NCT06661343Not yet recruiting
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
Source: ClinicalTrials.gov · Last updated 18 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 500 (estimated)
- First submitted
- 24 Oct 2024
- Start date
- 1 Aug 2026
- Primary completion date
- 1 Jan 2029
- Lead sponsor
- Yale University
- Diseases
- HIV
- NCT number
- NCT06661343
What you commit to
- Study type: Interventional
- Planned participants: 500
- From 1 Aug 2026 to the primary completion date, 1 Jan 2029
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Currently diagnosed with HIV.
Other
- Unable to provide informed consent.
- Unable to fully engage with the intervention due to health issues.
- Participating in another clinical trial with conflicting outcomes.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Male · Accepts healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Abounding Prosperity Inc. Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Bronx Health Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.