NCT05087680

An Acceptance Based PrEP Intervention to Engage Young Black MSM in the South

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: Rhode Island Hospital · Academic / Other
• Sex: Male
• Age: 18 Years – 34 Years
• Healthy volunteers: Accepted

Summary

Investigators will use a generalized framework for the adaptation of EBIs to inform the development of a brief Acceptance and Commitment Therapy (ACT)-based culturally appropriate pre-exposure prophylaxis (PrEP) intervention tailored to young Black men who have sex with men (YBMSM), named ACTPrEP.

Detailed description

Investigators will use a generalized framework for the adaptation of EBIs to inform the development of a brief Acceptance and Commitment Therapy (ACT)-based culturally appropriate pre-exposure prophylaxis (PrEP) intervention tailored to young Black men who have sex with men (YBMSM), named ACTPrEP. Specific Aim 1) Gather data from YBMSM (n = 20) and clinic staff (n = 10) through in-depth interviews to assess quantitative measures, intervention design, and experiences most relevant to PrEP engagement. Specific Aim 2) Develop ACTPrEP utilizing Aim 1 data, working iteratively with experts, and an intervention "run through" with a sample of participants. CLINICAL TRIAL IS AIM 3 ONLY Specific Aim 3) Evaluate ACTPrEP. Enroll 66 participants. Primary outcomes will be feasibility (measured by percentage eligible, consented, randomized, and retained) and acceptability (measured by the Client Satisfaction Questionnaire). Secondary outcomes will compare ACTPrEP vs. enhanced standard of care condition (ESOC) on behavior outcomes (uptake, adherence, and PrEP persistence) and possible mediators over the course of 24 weeks. Barriers and facilitators to implementing ACTPrEP will be assessed with post-RCT qualitative interviews using the i-PARIHS framework.

Conditions

• HIV Prevention

Interventions

Type	Name	Description
BEHAVIORAL	ACTPrEP	ACTPrEP will include a 60-minute initial session and a series of 30-minute follow-up sessions. Sessions will focus on the Thoughts, Emotions, Associations, Memories, and Sensations (TEAMS) relevant to PrEP uptake and adherence.
BEHAVIORAL	Enhanced Standard of Care	Enhanced Standard of Care (ESOC) will include one 30-minute PrEP education session.

Timeline

• Start date: 2023-09-14
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2021-10-21
• Last updated: 2024-11-19

Locations

1 site across 1 country: United States