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Pre-exposure Prophylaxis (PrEP) Adherence for Black MSM

NCT06661343 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2026-05-18

No results posted yet for this study

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.

Conditions

  • HIV Prevention

Interventions

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.

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • Yale University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2029-01-01
Completion
2029-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06661343 on ClinicalTrials.gov