A Multi-Level Integrated Strategy to Optimize PrEP Adherence for Black MSM and Accelerate Implementation at Scale
Yale University
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.
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 par…
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- Yes
Inclusion Criteria: * Self-identify as male. * Self-Identify as Black people. * Aged 18 or older. * Self Report having sex with men in the past 6 months. * Eligible for PrEP or currently prescribed PrEP. * Willing to participate in behavioral intervention sessions. Exclusion Criteria: * Currently diagnosed with HIV. * Unable to provide informed consent. * Unable to fully engage with the intervention due to health issues. * Participating in another clinical trial with conflicting outcomes.
Interventions
- BehavioralC4 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.
- BehavioralC4 + 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.
Locations (2)
- South Florida Afro Pride FederationLauderdale Lakes, Florida
- Abounding Prosperity, Inc.Dallas, Texas