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

Not Applicable

Recruiting

• Conditions: HIV Prevention
• Interventions: Behavioral: Enhanced Standard of Care; Behavioral: ACTPrEP

• Registration Number: NCT05087680
• Lead Sponsor: Rhode Island Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2021-09-13
• Study First Submitted QC: 2021-10-08
• Study First Posted: 2021-10-21
• Study Start: 2023-09-14
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-17
• Last Update Posted: 2024-11-19
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 66

Inclusion Criteria

• English speaking
• Between 18-34 years old
• Male sex assigned at birth
• Identify as African American/Black
• Not enrolled in another PrEP related study
• Able to give consent
• Not taken PrEP in past 3 months
• Report having sex with a man in the past 3 months
• PrEP-eligible according to CDC guidelines

Exclusion Criteria

• Participating in another PrEP study
• Unable to provide consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Enhanced Standard of Care	Control group will include one 30-minute PrEP education session.
ACTPrEP	ACTPrEP	ACTPrEP will include a 60-minute initial session and 30-minute sessions at 2, 6, and 12 weeks.

Primary Outcome Measures

Name	Time	Method
ACTPrEP Feasibility	12 week visit	ACTPrEP feasibility is measured by percentage of participants retained in the study.
ACTPrEP Acceptability	12 week visit	Acceptability is measured with the Client Satisfaction Questionnaire.

Trial Locations

Locations (1)

Univeristy of Mississippi Medical Center; 🇺🇸 Jackson, Mississippi, United States