HIV Infections
Conditions
Keywords
Cabotegravir, Rilpivirine, Long-acting injectables, Patient study participants, Staff study participants
Brief summary
The overall objective of the CAB LA + RPV LA clinical development program is to develop a highly effective, well-tolerated, two-drug, LA injectable regimen which has the potential to offer improved treatment convenience, compliance and improved quality of life for people living with HIV compared to current standard of care. This interventional study will examine different implementation strategies in different clinic settings across European countries to identify strategies which best meet the needs in each local context and involve both participants receiving study treatment CAB LA + RPV LA (patient study participants \[PSP\]) as well as the healthcare providers at the investigator site level (staff study participants \[SSP\]). SSPs consists of 2 groups: standard and enhanced arm.
Interventions
DRUGCAB OLI
CAB will be available as 30 milligrams (mg) tablet. It will be administered as one tablet once daily with food from Day 1 to Month 1.
DRUGCAB LA
CAB LA 600 mg will be administered as intramuscular (IM) injection.
DRUGRPV OLI
RPV will be available as 25 mg tablet. It will be administered as one tablet once daily with food from Day 1 to Month 1.
DRUGRPV LA
RPV LA 900 mg will be administered as IM injection.
OTHERContinuous Quality Improvement (CQI) calls
CQI will be attended by the enhanced arm (Arm-E). The CQI calls will be conducted to identify problems/challenges, generate plans to address the challenges, and identify how to measure the change that results from the plan.
Sponsors
Janssen Pharmaceuticals
ViiV Healthcare
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
This is an open-label study hence no blinding is required
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants aged 18 years or older at the time of signing the informed consent. * HIV-1 infected and must be suppressed on a guideline recommended active Highly active antiretroviral therapy (HAART) 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 virologic failure (on treatment HIV-1 RNA more than or equal to \[\>=\]200 c/mL). * Documented evidence of at least two plasma HIV-1 RNA measurements \<50 c/mL in the 12 months prior to Screening: at least one \<6 months prior to screening and one 6-12 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 is 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. 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. 2. 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. * 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. * French participants: In France, a participant will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.
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. * 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 \[CDC, 2014\], except cutaneous Kaposi's sarcoma not requiring systemic therapy, and historical or current Cluster of Differentiation 4 (CD4)+ counts \<200 cells per millimeter cube (cells/mm\^3) 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, gluteal implant/ enhancements 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. * Participants who are anticipated to require Hepatitis C virus (HCV) treatment within 12 months must be excluded. Asymptomatic individuals with chronic 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 DAA based therapy being considered with the medical monitor). * Participants with HCV co-infection will be allowed entry into this study if: 1. Liver enzymes meet entry criteria. 2. 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. 3. 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 more than (\>)3.25 is exclusionary. * Fib-4 score 1.45-3.25 requires Medical Monitor consultation Fibrosis 4 score formula: (Age times Aspartate aminotransferase \[AST\]) / (Platelets times (square \[Alanine aminotransferase\]{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 (less than or equal to \[\<=\]325 mg per day) or hereditary coagulation and platelet disorders such as hemophilia or Von Willebrand Disease * Any evidence of primary resistance based on the presence of any major known Integrase inhibitor (INI) or Non-nucleoside reverse transcriptase inhibitor (NNRTI) resistance-associated mutation, except for K103N, by any historical resistance test result. * ALT \>=5 times the upper limit of normal (ULN) or ALT \>=3 times ULN and bilirubin \>=1.5 times ULN (with \>35 percent \[%\] direct bilirubin). * 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 milliliters per minute (mL/min)/1.73 m\^2 via the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation. * 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 except for isoniazid (isonicotinylhydrazid \[INH\]). * Anti-coagulation agents. * Immunomodulators that alter immune responses such as chronic systemic corticosteroids, interleukins, or interferons. * 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. * Participants receiving any prohibited medication and who are unwilling or unable to switch to an alternate medication. * A participant with known or suspected active Coronavirus Disease 2019 (COVID-19) infection OR contact with an individual with known COVID-19, within 14 days of study enrollment (World Health Organization \[WHO\] definitions).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Acceptability of Implementation Measure (AIM-Imp) Score in SSP at Month 12 | Baseline (Month 1) and Month 12 | The AIM-Imp was designed to assess the acceptability of an implementation process (i.e., perception among implementation stakeholders that a given treatment, service, practice, or innovation is agreeable, palatable, or satisfactory). The measure consists of four items/statements (1. The implementation support thus far meets my approval 2. The implementation support thus far is appealing to me 3. I like the implementation support I have received 4. I welcome implementation support for the CAB + RPV injection treatment), each with a five-point rating scale (1 = completely disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, and 5 = completely agree). The mean score ranges from 1 to 5 with 1 indicating the least acceptability and 5 the most acceptability. |
| Change From Baseline in Implementation Appropriateness Measure (IAM-Imp) Score in SSPs at Month 12 | Baseline (Month 1) and Month 12 | The IAM-Imp is designed to assess the appropriateness of an implementation process (i.e., the perceived fit, relevance, or compatibility of the innovation for a given practice setting, provider, or consumer, and the perceived fit of the innovation to address a particular issue or problem). The IAM-Imp is a four-item/statement measure (1. The implementation support thus far seems fitting 2. The implementation support seems suitable for using the CAB + RPV injection treatment 3. The implementation support seems applicable for the CAB + RPV injection treatment 4. The implementation support seems like a good match) with a five-point rating scale (1 = completely disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, and 5 = completely agree). The mean score ranges from 1 to 5 with 1 indicating the least appropriateness and 5 the most appropriateness. |
| Change From Baseline in Feasibility of Implementation Measure (FIM-Imp) Score at Month 12 | Baseline (Month 1) and Month 12 | The FIM-Imp was a four-item/statement measure (1. The implementation support seems implementable in our clinic/practice 2. The implementation support seems possible in our clinic/practice 3. The implementation support seems doable in our clinic/practice 4. The implementation support seems easy to use in our clinic/practice) and was measured on a five-point rating scale (1 = completely disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, and 5 = completely agree). The mean score ranges from 1 to 5 with 1 indicating the least feasibility and 5 the most feasibility. |
| Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Acceptability | Up to 12 Months | A semi-structured interview guide was designed to support the discussion surrounding experience with the implementation of CAB+RPV LA injection treatment. The interview guide topics were informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and Proctor Outcomes to facilitate discussions on the acceptability from the SSPs' perspective. The results of themes that are integral to successful implementation are presented based on implementation strategies. |
| Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Appropriateness | Up to Month 12 | A semi-structured interview guide was designed to support the discussion surrounding experience with the implementation of CAB+RPV LA injection treatment. The interview guide topics were informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and Proctor Outcomes to facilitate discussions on the appropriateness from the SSPs' perspective. The results of themes that are integral to successful implementation are presented based on implementation strategies. |
| Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility | Up to Month 12 | A semi-structured interview guide was designed to support the discussion surrounding experience with the implementation of CAB+RPV LA injection treatment. The interview guide topics were informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and Proctor Outcomes to facilitate discussions on the feasibility from the SSPs' perspective. The results of themes that are integral to successful implementation are presented based on implementation strategies. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Staff Study Participants That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs) | Up to 12 Months | A semi-structured interview guide was designed to support the discussion surrounding experience with the implementation of CAB+RPV LA injection treatment. The interview guide topics were informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and Proctor Outcomes to facilitate discussions on the acceptability from the SSPs' perspective. The results for facilitators that are integral to successful implementation are presented. |
| Number of Staff Study Participants That Discussed Barriers for Acceptability Assessed Via SSIs | Up to 12 Months | A semi-structured interview guide was designed to support the discussion surrounding experience with for the implementation of CAB+RPV LA injection treatment. The interview guide topics were informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and Proctor Outcomes to facilitate discussions on the acceptability from the SSPs' perspective. The results for barriers that are integral to successful implementation are presented. |
| Number of Staff Study Participants That Discussed Facilitators for Appropriateness Assessed Via SSIs | Up to 12 Months | A semi-structured interview guide was designed to support the discussion surrounding experience with for the implementation of CAB+RPV LA injection treatment. The interview guide topics were informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and Proctor Outcomes to facilitate discussions on the appropriateness from the SSPs' perspective. The results for facilitators that are integral to successful implementation are presented. |
| Number of Staff Study Participants That Discussed Barriers for Appropriateness Assessed Via SSIs | Up to 12 Months | A semi-structured interview guide was designed to support the discussion surrounding experience with for the implementation of CAB+RPV LA injection treatment. The interview guide topics were informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and Proctor Outcomes to facilitate discussions on the appropriateness from the SSPs' perspective. The results for barriers that are integral to successful implementation are presented. |
| Number of Staff Study Participants That Discussed Facilitators for Feasibility Assessed Via SSIs | Up to 12 Months | A semi-structured interview guide was designed to support the discussion surrounding experience with for the implementation of CAB+RPV LA injection treatment. The interview guide topics were informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and Proctor Outcomes to facilitate discussions on the feasibility from the SSPs' perspective. The results for facilitators that are integral to successful implementation are presented. |
| Number of Staff Study Participants That Discussed Barriers for Feasibility Assessed Via SSIs | Up to 12 Months | A semi-structured interview guide was designed to support the discussion surrounding experience with for the implementation of CAB+RPV LA injection treatment. The interview guide topics were informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and Proctor Outcomes to facilitate discussions on the feasibility from the SSPs' perspective. The results for barriers that are integral to successful implementation are presented. |
| Change From Baseline in Implementation Leadership Scale (ILS) Score at Month 12 | Baseline (Month 1) and Month 12 | The ILS is a 12-item (facilitate implementation, obstacles, clear department standards, knowledge, ability to answer questions, awareness of concept, recognition, support employee efforts to learn, support employee efforts to use intervention, persevere(s) through the ups and downs, carries on through the challenges and reaction to criticial issues) measure that assesses SSP understanding of the degree to which leadership in their clinic/practice setting is proactive, knowledgeable, supportive, and perseverant with regards to implementing the CAB LA + RPV LA injection treatment in their settings. The items are measured on a five-point rating scale (1 = very great extent, 2 = great extent, 3 = moderate extent, 4 = slight extent, and 5 = not at all). The mean score ranges from 1 to 5. Higher the score means less understanding in leadership. |
| Absolute Values of Implementation Climate Scale (ICS) Scores at Month 1 and Month 12 | Month 1 and Month 12 | The ICS is a 9 item (team's main goals, importance of implementation, top priority, workshops, treatment training, training material, staff adaptability, flexibility, openness to new intervention) measure that assesses SSPs' perceptions of their team (i.e., the people that they work with) while using the CAB LA + RPV LA injection treatment in their clinic/practice setting. The items were measured on a five-point rating scale (1 = very great extent, 2 = great extent, 3 = moderate extent, 4 = slight extent, and 5 = not at all). The mean score ranges from 1 to 5. Higher the score means less seriousness for implementation in staff. |
| Number of Modifications Reported by SSPs Assessed Via FRAME-IS | Month 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 | The Framework for Reporting Adaptations and Modifications to Evidence-based interventions - Implementation Strategies (FRAME-IS) was a seven-question measure (contained both open and closed categorical questions) used to record details the modifications made to the implementation of the CAB LA + RPV LA injection treatment procedures. |
| Number of Plan, Do, Study, Act (PDSA) Cycles Developed During the Continuous Quality Improvement (CQI) Calls Course | Month 2 to Month 7 | CQI were a 60 minutes calls involved working through a plan to address the identified barriers, optimize processes, and evaluate these efforts. This process of addressing barriers was guided by a series of Plan, Do, Study, Act (PDSA) cycles. Number of PDSA cycles developed are presented. |
| Number of Participants Spending Average Time in the Clinic/Practice for Each Injection Visit Assessed Via Questionnaire | Up to Month 12 | Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The average time was categorized as: Up to 20 Minutes, Up to 40 Minutes, Up to 60 Minutes, Up to 90 Minutes, More than 90 Minutes and missing. Missing include participants who did not provide a response for the question. |
| Number of Participants Spending Average Time in an Exam Room Waiting for a Nurse (or Other Healthcare Provider) to Get the Injection Administered Assessed Via Questionnaire | Month 12 | Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The average time was categorized as: Up to 10 Minutes, 11-20 Minutes, 21-30 Minutes, 31-45 Minutes, More than 45 Minutes and Missing. Missing include participants who did not provide a response for the question. |
| Number of Participants Rating Acceptability With the Amount of Time Spent in The Clinic/Practice for Each Injection Visit Assessed Via Questionnaire | Month 12 | Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The rating of acceptability was categorized as extremely acceptable, very acceptable, somewhat acceptable, a little acceptable, not at all acceptable and missing. Missing include participants who did not provide a response for the question. |
| Number of Participants Rating Acceptability to Come to the Clinic/Practice Every 2 Months for the Injection Visit Assessed Via Questionnaire | Month 12 | Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The rating of acceptability was categorized as extremely acceptable, very acceptable, somewhat acceptable, a little acceptable, not at all acceptable and missing. Missing include participants who did not provide a response for the question. |
| Number of Participants Taking Time Off From Work to Attend Appointment Assessed Via Questionnaire | Month 12 | Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The time off responses were categorized as Whole day annual leave, Half day annual leave, Whole day sick leave, Half day sick leave, Whole day unpaid, Half day unpaid, Other, Not taken time off and missing. Missing include participants who did not provide a response for the question. |
| Number of Participants With Time it Took Them to Get to the Clinic Where They Receive HIV Treatment/Check-ups Assessed Via Questionnaire | Month 12 | Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The responses were categorized as Up to 15 minutes, 16-30 minutes, 31-45 minutes, 46-60 minutes, More than 60 minutes, and missing. Missing include participants who did not provide a response for the question. |
| Number of Participants Who Seek Additional Care From a Dependent to Attend Appointment Assessed Via Questionnaire | Month 12 | Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The responses were categorized as Yes, No, Not Applicable and Missing. Missing include participants who did not provide a response for the question. |
| Number of Participants That Endorsed Type of Transportation Used to Attend Appointments | Month 12 | Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The responses were categorized as Taxi- Transportation service, Dropped-off, Private vehicle, Bicycle/scooter/ skateboard/ walked, Public transport and Missing. Missing include participants who did not provide a response for the question. |
| Number of Participants Taking Time Off From Work to Recover From Any Injection Site Reaction Issue Assessed Via Questionnaire | Month 12 | Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The time off responses were categorized as No, Yes - On the day of receiving the treatment, Yes - One day after receiving the treatment, Yes-Two days after receiving the treatment, Yes-More than two days after receiving the treatment, Not Applicable, Missing and Missing Response for 'Yes'. Missing include participants who did not provide a response for the question. Missing Response for 'Yes' include participants who responded 'Yes' but did not provide duration of time off. |
| Number of Participants Rating Convenience of Clinic/Practice's Procedures for Scheduling Injections Assessed Via Questionnaire | Month 12 | Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The convenience responses were categorized as Extremely convenient, Very convenient, Somewhat convenient, A little convenient, Not at all convenient, and Missing. Missing include participants who did not provide a response for the question. |
| Number of Participants Rating Convenience of Clinic/Practice's Procedures for Rescheduling Injections Assessed Via Questionnaire | Month 12 | Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The responses were categorized as Extremely convenient, Very convenient, Somewhat convenient, A little convenient, Not at all convenient, Not applicable; I did not have to reschedule and Missing. Missing include participants who did not provide a response for the question. |
| Number of Participants Rating Feelings About Getting CAB+RPV Injection Treatment Assessed Via Questionnaire | Month 12 | Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The responses were categorized as Extremely positive, Very positive, Somewhat positive, A little positive, Not at all positive and Missing. Missing include participants who did not provide a response for the question. |
| Number of Participants That Rated Perceived Knowledge About CAB+RPV Injection Treatment Assessed Via Questionnaire | Month 12 | Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The responses were categorized as Extremely knowledgeable, Very knowledgeable, Somewhat knowledgeable, A little knowledgeable, Not at all knowledgeable and Missing. Missing include participants who did not provide a response for the question. |
| Number of Participants With Appointment Reminders Received Assessed Via Questionnaire | Month 12 | Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question.The responses were categorized as Phone calls, Text/SMS messages, Existing clinic app, E-mail, Reminder in the mail, Another reminder and I did not receive reminders. The responses are not mutually exclusive. |
| Number of Participants Who Rated Helpfulness of Appointment Outside of Typical Work Times Assessed Via Questionnaire | Month 12 | Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The responses were categorized as Extremely helpful, Very helpful, Somewhat helpful, A Little helpful, Not at all helpful and Missing. Missing include participants who did not provide a response for the question. |
| Number of Participants That Rated Agreement in Recommending the CAB+RPV Injections to Others Assessed Via Questionnaire | Month 12 | Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The responses were categorized as Completely agree, Agree, Neutral, Disagree, Completely disagree and Missing. Missing include participants who did not provide a response for the question. |
| Number of Participants With Things Tried to Reduce Soreness Following Injections Assessed Via Questionnaire | Month 12 | Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The responses were categorized as Take over-the-counter pain relievers, Use a hot compress, Use a cold compress, Avoid sitting for long periods of time, Light stretching and exercise, None of the above, Other and I don't get sore after my injections. |
| Number of PSPs That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs) | Up to Month 12 | A semi-structured interview guide was developed to support the discussion surrounding experience with for the implementation of CAB+RPV LA injection treatment. The interview guide topics were informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and Proctor Outcomes to facilitate discussions on the Acceptability, Appropriateness, Feasibility, and Sustainability from the PSPs' perspective. Results of number of PSPs that discussed facilitators for acceptability are presented. |
| Number of PSPs That Discussed Barriers for Acceptability Assessed Via SSIs | Up to Month 12 | A semi-structured interview guide was developed to support the discussion surrounding experience with for the implementation of CAB+RPV LA injection treatment. The interview guide topics were informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and Proctor Outcomes to facilitate discussions on the Acceptability, Appropriateness, Feasibility, and Sustainability from the PSPs' perspective. Results of number of PSPs that discussed barriers for acceptability are presented. |
| Number of PSPs That Discussed Facilitators for Appropriateness Assessed Via SSIs | Up to Month 12 | A semi-structured interview guide was developed to support the discussion surrounding experience with for the implementation of CAB+RPV LA injection treatment. The interview guide topics were informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and Proctor Outcomes to facilitate discussions on the Acceptability, Appropriateness, Feasibility, and Sustainability from the PSPs' perspective. Results of number of PSPs that discussed facilitators for appropriateness are presented. |
| Number of PSPs That Discussed Barriers for Appropriateness Assessed Via SSIs | Up to Month 12 | A semi-structured interview guide was developed to support the discussion surrounding experience with for the implementation of CAB+RPV LA injection treatment. The interview guide topics were informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and Proctor Outcomes to facilitate discussions on the Acceptability, Appropriateness, Feasibility, and Sustainability from the PSPs' perspective. Results of number of PSPs with barriers for appropriateness are presented. |
| Number of PSPs That Discussed Facilitators for Feasibility Assessed Via SSIs | Up to Month 12 | A semi-structured interview guide was developed to support the discussion surrounding experience with for the implementation of CAB+RPV LA injection treatment. The interview guide topics were informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and Proctor Outcomes to facilitate discussions on the Acceptability, Appropriateness, Feasibility, and Sustainability from the PSPs' perspective. Results of number of PSPs that discussed facilitators for feasibility are presented. |
| Number of PSPs That Discussed Barriers for Feasibility Assessed Via SSIs | Up to Month 12 | A semi-structured interview guide was developed to support the discussion surrounding experience with for the implementation of CAB+RPV LA injection treatment. The interview guide topics were informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and Proctor Outcomes to facilitate discussions on the Acceptability, Appropriateness, Feasibility, and Sustainability from the PSPs' perspective. Results of number of PSPs that discussed barriers for feasibility are presented. |
| Change From Baseline in Acceptability of Intervention Measure (AIM) Score in PSPs at Month 12 | Baseline (Month 1) and Month 12 | AIM assesses the acceptability of an intervention (i.e., perception among stakeholders that a given treatment, service, practice, or innovation is agreeable, palatable, or satisfactory). It is a four-item (1. The CAB+RPV injection treatment meets my approval for treating my HIV, 2. The CAB+RPV injection treatment is appealing to me, 3. I like the CAB+RPV injection treatment for my HIV, 4. I welcome the CAB+RPV injection treatment for my HIV) measure with a five-point rating scale, where 1=completely disagree, 2=disagree, 3=neither agree nor disagree, 4=agree, and 5=completely agree. The mean score ranges from 1 to 5 with 1 indicating the least acceptability and 5 the most acceptability. |
| Change From Baseline in Intervention Appropriateness Measure (IAM) Score in PSPs at Month 12 | Baseline (Month 1) and Month 12 | IAM assesses the appropriateness of an intervention (i.e., the perceived fit, relevance, or compatibility of the innovation for a given practice setting, provider, or consumer; and the perceived fit of the innovation to address a particular issue or problem). It is a four-item (1. The CAB+RPV injection treatment is fitting for my life, 2. The CAB+RPV injection treatment is suitable for my life, 3. The CAB+RPV injection treatment is applicable to my life, 4. The CAB+RPV injection treatment is a good match for my life) measure with a five-point rating scale, where 1=completely disagree, 2=disagree, 3=neither agree nor disagree, 4=agree, and 5=completely agree. The mean score ranges from 1 to 5 with 1 indicating the least appropriateness and 5 the most appropriateness. |
| Change From Baseline in Feasibility of Intervention Measure (FIM) Score in PSPs at Month 12 | Baseline (Month 1) and Month 12 | The four-item (1. The CAB+RPV injection treatment seems implementable in my life 2. The CAB+RPV injection treatment every 2 months is possible for me to use 3. The CAB+RPV injection treatment every 2 months seems doable in my life 4. The CAB+RPV injection treatment every 2 months seems easy to use in my life). FIM assesses perceived intervention feasibility. The items are measured on a five-point rating scale, where 1=completely disagree, 2=disagree, 3=neither agree nor disagree, 4=agree, and 5=completely agree. The mean score ranges from 1 to 5 with 1 indicating the least feasibility and 5 the most feasibility. |
| Associated Person Clinical Sustainability Assessment Tool (APCSAT) Average Domain Score at Month 12 | Month 12 | The APCSAT is a 35-item measure that assesses SSP impressions of the data in their clinic. Sustainability refers to the ability to maintain and expand the CAB LA + RPV LA injection treatment and its benefits over time. SSPs were asked to rate their clinic/practice along a range of specific domains that affect sustainability, including: 'Engages Staff & Leadership,' 'Engaging Stakeholders,' 'Monitoring and Evaluation,' 'Implementation & Training,' 'Outcomes & Effectiveness,' 'Workflow Integration,' and 'Organizational Readiness.' Five items were presented to SSPs in each section. The items were measured on a seven-point rating scale (1 = little to no extent to 7 = to a very great extent. Domain total was divided by the total number of items with a score to get average score. |
| Percentage of PSP Receiving Injections Within Target Window | Day -7 to Day 7 of Month 2, 4, 6, 8, 10 and 12 | The target window for participants to receive injection was from Day -7 to Day 7. |
| Percentage of PSPs With Plasma HIV-1 Ribonucleic Acid (RNA) Less Than (<)50 Copies Per Milliliter (c/ml) | Month 1, 2, 4, 8 and 12 | Plasma samples were collected from the participant at specific time points. |
| Number of Participants With Confirmed Virologic Failure (CVF) Over Time | Month 1, 2, 4, 8, 10 and 12 | CVF was defined as rebound as indicated by two consecutive plasma HIV-1 RNA levels \>=200 c/ml. |
| Number of PSPs With Adverse Events (AEs) And Serious AEs (SAEs) | Up to 12 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 PSPs Discontinuing Treatment Due to AEs | Up to 12 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. |
| Number of PSP With Preference for Therapy Assessed Via Preference Questionnaire | Up to 12 Months | PSPs were asked to think about their experience of using the long-acting injectable medication versus the daily oral HIV medication, and to select their preferred treatment and all the reasons that support their preference. Results are categorized as: 'long-acting injectable HIV medication', 'daily oral HIV medication', 'no preference', Missing and Erroneous. Missing include participants who did not provide a response for the question. PSPs who completed this question incorrectly (i.e., checked reasons without a ticking a leading preference or checked more than one leading preference box) were included in Erroneous. |
Countries
Belgium, France, Germany, Netherlands, Spain
Participant flow
Recruitment details
A total of 437 patient study participants (PSPs) \[people living with HIV\] were enrolled. 430 PSP received study treatment and were included in the safety population. Staff Study Participants (SSP) (HIV care providers, nurses/staff performing injections administrators/clinic managers) were not counted as enrolled. SSP were randomized based on implementation strategy - Enhanced (Arm-E) and Standard (Arm -S).
Pre-assignment details
SSP provided input through surveys, semi-structured interviews and a selected group from the enhanced arm (Arm-E) participated in facilitation calls. Participant flow, Baseline characteristics or adverse events for SSP were not collected as it was not required per study design.
Participants by arm
| Arm | Count |
|---|---|
| Patient Study Participants PSPs received one tablet of cabotegravir (CAB) 30 milligrams (mg) + rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month during the oral lead-in phase (OLI). Participants received last dose of oral regimen followed by CAB long-acting injectable (LA) 600 mg + RPV LA 900 mg injections in Month 1, one month later (Month 2), and every 2 months (Q2M) thereafter via intramuscular (IM) route. | 430 |
| Total | 430 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 15 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Physician Decision | 3 |
| Overall Study | Protocol Deviation | 2 |
| Overall Study | Withdrawal by Subject | 6 |
Baseline characteristics
| Characteristic | Patient Study Participants |
|---|---|
| Age, Continuous | 44.2 Years STANDARD_DEVIATION 10.13 |
| Race/Ethnicity, Customized American Indian Or Alaska Native | 7 Participants |
| Race/Ethnicity, Customized Asian | 9 Participants |
| Race/Ethnicity, Customized Black Or African American | 76 Participants |
| Race/Ethnicity, Customized Multiple | 2 Participants |
| Race/Ethnicity, Customized White | 336 Participants |
| Sex: Female, Male Female | 115 Participants |
| Sex: Female, Male Male | 315 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 430 |
| other Total, other adverse events | 384 / 430 |
| serious Total, serious adverse events | 17 / 430 |
Outcome results
Primary
Change From Baseline in Acceptability of Implementation Measure (AIM-Imp) Score in SSP at Month 12
The AIM-Imp was designed to assess the acceptability of an implementation process (i.e., perception among implementation stakeholders that a given treatment, service, practice, or innovation is agreeable, palatable, or satisfactory). The measure consists of four items/statements (1. The implementation support thus far meets my approval 2. The implementation support thus far is appealing to me 3. I like the implementation support I have received 4. I welcome implementation support for the CAB + RPV injection treatment), each with a five-point rating scale (1 = completely disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, and 5 = completely agree). The mean score ranges from 1 to 5 with 1 indicating the least acceptability and 5 the most acceptability.
Time frame: Baseline (Month 1) and Month 12
Population: Full analysis set included all staff study participants (SSPs) who completed at least one survey at any timepoint. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Staff Study Participants - Enhanced Implementation Arm | Change From Baseline in Acceptability of Implementation Measure (AIM-Imp) Score in SSP at Month 12 | Baseline (Month 1) | 3.8 Scores on a scale | Standard Deviation 0.76 |
| Staff Study Participants - Enhanced Implementation Arm | Change From Baseline in Acceptability of Implementation Measure (AIM-Imp) Score in SSP at Month 12 | Month 12 | 0.28 Scores on a scale | Standard Deviation 0.828 |
| Staff Study Participants - Standard Implementation Arm | Change From Baseline in Acceptability of Implementation Measure (AIM-Imp) Score in SSP at Month 12 | Baseline (Month 1) | 3.9 Scores on a scale | Standard Deviation 0.75 |
| Staff Study Participants - Standard Implementation Arm | Change From Baseline in Acceptability of Implementation Measure (AIM-Imp) Score in SSP at Month 12 | Month 12 | 0.33 Scores on a scale | Standard Deviation 0.666 |
Primary
Change From Baseline in Feasibility of Implementation Measure (FIM-Imp) Score at Month 12
The FIM-Imp was a four-item/statement measure (1. The implementation support seems implementable in our clinic/practice 2. The implementation support seems possible in our clinic/practice 3. The implementation support seems doable in our clinic/practice 4. The implementation support seems easy to use in our clinic/practice) and was measured on a five-point rating scale (1 = completely disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, and 5 = completely agree). The mean score ranges from 1 to 5 with 1 indicating the least feasibility and 5 the most feasibility.
Time frame: Baseline (Month 1) and Month 12
Population: Full analysis set included all staff study participants (SSPs) who completed at least one survey at any timepoint. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Staff Study Participants - Enhanced Implementation Arm | Change From Baseline in Feasibility of Implementation Measure (FIM-Imp) Score at Month 12 | Baseline (Month 1) | 4.0 Scores on a scale | Standard Deviation 0.66 |
| Staff Study Participants - Enhanced Implementation Arm | Change From Baseline in Feasibility of Implementation Measure (FIM-Imp) Score at Month 12 | Month 12 | 0.06 Scores on a scale | Standard Deviation 1.047 |
| Staff Study Participants - Standard Implementation Arm | Change From Baseline in Feasibility of Implementation Measure (FIM-Imp) Score at Month 12 | Baseline (Month 1) | 4.0 Scores on a scale | Standard Deviation 0.64 |
| Staff Study Participants - Standard Implementation Arm | Change From Baseline in Feasibility of Implementation Measure (FIM-Imp) Score at Month 12 | Month 12 | 0.34 Scores on a scale | Standard Deviation 0.773 |
Primary
Change From Baseline in Implementation Appropriateness Measure (IAM-Imp) Score in SSPs at Month 12
The IAM-Imp is designed to assess the appropriateness of an implementation process (i.e., the perceived fit, relevance, or compatibility of the innovation for a given practice setting, provider, or consumer, and the perceived fit of the innovation to address a particular issue or problem). The IAM-Imp is a four-item/statement measure (1. The implementation support thus far seems fitting 2. The implementation support seems suitable for using the CAB + RPV injection treatment 3. The implementation support seems applicable for the CAB + RPV injection treatment 4. The implementation support seems like a good match) with a five-point rating scale (1 = completely disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, and 5 = completely agree). The mean score ranges from 1 to 5 with 1 indicating the least appropriateness and 5 the most appropriateness.
Time frame: Baseline (Month 1) and Month 12
Population: Full analysis set included all staff study participants (SSPs) who completed at least one survey at any timepoint. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Staff Study Participants - Enhanced Implementation Arm | Change From Baseline in Implementation Appropriateness Measure (IAM-Imp) Score in SSPs at Month 12 | Baseline (Month 1) | 3.8 Scores on a scale | Standard Deviation 0.78 |
| Staff Study Participants - Enhanced Implementation Arm | Change From Baseline in Implementation Appropriateness Measure (IAM-Imp) Score in SSPs at Month 12 | Month 12 | 0.22 Scores on a scale | Standard Deviation 0.74 |
| Staff Study Participants - Standard Implementation Arm | Change From Baseline in Implementation Appropriateness Measure (IAM-Imp) Score in SSPs at Month 12 | Baseline (Month 1) | 3.9 Scores on a scale | Standard Deviation 0.78 |
| Staff Study Participants - Standard Implementation Arm | Change From Baseline in Implementation Appropriateness Measure (IAM-Imp) Score in SSPs at Month 12 | Month 12 | 0.31 Scores on a scale | Standard Deviation 0.729 |
Primary
Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Acceptability
A semi-structured interview guide was designed to support the discussion surrounding experience with the implementation of CAB+RPV LA injection treatment. The interview guide topics were informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and Proctor Outcomes to facilitate discussions on the acceptability from the SSPs' perspective. The results of themes that are integral to successful implementation are presented based on implementation strategies.
Time frame: Up to 12 Months
Population: Full analysis set included all staff study participants (SSPs) who completed at least one survey at any timepoint. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Acceptability | Positive opinion about CAB+RPV LA | 28 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Acceptability | Negative opinion about CAB+RPV LA | 0 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Acceptability | Ambivalent opinion about CAB+RPV LA | 3 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Acceptability | Opinion about CAB+RPV LA did not change | 15 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Acceptability | Opinion about CAB+RPV LA changed | 9 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Acceptability | Treatment and/or its implementation is better than expected | 7 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Acceptability | Treatment and/or its implementation is worse than expected | 2 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Acceptability | Implementation facilitators reported | 16 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Acceptability | Did NOT encounter resistance to using CAB+RPV LA | 8 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Acceptability | ADMINISTRATION OUTSIDE CLINIC: Other clinical settings | 15 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Acceptability | ADMINISTRATION OUTSIDE CLINIC: Self-administered | 20 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Acceptability | What would do differently | 2 Participants |
| Staff Study Participants - Standard Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Acceptability | ADMINISTRATION OUTSIDE CLINIC: Self-administered | 23 Participants |
| Staff Study Participants - Standard Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Acceptability | Positive opinion about CAB+RPV LA | 28 Participants |
| Staff Study Participants - Standard Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Acceptability | Treatment and/or its implementation is worse than expected | 0 Participants |
| Staff Study Participants - Standard Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Acceptability | Negative opinion about CAB+RPV LA | 0 Participants |
| Staff Study Participants - Standard Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Acceptability | ADMINISTRATION OUTSIDE CLINIC: Other clinical settings | 15 Participants |
| Staff Study Participants - Standard Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Acceptability | Ambivalent opinion about CAB+RPV LA | 1 Participants |
| Staff Study Participants - Standard Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Acceptability | Implementation facilitators reported | 19 Participants |
| Staff Study Participants - Standard Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Acceptability | Opinion about CAB+RPV LA did not change | 14 Participants |
| Staff Study Participants - Standard Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Acceptability | What would do differently | 4 Participants |
| Staff Study Participants - Standard Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Acceptability | Opinion about CAB+RPV LA changed | 11 Participants |
| Staff Study Participants - Standard Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Acceptability | Did NOT encounter resistance to using CAB+RPV LA | 19 Participants |
| Staff Study Participants - Standard Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Acceptability | Treatment and/or its implementation is better than expected | 11 Participants |
Primary
Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Appropriateness
A semi-structured interview guide was designed to support the discussion surrounding experience with the implementation of CAB+RPV LA injection treatment. The interview guide topics were informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and Proctor Outcomes to facilitate discussions on the appropriateness from the SSPs' perspective. The results of themes that are integral to successful implementation are presented based on implementation strategies.
Time frame: Up to Month 12
Population: Full analysis set included all staff study participants (SSPs) who completed at least one survey at any timepoint. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Appropriateness | Implementation facilitators reported | 16 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Appropriateness | ADMINISTRATION OUTSIDE CLINIC: Home administration by HCP | 24 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Appropriateness | What would do differently | 2 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Appropriateness | Recommended strategies to support patient adherence | 20 Participants |
| Staff Study Participants - Standard Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Appropriateness | Recommended strategies to support patient adherence | 22 Participants |
| Staff Study Participants - Standard Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Appropriateness | Implementation facilitators reported | 19 Participants |
| Staff Study Participants - Standard Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Appropriateness | What would do differently | 4 Participants |
| Staff Study Participants - Standard Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Appropriateness | ADMINISTRATION OUTSIDE CLINIC: Home administration by HCP | 19 Participants |
Primary
Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility
A semi-structured interview guide was designed to support the discussion surrounding experience with the implementation of CAB+RPV LA injection treatment. The interview guide topics were informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and Proctor Outcomes to facilitate discussions on the feasibility from the SSPs' perspective. The results of themes that are integral to successful implementation are presented based on implementation strategies.
Time frame: Up to Month 12
Population: Full analysis set included all staff study participants (SSPs) who completed at least one survey at any timepoint. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility | Staffing and workload issues: Not a challenge at present | 8 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility | Changes made to accommodate clinic needs | 22 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility | Implementation facilitators reported | 16 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility | Developed supplemental materials for implementation | 3 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility | Staffing and workload issues was not a challenge | 12 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility | Staffing and workload issues was a challenge | 18 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility | Staffing and workload issues: How tried to/overcame this challenge | 7 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility | Staffing and workload issues: Still a challenge | 7 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility | No changes made to accommodate clinic needs | 10 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility | Availability of rooms and designated space: Was not a challenge | 19 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility | Availability of rooms and designated space: Was a challenge | 13 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility | Availability of rooms and designated space: How overcame this challenge | 9 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility | Availability of rooms and designated space: Still a challenge | 8 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility | Availability of rooms and designated space: Not a challenge at present | 4 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility | Coordination between the clinic and pharmacy: Was not a challenge | 23 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility | Coordination between the clinic and pharmacy: Was a challenge | 4 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility | Coordination between the clinic and pharmacy: How overcame this challenge | 3 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility | Coordination between the clinic and pharmacy: Still a challenge | 3 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility | Coordination between the clinic and pharmacy: Not a challenge at present | 0 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility | Medication supply and storage: Was not a challenge | 16 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility | Medication supply and storage: Was a challenge | 9 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility | Medication supply and storage: How tried to/overcame this challenge | 7 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility | Medication supply and storage: Still a challenge | 2 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility | Medication supply and storage: Not a challenge at present | 5 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility | Being able to administer injections: Was not a challenge | 24 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility | Being able to administer injections: Was a challenge | 3 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility | Being able to administer injections: How overcame this challenge | 1 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility | Being able to administer injections: Still a challenge | 1 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility | Being able to administer injections: Not a challenge at present | 2 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility | Being able to administer injections: ViiV not supportive of CAB+RPV LA implementation | 0 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility | Being able to administer injections: ViiV supportive of CAB+RPV LA implementation | 31 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility | Being able to administer injections: What would do differently | 2 Participants |
| Staff Study Participants - Standard Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility | Being able to administer injections: What would do differently | 4 Participants |
| Staff Study Participants - Standard Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility | No changes made to accommodate clinic needs | 7 Participants |
| Staff Study Participants - Standard Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility | Coordination between the clinic and pharmacy: How overcame this challenge | 6 Participants |
| Staff Study Participants - Standard Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility | Changes made to accommodate clinic needs | 22 Participants |
| Staff Study Participants - Standard Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility | Being able to administer injections: Was not a challenge | 17 Participants |
| Staff Study Participants - Standard Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility | Implementation facilitators reported | 19 Participants |
| Staff Study Participants - Standard Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility | Coordination between the clinic and pharmacy: Still a challenge | 3 Participants |
| Staff Study Participants - Standard Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility | Developed supplemental materials for implementation | 5 Participants |
| Staff Study Participants - Standard Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility | Being able to administer injections: Not a challenge at present | 1 Participants |
| Staff Study Participants - Standard Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility | Staffing and workload issues was not a challenge | 7 Participants |
| Staff Study Participants - Standard Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility | Coordination between the clinic and pharmacy: Not a challenge at present | 4 Participants |
| Staff Study Participants - Standard Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility | Staffing and workload issues was a challenge | 14 Participants |
| Staff Study Participants - Standard Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility | Being able to administer injections: Was a challenge | 3 Participants |
| Staff Study Participants - Standard Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility | Staffing and workload issues: How tried to/overcame this challenge | 10 Participants |
| Staff Study Participants - Standard Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility | Medication supply and storage: Was not a challenge | 15 Participants |
| Staff Study Participants - Standard Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility | Staffing and workload issues: Still a challenge | 4 Participants |
| Staff Study Participants - Standard Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility | Being able to administer injections: ViiV supportive of CAB+RPV LA implementation | 23 Participants |
| Staff Study Participants - Standard Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility | Staffing and workload issues: Not a challenge at present | 5 Participants |
| Staff Study Participants - Standard Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility | Medication supply and storage: Was a challenge | 3 Participants |
| Staff Study Participants - Standard Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility | Availability of rooms and designated space: Was not a challenge | 15 Participants |
| Staff Study Participants - Standard Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility | Being able to administer injections: How overcame this challenge | 3 Participants |
| Staff Study Participants - Standard Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility | Availability of rooms and designated space: Was a challenge | 7 Participants |
| Staff Study Participants - Standard Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility | Medication supply and storage: How tried to/overcame this challenge | 2 Participants |
| Staff Study Participants - Standard Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility | Availability of rooms and designated space: How overcame this challenge | 7 Participants |
| Staff Study Participants - Standard Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility | Being able to administer injections: ViiV not supportive of CAB+RPV LA implementation | 5 Participants |
| Staff Study Participants - Standard Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility | Availability of rooms and designated space: Still a challenge | 4 Participants |
| Staff Study Participants - Standard Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility | Medication supply and storage: Still a challenge | 1 Participants |
| Staff Study Participants - Standard Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility | Availability of rooms and designated space: Not a challenge at present | 3 Participants |
| Staff Study Participants - Standard Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility | Being able to administer injections: Still a challenge | 2 Participants |
| Staff Study Participants - Standard Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility | Coordination between the clinic and pharmacy: Was not a challenge | 17 Participants |
| Staff Study Participants - Standard Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility | Medication supply and storage: Not a challenge at present | 2 Participants |
| Staff Study Participants - Standard Implementation Arm | Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility | Coordination between the clinic and pharmacy: Was a challenge | 9 Participants |
Secondary
Absolute Values of Implementation Climate Scale (ICS) Scores at Month 1 and Month 12
The ICS is a 9 item (team's main goals, importance of implementation, top priority, workshops, treatment training, training material, staff adaptability, flexibility, openness to new intervention) measure that assesses SSPs' perceptions of their team (i.e., the people that they work with) while using the CAB LA + RPV LA injection treatment in their clinic/practice setting. The items were measured on a five-point rating scale (1 = very great extent, 2 = great extent, 3 = moderate extent, 4 = slight extent, and 5 = not at all). The mean score ranges from 1 to 5. Higher the score means less seriousness for implementation in staff.
Time frame: Month 1 and Month 12
Population: Full Analysis Set. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Staff Study Participants - Enhanced Implementation Arm | Absolute Values of Implementation Climate Scale (ICS) Scores at Month 1 and Month 12 | Month 1 | 2.5 Scores on a scale | Standard Deviation 0.65 |
| Staff Study Participants - Enhanced Implementation Arm | Absolute Values of Implementation Climate Scale (ICS) Scores at Month 1 and Month 12 | Month 12 | 2.7 Scores on a scale | Standard Deviation 0.72 |
| Staff Study Participants - Standard Implementation Arm | Absolute Values of Implementation Climate Scale (ICS) Scores at Month 1 and Month 12 | Month 1 | 2.8 Scores on a scale | Standard Deviation 0.8 |
| Staff Study Participants - Standard Implementation Arm | Absolute Values of Implementation Climate Scale (ICS) Scores at Month 1 and Month 12 | Month 12 | 2.6 Scores on a scale | Standard Deviation 0.8 |
Secondary
Associated Person Clinical Sustainability Assessment Tool (APCSAT) Average Domain Score at Month 12
The APCSAT is a 35-item measure that assesses SSP impressions of the data in their clinic. Sustainability refers to the ability to maintain and expand the CAB LA + RPV LA injection treatment and its benefits over time. SSPs were asked to rate their clinic/practice along a range of specific domains that affect sustainability, including: 'Engages Staff & Leadership,' 'Engaging Stakeholders,' 'Monitoring and Evaluation,' 'Implementation & Training,' 'Outcomes & Effectiveness,' 'Workflow Integration,' and 'Organizational Readiness.' Five items were presented to SSPs in each section. The items were measured on a seven-point rating scale (1 = little to no extent to 7 = to a very great extent. Domain total was divided by the total number of items with a score to get average score.
Time frame: Month 12
Population: Full Analysis Set. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Staff Study Participants - Enhanced Implementation Arm | Associated Person Clinical Sustainability Assessment Tool (APCSAT) Average Domain Score at Month 12 | Monitoring and Evaluation | 5.37 Scores on a scale | Standard Deviation 0.16 |
| Staff Study Participants - Enhanced Implementation Arm | Associated Person Clinical Sustainability Assessment Tool (APCSAT) Average Domain Score at Month 12 | Outcomes & Effectiveness | 5.39 Scores on a scale | Standard Deviation 0.7 |
| Staff Study Participants - Enhanced Implementation Arm | Associated Person Clinical Sustainability Assessment Tool (APCSAT) Average Domain Score at Month 12 | Engaging Stakeholders | 5.00 Scores on a scale | Standard Deviation 1.06 |
| Staff Study Participants - Enhanced Implementation Arm | Associated Person Clinical Sustainability Assessment Tool (APCSAT) Average Domain Score at Month 12 | Workflow Integration | 5.46 Scores on a scale | Standard Deviation 0.35 |
| Staff Study Participants - Enhanced Implementation Arm | Associated Person Clinical Sustainability Assessment Tool (APCSAT) Average Domain Score at Month 12 | Implementation & Training | 5.62 Scores on a scale | Standard Deviation 0.56 |
| Staff Study Participants - Enhanced Implementation Arm | Associated Person Clinical Sustainability Assessment Tool (APCSAT) Average Domain Score at Month 12 | Organizational Readiness | 5.30 Scores on a scale | Standard Deviation 0.32 |
| Staff Study Participants - Enhanced Implementation Arm | Associated Person Clinical Sustainability Assessment Tool (APCSAT) Average Domain Score at Month 12 | Engages Staff & Leadership | 5.57 Scores on a scale | Standard Deviation 0.72 |
| Staff Study Participants - Standard Implementation Arm | Associated Person Clinical Sustainability Assessment Tool (APCSAT) Average Domain Score at Month 12 | Organizational Readiness | 5.05 Scores on a scale | Standard Deviation 0.36 |
| Staff Study Participants - Standard Implementation Arm | Associated Person Clinical Sustainability Assessment Tool (APCSAT) Average Domain Score at Month 12 | Engages Staff & Leadership | 5.58 Scores on a scale | Standard Deviation 0.49 |
| Staff Study Participants - Standard Implementation Arm | Associated Person Clinical Sustainability Assessment Tool (APCSAT) Average Domain Score at Month 12 | Engaging Stakeholders | 5.05 Scores on a scale | Standard Deviation 0.79 |
| Staff Study Participants - Standard Implementation Arm | Associated Person Clinical Sustainability Assessment Tool (APCSAT) Average Domain Score at Month 12 | Monitoring and Evaluation | 5.49 Scores on a scale | Standard Deviation 0.11 |
| Staff Study Participants - Standard Implementation Arm | Associated Person Clinical Sustainability Assessment Tool (APCSAT) Average Domain Score at Month 12 | Implementation & Training | 5.56 Scores on a scale | Standard Deviation 0.43 |
| Staff Study Participants - Standard Implementation Arm | Associated Person Clinical Sustainability Assessment Tool (APCSAT) Average Domain Score at Month 12 | Outcomes & Effectiveness | 5.41 Scores on a scale | Standard Deviation 0.69 |
| Staff Study Participants - Standard Implementation Arm | Associated Person Clinical Sustainability Assessment Tool (APCSAT) Average Domain Score at Month 12 | Workflow Integration | 5.23 Scores on a scale | Standard Deviation 0.34 |
Secondary
Change From Baseline in Acceptability of Intervention Measure (AIM) Score in PSPs at Month 12
AIM assesses the acceptability of an intervention (i.e., perception among stakeholders that a given treatment, service, practice, or innovation is agreeable, palatable, or satisfactory). It is a four-item (1. The CAB+RPV injection treatment meets my approval for treating my HIV, 2. The CAB+RPV injection treatment is appealing to me, 3. I like the CAB+RPV injection treatment for my HIV, 4. I welcome the CAB+RPV injection treatment for my HIV) measure with a five-point rating scale, where 1=completely disagree, 2=disagree, 3=neither agree nor disagree, 4=agree, and 5=completely agree. The mean score ranges from 1 to 5 with 1 indicating the least acceptability and 5 the most acceptability.
Time frame: Baseline (Month 1) and Month 12
Population: PSPs who completed the surveys at the relevant timepoints were included in the analysis. Only those participants with data available at the specified time points were analysed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Staff Study Participants - Enhanced Implementation Arm | Change From Baseline in Acceptability of Intervention Measure (AIM) Score in PSPs at Month 12 | Baseline (Month 1) | 4.55 Scores on a scale | Standard Deviation 0.666 |
| Staff Study Participants - Enhanced Implementation Arm | Change From Baseline in Acceptability of Intervention Measure (AIM) Score in PSPs at Month 12 | Month 12 | 0.10 Scores on a scale | Standard Deviation 0.834 |
Secondary
Change From Baseline in Feasibility of Intervention Measure (FIM) Score in PSPs at Month 12
The four-item (1. The CAB+RPV injection treatment seems implementable in my life 2. The CAB+RPV injection treatment every 2 months is possible for me to use 3. The CAB+RPV injection treatment every 2 months seems doable in my life 4. The CAB+RPV injection treatment every 2 months seems easy to use in my life). FIM assesses perceived intervention feasibility. The items are measured on a five-point rating scale, where 1=completely disagree, 2=disagree, 3=neither agree nor disagree, 4=agree, and 5=completely agree. The mean score ranges from 1 to 5 with 1 indicating the least feasibility and 5 the most feasibility.
Time frame: Baseline (Month 1) and Month 12
Population: PSPs who completed the surveys at the relevant timepoints were included in the analysis. Only those participants with data available at the specified time points were analysed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Staff Study Participants - Enhanced Implementation Arm | Change From Baseline in Feasibility of Intervention Measure (FIM) Score in PSPs at Month 12 | Baseline (Month 1) | 4.51 Scores on a scale | Standard Deviation 0.672 |
| Staff Study Participants - Enhanced Implementation Arm | Change From Baseline in Feasibility of Intervention Measure (FIM) Score in PSPs at Month 12 | Month 12 | 0.07 Scores on a scale | Standard Deviation 0.857 |
Secondary
Change From Baseline in Implementation Leadership Scale (ILS) Score at Month 12
The ILS is a 12-item (facilitate implementation, obstacles, clear department standards, knowledge, ability to answer questions, awareness of concept, recognition, support employee efforts to learn, support employee efforts to use intervention, persevere(s) through the ups and downs, carries on through the challenges and reaction to criticial issues) measure that assesses SSP understanding of the degree to which leadership in their clinic/practice setting is proactive, knowledgeable, supportive, and perseverant with regards to implementing the CAB LA + RPV LA injection treatment in their settings. The items are measured on a five-point rating scale (1 = very great extent, 2 = great extent, 3 = moderate extent, 4 = slight extent, and 5 = not at all). The mean score ranges from 1 to 5. Higher the score means less understanding in leadership.
Time frame: Baseline (Month 1) and Month 12
Population: Full analysis set included all staff study participants (SSPs) who completed at least one survey at any timepoint. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Staff Study Participants - Enhanced Implementation Arm | Change From Baseline in Implementation Leadership Scale (ILS) Score at Month 12 | Baseline (Month 1) | 2.3 Scores on a scale | Standard Deviation 0.86 |
| Staff Study Participants - Enhanced Implementation Arm | Change From Baseline in Implementation Leadership Scale (ILS) Score at Month 12 | Month 12 | -0.1 Scores on a scale | Standard Deviation 1.19 |
| Staff Study Participants - Standard Implementation Arm | Change From Baseline in Implementation Leadership Scale (ILS) Score at Month 12 | Baseline (Month 1) | 2.0 Scores on a scale | Standard Deviation 0.81 |
| Staff Study Participants - Standard Implementation Arm | Change From Baseline in Implementation Leadership Scale (ILS) Score at Month 12 | Month 12 | 0.2 Scores on a scale | Standard Deviation 0.51 |
Secondary
Change From Baseline in Intervention Appropriateness Measure (IAM) Score in PSPs at Month 12
IAM assesses the appropriateness of an intervention (i.e., the perceived fit, relevance, or compatibility of the innovation for a given practice setting, provider, or consumer; and the perceived fit of the innovation to address a particular issue or problem). It is a four-item (1. The CAB+RPV injection treatment is fitting for my life, 2. The CAB+RPV injection treatment is suitable for my life, 3. The CAB+RPV injection treatment is applicable to my life, 4. The CAB+RPV injection treatment is a good match for my life) measure with a five-point rating scale, where 1=completely disagree, 2=disagree, 3=neither agree nor disagree, 4=agree, and 5=completely agree. The mean score ranges from 1 to 5 with 1 indicating the least appropriateness and 5 the most appropriateness.
Time frame: Baseline (Month 1) and Month 12
Population: PSPs who completed the surveys at the relevant timepoints were included in the analysis. Only those participants with data available at the specified time points were analysed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Staff Study Participants - Enhanced Implementation Arm | Change From Baseline in Intervention Appropriateness Measure (IAM) Score in PSPs at Month 12 | Baseline (Month 1) | 4.47 Scores on a scale | Standard Deviation 0.762 |
| Staff Study Participants - Enhanced Implementation Arm | Change From Baseline in Intervention Appropriateness Measure (IAM) Score in PSPs at Month 12 | Month 12 | 0.13 Scores on a scale | Standard Deviation 0.928 |
Secondary
Number of Modifications Reported by SSPs Assessed Via FRAME-IS
The Framework for Reporting Adaptations and Modifications to Evidence-based interventions - Implementation Strategies (FRAME-IS) was a seven-question measure (contained both open and closed categorical questions) used to record details the modifications made to the implementation of the CAB LA + RPV LA injection treatment procedures.
Time frame: Month 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12
Population: Full analysis set included all staff study participants (SSPs) who completed at least one survey at any timepoint. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Staff Study Participants - Enhanced Implementation Arm | Number of Modifications Reported by SSPs Assessed Via FRAME-IS | Month 5 | 1 Number of Modifications |
| Staff Study Participants - Enhanced Implementation Arm | Number of Modifications Reported by SSPs Assessed Via FRAME-IS | Month 8 | 0 Number of Modifications |
| Staff Study Participants - Enhanced Implementation Arm | Number of Modifications Reported by SSPs Assessed Via FRAME-IS | Month 4 | 5 Number of Modifications |
| Staff Study Participants - Enhanced Implementation Arm | Number of Modifications Reported by SSPs Assessed Via FRAME-IS | Month 9 | 3 Number of Modifications |
| Staff Study Participants - Enhanced Implementation Arm | Number of Modifications Reported by SSPs Assessed Via FRAME-IS | Month 6 | 3 Number of Modifications |
| Staff Study Participants - Enhanced Implementation Arm | Number of Modifications Reported by SSPs Assessed Via FRAME-IS | Month 10 | 0 Number of Modifications |
| Staff Study Participants - Enhanced Implementation Arm | Number of Modifications Reported by SSPs Assessed Via FRAME-IS | Month 3 | 10 Number of Modifications |
| Staff Study Participants - Enhanced Implementation Arm | Number of Modifications Reported by SSPs Assessed Via FRAME-IS | Month 11 | 3 Number of Modifications |
| Staff Study Participants - Enhanced Implementation Arm | Number of Modifications Reported by SSPs Assessed Via FRAME-IS | Month 7 | 4 Number of Modifications |
| Staff Study Participants - Enhanced Implementation Arm | Number of Modifications Reported by SSPs Assessed Via FRAME-IS | Month 12 | 0 Number of Modifications |
| Staff Study Participants - Enhanced Implementation Arm | Number of Modifications Reported by SSPs Assessed Via FRAME-IS | Month 2 | 15 Number of Modifications |
| Staff Study Participants - Standard Implementation Arm | Number of Modifications Reported by SSPs Assessed Via FRAME-IS | Month 12 | 1 Number of Modifications |
| Staff Study Participants - Standard Implementation Arm | Number of Modifications Reported by SSPs Assessed Via FRAME-IS | Month 2 | 7 Number of Modifications |
| Staff Study Participants - Standard Implementation Arm | Number of Modifications Reported by SSPs Assessed Via FRAME-IS | Month 3 | 2 Number of Modifications |
| Staff Study Participants - Standard Implementation Arm | Number of Modifications Reported by SSPs Assessed Via FRAME-IS | Month 4 | 2 Number of Modifications |
| Staff Study Participants - Standard Implementation Arm | Number of Modifications Reported by SSPs Assessed Via FRAME-IS | Month 5 | 1 Number of Modifications |
| Staff Study Participants - Standard Implementation Arm | Number of Modifications Reported by SSPs Assessed Via FRAME-IS | Month 6 | 0 Number of Modifications |
| Staff Study Participants - Standard Implementation Arm | Number of Modifications Reported by SSPs Assessed Via FRAME-IS | Month 7 | 0 Number of Modifications |
| Staff Study Participants - Standard Implementation Arm | Number of Modifications Reported by SSPs Assessed Via FRAME-IS | Month 8 | 0 Number of Modifications |
| Staff Study Participants - Standard Implementation Arm | Number of Modifications Reported by SSPs Assessed Via FRAME-IS | Month 9 | 0 Number of Modifications |
| Staff Study Participants - Standard Implementation Arm | Number of Modifications Reported by SSPs Assessed Via FRAME-IS | Month 10 | 0 Number of Modifications |
| Staff Study Participants - Standard Implementation Arm | Number of Modifications Reported by SSPs Assessed Via FRAME-IS | Month 11 | 1 Number of Modifications |
Secondary
Number of Participants Rating Acceptability to Come to the Clinic/Practice Every 2 Months for the Injection Visit Assessed Via Questionnaire
Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The rating of acceptability was categorized as extremely acceptable, very acceptable, somewhat acceptable, a little acceptable, not at all acceptable and missing. Missing include participants who did not provide a response for the question.
Time frame: Month 12
Population: Patient study participants (PSPs) included all participants who successfully completed the survey at Month 12. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants Rating Acceptability to Come to the Clinic/Practice Every 2 Months for the Injection Visit Assessed Via Questionnaire | Extremely acceptable | 163 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants Rating Acceptability to Come to the Clinic/Practice Every 2 Months for the Injection Visit Assessed Via Questionnaire | Very acceptable | 154 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants Rating Acceptability to Come to the Clinic/Practice Every 2 Months for the Injection Visit Assessed Via Questionnaire | Somewhat acceptable | 51 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants Rating Acceptability to Come to the Clinic/Practice Every 2 Months for the Injection Visit Assessed Via Questionnaire | A little acceptable | 6 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants Rating Acceptability to Come to the Clinic/Practice Every 2 Months for the Injection Visit Assessed Via Questionnaire | Not at all acceptable | 0 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants Rating Acceptability to Come to the Clinic/Practice Every 2 Months for the Injection Visit Assessed Via Questionnaire | Missing | 5 Participants |
Secondary
Number of Participants Rating Acceptability With the Amount of Time Spent in The Clinic/Practice for Each Injection Visit Assessed Via Questionnaire
Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The rating of acceptability was categorized as extremely acceptable, very acceptable, somewhat acceptable, a little acceptable, not at all acceptable and missing. Missing include participants who did not provide a response for the question.
Time frame: Month 12
Population: Patient study participants (PSPs) included all participants who successfully completed the survey at Month 12. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants Rating Acceptability With the Amount of Time Spent in The Clinic/Practice for Each Injection Visit Assessed Via Questionnaire | Extremely acceptable | 140 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants Rating Acceptability With the Amount of Time Spent in The Clinic/Practice for Each Injection Visit Assessed Via Questionnaire | Very acceptable | 151 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants Rating Acceptability With the Amount of Time Spent in The Clinic/Practice for Each Injection Visit Assessed Via Questionnaire | Somewhat acceptable | 72 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants Rating Acceptability With the Amount of Time Spent in The Clinic/Practice for Each Injection Visit Assessed Via Questionnaire | A little acceptable | 11 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants Rating Acceptability With the Amount of Time Spent in The Clinic/Practice for Each Injection Visit Assessed Via Questionnaire | Not at all acceptable | 0 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants Rating Acceptability With the Amount of Time Spent in The Clinic/Practice for Each Injection Visit Assessed Via Questionnaire | Missing | 5 Participants |
Secondary
Number of Participants Rating Convenience of Clinic/Practice's Procedures for Rescheduling Injections Assessed Via Questionnaire
Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The responses were categorized as Extremely convenient, Very convenient, Somewhat convenient, A little convenient, Not at all convenient, Not applicable; I did not have to reschedule and Missing. Missing include participants who did not provide a response for the question.
Time frame: Month 12
Population: Patient study participants (PSPs) included all participants who successfully completed the survey at Month 12. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants Rating Convenience of Clinic/Practice's Procedures for Rescheduling Injections Assessed Via Questionnaire | Extremely convenient | 158 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants Rating Convenience of Clinic/Practice's Procedures for Rescheduling Injections Assessed Via Questionnaire | Very convenient | 153 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants Rating Convenience of Clinic/Practice's Procedures for Rescheduling Injections Assessed Via Questionnaire | Somewhat convenient | 25 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants Rating Convenience of Clinic/Practice's Procedures for Rescheduling Injections Assessed Via Questionnaire | A little convenient | 2 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants Rating Convenience of Clinic/Practice's Procedures for Rescheduling Injections Assessed Via Questionnaire | Not at all convenient | 0 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants Rating Convenience of Clinic/Practice's Procedures for Rescheduling Injections Assessed Via Questionnaire | Not applicable; I did not have to schedule | 39 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants Rating Convenience of Clinic/Practice's Procedures for Rescheduling Injections Assessed Via Questionnaire | Missing | 2 Participants |
Secondary
Number of Participants Rating Convenience of Clinic/Practice's Procedures for Scheduling Injections Assessed Via Questionnaire
Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The convenience responses were categorized as Extremely convenient, Very convenient, Somewhat convenient, A little convenient, Not at all convenient, and Missing. Missing include participants who did not provide a response for the question.
Time frame: Month 12
Population: Patient study participants (PSPs) included all participants who successfully completed the survey at Month 12. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants Rating Convenience of Clinic/Practice's Procedures for Scheduling Injections Assessed Via Questionnaire | Extremely convenient | 175 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants Rating Convenience of Clinic/Practice's Procedures for Scheduling Injections Assessed Via Questionnaire | Very convenient | 154 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants Rating Convenience of Clinic/Practice's Procedures for Scheduling Injections Assessed Via Questionnaire | Somewhat convenient | 43 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants Rating Convenience of Clinic/Practice's Procedures for Scheduling Injections Assessed Via Questionnaire | A little convenient | 4 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants Rating Convenience of Clinic/Practice's Procedures for Scheduling Injections Assessed Via Questionnaire | Not at all convenient | 0 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants Rating Convenience of Clinic/Practice's Procedures for Scheduling Injections Assessed Via Questionnaire | Missing | 3 Participants |
Secondary
Number of Participants Rating Feelings About Getting CAB+RPV Injection Treatment Assessed Via Questionnaire
Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The responses were categorized as Extremely positive, Very positive, Somewhat positive, A little positive, Not at all positive and Missing. Missing include participants who did not provide a response for the question.
Time frame: Month 12
Population: Patient study participants (PSPs) included all participants who successfully completed the survey at Month 12. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants Rating Feelings About Getting CAB+RPV Injection Treatment Assessed Via Questionnaire | Extremely positive | 234 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants Rating Feelings About Getting CAB+RPV Injection Treatment Assessed Via Questionnaire | Very positive | 112 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants Rating Feelings About Getting CAB+RPV Injection Treatment Assessed Via Questionnaire | Somewhat positive | 23 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants Rating Feelings About Getting CAB+RPV Injection Treatment Assessed Via Questionnaire | A little positive | 4 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants Rating Feelings About Getting CAB+RPV Injection Treatment Assessed Via Questionnaire | Not at all positive | 0 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants Rating Feelings About Getting CAB+RPV Injection Treatment Assessed Via Questionnaire | Missing | 6 Participants |
Secondary
Number of Participants Spending Average Time in an Exam Room Waiting for a Nurse (or Other Healthcare Provider) to Get the Injection Administered Assessed Via Questionnaire
Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The average time was categorized as: Up to 10 Minutes, 11-20 Minutes, 21-30 Minutes, 31-45 Minutes, More than 45 Minutes and Missing. Missing include participants who did not provide a response for the question.
Time frame: Month 12
Population: Patient study participants (PSPs) included all participants who successfully completed the survey at Month 12. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants Spending Average Time in an Exam Room Waiting for a Nurse (or Other Healthcare Provider) to Get the Injection Administered Assessed Via Questionnaire | Up to 10 Minutes | 190 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants Spending Average Time in an Exam Room Waiting for a Nurse (or Other Healthcare Provider) to Get the Injection Administered Assessed Via Questionnaire | 11-20 Minutes | 100 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants Spending Average Time in an Exam Room Waiting for a Nurse (or Other Healthcare Provider) to Get the Injection Administered Assessed Via Questionnaire | 21-30 Minutes | 54 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants Spending Average Time in an Exam Room Waiting for a Nurse (or Other Healthcare Provider) to Get the Injection Administered Assessed Via Questionnaire | 31-45 Minutes | 25 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants Spending Average Time in an Exam Room Waiting for a Nurse (or Other Healthcare Provider) to Get the Injection Administered Assessed Via Questionnaire | More than 45 Minutes | 5 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants Spending Average Time in an Exam Room Waiting for a Nurse (or Other Healthcare Provider) to Get the Injection Administered Assessed Via Questionnaire | Missing | 5 Participants |
Secondary
Number of Participants Spending Average Time in the Clinic/Practice for Each Injection Visit Assessed Via Questionnaire
Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The average time was categorized as: Up to 20 Minutes, Up to 40 Minutes, Up to 60 Minutes, Up to 90 Minutes, More than 90 Minutes and missing. Missing include participants who did not provide a response for the question.
Time frame: Up to Month 12
Population: Patient study participants (PSPs) included all participants who successfully completed the survey at Month 12. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants Spending Average Time in the Clinic/Practice for Each Injection Visit Assessed Via Questionnaire | Up to 20 Minutes | 71 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants Spending Average Time in the Clinic/Practice for Each Injection Visit Assessed Via Questionnaire | Up to 40 Minutes | 134 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants Spending Average Time in the Clinic/Practice for Each Injection Visit Assessed Via Questionnaire | Up to 60 Minutes | 99 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants Spending Average Time in the Clinic/Practice for Each Injection Visit Assessed Via Questionnaire | Up to 90 Minutes | 48 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants Spending Average Time in the Clinic/Practice for Each Injection Visit Assessed Via Questionnaire | More than 90 Minutes | 19 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants Spending Average Time in the Clinic/Practice for Each Injection Visit Assessed Via Questionnaire | Missing | 8 Participants |
Secondary
Number of Participants Taking Time Off From Work to Attend Appointment Assessed Via Questionnaire
Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The time off responses were categorized as Whole day annual leave, Half day annual leave, Whole day sick leave, Half day sick leave, Whole day unpaid, Half day unpaid, Other, Not taken time off and missing. Missing include participants who did not provide a response for the question.
Time frame: Month 12
Population: Patient study participants (PSPs) included all participants who successfully completed the survey at Month 12. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants Taking Time Off From Work to Attend Appointment Assessed Via Questionnaire | Whole day annual leave | 27 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants Taking Time Off From Work to Attend Appointment Assessed Via Questionnaire | Half day annual leave | 20 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants Taking Time Off From Work to Attend Appointment Assessed Via Questionnaire | Whole day sick leave | 5 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants Taking Time Off From Work to Attend Appointment Assessed Via Questionnaire | Half day sick leave | 3 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants Taking Time Off From Work to Attend Appointment Assessed Via Questionnaire | Whole day unpaid | 9 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants Taking Time Off From Work to Attend Appointment Assessed Via Questionnaire | Half day unpaid | 20 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants Taking Time Off From Work to Attend Appointment Assessed Via Questionnaire | Other | 64 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants Taking Time Off From Work to Attend Appointment Assessed Via Questionnaire | Not taken Time Off | 222 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants Taking Time Off From Work to Attend Appointment Assessed Via Questionnaire | Missing | 9 Participants |
Secondary
Number of Participants Taking Time Off From Work to Recover From Any Injection Site Reaction Issue Assessed Via Questionnaire
Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The time off responses were categorized as No, Yes - On the day of receiving the treatment, Yes - One day after receiving the treatment, Yes-Two days after receiving the treatment, Yes-More than two days after receiving the treatment, Not Applicable, Missing and Missing Response for 'Yes'. Missing include participants who did not provide a response for the question. Missing Response for 'Yes' include participants who responded 'Yes' but did not provide duration of time off.
Time frame: Month 12
Population: Patient study participants (PSPs) included all participants who successfully completed the survey at Month 12. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants Taking Time Off From Work to Recover From Any Injection Site Reaction Issue Assessed Via Questionnaire | No | 294 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants Taking Time Off From Work to Recover From Any Injection Site Reaction Issue Assessed Via Questionnaire | Yes, on the day of receiving the treatment | 45 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants Taking Time Off From Work to Recover From Any Injection Site Reaction Issue Assessed Via Questionnaire | Yes, one day after receiving the treatment | 9 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants Taking Time Off From Work to Recover From Any Injection Site Reaction Issue Assessed Via Questionnaire | Yes, two days after receiving the treatment | 7 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants Taking Time Off From Work to Recover From Any Injection Site Reaction Issue Assessed Via Questionnaire | Yes, more than two days after receiving the treatment | 5 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants Taking Time Off From Work to Recover From Any Injection Site Reaction Issue Assessed Via Questionnaire | Not Applicable | 16 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants Taking Time Off From Work to Recover From Any Injection Site Reaction Issue Assessed Via Questionnaire | Missing | 5 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants Taking Time Off From Work to Recover From Any Injection Site Reaction Issue Assessed Via Questionnaire | Missing response for 'Yes' | 2 Participants |
Secondary
Number of Participants That Endorsed Type of Transportation Used to Attend Appointments
Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The responses were categorized as Taxi- Transportation service, Dropped-off, Private vehicle, Bicycle/scooter/ skateboard/ walked, Public transport and Missing. Missing include participants who did not provide a response for the question.
Time frame: Month 12
Population: Patient study participants (PSPs) included all participants who successfully completed the survey at Month 12. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants That Endorsed Type of Transportation Used to Attend Appointments | Missing | 3 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants That Endorsed Type of Transportation Used to Attend Appointments | Taxi-Transportation service | 13 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants That Endorsed Type of Transportation Used to Attend Appointments | Dropped-off | 12 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants That Endorsed Type of Transportation Used to Attend Appointments | Private vehicle | 164 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants That Endorsed Type of Transportation Used to Attend Appointments | Bicycle/ scooter/ skateboard/ walked | 49 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants That Endorsed Type of Transportation Used to Attend Appointments | Public transport | 138 Participants |
Secondary
Number of Participants That Rated Agreement in Recommending the CAB+RPV Injections to Others Assessed Via Questionnaire
Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The responses were categorized as Completely agree, Agree, Neutral, Disagree, Completely disagree and Missing. Missing include participants who did not provide a response for the question.
Time frame: Month 12
Population: Patient study participants (PSPs) included all participants who successfully completed the survey at Month 12. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants That Rated Agreement in Recommending the CAB+RPV Injections to Others Assessed Via Questionnaire | Completely agree | 283 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants That Rated Agreement in Recommending the CAB+RPV Injections to Others Assessed Via Questionnaire | Agree | 75 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants That Rated Agreement in Recommending the CAB+RPV Injections to Others Assessed Via Questionnaire | Neutral | 15 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants That Rated Agreement in Recommending the CAB+RPV Injections to Others Assessed Via Questionnaire | Disagree | 1 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants That Rated Agreement in Recommending the CAB+RPV Injections to Others Assessed Via Questionnaire | Completely disagree | 1 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants That Rated Agreement in Recommending the CAB+RPV Injections to Others Assessed Via Questionnaire | Missing | 4 Participants |
Secondary
Number of Participants That Rated Perceived Knowledge About CAB+RPV Injection Treatment Assessed Via Questionnaire
Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The responses were categorized as Extremely knowledgeable, Very knowledgeable, Somewhat knowledgeable, A little knowledgeable, Not at all knowledgeable and Missing. Missing include participants who did not provide a response for the question.
Time frame: Month 12
Population: Patient study participants (PSPs) included all participants who successfully completed the survey at Month 12. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants That Rated Perceived Knowledge About CAB+RPV Injection Treatment Assessed Via Questionnaire | Extremely knowledgeable | 124 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants That Rated Perceived Knowledge About CAB+RPV Injection Treatment Assessed Via Questionnaire | Very knowledgeable | 188 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants That Rated Perceived Knowledge About CAB+RPV Injection Treatment Assessed Via Questionnaire | Somewhat knowledgeable | 57 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants That Rated Perceived Knowledge About CAB+RPV Injection Treatment Assessed Via Questionnaire | A little knowledgeable | 6 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants That Rated Perceived Knowledge About CAB+RPV Injection Treatment Assessed Via Questionnaire | Not at all knowledgeable | 0 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants That Rated Perceived Knowledge About CAB+RPV Injection Treatment Assessed Via Questionnaire | Missing | 4 Participants |
Secondary
Number of Participants Who Rated Helpfulness of Appointment Outside of Typical Work Times Assessed Via Questionnaire
Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The responses were categorized as Extremely helpful, Very helpful, Somewhat helpful, A Little helpful, Not at all helpful and Missing. Missing include participants who did not provide a response for the question.
Time frame: Month 12
Population: Patient study participants (PSPs) included all participants who successfully completed the survey at Month 12. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants Who Rated Helpfulness of Appointment Outside of Typical Work Times Assessed Via Questionnaire | Extremely helpful | 135 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants Who Rated Helpfulness of Appointment Outside of Typical Work Times Assessed Via Questionnaire | Very helpful | 123 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants Who Rated Helpfulness of Appointment Outside of Typical Work Times Assessed Via Questionnaire | Somewhat helpful | 50 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants Who Rated Helpfulness of Appointment Outside of Typical Work Times Assessed Via Questionnaire | A Little helpful | 38 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants Who Rated Helpfulness of Appointment Outside of Typical Work Times Assessed Via Questionnaire | Not at all helpful | 28 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants Who Rated Helpfulness of Appointment Outside of Typical Work Times Assessed Via Questionnaire | Missing | 5 Participants |
Secondary
Number of Participants Who Seek Additional Care From a Dependent to Attend Appointment Assessed Via Questionnaire
Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The responses were categorized as Yes, No, Not Applicable and Missing. Missing include participants who did not provide a response for the question.
Time frame: Month 12
Population: Patient study participants (PSPs) included all participants who successfully completed the survey at Month 12. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants Who Seek Additional Care From a Dependent to Attend Appointment Assessed Via Questionnaire | Yes | 16 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants Who Seek Additional Care From a Dependent to Attend Appointment Assessed Via Questionnaire | No | 318 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants Who Seek Additional Care From a Dependent to Attend Appointment Assessed Via Questionnaire | Not Applicable | 39 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants Who Seek Additional Care From a Dependent to Attend Appointment Assessed Via Questionnaire | Missing | 6 Participants |
Secondary
Number of Participants With Appointment Reminders Received Assessed Via Questionnaire
Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question.The responses were categorized as Phone calls, Text/SMS messages, Existing clinic app, E-mail, Reminder in the mail, Another reminder and I did not receive reminders. The responses are not mutually exclusive.
Time frame: Month 12
Population: Patient study participants (PSPs) included all participants who successfully completed the survey at Month 12. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants With Appointment Reminders Received Assessed Via Questionnaire | Phone calls | 80 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants With Appointment Reminders Received Assessed Via Questionnaire | Text/SMS messages | 275 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants With Appointment Reminders Received Assessed Via Questionnaire | Existing clinic app | 48 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants With Appointment Reminders Received Assessed Via Questionnaire | 161 Participants | |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants With Appointment Reminders Received Assessed Via Questionnaire | Reminder in the mail | 21 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants With Appointment Reminders Received Assessed Via Questionnaire | Another reminder | 3 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants With Appointment Reminders Received Assessed Via Questionnaire | I did not receive reminders | 14 Participants |
Secondary
Number of Participants With Confirmed Virologic Failure (CVF) Over Time
CVF was defined as rebound as indicated by two consecutive plasma HIV-1 RNA levels \>=200 c/ml.
Time frame: Month 1, 2, 4, 8, 10 and 12
Population: Safety population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants With Confirmed Virologic Failure (CVF) Over Time | Month 12 | 0 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants With Confirmed Virologic Failure (CVF) Over Time | Month 1 | 0 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants With Confirmed Virologic Failure (CVF) Over Time | Month 2 | 0 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants With Confirmed Virologic Failure (CVF) Over Time | Month 4 | 0 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants With Confirmed Virologic Failure (CVF) Over Time | Month 6 | 0 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants With Confirmed Virologic Failure (CVF) Over Time | Month 8 | 0 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants With Confirmed Virologic Failure (CVF) Over Time | Month 10 | 1 Participants |
Secondary
Number of Participants With Things Tried to Reduce Soreness Following Injections Assessed Via Questionnaire
Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The responses were categorized as Take over-the-counter pain relievers, Use a hot compress, Use a cold compress, Avoid sitting for long periods of time, Light stretching and exercise, None of the above, Other and I don't get sore after my injections.
Time frame: Month 12
Population: Patient study participants (PSPs) included all participants who successfully completed the survey at Month 12.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants With Things Tried to Reduce Soreness Following Injections Assessed Via Questionnaire | Other | 31 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants With Things Tried to Reduce Soreness Following Injections Assessed Via Questionnaire | Take over-the-counter pain relievers | 139 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants With Things Tried to Reduce Soreness Following Injections Assessed Via Questionnaire | Use a hot compress | 20 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants With Things Tried to Reduce Soreness Following Injections Assessed Via Questionnaire | Use a cold compress | 19 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants With Things Tried to Reduce Soreness Following Injections Assessed Via Questionnaire | Avoid sitting for long periods of time | 87 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants With Things Tried to Reduce Soreness Following Injections Assessed Via Questionnaire | Light stretching and exercise | 71 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants With Things Tried to Reduce Soreness Following Injections Assessed Via Questionnaire | None of the above | 61 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants With Things Tried to Reduce Soreness Following Injections Assessed Via Questionnaire | I don't get sore after my injections | 72 Participants |
Secondary
Number of Participants With Time it Took Them to Get to the Clinic Where They Receive HIV Treatment/Check-ups Assessed Via Questionnaire
Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The responses were categorized as Up to 15 minutes, 16-30 minutes, 31-45 minutes, 46-60 minutes, More than 60 minutes, and missing. Missing include participants who did not provide a response for the question.
Time frame: Month 12
Population: Patient study participants (PSPs) included all participants who successfully completed the survey at Month 12. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants With Time it Took Them to Get to the Clinic Where They Receive HIV Treatment/Check-ups Assessed Via Questionnaire | Up to 15 minutes | 66 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants With Time it Took Them to Get to the Clinic Where They Receive HIV Treatment/Check-ups Assessed Via Questionnaire | 16-30 minutes | 138 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants With Time it Took Them to Get to the Clinic Where They Receive HIV Treatment/Check-ups Assessed Via Questionnaire | 31-45 minutes | 87 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants With Time it Took Them to Get to the Clinic Where They Receive HIV Treatment/Check-ups Assessed Via Questionnaire | 46-60 minutes | 44 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants With Time it Took Them to Get to the Clinic Where They Receive HIV Treatment/Check-ups Assessed Via Questionnaire | More than 60 minutes | 39 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Participants With Time it Took Them to Get to the Clinic Where They Receive HIV Treatment/Check-ups Assessed Via Questionnaire | Missing | 5 Participants |
Secondary
Number of Plan, Do, Study, Act (PDSA) Cycles Developed During the Continuous Quality Improvement (CQI) Calls Course
CQI were a 60 minutes calls involved working through a plan to address the identified barriers, optimize processes, and evaluate these efforts. This process of addressing barriers was guided by a series of Plan, Do, Study, Act (PDSA) cycles. Number of PDSA cycles developed are presented.
Time frame: Month 2 to Month 7
Population: Full Analysis Set. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Staff Study Participants - Enhanced Implementation Arm | Number of Plan, Do, Study, Act (PDSA) Cycles Developed During the Continuous Quality Improvement (CQI) Calls Course | 23 Cycles |
Secondary
Number of PSPs Discontinuing Treatment Due to AEs
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.
Time frame: Up to 12 Months
Population: Safety population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Staff Study Participants - Enhanced Implementation Arm | Number of PSPs Discontinuing Treatment Due to AEs | 2 Participants |
Secondary
Number of PSPs That Discussed Barriers for Acceptability Assessed Via SSIs
A semi-structured interview guide was developed to support the discussion surrounding experience with for the implementation of CAB+RPV LA injection treatment. The interview guide topics were informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and Proctor Outcomes to facilitate discussions on the Acceptability, Appropriateness, Feasibility, and Sustainability from the PSPs' perspective. Results of number of PSPs that discussed barriers for acceptability are presented.
Time frame: Up to Month 12
Population: Patient study participants (PSPs) who participated in interviews were analysed. Only those participants with data available at the specified time points were analysed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Staff Study Participants - Enhanced Implementation Arm | Number of PSPs That Discussed Barriers for Acceptability Assessed Via SSIs | Injection side effects including pain (Topic - Treatment Components Difficult for PSP) | 67 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of PSPs That Discussed Barriers for Acceptability Assessed Via SSIs | Injection side effects including pain (Topic-Experienced Challenges to Receive CAB+PRV LA Injection) | 33 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of PSPs That Discussed Barriers for Acceptability Assessed Via SSIs | CAB+RPV LA injection experience worse than expected | 11 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of PSPs That Discussed Barriers for Acceptability Assessed Via SSIs | Waiting time | 11 Participants |
Secondary
Number of PSPs That Discussed Barriers for Appropriateness Assessed Via SSIs
A semi-structured interview guide was developed to support the discussion surrounding experience with for the implementation of CAB+RPV LA injection treatment. The interview guide topics were informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and Proctor Outcomes to facilitate discussions on the Acceptability, Appropriateness, Feasibility, and Sustainability from the PSPs' perspective. Results of number of PSPs with barriers for appropriateness are presented.
Time frame: Up to Month 12
Population: Patient study participants (PSPs) who participated in interviews were analysed. Only those participants with data available at the specified time points were analysed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Staff Study Participants - Enhanced Implementation Arm | Number of PSPs That Discussed Barriers for Appropriateness Assessed Via SSIs | Patient fearing or squeamish about injections | 22 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of PSPs That Discussed Barriers for Appropriateness Assessed Via SSIs | Patients not tolerating intramuscular injection | 12 Participants |
Secondary
Number of PSPs That Discussed Barriers for Feasibility Assessed Via SSIs
A semi-structured interview guide was developed to support the discussion surrounding experience with for the implementation of CAB+RPV LA injection treatment. The interview guide topics were informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and Proctor Outcomes to facilitate discussions on the Acceptability, Appropriateness, Feasibility, and Sustainability from the PSPs' perspective. Results of number of PSPs that discussed barriers for feasibility are presented.
Time frame: Up to Month 12
Population: Patient study participants (PSPs) who participated in interviews were analysed. Only those participants with data available at the specified time points were analysed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Staff Study Participants - Enhanced Implementation Arm | Number of PSPs That Discussed Barriers for Feasibility Assessed Via SSIs | Target date not explained | 38 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of PSPs That Discussed Barriers for Feasibility Assessed Via SSIs | Missed appointment and/or rescheduling | 23 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of PSPs That Discussed Barriers for Feasibility Assessed Via SSIs | Issues due to work | 21 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of PSPs That Discussed Barriers for Feasibility Assessed Via SSIs | Issues due to transportation and/or parking | 14 Participants |
Secondary
Number of PSPs That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs)
A semi-structured interview guide was developed to support the discussion surrounding experience with for the implementation of CAB+RPV LA injection treatment. The interview guide topics were informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and Proctor Outcomes to facilitate discussions on the Acceptability, Appropriateness, Feasibility, and Sustainability from the PSPs' perspective. Results of number of PSPs that discussed facilitators for acceptability are presented.
Time frame: Up to Month 12
Population: Patient study participants (PSPs) who participated in interviews were analysed. Only those participants with data available at the specified time points were analysed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Staff Study Participants - Enhanced Implementation Arm | Number of PSPs That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs) | Feeling informed about CAB+RPV LA injection | 105 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of PSPs That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs) | Overall positive experience with CAB+RPV LA | 100 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of PSPs That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs) | Acceptable overall experience at clinic | 82 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of PSPs That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs) | In-person communication with HCP | 76 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of PSPs That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs) | Not thinking and/or worrying about taking medication | 66 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of PSPs That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs) | Experienced injector | 64 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of PSPs That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs) | Acceptable clinic hours to receive CAB+RPV LA injections | 51 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of PSPs That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs) | CAB+RPV LA injection experience met expectations | 43 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of PSPs That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs) | Patient travel facilitation | 33 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of PSPs That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs) | CAB+RPV LA injection experience better than expected | 32 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of PSPs That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs) | Staff responsiveness | 34 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of PSPs That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs) | Number of visits | 30 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of PSPs That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs) | Satisfaction with rescheduling process | 29 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of PSPs That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs) | Distance to clinic | 27 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of PSPs That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs) | Not being reminded about HIV | 26 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of PSPs That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs) | Acceptable time spent in clinic | 25 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of PSPs That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs) | Treatment adherence | 24 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of PSPs That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs) | Gaining a sense of freedom | 24 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of PSPs That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs) | Discreet treatment | 23 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of PSPs That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs) | Communication with staff | 22 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of PSPs That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs) | Reduced stigma due to CAB+RPV LA injection | 22 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of PSPs That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs) | Reduction in injection pain | 20 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of PSPs That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs) | [Patient-perspective] Medication for injection pain management | 19 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of PSPs That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs) | Reduced stress or worry due to CAB+RPV LA injection | 19 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of PSPs That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs) | HCP advice on pain management | 18 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of PSPs That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs) | [Patient-perspective] Activities to avoid for injection pain management | 16 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of PSPs That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs) | Website and/or internet | 15 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of PSPs That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs) | Characteristics of HCP communication | 14 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of PSPs That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs) | Written materials and brochures | 14 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of PSPs That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs) | Study materials | 14 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of PSPs That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs) | Time of informing | 13 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of PSPs That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs) | Medication collection, storage and/or preparation | 12 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of PSPs That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs) | Fewer side effects | 12 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of PSPs That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs) | Time-saving approach | 12 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of PSPs That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs) | [Patient-perspective] Activities to do for injection pain management | 11 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of PSPs That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs) | Administration in other clinical setting | 11 Participants |
Secondary
Number of PSPs That Discussed Facilitators for Appropriateness Assessed Via SSIs
A semi-structured interview guide was developed to support the discussion surrounding experience with for the implementation of CAB+RPV LA injection treatment. The interview guide topics were informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and Proctor Outcomes to facilitate discussions on the Acceptability, Appropriateness, Feasibility, and Sustainability from the PSPs' perspective. Results of number of PSPs that discussed facilitators for appropriateness are presented.
Time frame: Up to Month 12
Population: Patient study participants (PSPs) who participated in interviews were analysed. Only those participants with data available at the specified time points were analysed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Staff Study Participants - Enhanced Implementation Arm | Number of PSPs That Discussed Facilitators for Appropriateness Assessed Via SSIs | 0 Participants |
Secondary
Number of PSPs That Discussed Facilitators for Feasibility Assessed Via SSIs
A semi-structured interview guide was developed to support the discussion surrounding experience with for the implementation of CAB+RPV LA injection treatment. The interview guide topics were informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and Proctor Outcomes to facilitate discussions on the Acceptability, Appropriateness, Feasibility, and Sustainability from the PSPs' perspective. Results of number of PSPs that discussed facilitators for feasibility are presented.
Time frame: Up to Month 12
Population: Patient study participants (PSPs) who participated in interviews were analysed. Only those participants with data available at the specified time points were analysed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Staff Study Participants - Enhanced Implementation Arm | Number of PSPs That Discussed Facilitators for Feasibility Assessed Via SSIs | Person to contact during CARISEL study | 102 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of PSPs That Discussed Facilitators for Feasibility Assessed Via SSIs | [Patient-perspective] Calendar, Diary, Notes and/or Reminders | 69 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of PSPs That Discussed Facilitators for Feasibility Assessed Via SSIs | No missed appointment and/or rescheduling | 65 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of PSPs That Discussed Facilitators for Feasibility Assessed Via SSIs | Target date explained | 57 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of PSPs That Discussed Facilitators for Feasibility Assessed Via SSIs | Easy to contact | 57 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of PSPs That Discussed Facilitators for Feasibility Assessed Via SSIs | Contacting clinic staff during CARISEL study | 52 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of PSPs That Discussed Facilitators for Feasibility Assessed Via SSIs | Home administration by HCP | 41 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of PSPs That Discussed Facilitators for Feasibility Assessed Via SSIs | No issues due to transportation and/or parking | 37 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of PSPs That Discussed Facilitators for Feasibility Assessed Via SSIs | No challenges to receive CAB+RPV LA injection | 33 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of PSPs That Discussed Facilitators for Feasibility Assessed Via SSIs | Not contacting clinic staff during CARISEL study | 31 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of PSPs That Discussed Facilitators for Feasibility Assessed Via SSIs | No issues due to work | 28 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of PSPs That Discussed Facilitators for Feasibility Assessed Via SSIs | Clinic Reminder [all types] | 27 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of PSPs That Discussed Facilitators for Feasibility Assessed Via SSIs | Term of target date helpful | 25 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of PSPs That Discussed Facilitators for Feasibility Assessed Via SSIs | [Patient-perspective] Setting reminders | 23 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of PSPs That Discussed Facilitators for Feasibility Assessed Via SSIs | CAB+RPV LA administration at GP office | 22 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of PSPs That Discussed Facilitators for Feasibility Assessed Via SSIs | CAB+RPV LA administration at nurse office and/or healthcare centers | 19 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of PSPs That Discussed Facilitators for Feasibility Assessed Via SSIs | No issues to attend visits due to childcare or family commitments | 16 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of PSPs That Discussed Facilitators for Feasibility Assessed Via SSIs | [Patient-perspective] Arrangements at work | 16 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of PSPs That Discussed Facilitators for Feasibility Assessed Via SSIs | Clinic reminder: Text and/or SMS | 14 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of PSPs That Discussed Facilitators for Feasibility Assessed Via SSIs | [Patient-perspective] Appointment scheduling strategies | 14 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of PSPs That Discussed Facilitators for Feasibility Assessed Via SSIs | No issues due to clinic hours | 13 Participants |
Secondary
Number of PSPs With Adverse Events (AEs) And Serious AEs (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.
Time frame: Up to 12 Months
Population: Safety population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Staff Study Participants - Enhanced Implementation Arm | Number of PSPs With Adverse Events (AEs) And Serious AEs (SAEs) | Any AEs | 420 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of PSPs With Adverse Events (AEs) And Serious AEs (SAEs) | Any SAEs | 15 Participants |
Secondary
Number of PSP With Preference for Therapy Assessed Via Preference Questionnaire
PSPs were asked to think about their experience of using the long-acting injectable medication versus the daily oral HIV medication, and to select their preferred treatment and all the reasons that support their preference. Results are categorized as: 'long-acting injectable HIV medication', 'daily oral HIV medication', 'no preference', Missing and Erroneous. Missing include participants who did not provide a response for the question. PSPs who completed this question incorrectly (i.e., checked reasons without a ticking a leading preference or checked more than one leading preference box) were included in Erroneous.
Time frame: Up to 12 Months
Population: Patient study participants (PSPs) included all participants who successfully completed the survey at Month 12. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Staff Study Participants - Enhanced Implementation Arm | Number of PSP With Preference for Therapy Assessed Via Preference Questionnaire | Daily oral HIV medication | 2 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of PSP With Preference for Therapy Assessed Via Preference Questionnaire | Long-acting injectable HIV medication | 275 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of PSP With Preference for Therapy Assessed Via Preference Questionnaire | No preference | 0 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of PSP With Preference for Therapy Assessed Via Preference Questionnaire | Missing | 2 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of PSP With Preference for Therapy Assessed Via Preference Questionnaire | Erroneous | 100 Participants |
Secondary
Number of Staff Study Participants That Discussed Barriers for Acceptability Assessed Via SSIs
A semi-structured interview guide was designed to support the discussion surrounding experience with for the implementation of CAB+RPV LA injection treatment. The interview guide topics were informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and Proctor Outcomes to facilitate discussions on the acceptability from the SSPs' perspective. The results for barriers that are integral to successful implementation are presented.
Time frame: Up to 12 Months
Population: Full analysis set included all staff study participants (SSPs) who completed at least one survey at any timepoint. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Staff Study Participants - Enhanced Implementation Arm | Number of Staff Study Participants That Discussed Barriers for Acceptability Assessed Via SSIs | 1 Participants |
| Staff Study Participants - Standard Implementation Arm | Number of Staff Study Participants That Discussed Barriers for Acceptability Assessed Via SSIs | 1 Participants |
Secondary
Number of Staff Study Participants That Discussed Barriers for Appropriateness Assessed Via SSIs
A semi-structured interview guide was designed to support the discussion surrounding experience with for the implementation of CAB+RPV LA injection treatment. The interview guide topics were informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and Proctor Outcomes to facilitate discussions on the appropriateness from the SSPs' perspective. The results for barriers that are integral to successful implementation are presented.
Time frame: Up to 12 Months
Population: Full analysis set included all staff study participants (SSPs) who completed at least one survey at any timepoint. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Staff Study Participants - Enhanced Implementation Arm | Number of Staff Study Participants That Discussed Barriers for Appropriateness Assessed Via SSIs | 0 Participants |
| Staff Study Participants - Standard Implementation Arm | Number of Staff Study Participants That Discussed Barriers for Appropriateness Assessed Via SSIs | 0 Participants |
Secondary
Number of Staff Study Participants That Discussed Barriers for Feasibility Assessed Via SSIs
A semi-structured interview guide was designed to support the discussion surrounding experience with for the implementation of CAB+RPV LA injection treatment. The interview guide topics were informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and Proctor Outcomes to facilitate discussions on the feasibility from the SSPs' perspective. The results for barriers that are integral to successful implementation are presented.
Time frame: Up to 12 Months
Population: Full analysis set included all staff study participants (SSPs) who completed at least one survey at any timepoint. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Staff Study Participants - Enhanced Implementation Arm | Number of Staff Study Participants That Discussed Barriers for Feasibility Assessed Via SSIs | 0 Participants |
| Staff Study Participants - Standard Implementation Arm | Number of Staff Study Participants That Discussed Barriers for Feasibility Assessed Via SSIs | 0 Participants |
Secondary
Number of Staff Study Participants That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs)
A semi-structured interview guide was designed to support the discussion surrounding experience with the implementation of CAB+RPV LA injection treatment. The interview guide topics were informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and Proctor Outcomes to facilitate discussions on the acceptability from the SSPs' perspective. The results for facilitators that are integral to successful implementation are presented.
Time frame: Up to 12 Months
Population: Full analysis set included all staff study participants (SSPs) who completed at least one survey at any timepoint. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Staff Study Participants - Enhanced Implementation Arm | Number of Staff Study Participants That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs) | Improved Patient's Quality of Life | 0 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Staff Study Participants That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs) | Injection pain management | 2 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Staff Study Participants That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs) | No commute to clinic | 1 Participants |
| Staff Study Participants - Standard Implementation Arm | Number of Staff Study Participants That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs) | Improved Patient's Quality of Life | 1 Participants |
| Staff Study Participants - Standard Implementation Arm | Number of Staff Study Participants That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs) | Injection pain management | 0 Participants |
| Staff Study Participants - Standard Implementation Arm | Number of Staff Study Participants That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs) | No commute to clinic | 3 Participants |
Secondary
Number of Staff Study Participants That Discussed Facilitators for Appropriateness Assessed Via SSIs
A semi-structured interview guide was designed to support the discussion surrounding experience with for the implementation of CAB+RPV LA injection treatment. The interview guide topics were informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and Proctor Outcomes to facilitate discussions on the appropriateness from the SSPs' perspective. The results for facilitators that are integral to successful implementation are presented.
Time frame: Up to 12 Months
Population: Full analysis set included all staff study participants (SSPs) who completed at least one survey at any timepoint. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Staff Study Participants - Enhanced Implementation Arm | Number of Staff Study Participants That Discussed Facilitators for Appropriateness Assessed Via SSIs | Patient characteristics | 1 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Staff Study Participants That Discussed Facilitators for Appropriateness Assessed Via SSIs | Patient selection | 0 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Staff Study Participants That Discussed Facilitators for Appropriateness Assessed Via SSIs | Hours of home visit | 1 Participants |
| Staff Study Participants - Standard Implementation Arm | Number of Staff Study Participants That Discussed Facilitators for Appropriateness Assessed Via SSIs | Patient characteristics | 2 Participants |
| Staff Study Participants - Standard Implementation Arm | Number of Staff Study Participants That Discussed Facilitators for Appropriateness Assessed Via SSIs | Patient selection | 2 Participants |
| Staff Study Participants - Standard Implementation Arm | Number of Staff Study Participants That Discussed Facilitators for Appropriateness Assessed Via SSIs | Hours of home visit | 1 Participants |
Secondary
Number of Staff Study Participants That Discussed Facilitators for Feasibility Assessed Via SSIs
A semi-structured interview guide was designed to support the discussion surrounding experience with for the implementation of CAB+RPV LA injection treatment. The interview guide topics were informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and Proctor Outcomes to facilitate discussions on the feasibility from the SSPs' perspective. The results for facilitators that are integral to successful implementation are presented.
Time frame: Up to 12 Months
Population: Full analysis set included all staff study participants (SSPs) who completed at least one survey at any timepoint. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Staff Study Participants - Enhanced Implementation Arm | Number of Staff Study Participants That Discussed Facilitators for Feasibility Assessed Via SSIs | Experience with the medication | 0 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Staff Study Participants That Discussed Facilitators for Feasibility Assessed Via SSIs | Pharmacy flexibility | 0 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Staff Study Participants That Discussed Facilitators for Feasibility Assessed Via SSIs | Medication storage | 2 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Staff Study Participants That Discussed Facilitators for Feasibility Assessed Via SSIs | Room/space characteristics | 1 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Staff Study Participants That Discussed Facilitators for Feasibility Assessed Via SSIs | Clinic or unit characteristics (e.g., autonomy, size, flexibility) | 2 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Staff Study Participants That Discussed Facilitators for Feasibility Assessed Via SSIs | Staff availability | 0 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Staff Study Participants That Discussed Facilitators for Feasibility Assessed Via SSIs | Number of patients | 1 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Staff Study Participants That Discussed Facilitators for Feasibility Assessed Via SSIs | Staff characteristics (e.g., experience, qualification, motivation) | 6 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Staff Study Participants That Discussed Facilitators for Feasibility Assessed Via SSIs | Implementation processes | 2 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Staff Study Participants That Discussed Facilitators for Feasibility Assessed Via SSIs | Training | 1 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Staff Study Participants That Discussed Facilitators for Feasibility Assessed Via SSIs | Nursing staff in consultation department | 0 Participants |
| Staff Study Participants - Enhanced Implementation Arm | Number of Staff Study Participants That Discussed Facilitators for Feasibility Assessed Via SSIs | ViiV support and materials | 3 Participants |
| Staff Study Participants - Standard Implementation Arm | Number of Staff Study Participants That Discussed Facilitators for Feasibility Assessed Via SSIs | Nursing staff in consultation department | 1 Participants |
| Staff Study Participants - Standard Implementation Arm | Number of Staff Study Participants That Discussed Facilitators for Feasibility Assessed Via SSIs | Clinic or unit characteristics (e.g., autonomy, size, flexibility) | 3 Participants |
| Staff Study Participants - Standard Implementation Arm | Number of Staff Study Participants That Discussed Facilitators for Feasibility Assessed Via SSIs | Experience with the medication | 1 Participants |
| Staff Study Participants - Standard Implementation Arm | Number of Staff Study Participants That Discussed Facilitators for Feasibility Assessed Via SSIs | Implementation processes | 2 Participants |
| Staff Study Participants - Standard Implementation Arm | Number of Staff Study Participants That Discussed Facilitators for Feasibility Assessed Via SSIs | Medication storage | 1 Participants |
| Staff Study Participants - Standard Implementation Arm | Number of Staff Study Participants That Discussed Facilitators for Feasibility Assessed Via SSIs | Number of patients | 2 Participants |
| Staff Study Participants - Standard Implementation Arm | Number of Staff Study Participants That Discussed Facilitators for Feasibility Assessed Via SSIs | ViiV support and materials | 1 Participants |
| Staff Study Participants - Standard Implementation Arm | Number of Staff Study Participants That Discussed Facilitators for Feasibility Assessed Via SSIs | Pharmacy flexibility | 1 Participants |
| Staff Study Participants - Standard Implementation Arm | Number of Staff Study Participants That Discussed Facilitators for Feasibility Assessed Via SSIs | Room/space characteristics | 1 Participants |
| Staff Study Participants - Standard Implementation Arm | Number of Staff Study Participants That Discussed Facilitators for Feasibility Assessed Via SSIs | Staff availability | 2 Participants |
| Staff Study Participants - Standard Implementation Arm | Number of Staff Study Participants That Discussed Facilitators for Feasibility Assessed Via SSIs | Staff characteristics (e.g., experience, qualification, motivation) | 8 Participants |
| Staff Study Participants - Standard Implementation Arm | Number of Staff Study Participants That Discussed Facilitators for Feasibility Assessed Via SSIs | Training | 0 Participants |
Secondary
Percentage of PSP Receiving Injections Within Target Window
The target window for participants to receive injection was from Day -7 to Day 7.
Time frame: Day -7 to Day 7 of Month 2, 4, 6, 8, 10 and 12
Population: Safety population included all enrolled participants who received at least one dose of CAB + RPV Oral or CAB LA + RPV LA.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Staff Study Participants - Enhanced Implementation Arm | Percentage of PSP Receiving Injections Within Target Window | Month 2 | 99 Percentage of Participants |
| Staff Study Participants - Enhanced Implementation Arm | Percentage of PSP Receiving Injections Within Target Window | Month 4 | 93 Percentage of Participants |
| Staff Study Participants - Enhanced Implementation Arm | Percentage of PSP Receiving Injections Within Target Window | Month 6 | 91 Percentage of Participants |
| Staff Study Participants - Enhanced Implementation Arm | Percentage of PSP Receiving Injections Within Target Window | Month 8 | 91 Percentage of Participants |
| Staff Study Participants - Enhanced Implementation Arm | Percentage of PSP Receiving Injections Within Target Window | Month 10 | 94 Percentage of Participants |
| Staff Study Participants - Enhanced Implementation Arm | Percentage of PSP Receiving Injections Within Target Window | Month 12 | 91 Percentage of Participants |
Secondary
Percentage of PSPs With Plasma HIV-1 Ribonucleic Acid (RNA) Less Than (<)50 Copies Per Milliliter (c/ml)
Plasma samples were collected from the participant at specific time points.
Time frame: Month 1, 2, 4, 8 and 12
Population: Safety population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Staff Study Participants - Enhanced Implementation Arm | Percentage of PSPs With Plasma HIV-1 Ribonucleic Acid (RNA) Less Than (<)50 Copies Per Milliliter (c/ml) | Month 1 | 99 Percentage of Participants |
| Staff Study Participants - Enhanced Implementation Arm | Percentage of PSPs With Plasma HIV-1 Ribonucleic Acid (RNA) Less Than (<)50 Copies Per Milliliter (c/ml) | Month 2 | 96 Percentage of Participants |
| Staff Study Participants - Enhanced Implementation Arm | Percentage of PSPs With Plasma HIV-1 Ribonucleic Acid (RNA) Less Than (<)50 Copies Per Milliliter (c/ml) | Month 4 | 93 Percentage of Participants |
| Staff Study Participants - Enhanced Implementation Arm | Percentage of PSPs With Plasma HIV-1 Ribonucleic Acid (RNA) Less Than (<)50 Copies Per Milliliter (c/ml) | Month 8 | 86 Percentage of Participants |
| Staff Study Participants - Enhanced Implementation Arm | Percentage of PSPs With Plasma HIV-1 Ribonucleic Acid (RNA) Less Than (<)50 Copies Per Milliliter (c/ml) | Month 12 | 87 Percentage of Participants |