NCT06661343

Pre-exposure Prophylaxis (PrEP) Adherence for Black MSM

A Multi-Level Integrated Strategy to Optimize PrEP Adherence for Black MSM and Accelerate Implementation at Scale

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Yale University · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to learn if two interventions-C4 and C4+3MV-can improve PrEP adherence (taking medication to prevent HIV) among Black men who have sex with men (MSM). The study will also explore the most effective ways to support participants in continuing their PrEP use over time. The main questions it aims to answer are: * Does the C4 program help participants take PrEP more regularly? * Does adding the 3MV intervention to C4 provide additional support for adherence? Researchers will compare two intervention strategies to see if they result in better PrEP adherence: * C4 Intervention: A program focused on individualized care coordination and addressing structural needs. * C4 + 3MV Intervention: A combination of care coordination with additional behavioral change sessions. Participants will: * Participate in PrEP education and counseling sessions. * Have their PrEP use monitored through dried blood spot (DBS) tests. * Complete questionnaires about their experiences and challenges with PrEP. Receive support sessions tailored to address individual barriers to PrEP adherence.

Detailed description

This clinical trial aims to evaluate two intervention strategies-C4 and C4 + 3MV-to improve adherence to PrEP (pre-exposure prophylaxis) among Black men who have sex with men (MSM) in two metropolitan areas: Dallas/Fort Worth and Miami/Fort Lauderdale. The study addresses structural and behavioral barriers to PrEP adherence, aiming to reduce disparities in HIV prevention efforts. Study Design and Methodology: * Trial Type: Multi-site, staircase stepped-wedge randomized controlled trial (RCT) * Duration: 24 months total, with 9-month intervention periods for each group * Participants: 500 participants (250 at each site); Participants are recruited from community-based organizations and through network-based referrals Randomization: * 48 networks will be randomized into 8 sequences. * Each network will experience a 3-month control period, followed by either the C4 intervention or the C4 + 3MV intervention. Interventions: * C4 Intervention: Focuses on care coordination, addressing participants' needs related to healthcare access, stigma, and mental health services. Uses individualized care plans and support systems to facilitate adherence. * C4 + 3MV Intervention: Incorporates both care coordination and the 3MV (Many Men, Many Voices) behavioral change program. 3MV focuses on reducing stigma, promoting safe behaviors, and improving self-efficacy through group sessions. Primary and Secondary Outcomes: * Primary Outcome: PrEP adherence, measured through dried blood spot (DBS) assays to assess drug levels over time. * Secondary Outcomes: Changes in HIV-related health-seeking behavior (e.g., frequency of HIV testing); Autonomy and social support, measured through validated scales; Reduction in stigma and mental health improvements Data Collection and Monitoring: * Data will be collected at multiple points using questionnaires, DBS tests, and counseling session evaluations. * A Learn-as-You-Go (LAGO) adaptive analysis will be conducted every 6 months to optimize intervention delivery.

Conditions

• HIV Prevention
• PrEP Adherence
• HIV Risk Reduction

Interventions

Type	Name	Description
BEHAVIORAL	C4 Program	The C4 intervention is a behavioral program designed to provide care coordination to address structural barriers to PrEP adherence among Black men who have sex with men (MSM). It includes personalized support services, focusing on healthcare access, mental health, and stigma reduction to promote consistent PrEP use. Participants will receive counseling sessions and follow-ups based on their individual needs.
BEHAVIORAL	C4 + 3MV Program	This intervention combines the C4 care coordination with the 3MV behavioral program. The 3MV program focuses on behavior change, addressing self-efficacy, stigma, and promoting healthy practices. Through this combination, participants receive both structural and behavioral support to maximize their adherence to PrEP.

Timeline

• Start date: 2026-02-01
• Primary completion: 2029-06-30
• Completion: 2029-06-30
• First posted: 2024-10-28
• Last updated: 2025-11-24

Locations

2 sites across 1 country: United States