A Study Evaluating Implementation Strategies for the Delivery of Cabotegravir in Low and High-Volume PrEP Site in the United States

Study Overview
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Brief Summary
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This is a two-arm study evaluating the impact of two implementation strategy conditions, dynamic implementation and routine implementation on the feasibility of delivering of Cabotegravir PrEP in low and high-volume PrEP sites in the United States for men who have sex with men (MSM) and Transgender men ≥ 18 years of age. There are two types of participants in the study. Patient Study Participants (PSPs) will refer to individuals who are enrolled in the study and who will receive commercially available Cabotegravir PrEP via prescription from the PrEP provider at the corresponding site. Staff Study Participants (SSPs) will refer to site staff who are involved in administrative and clinical aspects of offering and administering PrEP to PSPs and will participate in the staff study assessments. PSPs who choose to opt for 1-month oral lead-in (OLI) will receive cabotegravir tablets for PrEP at Month 1 followed by APPRETUDE intramuscular (IM) injections on Month 2, 3 and every two months thereafter up to Month 13. PSPs who opt for Direct to injections (DTI) will receive APPRETUDE IM injections on Month 1, 2 and every two months thereafter up to Month 12. Month 6/7 refers to Month 6 (DTI)/ Month 7 (OLI). Month 12/13 refers to Month 12 (DTI)/ Month 13 (OLI).

Official Title
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A Phase 4, Randomized, Open-label, Two-arm Study Evaluating Implementation Strategies for the Delivery of Cabotegravir in Low and High-volume Pre-exposure Prophylaxis (PrEP) Sites in the U.S. for HIV Uninfected MSM and Transgender Men ≥ 18

Conditions
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HIV Infections

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant must be ≥ 18 years of age inclusive, at the time of signing the informed consent. No prior history of receiving CAB PrEP HIV negative test result at screening Capable of giving signed informed consent form Exclusion Criteria: HIV indeterminate or positive test result during screening and prior to initiation of CAB PrEP A participant of concurrent interventional clinical or implementation science study at any time during the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Routine Implementation (RI)<br>PSPs will receive APRETUDE injection and optional Cabotegravir tablets as oral lead in (OLI) . PSPs and SSPs will have access to standard toolkits for APRETUDE to use as needed. | Drug: APRETUDE<br>* Available as intramuscular injection.<br>Drug: Cabotegravir OLI<br>* Available as marketed orally administered tablets.<br>|
| Experimental: Dynamic Implementation (DI)<br>PSPs will receive APRETUDE injection and optional Cabotegravir tablets as oral lead in (OLI). PSPs and SSPs will have access to enhanced toolkits, a digital health implementation strategy and implementation facilitation for APRETUDE to use. | Drug: APRETUDE<br>* Available as intramuscular injection.<br>Drug: Cabotegravir OLI<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 Feasibility of Intervention Measure (FIM) Score Assessed from SSPs | The responses for feasibility will be measured on a 5-point Likert scale ranging from 1 to 5 with higher values representing better outcomes. | Month 13 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in FIM Score Assessed from SSPs | The responses for feasibility will be measured on a 5-point Likert scale ranging from 1 to 5 with higher values representing better outcomes. | Baseline (Month 1), Month 5 and 13 | 
| Perceptions of Facilitators and Barriers to RI, DI, and Overall Implementation of PrEP into Routine Care Assessed from SSPs Through Month 13 | Perception of facilitators and barriers to RI, DI and overall implementation of PrEP measured from themes emerging from Proctor and Consolidated Framework for Implementation Research (CFIR) framework guided semi-structured qualitative interview. | Up to Month 13 | 
| Mean FIM Score Assessed from PSPs | The responses for feasibility will be measured on a 5-point Likert scale ranging from 1 to 5 with higher values representing better outcomes. | Baseline (Month 1), Month 6 (DTI) / Month 7 (OLI) and Month 12 (DTI) / Month 13 (OLI) | 
| Mean Acceptability of Implementation Measure (AIM) Score Assessed from PSPs | The responses for acceptability will be measured on a Likert scale ranging from 1 to 5 with higher values representing better outcomes. | Baseline (Month 1), Month 6 (DTI) / Month 7 (OLI) and Month 12 (DTI) / Month 13 (OLI) | 
| ISQ Responses Assessed from PSPs | Implementation Science Questionnaire (ISQ) measures a range, including acceptability, feasibility, and utility. | Baseline (Month 1), Month 6 (DTI) / Month 7 (OLI) and Month 12 (DTI) / Month 13 (OLI) | 
| Change from Baseline in AIM Score Assessed from PSPs | The responses for acceptability will be measured on a Likert scale ranging from 1 to 5 with higher values representing better outcomes. | Baseline (Month 1), Month 6 (DTI) / Month 7 (OLI) and Month 12 (DTI) / Month 13 (OLI) | 
| Change from Baseline in FIM Score Assessed from PSPs | The responses for feasibility will be measured on a 5-point Likert scale ranging from 1 to 5 with higher values representing better outcomes. | Baseline (Month 1), Month 6 (DTI) / Month 7 (OLI) and Month 12 (DTI) / Month 13 (OLI) | 
| Change from Baseline in ISQ Responses Assessed from PSPs | ISQ measures a range, including acceptability, feasibility, and utility. | Baseline (Month 1), Month 6 (DTI) / Month 7 (OLI) and Month 12 (DTI) / Month 13 (OLI) | 
| Perception of Facilitators and Barriers to Feasibility and Acceptability of APRETUDE Assessed from PSPs | Facilitators and barriers to feasibility and acceptability of APRETUDE measured from themes emerging from Proctor and Consolidated Framework for Implementation Research (CFIR) framework guided semi-structured qualitative interviews. | Up to Month 13 | 
| Mean FIM Score for Telehealth Delivery Assessed from SSPs | The responses for feasibility will be measured on a 5-point Likert scale ranging from 1 to 5 with higher values representing better outcomes. | Baseline (Month 1), Month 5, and 13 | 
| Mean AIM Score for Telehealth Delivery Assessed from SSPs | The responses for acceptability will be measured on a Likert scale ranging from 1 to 5 with higher values representing better outcomes. | Baseline (Month 1), Month 5, and 13 | 
| ISQ Responses for Telehealth Delivery Assessed from SSPs | ISQ measures a range, including acceptability, feasibility, and utility. | Baseline (Month 1), Month 5, and 13 | 
| Change from Baseline in FIM Score for Telehealth Delivery Assessed from SSPs | The responses for feasibility will be measured on a 5-point Likert scale ranging from 1 to 5 with higher values representing better outcomes. | Baseline (Month 1) and Month 5, and 13 | 
| Change from Baseline in AIM Score for Telehealth Delivery Assessed from SSPs | The responses for acceptability will be measured on a Likert scale ranging from 1 to 5 with higher values representing better outcomes. | Baseline (Month 1) and Month 5, and 13 | 
| Change from Baseline in ISQ Responses for Telehealth Delivery Assessed from SSPs | ISQ measures a range, including acceptability, feasibility, and utility. | Baseline (Month 1) and Month 5, and 13 | 
| Mean FIM Score for Telehealth Delivery Assessed from PSPs | The responses for feasibility will be measured on a 5-point Likert scale ranging from 1 to 5 with higher values representing better outcomes. | Baseline (Month 1), Month 6 (DTI) / Month 7 (OLI) and Month 12 (DTI) / Month 13 (OLI) | 
| Mean AIM Score for Telehealth Delivery Assessed from PSPs | The responses for acceptability will be measured on a Likert scale ranging from 1 to 5 with higher values representing better outcomes. | Baseline (Month 1), Month 6 (DTI) / Month 7 (OLI) and Month 12 (DTI) / Month 13 (OLI) | 
| ISQ Responses for Telehealth Delivery Assessed from PSPs | ISQ measures a range, including acceptability, feasibility, and utility. | Baseline (Month 1), Month 6 (DTI) / Month 7 (OLI) and Month 12 (DTI) / Month 13 (OLI) | 
| Change from Baseline in FIM Score for Telehealth Delivery Assessed from PSPs | The responses for feasibility will be measured on a 5-point Likert scale ranging from 1 to 5 with higher values representing better outcomes. | Baseline (Month 1), Month 6 (DTI) / Month 7 (OLI) and Month 12 (DTI) / Month 13 (OLI) | 
| Change from Baseline in AIM Score for Telehealth Delivery Assessed from PSPs | The responses for acceptability will be measured on a Likert scale ranging from 1 to 5 with higher values representing better outcomes. | Baseline (Month 1), Month 6 (DTI) / Month 7 (OLI) and Month 12 (DTI) / Month 13 (OLI) | 
| Change from Baseline in ISQ Responses for Telehealth Delivery Assessed from PSPs | ISQ measures a range, including acceptability, feasibility, and utility. | Baseline (Month 1), Month 6 (DTI) / Month 7 (OLI) and Month 12 (DTI) / Month 13 (OLI) | 
| Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery Assessed for SSPs | Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery will be measured from themes emerging from Proctor and CFIR framework guided semi-structured qualitative interview. | Up to Month 13 | 
| Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery Assessed for PSPs | Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery will be measured from themes emerging from Proctor and CFIR framework guided semi-structured qualitative interview. | Up to Month 13 | 
| Mean AIM Score Assessed from SSPs | The responses for acceptability of the implementation interventions will be measured on a Likert scale ranging from 1 to 5 with higher values representing better outcomes. | Baseline (Month 1), Month 5 and 13 | 
| ISQ Responses Assessed from SSPs | ISQ measures a range, including acceptability, feasibility, and utility. | Baseline (Month 1), Month 5 and 13 | 
| Change From Baseline in AIM Score Assessed from SSPs | The responses for acceptability of the implementation interventions will be measured on a Likert scale ranging from 1 to 5 with higher values representing better outcomes | Baseline (Month 1) and Month 5 and 13 | 
| Change From Baseline in ISQ Responses Assessed from SSPs | ISQ measures a range, including acceptability, feasibility, and utility. | Baseline (Month 1) and Month 5 and 13 | 
| Mean AIM Score Based on Implementation Strategy in PSPs | The responses for acceptability will be measured on a Likert scale ranging from 1 to 5 with higher values representing better outcomes. | Baseline (Month 1), Month 6 (DTI) / Month 7 (OLI) and Month 12 (DTI) / Month 13 (OLI) | 
| ISQ Responses Based on Implementation Strategy in PSPs | ISQ measures a range, including acceptability, feasibility, and utility. | Baseline (Month 1), Month 6 (DTI) / Month 7 (OLI) and Month 12 (DTI) / Month 13 (OLI) | 
| Change from Baseline in Mean AIM Score Under Implementation Strategy in PSPs | The responses for acceptability will be measured on a Likert scale ranging from 1 to 5 with higher values representing better outcomes. | Baseline (Month 1), Month 6 (DTI) / Month 7 (OLI) and Month 12 (DTI) / Month 13 (OLI) | 
| Change from Baseline in ISQ Responses Under Implementation Strategy in PSPs | ISQ measures a range, including acceptability, feasibility, and utility. | Baseline (Month 1), Month 6 (DTI) / Month 7 (OLI) and Month 12 (DTI) / Month 13 (OLI) | 
| Percentage of SSPs that Respond in Agreement on Relevant Items on the ISQ that each Implementation Strategy is Fit for Use | ISQ measures a range, including acceptability, feasibility, and utility. | Up to Month 13 | 
| Percentage of PSPs that Respond in Agreement on Relevant Items on the ISQ that each Implementation Strategy is Fit for Use | ISQ measures a range, including acceptability, feasibility, and utility. | Up to Month 13 | 
| Perceptions of Utility of Implementation Strategies and Facilitators and Barriers to Acceptability of RI and DI Assessed from SSPs | Perceptions of Utility of Implementation Strategies and Facilitators and Barriers to Acceptability of RI and DI measured from themes emerging from Proctor and CFIR framework guided semi-structured qualitative interview. | Up to Month 13 | 
| Perceptions of Utility of Implementation Strategies Through SSIs Assessed from PSPs | Perceptions of Utility of Implementation Strategies and Facilitators and Barriers to Acceptability of RI and DI 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 | The target window is ± 7 days for injection dose 2 and subsequent injections. | Up to Month 13 | 
| Percentage of PSPs Completing Target Number of Injections | The target window is ± 7 days for injection dose 2 and subsequent injections. | Up to Month 13 | 
| Perception of Barriers and Facilitators to Fidelity to Injections Assessed from PSPs | Perceptions of fidelity to injections measured from themes emerging from Proctor and CFIR framework guided semi-structured qualitative interview. | Up to Month 13 | 
| Perception of Barriers and Facilitators to Fidelity to Injections Assessed from SSPs | Perception to fidelity of injections measured from themes emerged from IMC with sites using an interview guide. | Up to Month 13 | 
| Percentage of Site Staff who Administer Sexual Health Assessment |  | Up to Month 13 | 
| Percentage of Eligible PSPs for Which Sexual Health Assessment are Administered |  | Up to Month 13 | 
| Percentage of MSM and TGM who Take the Sexual Health Assessment |  | Up to Month 13 | 
| Percentage of MSM and TGM who Report Having had Sex in the Last 6 Months Through Month 13 on the Sexual Health Assessment |  | Up to Month 13 | 
| Percentage of MSM and TGM who Expressed Interest in PrEP or Never Heard of PrEP out of Those who Report Having had Sex in the last 6 Months Through Month 13 |  | Up to Month 13 | 
| Percentage of PSPs who Initiate APRETUDE After Taking the Sexual Health Assessment |  | Up to Month 13 | 
| Perceptions of Sexual Health Assessment Assessed from SSPs | Perceptions of sexual health assessment measured from themes emerging from Proctor and CFIR framework guided semi-structured qualitative interview | Up to Month 13 | 
| Perceptions of Sexual Health Assessment Assessed from PSPs | Perceptions of sexual health assessment measured from themes emerging from Proctor and CFIR framework guided semi-structured qualitative interview. | Up to Month 13 | 
| Number of Participants who Discussed Components of Adaptations and Changes to Implementation Strategies Using FRAME-IS | The Framework for Reporting Adaptations and Modifications to Evidence-based Implementation Strategies (FRAME-IS) is a measure that will provide a precise understanding of modifications, the process of modifying or adapting, and the relationship between different forms of modification and subsequent health and implementation outcomes. | Pre-implementation and up to Month 13 | 
| Perceptions of Adaptations to Implementation Strategies Assessed from SSPs |  | Up to Month 13 | 
| Perceptions of Adaptations to Implementation Strategies Assessed from PSPs |  | Up to Month 13 | 
| Percentage of PSPs with History of PrEP Use that Complete the Sexual Health Assessment and ISQ and Start APRETUDE | ISQ measures a range, including acceptability, feasibility, and utility. | Up to Month 13 | 
| Reasons for Choosing and Switching to APRETUDE Assessed by SSI From PSPs | Reasons for choosing and switching to APRETUDE assessed from themes emerging from Proctor and CFIR framework guided semi-structured qualitative interview. | Up to Month 13 | 
| Reasons for Choosing and Switching to APRETUDE Assessed by ISQ From PSPs | ISQ measures a range, including acceptability, feasibility, and utility. | Up to Month 13 | 
| Perception of Barriers and Facilitators Assessed from PSPs | Perception of facilitators and barriers to RI, DI and overall implementation of PrEP measured from themes emerging from Proctor and Consolidated Framework for Implementation Research (CFIR) framework guided semi-structured qualitative interview. | Up to Month 13 | 
| Perception of Barriers and Facilitators Assessed from SSPs | Perception of facilitators and barriers to RI, DI and overall implementation of PrEP measured from themes emerging from Proctor and Consolidated Framework for Implementation Research (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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Cabotegravir, Long-acting injectables, Implementation science, HIV, Pre-exposure prophylaxis