A Study Evaluating Implementation Strategies for the Delivery of APRETUDE for Black cis-and Transgender Women in United States EHE Territories

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 4, Randomized, Open-label, Three-arm Study to Evaluate Implementation Strategies for the Delivery of CAB for HIV Pre-exposure Prophylaxis (PrEP) Across Clinical Settings for Adult (≥18 Years) Black cis-and Transgender Women Without HIV Infection Living in the United States Ending the Epidemic (EHE) Territories

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: APRETUDE
* Drug: Cabotegravir tablet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Implementation (SI)<br>PSPs will receive APRETUDE injection and could receive optional Cabotegravir tablets as oral lead in (OLI). The SI arm receives the standard toolkits that are anticipated to be available for APRETUDE that includes information resource for PSPs and SSPs. | Drug: APRETUDE<br>* Available as intramuscular injection.<br>Drug: Cabotegravir tablet<br>* Available as marketed orally administered tablets.<br>|
| Experimental: Enhanced Implementation (EI)<br>PSPs will receive APRETUDE injection and could receive optional Cabotegravir tablets as OLI. The EI arm will receive all components of SI arm and additional provider-focused implementation strategies. Provider-focused strategies will include a patient-provider communication tool, Provider Education, and enhanced tool kit materials. | Drug: APRETUDE<br>* Available as intramuscular injection.<br>Drug: Cabotegravir tablet<br>* Available as marketed orally administered tablets.<br>|
| Experimental: Enhanced Collaborative Implementation (ECI)<br>PSPs will receive APRETUDE injection and could receive optional Cabotegravir tablets as OLI. The ECI arm will involve implementation strategies to support patient activation and provider awareness. Clinics randomized to ECI will receive all components of SI and additional implementation strategies to support patient activation and ensure provider awareness. ECI strategies will include a patient information and product resources and peer support. | Drug: APRETUDE<br>* Available as intramuscular injection.<br>Drug: Cabotegravir tablet<br>* Available as marketed orally administered tablets.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Intervention Appropriateness Measure (IAM) Score in SSPs | The responses for appropriateness will be measured on a Likert scale ranging from 0 to 5 with higher values representing better outcomes. | Up to Month 13 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean IAM Score in SSPs at 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. | Month 1, 4, 5, 12 and 13 | 
| Change from Baseline in Mean IAM Score in SSPs at 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. | Baseline (Month 1) and Month 4, 5, 12 and 13 | 
| Appropriateness of APRETUDE Assessed by SSP Questionnaire responses at 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. | Month 1, 4, 5, 12 and 13 | 
| Appropriateness of APRETUDE Assessed by Semi-structured interview (SSI) at Month 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. | Month 1, 4, 5, 12 and 13 | 
| Appropriateness of APRETUDE Assessed by Semi-structured interview (SSI) at Month 4, 5, 12 and 13 | 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. | Month 4, 5 12 and 13 | 
| Mean IAM Score in PSPs at 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. | Month 1, 4, 5, 12 and 13 | 
| Change from Baseline in Mean IAM Score in PSPs at 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. | Baseline (Month 1) and Month 4, 5, 12 and 13 | 
| Perception of Appropriateness of APRETUDE Assessed by PSP Questionnaire responses at 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. | Month 1, 4, 5, 12 and 13 | 
| Perception of Appropriateness of APRETUDE Assessed by SSI in PSPs at 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. | Month 4, 5, 12 and 13 | 
| 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 | 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. | Month 1 and 4, 5, 12 and 13 | 
| Change from Baseline in FIM Score in SSPs for Implementation Strategies | 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. | Baseline (Month 1) and Month 4, 5, 12 and 13 | 
| Feasibility of Strategy Assessed by SSPs Questionnaire responses at 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. | Month 1, 4, 5, 12 and 13 | 
| Feasibility and Utility of Strategy Assessed in SSPs by SSI at 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. | Month 4, 5, 12 and 13 | 
| 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 | ISQ measures a range, including acceptability, feasibility, and utility. | Up to Month 13 | 
| 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 | ISQ measures a range, including acceptability, feasibility, and utility. | Up to Month 13 | 
| 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 | ISQ measures a range, including acceptability, feasibility, and utility. | Up to Month 13 | 
| 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 | ISQ measures a range, including acceptability, feasibility, and utility. | Up to Month 13 | 
| 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 | ISQ measures a range, including acceptability, feasibility, and utility. | Up to Month 13 | 
| 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 | ISQ measures a range, including acceptability, feasibility, and utility. | Up to Month 13 | 
| Perceptions of Utility of Implementation tools and strategies Assessed by SSIs in PSPs through Month 13 based on Patient Subgroups | Perceptions of Utility of Implementation tools and strategies will be measured from themes emerging from Proctor and CFIR framework guided semi-structured qualitative interview. | Up to Month 13 | 
| 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 | 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. | Month 1, 12 and 13 | 
| Perception of Barriers and Facilitators to Fidelity to Injections Window Assessed by Surveys in PSPs | 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. | Month 1, 4, 5, 12 and 13 | 
| Perception of Barriers and Facilitators to Fidelity to Injections Window Assessed by Implementation Monitoring Calls (IMC) in SSPs | 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. | Month 4, 5, 12 and 13 | 
| 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 | 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. | Month 1, 4, 5, 12 and 13 | 
| Perception to Facilitators and Barriers to Implementation in SSPs Assessed by SSI | 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. | Month 4, 5, 12 and 13 | 
| Perception to Facilitators and Barriers to Implementation in SSPs Assessed by IMC | 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. | Month 4, 5, 12 and 13 | 
| Perception to Facilitators and Barriers to Implementation in PSPs Assessed by SSI | 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. | Month 1, 12 and 13 | 
| Acceptability of Intervention Measure (AIM) Score for APRETUDE in SSPs and PSPs | 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. | Month 1, 4, 5, 12 and 13 | 
| FIM Score for APRETUDE in SSPs and PSPs | 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. | Month 1, 4, 5, 12 and 13 | 
| Feasibility and Acceptability of APRETUDE in SSPs and PSPs Assessed by Questionnaire Responses | 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. | Month 1, 4, 5, 12 and 13 | 
| Feasibility and Acceptability of APRETUDE in SSPs Assessed by SSIs | 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. | Month 4, 12 and 13 | 
| Feasibility and Acceptability of APRETUDE in PSPs Assessed by SSIs | 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. | Month 1, 12 and 13 | 
| 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 | 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. | Month 1, 4, 5, 12 and 13 | 
| Perception on Reason for Decision to Use Oral lead-in SSPs Assessed by Survey responses | 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. | Month 1, 4, 5, 12 and 13 | 
| Perception on Reason for Decision to Use Oral lead-in PSPs Assessed by SSIs | 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. | Month 1 | 
| 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 | 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. | Up to Month 13 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Cabotegravir, Long acting injectables, Implementation science, PrEP, HIV Disparities, Ending the Epidemic, Engaging Black Women on APRETUDE by Optimizing Novel Implementation Strategies (EBONI)