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NCT Number: NCT06661343

Pre-exposure Prophylaxis (PrEP) Adherence for Black MSM

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.

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Key information

Conditions

HIV Prevention

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Bronx Health Center, New York, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Client Centered Care Coordination

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.

Other names: Many Men Many Voices and Client Centered Care Coordination Integrated Intervention

Primary outcomes

  1. PrEP adherence- self report

    Time frame: 0, 3, 6, 9, 12 months

    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.

  2. PrEP adherence- biomarker validation

    Time frame: 0, 6, and 12 months

    PrEP adherence will be assessed through biomarker validation using dried blood samples. A tenofovir disoproxil fumarate (TFV-DF) level >700 fmol/punch confirms adherence.

Secondary outcomes

  1. HIV Testing Frequency

    Time frame: Every 3 months for 12 months

    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

Other outcomes

  1. Perceived Competence for PrEP use

    Time frame: Baseline, 6 months, and 12 months

    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.

  2. PrEP Use Self-Regulation

    Time frame: Baseline, 6 months, and 12 months

    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.

  3. Basic Needs Satisfaction Scale

    Time frame: Every 3 months for 12 months

    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.

  4. Healthcare Climate Questionnaire

    Time frame: Baseline, 6, and 12 months

    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.

  5. Depression (PHQ-9)

    Time frame: Baseline, 6 months, and 12 months

    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.

  6. HIV Stigma Scale

    Time frame: Baseline, 3, 6, 9, and 12 months

    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.

  7. Quality Client Perception of Coordination Quality

    Time frame: Baseline, 6 months, and 12 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

LaRon Nelson, PhD, RN, FNP, FNAP, FNYAM, FAA

CONTACT

[email protected]

203-785-5797

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

CONTACT

[email protected]

203-737-2339

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

A Multi-Level Integrated Strategy to Optimize PrEP Adherence for Black MSM and Accelerate Implementation at Scale

Acronym: C4+3MV

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Oct 28, 2024
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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