Pre-exposure Prophylaxis (PrEP) Adherence for Black MSM (C4+3MV)

Yale University

Status: Not yet enrolling

Conditions: PrEP Adherence; HIV Prevention; HIV Risk Reduction

Treatments: Behavioral: C4 + 3MV Program; Behavioral: C4 Program

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06661343

2000037790

1R01MH138225-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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 Miami/Fort Lauderdale. 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 (250 at each site); 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.

Enrollment: 500 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

500 participants in 2 patient groups

C4 Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: C4 Program

C4 + 3MV Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: C4 + 3MV Program