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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: HIV Prevention
• Intervention / Treatment: Behavioral: C4 Program; Behavioral: C4 + 3MV Program

Detailed Description

This clinical trial aims to evaluate two intervention strategies-C4 and C4 + 3MV-to improve adherence to PrEP (pre-exposure prophylaxis) among Black men who have sex with men (MSM) in two metropolitan areas: Dallas/Fort Worth and New York City. The study addresses structural and behavioral barriers to PrEP adherence, aiming to reduce disparities in HIV prevention efforts.

Study Design and Methodology:

• Trial Type: Multi-site, staircase stepped-wedge randomized controlled trial (RCT)
• Duration: 24 months total, with 9-month intervention periods for each group
• Participants: 500 participants (Texas n=150 and NYC n=350); Participants are recruited from community-based organizations and through network-based referrals

Randomization:

• 48 networks will be randomized into 8 sequences.
• Each network will experience a 3-month control period, followed by either the C4 intervention or the C4 + 3MV intervention.

Interventions:

• C4 Intervention: Focuses on care coordination, addressing participants' needs related to healthcare access, stigma, and mental health services. Uses individualized care plans and support systems to facilitate adherence.
• C4 + 3MV Intervention: Incorporates both care coordination and the 3MV (Many Men, Many Voices) behavioral change program. 3MV focuses on reducing stigma, promoting safe behaviors, and improving self-efficacy through group sessions.

Primary and Secondary Outcomes:

• Primary Outcome: PrEP adherence, measured through dried blood spot (DBS) assays to assess drug levels over time.
• Secondary Outcomes: Changes in HIV-related health-seeking behavior (e.g., frequency of HIV testing); Autonomy and social support, measured through validated scales; Reduction in stigma and mental health improvements

Data Collection and Monitoring:

• Data will be collected at multiple points using questionnaires, DBS tests, and counseling session evaluations.
• A Learn-as-You-Go (LAGO) adaptive analysis will be conducted every 6 months to optimize intervention delivery.

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Raquel Ramos, PhD, MBA, MSN, FNYAM, FAHA; Phone Number: 203-737-2339; Email: ysn.c4_3mvstudy@yale.edu
• Study Contact Backup: Name: LaRon Nelson, PhD, RN, FNP, FNAP, FNYAM, FAA; Phone Number: 203-785-5797; Email: ysn.c4_3mvstudy@yale.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10035
      • Bronx Health Center
      • Contact: 3MVCare Team; Email: ysn.c4_3mvstudy@yale.edu
  • Texas
    • Dallas, Texas, United States, 06477
      • Abounding Prosperity, Inc.
      • Contact: 3MVCare Study Team; Email: ysn.c4_3mvstudy@yale.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.; Other Names: Client Centered Care Coordination
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.	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.; Other Names: Many Men Many Voices and Client Centered Care Coordination Integrated Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
HIV Testing Frequency	HIV testing frequency will be assessed by the number of tests taken in the past 90 days, with more tests indicating higher engagement in testing	Every 3 months for 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived Competence for PrEP use	Perceived Competence for PrEP Use Scale will measure participants' confidence in their ability to follow PrEP recommendations. Scores range from 9 to 45, with higher scores reflecting greater competence.	Baseline, 6 months, and 12 months
PrEP Use Self-Regulation	PrEP Use Self-Regulation Questionnaire will assess participants' internalization of autonomous motivation to maintain adherence to PrEP. Scores range from 9 to 45, with higher scores indicating stronger self-regulation.	Baseline, 6 months, and 12 months
Basic Needs Satisfaction Scale	The Basic Needs Satisfaction Scale (9 items) assesses participants' fulfillment of psychological needs (autonomy, competence, and relatedness) within social relationships, especially from close friends. Scores range from 9 to 45, with higher scores indicating greater satisfaction.	Every 3 months for 12 months
Healthcare Climate Questionnaire	The Healthcare Climate Questionnaire (15 items) will measure participants' perception of their healthcare providers' support. Scores range from 15 to 75, with higher scores reflecting a more supportive healthcare environment.	Baseline, 6, and 12 months
Depression (PHQ-9)	Depression will be assessed using the PHQ-9. PHQ-9 is a 9-item validated questionnaire used to screen for depression with a range of scores from 0-27. A cumulative score of ≥10 is considered positive with lower scores indicating no or mild anxiety.	Baseline, 6 months, and 12 months
HIV Stigma Scale	Intersectional stigma will be measured across four subscales: Enacted Stigma (10 items) Vicarious Stigma (10 items) Perceived Stigma (10 items) Internalized Stigma (10 items) Each subscale ranges from 10 to 50, with higher scores indicating more stigma experienced.	Baseline, 3, 6, 9, and 12 months
Quality Client Perception of Coordination Quality	The Client Perception of Coordination Quality Questionnaire will assess participants' satisfaction with healthcare services. Scores range from 3 to 15, with higher scores indicating better care coordination.	Baseline, 6 months, and 12 months

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute of Mental Health (NIMH)

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): June 30, 2029

Study Registration Dates

• First Submitted: October 24, 2024
• First Submitted That Met QC Criteria: October 24, 2024
• First Posted (Actual): October 28, 2024

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: HIV; PrEP; Black MSM; Stigma Reduction; Client Centered Care Coordination; Many Men Many Voices; Evidence-based Intervention
• Other Study ID Numbers: 2000037790; 1R01MH138225-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No