A Study Evaluating Implementation Strategies for the Delivery of Cabotegravir in Low and High-Volume PrEP Site in the United States
- Registration Number
- NCT05374525
- Lead Sponsor
- ViiV Healthcare
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 201
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Routine Implementation (RI) APRETUDE 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. Dynamic Implementation (DI) APRETUDE 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. Routine Implementation (RI) Cabotegravir 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. Dynamic Implementation (DI) Cabotegravir OLI 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.
- Primary Outcome Measures
Name Time Method Mean Feasibility of Intervention Measure (FIM) Score Assessed from SSPs Month 13 The responses for feasibility will be measured on a 5-point Likert scale ranging from 1 to 5 with higher values representing better outcomes.
- Secondary Outcome Measures
Name Time Method Change from Baseline in FIM Score Assessed from SSPs Baseline (Month 1), Month 5 and 13 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 Up to Month 13 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.
ISQ Responses Assessed from PSPs Baseline (Month 1), Month 6 (DTI) / Month 7 (OLI) and Month 12 (DTI) / Month 13 (OLI) Implementation Science Questionnaire (ISQ) measures a range, including acceptability, feasibility, and utility.
Change from Baseline in AIM Score for Telehealth Delivery Assessed from SSPs Baseline (Month 1) and Month 5, and 13 The responses for acceptability will be measured on a Likert scale ranging from 1 to 5 with higher values representing better outcomes.
Change from Baseline in FIM Score for Telehealth Delivery Assessed from PSPs Baseline (Month 1), Month 6 (DTI) / Month 7 (OLI) and Month 12 (DTI) / Month 13 (OLI) 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 Utility of Implementation Strategies and Facilitators and Barriers to Acceptability of RI and DI Assessed from SSPs Up to Month 13 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.
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 Facilitators and Barriers to RI, DI, and Overall Implementation of PrEP into Routine Care Assessed from SSPs Through Month 13 Up to 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.
Mean Acceptability of Implementation Measure (AIM) Score Assessed from PSPs Baseline (Month 1), Month 6 (DTI) / Month 7 (OLI) and Month 12 (DTI) / Month 13 (OLI) The responses for acceptability will be measured on a Likert scale ranging from 1 to 5 with higher values representing better outcomes.
Mean AIM Score Assessed from SSPs Baseline (Month 1), Month 5 and 13 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.
Percentage of SSPs that Respond in Agreement on Relevant Items on the ISQ that each Implementation Strategy is Fit for Use Up to Month 13 ISQ measures a range, including acceptability, feasibility, and utility.
Proportion of Injections Occurring within Target Window from Target Date Up to Month 13 The target window is ± 7 days for injection dose 2 and subsequent injections.
Perception of Barriers and Facilitators to Fidelity to Injections Assessed from SSPs Up to Month 13 Perception to fidelity of injections measured from themes emerged from IMC with sites using an interview guide.
Percentage of Site Staff who Administer Sexual Health Assessment Up to Month 13 Number of Participants who Discussed Components of Adaptations and Changes to Implementation Strategies Using FRAME-IS Pre-implementation and up to Month 13 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.
ISQ Responses Assessed from SSPs Baseline (Month 1), Month 5 and 13 ISQ measures a range, including acceptability, feasibility, and utility.
Change from Baseline in FIM Score Assessed from PSPs Baseline (Month 1), Month 6 (DTI) / Month 7 (OLI) and Month 12 (DTI) / Month 13 (OLI) The responses for feasibility will be measured on a 5-point Likert scale ranging from 1 to 5 with higher values representing better outcomes.
Mean AIM Score for Telehealth Delivery Assessed from SSPs Baseline (Month 1), Month 5, and 13 The responses for acceptability will be measured on a Likert scale ranging from 1 to 5 with higher values representing better outcomes.
Mean AIM Score for Telehealth Delivery Assessed from PSPs Baseline (Month 1), Month 6 (DTI) / Month 7 (OLI) and Month 12 (DTI) / Month 13 (OLI) 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 Up to Month 13 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.
Change From Baseline in ISQ Responses Assessed from SSPs Baseline (Month 1) and Month 5 and 13 ISQ measures a range, including acceptability, feasibility, and utility.
Mean AIM Score Based on Implementation Strategy in PSPs Baseline (Month 1), Month 6 (DTI) / Month 7 (OLI) and Month 12 (DTI) / Month 13 (OLI) The responses for acceptability will be measured on a Likert scale ranging from 1 to 5 with higher values representing better outcomes.
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 Perceptions of Adaptations to Implementation Strategies Assessed from PSPs Up to Month 13 Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery Assessed for PSPs Up to Month 13 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.
Mean FIM Score Assessed from PSPs Baseline (Month 1), Month 6 (DTI) / Month 7 (OLI) and Month 12 (DTI) / Month 13 (OLI) The responses for feasibility will be measured on a 5-point Likert scale ranging from 1 to 5 with higher values representing better outcomes.
Change from Baseline in AIM Score Assessed from PSPs Baseline (Month 1), Month 6 (DTI) / Month 7 (OLI) and Month 12 (DTI) / Month 13 (OLI) The responses for acceptability will be measured on a Likert scale ranging from 1 to 5 with higher values representing better outcomes.
Change from Baseline in ISQ Responses Assessed from PSPs Baseline (Month 1), Month 6 (DTI) / Month 7 (OLI) and Month 12 (DTI) / Month 13 (OLI) ISQ measures a range, including acceptability, feasibility, and utility.
ISQ Responses for Telehealth Delivery Assessed from SSPs Baseline (Month 1), Month 5, and 13 ISQ measures a range, including acceptability, feasibility, and utility.
ISQ Responses for Telehealth Delivery Assessed from PSPs Baseline (Month 1), Month 6 (DTI) / Month 7 (OLI) and Month 12 (DTI) / Month 13 (OLI) ISQ measures a range, including acceptability, feasibility, and utility.
Change From Baseline in AIM Score Assessed from SSPs Baseline (Month 1) and Month 5 and 13 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
Change from Baseline in Mean AIM Score Under Implementation Strategy in PSPs Baseline (Month 1), Month 6 (DTI) / Month 7 (OLI) and Month 12 (DTI) / Month 13 (OLI) The responses for acceptability will be measured on a Likert scale ranging from 1 to 5 with higher values representing better outcomes.
Mean FIM Score for Telehealth Delivery Assessed from SSPs Baseline (Month 1), Month 5, and 13 The responses for feasibility will be measured on a 5-point Likert scale ranging from 1 to 5 with higher values representing better outcomes.
Change from Baseline in FIM Score for Telehealth Delivery Assessed from SSPs Baseline (Month 1) and Month 5, and 13 The responses for feasibility will be measured on a 5-point Likert scale ranging from 1 to 5 with higher values representing better outcomes.
Change from Baseline in ISQ Responses for Telehealth Delivery Assessed from SSPs Baseline (Month 1) and Month 5, and 13 ISQ measures a range, including acceptability, feasibility, and utility.
Mean FIM Score for Telehealth Delivery Assessed from PSPs Baseline (Month 1), Month 6 (DTI) / Month 7 (OLI) and Month 12 (DTI) / Month 13 (OLI) The responses for feasibility will be measured on a 5-point Likert scale ranging from 1 to 5 with higher values representing better outcomes.
Change from Baseline in AIM Score for Telehealth Delivery Assessed from PSPs Baseline (Month 1), Month 6 (DTI) / Month 7 (OLI) and Month 12 (DTI) / Month 13 (OLI) The responses for acceptability will be measured on a Likert scale ranging from 1 to 5 with higher values representing better outcomes.
Change from Baseline in ISQ Responses for Telehealth Delivery Assessed from PSPs Baseline (Month 1), Month 6 (DTI) / Month 7 (OLI) and Month 12 (DTI) / Month 13 (OLI) ISQ measures a range, including acceptability, feasibility, and utility.
ISQ Responses Based on Implementation Strategy in PSPs Baseline (Month 1), Month 6 (DTI) / Month 7 (OLI) and Month 12 (DTI) / Month 13 (OLI) ISQ measures a range, including acceptability, feasibility, and utility.
Change from Baseline in ISQ Responses Under Implementation Strategy in PSPs Baseline (Month 1), Month 6 (DTI) / Month 7 (OLI) and Month 12 (DTI) / Month 13 (OLI) ISQ measures a range, including acceptability, feasibility, and utility.
Percentage of PSPs Completing Target Number of Injections Up to Month 13 The target window is ± 7 days for injection dose 2 and subsequent injections.
Perception of Barriers and Facilitators to Fidelity to Injections Assessed from PSPs Up to Month 13 Perceptions of fidelity to injections measured from themes emerging from Proctor and CFIR framework guided semi-structured qualitative interview.
Perceptions of Adaptations to Implementation Strategies Assessed from SSPs Up to Month 13 Percentage of PSPs with History of PrEP Use that Complete the Sexual Health Assessment and ISQ and Start APRETUDE Up to Month 13 ISQ measures a range, including acceptability, feasibility, and utility.
Reasons for Choosing and Switching to APRETUDE Assessed by SSI From PSPs Up to Month 13 Reasons for choosing and switching to APRETUDE assessed from themes emerging from Proctor and CFIR framework guided semi-structured qualitative interview.
Perception of Barriers and Facilitators Assessed from SSPs Up to 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.
Percentage of PSPs that Respond in Agreement on Relevant Items on the ISQ that each Implementation Strategy is Fit for Use Up to Month 13 ISQ measures a range, including acceptability, feasibility, and utility.
Perceptions of Utility of Implementation Strategies Through SSIs Assessed from PSPs Up to Month 13 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.
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 Perception of Barriers and Facilitators Assessed from PSPs Up to 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.
Perceptions of Sexual Health Assessment Assessed from SSPs Up to 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 Assessed from PSPs Up to Month 13 Perceptions of sexual health assessment measured from themes emerging from Proctor and CFIR framework guided semi-structured qualitative interview.
Reasons for Choosing and Switching to APRETUDE Assessed by ISQ From PSPs Up to Month 13 ISQ measures a range, including acceptability, feasibility, and utility.
Trial Locations
- Locations (1)
GSK Investigational Site
🇺🇸Seattle, Washington, United States