Not Yet RecruitingNot Applicable

Pre-exposure Prophylaxis (PrEP) Adherence for Black MSM

United States500 participantsStarted 2026-08-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

PrEP adherence- self report

Timeframe: 0, 3, 6, 9, 12 months

PrEP adherence- biomarker validation

Timeframe: 0, 6, and 12 months

Trial details

NCT IDNCT06661343

SponsorYale University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-01-01

Contact for this trial

Raquel Ramos, PhD, MBA, MSN, FNYAM, FAHA

203-737-2339 ysn.c4_3mvstudy@yale.edu

View on ClinicalTrials.gov More HIV Prevention trials