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

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

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

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).

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.

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.

The responses for feasibility will be measured on a 5-point Likert scale ranging from 1 to 5 with higher values representing better outcomes.

The responses for feasibility will be measured on a 5-point Likert scale ranging from 1 to 5 with higher values representing better outcomes.

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.

The responses for feasibility will be measured on a 5-point Likert scale ranging from 1 to 5 with higher values representing better outcomes.

The responses for acceptability will be measured on a Likert scale ranging from 1 to 5 with higher values representing better outcomes.

Implementation Science Questionnaire (ISQ) measures a range, including acceptability, feasibility, and utility.

The responses for acceptability will be measured on a Likert scale ranging from 1 to 5 with higher values representing better outcomes.

The responses for feasibility will be measured on a 5-point Likert scale ranging from 1 to 5 with higher values representing better outcomes.

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.

The responses for feasibility will be measured on a 5-point Likert scale ranging from 1 to 5 with higher values representing better outcomes.

The responses for acceptability will be measured on a Likert scale ranging from 1 to 5 with higher values representing better outcomes.

The responses for feasibility will be measured on a 5-point Likert scale ranging from 1 to 5 with higher values representing better outcomes.

The responses for acceptability will be measured on a Likert scale ranging from 1 to 5 with higher values representing better outcomes.

The responses for feasibility will be measured on a 5-point Likert scale ranging from 1 to 5 with higher values representing better outcomes.

The responses for acceptability will be measured on a Likert scale ranging from 1 to 5 with higher values representing better outcomes.

The responses for feasibility will be measured on a 5-point Likert scale ranging from 1 to 5 with higher values representing better outcomes.

The responses for acceptability will be measured on a Likert scale ranging from 1 to 5 with higher values representing better outcomes.

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.

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.

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.

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

The responses for acceptability will be measured on a Likert scale ranging from 1 to 5 with higher values representing better outcomes.

The responses for acceptability will be measured on a Likert scale ranging from 1 to 5 with higher values representing better outcomes.

Percentage of SSPs that Respond in Agreement on Relevant Items on the ISQ that each Implementation Strategy is Fit for Use

Percentage of PSPs that Respond in Agreement on Relevant Items on the ISQ that each Implementation Strategy is Fit for Use

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.

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.

Perceptions of fidelity to injections measured from themes emerging from Proctor and CFIR framework guided semi-structured qualitative interview.

Perception to fidelity of injections measured from themes emerged from IMC with sites using an interview guide.

Percentage of MSM and TGM who Report Having had Sex in the Last 6 Months Through Month 13 on the Sexual Health Assessment

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

Perceptions of sexual health assessment measured from themes emerging from Proctor and CFIR framework guided semi-structured qualitative interview

Perceptions of sexual health assessment measured from themes emerging from Proctor and CFIR framework guided semi-structured qualitative interview.

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.

Percentage of PSPs with History of PrEP Use that Complete the Sexual Health Assessment and ISQ and Start APRETUDE

Reasons for choosing and switching to APRETUDE assessed from themes emerging from Proctor and CFIR framework guided semi-structured qualitative interview.

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.

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.

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

IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.

Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.