaging card, EH | 1 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | How to use new packaging card, VH | 3 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | How to use new packaging card, SH | 5 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | How to use new packaging card, ALH | 0 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | How to use new packaging card, NAAH | 0 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | How to use new packaging card, NA | 14 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | Study factsheet for healthcare providers, EH | 1 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | Study factsheet for healthcare providers, VH | 6 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | Study factsheet for healthcare providers, SH | 4 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | Study factsheet for healthcare providers, ALH | 1 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | Study factsheet for healthcare providers, NAAH | 0 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | Study factsheet for healthcare providers, NA | 11 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | Consultation aid, EH | 1 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | Consultation aid, VH | 1 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | Consultation aid, SH | 2 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | Consultation aid, ALH | 5 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | Consultation aid, NAAH | 0 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | Consultation aid, NA | 14 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | Reminder e-app, EH | 0 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | Reminder e-app, VH | 1 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | Reminder e-app, SH | 0 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | Reminder e-app, ALH | 0 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | Reminder e-app, NAAH | 1 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | Reminder e-app, NA | 21 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | Reminder SMS/text, EH | 1 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | Reminder SMS/text, VH | 1 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | Reminder SMS/text, SH | 0 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | Reminder SMS/text, ALH | 1 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | Reminder SMS/text, NAAH | 2 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | Reminder SMS/text, NA | 18 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | F2F training by healthcare staff, EH | 6 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | F2F training by healthcare staff, VH | 10 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | F2F training by healthcare staff, SH | 3 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | F2F training by healthcare staff, ALH | 0 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | F2F training by healthcare staff, NAAH | 0 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | F2F training by healthcare staff, NA | 4 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | Facilitation group calls, EH | 1 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | Facilitation group calls, VH | 1 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | Facilitation group calls, SH | 5 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | Facilitation group calls, ALH | 5 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | Facilitation group calls, NAAH | 4 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | Facilitation group calls, NA | 7 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | WB treatment planner, EH | 4 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | WB treatment planner, VH | 1 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | WB treatment planner, SH | 4 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | WB treatment planner, ALH | 0 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | WB treatment planner, NAAH | 1 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | WB health clinic capacity planning tool, EH | 0 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | WB health clinic capacity planning tool, VH | 0 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | WB health clinic capacity planning tool, SH | 2 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | WB health clinic capacity planning tool, ALH | 1 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | WB health clinic capacity planning tool, NAAH | 0 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | WB health clinic capacity planning tool, NA | 20 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | Injection flashcard for participants, EH | 2 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | Injection flashcard for participants, VH | 7 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | Injection flashcard for participants, SH | 2 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | Injection flashcard for participants, ALH | 1 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | Injection flashcard for participants, NAAH | 0 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | Injection flashcard for participants, NA | 11 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | Website for participants, EH | 0 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | Website for participants, VH | 3 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | Website for participants, SH | 3 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | Website for participants, ALH | 0 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | Website for participants, NAAH | 0 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | Website for participants, NA | 17 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | What to expect factsheet for participants, EH | 2 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | What to expect factsheet for participants, VH | 7 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | What to expect factsheet for participants, SH | 6 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | What to expect factsheet for participants, ALH | 1 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | What to expect factsheet for participants, NAAH | 0 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | What to expect factsheet for participants, NA | 7 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | Participant handbook, EH | 1 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | Participant handbook, VH | 5 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | Participant handbook, SH | 5 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | Participant handbook, ALH | 2 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | Participant handbook, NAAH | 0 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | Participant handbook, NA | 10 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | FAQs chatbot, EH | 0 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | FAQs chatbot, VH | 1 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | FAQs chatbot, SH | 0 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | FAQs chatbot, ALH | 1 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | FAQs chatbot, NAAH | 1 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | FAQs chatbot, NA | 20 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | Trial guide app, EH | 0 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | Trial guide app, VH | 0 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | Trial guide app, SH | 0 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | Trial guide app, ALH | 0 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | Trial guide app, NAAH | 1 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | Trial guide app, NA | 22 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | Video-what to expect, EH | 4 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | Video-what to expect, VH | 7 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | Video-what to expect, SH | 3 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | Video-what to expect, ALH | 0 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | Video-what to expect, NAAH | 0 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | Video-what to expect, NA | 9 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | Hot and cold packs for participants, EH | 6 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | Hot and cold packs for participants, VH | 6 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | Hot and cold packs for participants, SH | 6 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | Hot and cold packs for participants, ALH | 3 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | Hot and cold packs for participants, NAAH | 0 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | Hot and cold packs for participants, NA | 2 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | WB treatment planner, NA | 13 Participants |
Secondary
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
The helpfulness of the toolkit resources was identified using a 19-item survey and the helpfulness of the resources were rated on a five point scale where 1=Extremely helpful (EH), 2=Very helpful (VH), 3=Somewhat helpful (SH), 4=A little helpful (ALH) and 5=Not at all helpful (NAAH). Not Applicable (NA) in the categories mean response was not offered. The toolkit resources consisted of website for clinical staff, video on giving CAB + RPV LA, how to use new packaging card, study factsheet for healthcare providers, consultation aid, reminder e-application, reminder SMS/text, face-to-face training by healthcare staff, facilitation group calls, web-based (WB) treatment planner, WB health clinic capacity planning tool, injection flashcards, website for participants, what to expect factsheet, handbook, FAQ chatbot, trial guide app, video-what to expect and hot and cold packs. The number of participants with the rating on helpfulness for each toolkit resources at Month 4 is presented.
Time frame: At Month 4
Population: All staff study participants population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | Website for participants, VH | 3 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | Website for participants, SH | 4 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | Website for participants, ALH | 2 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | Website for participants, NAAH | 0 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | Website for participants, NA | 15 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | What to expect factsheet for participants, EH | 1 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | What to expect factsheet for participants, VH | 5 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | What to expect factsheet for participants, SH | 7 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | What to expect factsheet for participants, ALH | 2 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | What to expect factsheet for participants, NAAH | 0 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | What to expect factsheet for participants, NA | 9 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | Participant handbook, EH | 3 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | Participant handbook, VH | 3 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | Participant handbook, SH | 5 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | Participant handbook, ALH | 0 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | Participant handbook, NAAH | 1 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | Participant handbook, NA | 12 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | Frequently asked questions (FAQs) chatbot, EH | 0 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | FAQs chatbot, VH | 1 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | FAQs chatbot, SH | 3 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | FAQs chatbot, ALH | 1 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | FAQs chatbot, NAAH | 1 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | FAQs chatbot, NA | 18 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | Trial guide app, EH | 0 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | Trial guide app, VH | 1 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | Trial guide app, SH | 2 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | Trial guide app, ALH | 1 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | Trial guide app, NAAH | 1 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | Trial guide app, NA | 19 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | Video-what to expect, EH | 7 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | Video-what to expect, VH | 4 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | Video-what to expect, SH | 1 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | Video-what to expect, ALH | 3 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | Video-what to expect, NAAH | 1 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | Video-what to expect, NA | 8 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | Hot and cold packs for participants, EH | 5 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | Hot and cold packs for participants, VH | 5 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | Hot and cold packs for participants, SH | 6 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | Hot and cold packs for participants, ALH | 2 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | Hot and cold packs for participants, NAAH | 0 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | Hot and cold packs for participants, NA | 6 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | Website for clinical staff, EH | 2 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | Website for clinical staff, VH | 3 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | Website for clinical staff, SH | 3 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | Website for clinical staff, ALH | 5 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | Website for clinical staff, NAAH | 1 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | Website for clinical staff, NA | 10 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | Video on giving CAB + RPV LA injection, EH | 3 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | Video on giving CAB + RPV LA injection, VH | 6 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | Video on giving CAB + RPV LA injection, SH | 4 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | Video on giving CAB + RPV LA injection, ALH | 2 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | Video on giving CAB + RPV LA injection, NAAH | 0 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | Video on giving CAB + RPV LA injection, NA | 9 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | How to use new packaging card, EH | 0 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | How to use new packaging card, VH | 6 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | How to use new packaging card, SH | 3 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | How to use new packaging card, ALH | 3 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | How to use new packaging card, NAAH | 1 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | How to use new packaging card, NA | 11 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | Study factsheet for healthcare providers, EH | 1 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | Study factsheet for healthcare providers, VH | 4 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | Study factsheet for healthcare providers, SH | 8 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | Study factsheet for healthcare providers, ALH | 1 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | Study factsheet for healthcare providers, NAAH | 1 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | Study factsheet for healthcare providers, NA | 9 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | Consultation aid, EH | 0 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | Consultation aid, VH | 4 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | Consultation aid, SH | 4 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | Consultation aid, ALH | 2 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | Consultation aid, NAAH | 1 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | Consultation aid, NA | 13 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | Reminder-electronic (e)-application (app), EH | 1 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | Reminder e-app, VH | 2 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | Reminder e-app, SH | 1 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | Reminder e-app, ALH | 2 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | Reminder e-app, NAAH | 0 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | Reminder e-app, NA | 18 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | Reminder short message service (SMS)/text, EH | 1 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | Reminder SMS/text, VH | 1 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | Reminder SMS/text, SH | 1 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | Reminder SMS/text, ALH | 2 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | Reminder SMS/text, NAAH | 0 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | Reminder SMS/text, NA | 19 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | Face to face (F2F) training by healthcare staff, EH | 5 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | F2F training by healthcare staff, VH | 6 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | F2F training by healthcare staff, SH | 3 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | F2F training by healthcare staff, ALH | 1 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | F2F training by healthcare staff, NAAH | 0 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | F2F training by healthcare staff, NA | 9 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | Facilitation group calls, EH | 0 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | Facilitation group calls, VH | 0 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | Facilitation group calls, SH | 7 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | Facilitation group calls, ALH | 8 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | Facilitation group calls, NAAH | 4 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | Facilitation group calls, NA | 5 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | Web-based (WB) treatment planner, EH | 4 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | WB treatment planner, VH | 5 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | WB treatment planner, SH | 1 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | WB treatment planner, ALH | 1 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | WB treatment planner, NAAH | 1 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | WB treatment planner, NA | 12 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | WB health clinic capacity planning tool, EH | 0 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | WB health clinic capacity planning tool, VH | 1 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | WB health clinic capacity planning tool, SH | 0 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | WB health clinic capacity planning tool, ALH | 0 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | WB health clinic capacity planning tool, NAAH | 1 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | WB health clinic capacity planning tool, NA | 22 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | Injection flashcard for participants, EH | 2 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | Injection flashcard for participants, VH | 2 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | Injection flashcard for participants, SH | 5 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | Injection flashcard for participants, ALH | 3 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | Injection flashcard for participants, NAAH | 0 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | Injection flashcard for participants, NA | 12 Participants |
| Staff Study Participants | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | Website for participants, EH | 0 Participants |
Secondary
Number of Staff Study Participants Using Support Materials/Toolkit at Month 12
Number of staff study participants using support materials/toolkit at Month 12 was assessed by variables: Not used, Used similar resource, used the support materials/toolkit. The support materials/toolkit consisted of website for clinical staff, video on giving CAB + RPV LA, how to use new packaging card, study factsheet for healthcare providers, consultation aid, reminder e-application, reminder SMS/text, face-to-face training by healthcare staff, facilitation group calls, web-based (WB) treatment planner, WB health clinic capacity planning tool, injection flashcards, website for participants, what to expect factsheet for participants, handbook, FAQ chatbot, trial guide app, video-what to expect and hot and cold packs.
Time frame: At Month 12
Population: All staff study participants population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 12 | Website for clinical staff, not used | 13 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 12 | Website for clinical staff, used similar | 0 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 12 | Website for clinical staff, used | 10 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 12 | Video on giving CAB + RPV LA injection, not used | 6 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 12 | Video on giving CAB + RPV LA injection, used similar | 0 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 12 | Video on giving CAB + RPV LA injection, used | 17 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 12 | How to use new packaging card, not used | 14 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 12 | How to use new packaging card, used similar | 0 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 12 | How to use new packaging card, used | 9 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 12 | Study factsheet for HCP, not used | 10 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 12 | Study factsheet for HCP, used similar | 1 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 12 | Study factsheet for HCP, used | 12 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 12 | Consultation aid, not used | 14 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 12 | Consultation aid, used similar | 0 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 12 | Consultation aid, used | 9 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 12 | Reminder, e-app, not used | 15 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 12 | Reminder e-app, used similar | 6 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 12 | Reminder e-app, used | 2 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 12 | Reminder SMS/text, not used | 8 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 12 | Reminder SMS/text, used similar | 10 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 12 | Reminder SMS/text, used | 5 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 12 | F2F training, not used | 3 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 12 | F2F training, used similar | 1 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 12 | F2F training, used | 19 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 12 | Facilitation group calls, not used | 6 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 12 | Facilitation group calls, used similar | 1 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 12 | Facilitation group calls, used | 16 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 12 | WB treatment planner, not used | 11 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 12 | WB treatment planner, used similar | 2 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 12 | WB treatment planner, used | 10 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 12 | WB health clinic capacity planning tool, not used | 16 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 12 | WB health clinic planning tool, used similar | 4 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 12 | WB health clinic capacity planning tool, used | 3 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 12 | Injection flashcard, not used | 9 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 12 | Injection flashcard, used similar | 2 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 12 | Injection flashcard, used | 12 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 12 | Website for participants, not used | 15 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 12 | Website for participants, used similar | 2 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 12 | Website for participants, used | 6 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 12 | What to expect factsheet, not used | 5 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 12 | What to expect factsheet, used similar | 2 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 12 | What to expect factsheet, used | 16 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 12 | Participant handbook, not used | 8 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 12 | Participant handbook, used similar | 2 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 12 | Trial guide app, not used | 20 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 12 | Participant handbook, used | 13 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 12 | FAQ chatbot, not used | 18 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 12 | FAQ chatbot, used similar | 2 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 12 | FAQ chatbot, used | 3 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 12 | Trail guide app, used similar | 2 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 12 | Trial guide app, used | 1 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 12 | Video-what to expect, not used | 8 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 12 | Video-what to expect, used similar | 1 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 12 | Video-what to expect, used | 14 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 12 | Hot and cold pack, not used | 2 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 12 | Hot and cold pack, used similar | 0 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 12 | Hot and cold pack, used | 21 Participants |
Secondary
Number of Staff Study Participants Using Support Materials/Toolkit at Month 4
Number of staff study participants using support materials/toolkit at Month 4 was assessed by variables: Not used, Used similar resource, used the support materials/toolkit. The support materials/toolkit consisted of website for clinical staff, video on giving CAB + RPV LA, how to use new packaging card, study factsheet for healthcare providers, consultation aid, reminder e-application, reminder SMS/text, face-to-face training by healthcare staff, facilitation group calls, web-based (WB) treatment planner, WB health clinic capacity planning tool, injection flashcards, website for participants, what to expect factsheet for participants, handbook, FAQ chatbot, trial guide app, video-what to expect and hot and cold packs.
Time frame: At Month 4
Population: All Staff study participants population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 4 | Website for clinical staff, not used | 9 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 4 | Website for clinical staff, used similar | 1 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 4 | Website for clinical staff, used | 14 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 4 | Video on giving CAB + RPV LA injection, not used | 8 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 4 | Video on giving CAB + RPV LA injection, used similar | 1 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 4 | Video on giving CAB + RPV LA injection, used | 15 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 4 | How to use new packaging card, not used | 11 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 4 | How to use new packaging card, used similar | 0 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 4 | How to use new packaging card, used | 13 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 4 | Study factsheet for HCP, not used | 8 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 4 | Study factsheet for HCP, used similar | 1 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 4 | Study factsheet for HCP, used | 15 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 4 | Consultation aid, not used | 12 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 4 | Consultation aid, used similar | 1 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 4 | Consultation aid, used | 11 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 4 | Reminder, e-app, not used | 16 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 4 | Reminder e-app, used similar | 2 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 4 | Reminder e-app, used | 6 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 4 | Reminder SMS/text, not used | 15 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 4 | Reminder SMS/text, used similar | 4 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 4 | Reminder SMS/text, used | 5 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 4 | F2F training, not used | 8 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 4 | F2F training, used similar | 1 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 4 | F2F training, used | 15 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 4 | Facilitation group calls, not used | 4 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 4 | Facilitation group calls, used similar | 1 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 4 | Facilitation group calls, used | 19 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 4 | WB treatment planner, not used | 12 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 4 | WB treatment planner, used similar | 0 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 4 | WB treatment planner, used | 12 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 4 | WB health clinic capacity planning tool, not used | 20 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 4 | WB health clinic planning tool, used similar | 2 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 4 | WB health clinic capacity planning tool, used | 2 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 4 | Injection flashcard, not used | 10 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 4 | Injection flashcard, used similar | 2 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 4 | Injection flashcard, used | 12 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 4 | Website for participants, not used | 14 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 4 | Website for participants, used similar | 1 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 4 | Website for participants, used | 9 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 4 | What to expect factsheet, not used | 8 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 4 | What to expect factsheet, used similar | 1 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 4 | What to expect factsheet, used | 15 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 4 | Participant handbook, not used | 12 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 4 | Participant handbook, used similar | 0 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 4 | Participant handbook, used | 12 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 4 | FAQ chatbot, not used | 18 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 4 | FAQ chatbot, used similar | 0 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 4 | FAQ chatbot, used | 6 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 4 | Trial guide app, not used | 19 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 4 | Trail guide app, used similar | 0 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 4 | Trial guide app, used | 5 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 4 | Video-what to expect, not used | 8 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 4 | Video-what to expect, used similar | 0 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 4 | Video-what to expect, used | 16 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 4 | Hot and cold pack, not used | 6 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 4 | Hot and cold pack, used similar | 0 Participants |
| Staff Study Participants | Number of Staff Study Participants Using Support Materials/Toolkit at Month 4 | Hot and cold pack, used | 18 Participants |
Secondary
Percentage of Participants Who Discontinue Treatment or Withdraw From Study Due to AEs Over Time
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Percentage of participants with adverse events leading to study treatment or study withdrawal has been presented. The percentage value presented has been rounded off.
Time frame: Up to 30 months
Population: Safety population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Staff Study Participants | Percentage of Participants Who Discontinue Treatment or Withdraw From Study Due to AEs Over Time | 7 Percentage of participants |
Secondary
Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants
BIM is a 23-item survey which assessed barriers (i.e., difficulties and challenges) to successful implementation of the CAB LA + RPV LA injection treatment in the study clinic/practices. For each item, providers were asked to rate how much they agreed or disagreed that the issue is a barrier based on their experiences with implementing the CAB + RPV treatment on a five point rating scale (1=completely disagree to 5=completely agree). It is presented as fewer perceived barriers (FPB)=all negative change in scores from Baseline, some perceived barriers (SPB)=change in score of 0 from Baseline, and greater/more perceived barriers (MPB)=all positive change in scores from Baseline.
Time frame: Baseline and Month 12
Population: All staff study participants population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Staff Study Participants | Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants | Failing due to missed doses/injection apts, FPB | 78.1 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants | Failing due to missed doses/injection apts, SPB | 13.0 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants | Failing due to missed doses/injection apts, MPB | 8.7 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants | Flagging/awareness of missed injection visits, FPB | 69.5 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants | Flagging/awareness of missed injection visits, SPB | 26.1 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants | Flagging/awareness of missed injection visits, MPB | 4.3 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants | Ability to keep monthly appointments, FPB | 65.2 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants | Ability to keep monthly appointments, SPB | 34.8 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants | Ability to keep monthly appointments, MPB | 0.0 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants | Transportation for monthly apts, FPB | 60.8 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants | Transportation for monthly apts, SPB | 34.8 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants | Transportation for monthly apts, MPB | 4.3 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants | Time for new method implementation CAB+RPV LA, FPB | 60.8 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants | Time for new method implementation CAB+RPV LA, SPB | 26.1 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants | Time for new method implementation CAB+RPV LA, MPB | 13.0 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants | Incentives for clinical practice change, FPB | 60.7 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants | Incentives for clinical practice change, SPB | 21.7 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants | Incentives for clinical practice change, MPB | 17.4 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants | Interest in the new treatment, FPB | 56.5 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants | Interest in the new treatment, SPB | 26.1 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants | Competing clinic priorities, FPB | 52.1 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants | Interest in the new treatment, MPB | 17.4 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants | Transition from oral to injection treatment, FPB | 56.5 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants | Transition from oral to injection treatment, SPB | 39.1 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants | Transition from oral to injection treatment, MPB | 4.3 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants | Competing clinic priorities, SPB | 43.5 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants | Competing clinic priorities, MPB | 4.3 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants | Manage for inj visits with other care need, FPB | 52.1 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants | Manage for inj visits with other care need,SPB | 43.5 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants | Manage for inj visit with other care need, MPB | 4.3 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants | Number of exam rooms for injection, FPB | 52.1 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants | Number of exam rooms for injection, SPB | 21.7 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants | Number of exam rooms for injection, MPB | 26.1 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants | Staff resourcing for clinic flow, FPB | 52.1 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants | Staff resourcing for clinic flow, SPB | 30.4 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants | Staff resourcing for clinic flow, MPB | 17.4 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants | Scheduling of apt reminders, FPB | 52.1 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants | Scheduling of apt reminders, SPB | 34.8 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants | Scheduling of apt reminders, MPB | 13.0 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants | Time to administer the injection, FPB | 47.8 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants | Time to administer the injection, SPB | 43.5 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants | Time to administer the injection, MPB | 8.7 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants | Lack of familiarity with tools/resources, FPB | 47.7 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants | Lack of familiarity with tools/resources, SPB | 39.1 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants | Lack of familiarity with tools/resources, MPB | 13.0 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants | Rescheduling missed injections, FPB | 47.7 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants | Rescheduling missed injections, SPB | 39.1 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants | Rescheduling missed injections, MPB | 13.0 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants | Staff preparation, FPB | 43.4 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants | Staff preparation, SPB | 47.8 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants | Staff preparation, MPB | 8.7 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants | Scheduling of monthly apts, FPB | 43.4 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants | Scheduling of monthly apts, SPB | 30.4 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants | Scheduling of monthly apts, MPB | 8.7 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants | Answering questions between visits, FPB | 39.1 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants | Answering questions between visits, SPB | 43.5 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants | Answering questions between visits, MPB | 17.4 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants | Leadership support, FPB | 39.0 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants | Leadership support, SPB | 43.5 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants | Leadership support, MPB | 17.4 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants | Injection/pain soreness, FPB | 34.8 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants | Injection/pain soreness, SPB | 56.5 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants | Injection/pain soreness, MPB | 8.7 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants | Staff buy-in, FPB | 34.8 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants | Staff buy-in, SPB | 56.5 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants | Staff buy-in, MPB | 8.6 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants | Storage/refrigeration, FPB | 34.8 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants | Storage/refrigeration, SPB | 43.5 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants | Storage/refrigeration, MPB | 21.7 Percentage of participants |
Secondary
Percentage of Participants With Confirmed Virologic Failure (CVF)
Plasma samples were collected for quantitative analysis of HIV-1 RNA. The CVF is defined as rebound as indicated by two consecutive plasma HIV-1 RNA levels greater than or equal to (\>=)200 copies/mL after prior suppression to \<200 copies/mL.
Time frame: Up to 30 months
Population: Safety population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Staff Study Participants | Percentage of Participants With Confirmed Virologic Failure (CVF) | 0 Percentage of participants |
Secondary
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Participants with HIV infection were asked about their utilization of each element of the support materials/toolkit and were asked to categorize it as Extremely helpful (EH) Very helpful (VH), Somewhat helpful (SH), A little helpful (ALH), Not at all helpful (NAAH), did not receive (DNR), Received but did not use (RBDNU) and missing. Not Applicable (NA) in the data means participants were not offered the response option. The support materials/toolkit consisted of information and resources, hot and cold pack, written materials, website for participants, video, verbal information, reminder calls, reminder text messages, reminder app, peer group information session and appointments outside work time. Percentage of participants with the rating on helpfulness for each toolkit resources is presented.
Time frame: At Month 4
Population: Safety population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Apts outside work time, Missing | 0.0 Percentage of participants |
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Information and resources, EH | 49.5 Percentage of participants |
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Information and resources, VH | 38.1 Percentage of participants |
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Information and resources, SH | 6.7 Percentage of participants |
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Information and resources, ALH | 1.9 Percentage of participants |
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Information and resources, NAAH | 0.0 Percentage of participants |
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Information and resources, DNR | 3.8 Percentage of participants |
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Information and resources, RBDNU | 0.0 Percentage of participants |
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Information and resources, Missing | 0.0 Percentage of participants |
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Hot and cold pack, EH | 19.0 Percentage of participants |
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Hot and cold pack, VH | 8.6 Percentage of participants |
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Hot and cold pack, SH | 21.9 Percentage of participants |
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Hot and cold pack, ALH | 8.6 Percentage of participants |
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Hot and cold pack, NAAH | 2.9 Percentage of participants |
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Hot and cold pack, DNR | 14.3 Percentage of participants |
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Hot and cold pack, RBDNU | 23.8 Percentage of participants |
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Hot and cold pack, Missing | 1.0 Percentage of participants |
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Written materials, EH | 38.1 Percentage of participants |
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Written materials, VH | 35.2 Percentage of participants |
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Written materials, SH | 12.4 Percentage of participants |
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Written materials, ALH | 1.9 Percentage of participants |
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Written materials, NAAH | 1.0 Percentage of participants |
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Written materials, DNR | 1.9 Percentage of participants |
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Written materials, RBDNU | 9.5 Percentage of participants |
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Written materials, Missing | 0.0 Percentage of participants |
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Website, EH | 21.0 Percentage of participants |
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Website, VH | 28.6 Percentage of participants |
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Website, SH | 5.7 Percentage of participants |
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Website, ALH | 1.9 Percentage of participants |
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Website, NAAH | 1.9 Percentage of participants |
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Website, DNR | 6.7 Percentage of participants |
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Website, RBDNU | 34.3 Percentage of participants |
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Website, Missing | 0.0 Percentage of participants |
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Video, EH | 28.6 Percentage of participants |
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Video, VH | 41.0 Percentage of participants |
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Video, SH | 12.4 Percentage of participants |
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Video, ALH | 4.8 Percentage of participants |
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Video, NAAH | 1.9 Percentage of participants |
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Video, DNR | 8.6 Percentage of participants |
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Video, RBDNU | 2.9 Percentage of participants |
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Video, Missing | 0.0 Percentage of participants |
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Verbal information, EH | 62.9 Percentage of participants |
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Verbal information, VH | 32.4 Percentage of participants |
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Verbal information, SH | 3.8 Percentage of participants |
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Verbal information, ALH | 0.0 Percentage of participants |
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Verbal information, NAAH | 0.0 Percentage of participants |
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Verbal information, DNR | 0.0 Percentage of participants |
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Verbal information, RBDNU | 0.0 Percentage of participants |
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Verbal information, Missing | 1.0 Percentage of participants |
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Reminder calls, EH | 61.0 Percentage of participants |
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Reminder calls, VH | 23.8 Percentage of participants |
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Reminder calls, SH | 4.8 Percentage of participants |
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Reminder calls, ALH | 4.8 Percentage of participants |
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Reminder calls, NAAH | 0.0 Percentage of participants |
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Reminder calls, DNR | 4.8 Percentage of participants |
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Reminder calls, RBDNU | 0.0 Percentage of participants |
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Reminder calls, Missing | 1.0 Percentage of participants |
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Reminder text messages, EH | 56.2 Percentage of participants |
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Reminder text messages, VH | 19.0 Percentage of participants |
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Reminder text messages, SH | 4.8 Percentage of participants |
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Reminder text messages, ALH | 1.0 Percentage of participants |
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Reminder text messages, NAAH | 0.0 Percentage of participants |
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Reminder text messages, DNR | 18.1 Percentage of participants |
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Reminder text messages, RBDNU | 0.0 Percentage of participants |
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Reminder text messages, Missing | 1.0 Percentage of participants |
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Reminder app, EH | 23.8 Percentage of participants |
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Reminder app, VH | 16.2 Percentage of participants |
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Reminder app, SH | 2.9 Percentage of participants |
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Reminder app, ALH | 1.9 Percentage of participants |
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Reminder app, NAAH | 0.0 Percentage of participants |
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Reminder app, DNR | 26.7 Percentage of participants |
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Reminder app, RBDNU | 28.6 Percentage of participants |
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Reminder app, Missing | 0.0 Percentage of participants |
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Peer group informational (info) session, EH | 22.9 Percentage of participants |
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Peer group info session, VH | 20.0 Percentage of participants |
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Peer group info session, SH | 33.3 Percentage of participants |
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Peer group info session, ALH | 8.6 Percentage of participants |
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Peer group info session, NAAH | 14.3 Percentage of participants |
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Peer group info session, DNR | NA Percentage of participants |
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Peer group info session, RBDNU | NA Percentage of participants |
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Peer group info session, Missing | 1.0 Percentage of participants |
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Apts outside work time, EH | 57.1 Percentage of participants |
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Apts outside work time, VH | 26.7 Percentage of participants |
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Apts outside work time, SH | 6.7 Percentage of participants |
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Apts outside work time, ALH | 4.8 Percentage of participants |
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Apts outside work time, NAAH | 4.8 Percentage of participants |
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Apts outside work time, DNR | NA Percentage of participants |
| Staff Study Participants | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Apts outside work time, RBDNU | NA Percentage of participants |
Secondary
Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) Less Than (<)50 Copies/Milliliter (c/mL) by Modified Food and Drug Administration (FDA) Snapshot Algorithm
Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with plasma HIV-1 RNA \<50 c/mL (virologic success) was evaluated using the modified Food and Drug Administration (FDA) snapshot algorithm with Coronavirus Disease 2019 (COVID-19) related missing value imputed using the last observation carried forward (LOCF) approach.
Time frame: Month 1, Month 2, Month 4, Month 6, Month 8, Month 10 and Month 12
Population: Safety population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Staff Study Participants | Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) Less Than (<)50 Copies/Milliliter (c/mL) by Modified Food and Drug Administration (FDA) Snapshot Algorithm | Month 1 | 93.9 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) Less Than (<)50 Copies/Milliliter (c/mL) by Modified Food and Drug Administration (FDA) Snapshot Algorithm | Month 2 | 94.8 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) Less Than (<)50 Copies/Milliliter (c/mL) by Modified Food and Drug Administration (FDA) Snapshot Algorithm | Month 4 | 91.3 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) Less Than (<)50 Copies/Milliliter (c/mL) by Modified Food and Drug Administration (FDA) Snapshot Algorithm | Month 6 | 90.4 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) Less Than (<)50 Copies/Milliliter (c/mL) by Modified Food and Drug Administration (FDA) Snapshot Algorithm | Month 8 | 88.7 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) Less Than (<)50 Copies/Milliliter (c/mL) by Modified Food and Drug Administration (FDA) Snapshot Algorithm | Month 10 | 87.8 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) Less Than (<)50 Copies/Milliliter (c/mL) by Modified Food and Drug Administration (FDA) Snapshot Algorithm | Month 12 | 88.7 Percentage of participants |
Secondary
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL - Observed Case
Plasma samples were collected for quantitative analysis of HIV-1 RNA. The percentage value presented has been rounded off.
Time frame: Months 1, Month 2, Month 4, Month 6, Month 8, Month 10, Month 12, Month 13, Month 15, Month 16, Month 18, Month 19, Month 21, Month 22, Month 24, Month 25, Month 27, Month 28 and Month 30
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Staff Study Participants | Percentage of Participants With Plasma HIV-1 RNA <50 c/mL - Observed Case | Month 1; n=112 | 96 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Plasma HIV-1 RNA <50 c/mL - Observed Case | Month 2; n=109 | 100 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Plasma HIV-1 RNA <50 c/mL - Observed Case | Month 4; n=107 | 98 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Plasma HIV-1 RNA <50 c/mL - Observed Case | Month 6; n=103 | 100 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Plasma HIV-1 RNA <50 c/mL - Observed Case | Month 8; n=94 | 100 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Plasma HIV-1 RNA <50 c/mL - Observed Case | Month 10; n=100 | 99 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Plasma HIV-1 RNA <50 c/mL - Observed Case | Month 12, n=101 | 100 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Plasma HIV-1 RNA <50 c/mL - Observed Case | Month 13; n=101 | 100 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Plasma HIV-1 RNA <50 c/mL - Observed Case | Month 15; n=99 | 100 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Plasma HIV-1 RNA <50 c/mL - Observed Case | Month 16; n=94 | 99 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Plasma HIV-1 RNA <50 c/mL - Observed Case | Month 18; n=95 | 100 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Plasma HIV-1 RNA <50 c/mL - Observed Case | Month 19; n=89 | 100 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Plasma HIV-1 RNA <50 c/mL - Observed Case | Month 21; n=75 | 100 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Plasma HIV-1 RNA <50 c/mL - Observed Case | Month 22; n=61 | 100 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Plasma HIV-1 RNA <50 c/mL - Observed Case | Month 24; n=35 | 100 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Plasma HIV-1 RNA <50 c/mL - Observed Case | Month 25; n=17 | 100 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Plasma HIV-1 RNA <50 c/mL - Observed Case | Month 27; n=8 | 100 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Plasma HIV-1 RNA <50 c/mL - Observed Case | Month 28; n=7 | 100 Percentage of participants |
| Staff Study Participants | Percentage of Participants With Plasma HIV-1 RNA <50 c/mL - Observed Case | Month 30; n=1 | 100 Percentage of participants |
Other Pre-specified
Change From Baseline in Urinalysis Parameters: Urine Albumin to Creatinine Ratio
Urine samples were not planned to be collected for the analysis of urine albumin to creatinine ratio. The results for this outcome measure will never be posted.
Time frame: Baseline and up to Month 12
Population: Safety population. This was an other pre-specified outcome measure. The results for this outcome measure will never be posted.
Other Pre-specified
Change From Baseline in Urinalysis Parameters: Urine Phosphate
Urine samples were not planned to be collected for the analysis of urine phosphate. The results for this outcome measure will never be posted.
Time frame: Baseline and up to Month 12
Population: Safety population. This was an other pre-specified outcome measure. The results for this outcome measure will never be posted.
Other Pre-specified
Change From Baseline in Urinalysis Parameters: Urine Protein to Creatinine Ratio
Urine samples were not planned to be collected for the analysis of urine protein to creatinine ratio. The results for this outcome measure will never be posted.
Time frame: Baseline and up to Month 12
Population: Safety population. This was an other pre-specified outcome measure. The results for this outcome measure will never be posted.