Pre-exposure Prophylaxis (PrEP) Adherence for Black MSM

Not Applicable

Not yet recruiting

• Conditions: HIV Prevention; PrEP Adherence; HIV Risk Reduction

• Registration Number: NCT06661343
• Lead Sponsor: Yale University

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.

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 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.

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-24
• Study First Submitted QC: 2024-10-24
• Last Update Submitted: 2024-10-24
• Study First Posted: 2024-10-28
• Last Update Posted: 2024-10-28
• Study Start: 2025-02-01
• Primary Completion: 2027-02-01
• Study Completion: 2027-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 500

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
PrEP adherence- self report	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.
PrEP adherence- biomarker validation	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 Outcome Measures

Name	Time	Method
HIV Testing Frequency	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

Trial Locations

Locations (2)

South Florida Afro Pride Federation; 🇺🇸 Lauderdale Lakes, Florida, United States

Abounding Prosperity, Inc.; 🇺🇸 Dallas, Texas, United States