Pre-exposure Prophylaxis (PrEP) Adherence for Black MSM
C4+3MV
A Multi-Level Integrated Strategy to Optimize PrEP Adherence for Black MSM and Accelerate Implementation at Scale
2 other identifiers
interventional
500
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2026
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 24, 2024
CompletedFirst Posted
Study publicly available on registry
October 28, 2024
CompletedStudy Start
First participant enrolled
February 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2029
November 24, 2025
November 1, 2025
3.4 years
October 24, 2024
November 21, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
PrEP adherence- self report
PrEP adherence will be assessed through self-report. Self-reported adherence is measured by doses taken in the past 30 days, with fewer missed doses indicating higher adherence.
0, 3, 6, 9, 12 months
PrEP adherence- biomarker validation
PrEP adherence will be assessed through biomarker validation using dried blood samples. A tenofovir disoproxil fumarate (TFV-DF) level \>700 fmol/punch confirms adherence.
0, 6, and 12 months
Secondary Outcomes (1)
HIV Testing Frequency
Every 3 months for 12 months
Other Outcomes (7)
Perceived Competence for PrEP use
Baseline, 6 months, and 12 months
PrEP Use Self-Regulation
Baseline, 6 months, and 12 months
Basic Needs Satisfaction Scale
Every 3 months for 12 months
- +4 more other outcomes
Study Arms (2)
C4 Intervention
EXPERIMENTALParticipants 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.
C4 + 3MV Intervention
EXPERIMENTALParticipants 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
- National Institute of Mental Health (NIMH)collaborator
Study Sites (2)
South Florida Afro Pride Federation
Lauderdale Lakes, Florida, 33313, United States
Abounding Prosperity, Inc.
Dallas, Texas, 06477, United States
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 24, 2024
First Posted
October 28, 2024
Study Start
February 1, 2026
Primary Completion (Estimated)
June 30, 2029
Study Completion (Estimated)
June 30, 2029
Last Updated
November 24, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- The data will be made available within six months after the publication of the primary study results and will remain accessible for at least five years. The availability period may be extended depending on research needs and ethical guidelines.
- Access Criteria
- Access to the data will be granted to researchers with ethical approval from the Institutional Review Board (IRB). Researchers must submit a request outlining the purpose and intended use of the data, which will be reviewed by the study team. Approved users will be required to sign a Data Use Agreement to ensure the data is used for approved purposes only and that participant privacy is safeguarded.
Investigators plan to share de-identified participant data, including information on PrEP usage, behavioral intervention participation, survey responses, and biological specimen results (e.g., dried blood spot test results). The shared data will support future research on HIV prevention and PrEP adherence, ensuring participant privacy throughout the process.