Pre-exposure Prophylaxis (PrEP) Adherence for Black MSM

Part of paid clinical trials in New York, New York.

Sponsor
Yale University
Study ID
NCT06661343
Status
Not Yet Recruiting

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Conditions

  • HIV Prevention

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • C4 Program — BEHAVIORAL
    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.
  • C4 + 3MV Program — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Aug 1, 2026
Status verified
May 2026
Primary completion
Jan 1, 2029
Completion
Jun 30, 2029

Study Design

Enrollment
500 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION

Arms

  • Experimental: C4 Intervention
    Participants in this arm will receive care coordination and support through the C4 intervention. This program focuses on addressing structural barriers, such as healthcare access and mental health, to improve PrEP adherence. Participants will also attend regular counseling sessions and have their PrEP use monitored through dried blood spot (DBS) tests.
  • Experimental: C4 + 3MV Intervention
    Participants in this arm will receive the C4 intervention, along with the 3MV (Many Men, Many Voices) behavioral intervention. The 3MV program aims to reduce stigma, promote safer behaviors, and increase self-efficacy. This arm integrates both structural and behavioral approaches to enhance PrEP adherence. Participants will complete counseling sessions, group activities, and DBS testing for monitoring adherence.

Primary Outcome Measure

PrEP adherence- self report [ Time Frame: 0, 3, 6, 9, 12 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Bronx Health CenterNew YorkNew York10035
3MVCare Team
[email protected]
Abounding Prosperity, Inc.DallasTexas06477
3MVCare Study Team
[email protected]

Find similar trials in New York, NY

By research site
Bronx Health Center· New York, NYAbounding Prosperity, Inc.· Dallas, TX

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