HIV Infections
Conditions
Keywords
Cabotegravir, Long acting injectables, Implementation science, HIV, PrEP, HIV Disparities, Ending the Epidemic, Engaging Black Women on APRETUDE by Optimizing Novel Implementation Strategies (EBONI)
Brief summary
The purpose of the study is to evaluate the appropriateness, adoption, feasibility, fidelity, and acceptability of implementation strategies and Cabotegravir (CAB) pre-exposure prophylaxis (PrEP). The study objectives are also to identify barriers and facilitators to implementation. The first of two participant types in the study are the Patient Study Participants (PSPs) will refer to individuals who are enrolled in the study and who will receive commercially available CAB PrEP via prescription from the PrEP provider. The second are Staff Study Participants (SSPs) who are site staff involved in the administrative and clinical aspects of offering and administering PrEP to PSPs at the clinical site.
Interventions
DRUGAPRETUDE
Available as intramuscular injection.
DRUGCabotegravir tablet
Available as marketed orally administered tablets.
Sponsors
ViiV Healthcare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Participant must be ≥18 years of age, at the time of signing the informed consent. * HIV negative at screening. Type of HIV-1 test is per standard of care. * No prior history of receiving oral CAB or CAB LA injections. * PrEP provider deems CAB PrEP use to be appropriate per the applicable CAB PrEP prescribing information prior to enrollment in the study. * Female at birth or self-identified Transgender Female. * Self-identified as African American/Black * Capable of giving signed informed consent
Exclusion criteria
* HIV indeterminate or positive test result during screening. * A participant of concurrent interventional clinical or implementation science study at any time during the study. * Cis-gender or Transgender male
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Intervention Appropriateness Measure (IAM) Score in SSPs | Up to Month 13 | The responses for appropriateness will be measured on a Likert scale ranging from 0 to 5 with higher values representing better outcomes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean IAM Score in SSPs at Month 1, 4, 5, 12 and 13 | Month 1, 4, 5, 12 and 13 | The responses for appropriateness will be measured on a Likert scale ranging from 0 to 5 with higher values representing better outcomes. Data will be collected at Month 1, 4, and 12 for participants who start with injections and at Month 1, 5, 13 for participants who start with the oral lead in. |
| Change from Baseline in Mean IAM Score in SSPs at Month 4, 5, 12 and 13 | Baseline (Month 1) and Month 4, 5, 12 and 13 | The responses for appropriateness will be measured on a Likert scale ranging from 0 to 5 with higher values representing better outcomes. Data will be collected at Month 1, 4, and 12 for participants who start with injections and at Month 1, 5, 13 for participants who start with the oral lead in. |
| Appropriateness of APRETUDE Assessed by SSP Questionnaire responses at Month 1, 4, 5, 12 and 13 | Month 1, 4, 5, 12 and 13 | Data will be collected at Month 1, 4, and 12 for participants who start with injections and at Month 1, 5, 13 for participants who start with the oral lead in. |
| Appropriateness of APRETUDE Assessed by Semi-structured interview (SSI) at Month 4, 5, 12 and 13 | Month 1, 4, 5, 12 and 13 | Appropriateness of APRETUDE will be measured from themes emerging from Proctor and Consolidated Framework for Implementation Research (CFIR) guided semi-structured qualitative interview. Data will be collected at Month 1, 4, and 12 for participants who start with injections and at Month 1, 5, 13 for participants who start with the oral lead in. |
| Mean IAM Score in PSPs at Month 1, 4, 5, 12 and 13 | Month 1, 4, 5, 12 and 13 | The responses for appropriateness will be measured on a Likert scale ranging from 0 to 5 with higher values representing better outcomes. Data will be collected at Month 1, 4, and 12 for participants who start with injections and at Month 1, 5, 13 for participants who start with the oral lead in. |
| Change from Baseline in Mean IAM Score in PSPs at Month 4, 5, 12 and 13 | Baseline (Month 1) and Month 4, 5, 12 and 13 | The responses for appropriateness will be measured on a Likert scale ranging from 0 to 5 with higher values representing better outcomes. Data will be collected at Month 1, 4, and 12 for participants who start with injections and at Month 1, 5, 13 for participants who start with the oral lead in. |
| Perception of Appropriateness of APRETUDE Assessed by PSP Questionnaire responses at Month 1, 4, 5, 12 and 13 | Month 1, 4, 5, 12 and 13 | Data will be collected at Month 1, 4, and 12 for participants who start with injections and at Month 1, 5, 13 for participants who start with the oral lead in. |
| Perception of Appropriateness of APRETUDE Assessed by SSI in PSPs at Month 4, 5, 12 and 13 | Month 4, 5, 12 and 13 | Perception of Appropriateness of APRETUDE will be measured from themes emerging from Proctor and CFIR framework guided semi-structured qualitative interview. Data will be collected at Month 4, and 12 for participants who start with injections and at Month 5, 13 for participants who start with the oral lead in. |
| Number of cis-and trans Black women who Complete a Sexual Health Assessment through Month 13 in ECI Arm based on site-level PrEP Information Questionnaire | Up to Month 13 | — |
| Number of PSPs who Complete a Sexual Health Assessment through Month 13 in ECI Arm based on Site-level PrEP Information Questionnaire | Up to Month 13 | — |
| Number of cis-and trans Black Women who Initiate APRETUDE through Month 13 by Study Arm Based on Site level PrEP Information Questionnaire | Up to Month 13 | — |
| Number of cis-and trans Black Women who Initiate APRETUDE through Month 13 by Clinic Characteristics Based on Site level PrEP Information Questionnaire | Up to Month 13 | — |
| Proportion of cis-and trans Black Women who Initiate APRETUDE through Month 13 by Study Arm Based on Site level PrEP Information Questionnaire | Up to Month 13 | — |
| Proportion of cis-and trans Black Women who Initiate APRETUDE through Month 13 by Clinic Characteristics Based on Site level PrEP Information Questionnaire | Up to Month 13 | — |
| Number of cis-and trans Black Women who Continue APRETUDE beyond a First Dose through Month 13 by study arm based on Site-level PrEP Information Questionnaire | Up to Month 13 | — |
| Number of cis-and trans Black Women who Continue APRETUDE beyond a First Dose through Month 13 by Clinic Characteristics based on Site-level PrEP Information Questionnaire | Up to Month 13 | — |
| Mean Feasibility of Intervention Measure (FIM) score in SSPs for Implementation Strategies | Month 1 and 4, 5, 12 and 13 | The responses for feasibility will be measured on a 5-point Likert scale ranging from 0 to 5 with higher values representing better outcomes. Data will be collected at Month 1, 4, and 12 for participants who start with injections and at Month 1, 5, 13 for participants who start with the oral lead in. |
| Change from Baseline in FIM Score in SSPs for Implementation Strategies | Baseline (Month 1) and Month 4, 5, 12 and 13 | The responses for feasibility will be measured on a 5-point Likert scale ranging from 0 to 5 with higher values representing better outcomes. Data will be collected at Month 1, 4, and 12 for participants who start with injections and at Month 1, 5, 13 for participants who start with the oral lead in. |
| Feasibility of Strategy Assessed by SSPs Questionnaire responses at Month 1, 4, 5, 12 and 13 | Month 1, 4, 5, 12 and 13 | Data will be collected at Month 1, 4, and 12 for participants who start with injections and at Month 1, 5, 13 for participants who start with the oral lead in. |
| Feasibility and Utility of Strategy Assessed in SSPs by SSI at Month 4, 5, 12 and 13 | Month 4, 5, 12 and 13 | Perception of Appropriateness of APRETUDE will be measured from themes emerging from Proctor and CFIR framework guided semi-structured qualitative interview. Data will be collected at Month 4, and 12 for participants who start with injections and at Month 5, 13 for participants who start with the oral lead in. |
| Proportion of SSPs that Respond in Agreement on Relevant Items on the Implementation science questionnaire (ISQ) that each implementation tool and strategy is fit for use through Month 13 Based on Study Arm | Up to Month 13 | ISQ measures a range, including acceptability, feasibility, and utility. |
| Proportion of SSPs that Respond in Agreement on Relevant Items on the ISQ that each implementation tool and strategy is fit for use through Month 13 Based on Clinic Characteristics | Up to Month 13 | ISQ measures a range, including acceptability, feasibility, and utility. |
| Proportion of SSPs that Respond in Agreement on Relevant Items on the ISQ that each implementation tool and strategy is fit for use through Month 13 Based on Patient Subgroups | Up to Month 13 | ISQ measures a range, including acceptability, feasibility, and utility. |
| Proportion of PSPs that Respond in Agreement on Relevant Items on the Implementation science questionnaire (ISQ) that each implementation tool and strategy is fit for use through Month 13 Based on Study Arm | Up to Month 13 | ISQ measures a range, including acceptability, feasibility, and utility. |
| Proportion of PSPs that Respond in Agreement on Relevant Items on the ISQ that each implementation tool and strategy is fit for use through Month 13 Based on Clinic Characteristics | Up to Month 13 | ISQ measures a range, including acceptability, feasibility, and utility. |
| Proportion of PSPs that Respond in Agreement on Relevant Items on the ISQ that each implementation tool and strategy is fit for use through Month 13 Based on Patient Subgroups | Up to Month 13 | ISQ measures a range, including acceptability, feasibility, and utility. |
| Perceptions of Utility of Implementation tools and strategies Assessed by SSIs in PSPs through Month 13 based on Patient Subgroups | Up to Month 13 | Perceptions of Utility of Implementation tools and strategies will be measured from themes emerging from Proctor and CFIR framework guided semi-structured qualitative interview. |
| Proportion of Injections Occurring Within Target Window from Target Date (+-7 days of target date) | Up to Month 13 | — |
| Perception of Barriers and Facilitators to Fidelity to Injections Window Assessed by SSIs in PSPs | Month 1, 12 and 13 | Perception of Barriers and Facilitators to Fidelity to Injections Window will be measured from themes emerging from Proctor and CFIR framework guided semi-structured qualitative interview. Data will be collected at Month 1 and 12 for participants who start with injections and at Month 1 and 13 who start with oral lead in. |
| Perception of Barriers and Facilitators to Fidelity to Injections Window Assessed by Surveys in PSPs | Month 1, 4, 5, 12 and 13 | Data will be collected at Month 1, 4, and 12 for participants who start with injections and at Month 1, 5, 13 for participants who start with the oral lead in. |
| Perception of Barriers and Facilitators to Fidelity to Injections Window Assessed by Implementation Monitoring Calls (IMC) in SSPs | Month 4, 5, 12 and 13 | Data will be collected at Month 4, and 12 for participants who start with injections and at Month 5 and 13 for participants who start with the oral lead in. |
| Proportion of PSPs completing target number of injections | Up to Month 13 | — |
| Barriers, Facilitators, Concerns and Perception to Implementation in SSPs and PSPs Assessed by Questionnaire responses | Month 1, 4, 5, 12 and 13 | Data will be collected at Month 1, 4, and 12 for participants who start with injections and at Month 1, 5, 13 for participants who start with the oral lead in. |
| Perception to Facilitators and Barriers to Implementation in SSPs Assessed by SSI | Month 4, 5, 12 and 13 | Perception to Facilitators and Barriers to Implementation will be measured from themes emerging from Proctor and CFIR framework guided semi-structured qualitative interview. Data will be collected at Month 4, and 12 for participants who start with injections and at Month 5 and 13 for participants who start with the oral lead in. |
| Perception to Facilitators and Barriers to Implementation in SSPs Assessed by IMC | Month 4, 5, 12 and 13 | Data will be collected at Month 4, and 12 for participants who start with injections and at Month 5 and 13 for participants who start with the oral lead in. |
| Perception to Facilitators and Barriers to Implementation in PSPs Assessed by SSI | Month 1, 12 and 13 | Perception to Facilitators and Barriers to Implementation will be measured from themes emerging from Proctor and CFIR framework guided semi-structured qualitative interview. Data will be collected at Month 1 and 12 for participants who start with injections and at Month 1 and 13 for participants who start with the oral lead in. |
| Acceptability of Intervention Measure (AIM) Score for APRETUDE in SSPs and PSPs | Month 1, 4, 5, 12 and 13 | The responses for acceptability will be measured on a Likert scale ranging from 0 to 5 with higher values representing better outcomes. Data will be collected at Month 1, 4, and 12 for participants who start with injections and at Month 1, 5, 13 for participants who start with the oral lead in. |
| FIM Score for APRETUDE in SSPs and PSPs | Month 1, 4, 5, 12 and 13 | The responses for feasibility will be measured on a Likert scale ranging from 0 to 5 with higher values representing better outcomes. Data will be collected at Month 1, 4, and 12 for participants who start with injections and at Month 1, 5, 13 for participants who start with the oral lead in. |
| Feasibility and Acceptability of APRETUDE in SSPs and PSPs Assessed by Questionnaire Responses | Month 1, 4, 5, 12 and 13 | Data will be collected at Month 1, 4, and 12 for participants who start with injections and at Month 1, 5, 13 for participants who start with the oral lead in. |
| Feasibility and Acceptability of APRETUDE in SSPs Assessed by SSIs | Month 4, 12 and 13 | Feasibility and Acceptability of APRETUDE will be measured from themes emerging from Proctor and CFIR framework guided semi-structured qualitative interview. Data will be collected at Month 4, and 12 for participants who start with injections and at Month 13 for participants who start with the oral lead in. |
| Feasibility and Acceptability of APRETUDE in PSPs Assessed by SSIs | Month 1, 12 and 13 | Feasibility and Acceptability of APRETUDE will be measured from themes emerging from Proctor and CFIR framework guided semi-structured qualitative interview. Data will be collected at Month 1 and 12 for participants who start with injections and at Month 1 and 13 for participants who start with the oral lead in. |
| Proportion of PSPs that have one Oral lead-in before CAB Injection | Up to Month 13 | — |
| Perception on Reason for Decision to Use Oral lead-in in SSPs Assessed by SSI | Month 1, 4, 5, 12 and 13 | Perception on Reason for Decision to Use Oral lead-in will be measured from themes emerging from Proctor and CFIR framework guided semi-structured qualitative interview. Data will be collected at Month 1, 4, and 12 for participants who start with injections and at Month 1, 5, 13 for participants who start with the oral lead in. |
| Perception on Reason for Decision to Use Oral lead-in SSPs Assessed by Survey responses | Month 1, 4, 5, 12 and 13 | Data will be collected at Month 1, 4, and 12 for participants who start with injections and at Month 1, 5, 13 for participants who start with the oral lead in. |
| Perception on Reason for Decision to Use Oral lead-in PSPs Assessed by SSIs | Month 1 | Perception on Reason for Decision to Use Oral lead-in will be measured from themes emerging from Proctor and CFIR framework guided semi-structured qualitative interview. |
| Perception on Reason for Decision to Use Oral lead-in PSPs Assessed by Survey Responses | Month 1 | — |
| Proportion of PSPs that Complete a Sexual Health Assessment and Start or Switch from Oral PrEP to APRETUDE | Up to Month 13 | — |
| Reasons for Choosing or Switching from Oral PrEP to APRETUDE in PSPs Assessed by SSIs | Up to Month 13 | Reasons for Choosing or Switching from Oral PrEP to APRETUDE will be measured from themes emerging from Proctor and CFIR framework guided semi-structured qualitative interview. |
Countries
United States
Contacts
STUDY_DIRECTORGSK Clinical Trials
ViiV Healthcare
Outcome results
None listed