Intervention to improve PrEP use among Black men who have sex with men
Intervention to Enhance Prep Persistence Among African American Men Who Have Sex with Men
This study is testing a new support program to help Black men who have sex with men start and stick with PrEP to prevent HIV.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Brown University Academic / other |
| Locations | 3 sites (Washington D.C., District of Columbia and 2 other locations) |
| Trial ID | NCT06872307 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate a patient navigation intervention designed to enhance the initiation, adherence, and retention of pre-exposure prophylaxis (PrEP) among Black/African American men who have sex with men (B/AA MSM). The study addresses the significant barriers that this population faces in accessing and maintaining PrEP care, which is crucial for HIV prevention. Participants will be enrolled in a randomized controlled trial to assess the effectiveness of the RAMP-It-Up intervention, which builds on previous pilot studies that demonstrated its acceptability and preliminary effectiveness. The trial will involve collaboration with community health centers to ensure culturally congruent healthcare services are provided.
Who should consider this trial
Good fit: Ideal candidates for this study are Black/African American men aged 18 and older who have had at least one male sex partner in the past year and are HIV-negative.
Not a fit: Patients who do not identify as Black/African American or who have taken PrEP within the last 30 days will not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve PrEP uptake and retention in care among Black men who have sex with men, ultimately reducing HIV transmission rates in this high-risk population.
How similar studies have performed: Previous studies have shown promising results with similar patient navigation interventions aimed at improving PrEP outcomes among high-risk populations, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged 18 years and older * Assigned male sex at birth * Identify as Black/African American * Report at least one male sex partner in the past 12 months * Meet the CDC eligibility criteria for PrEP * Have not taken PrEP for at least 30 days * Are HIV-negative based on antibody testing at the time of enrollment * Understand and speak English * Able to provide informed consent * Agree to authorize study access to their EHR and pharmacy fill data. Eligible patients who are interested in participating will be consented and enrolled into the study. Exclusion Criteria: * Under the age of 18 * Assigned female sex at birth * Does not identify as Black/African American * Has not had a male sex partner in the past 12 months * Does not meet CDC eligibility criteria for PrEP * Has taken PrEP within the last 30 days * HIV-positive or inconclusive HIV status based on antibody testing at the time of enrollment * Does not understand or speak English * Unable to provide informed consent * Does not agree to authorize study access to their EHR and pharmacy fill data.
Where this trial is running
Washington D.C., District of Columbia and 2 other locations
- Whitman Walker Health — Washington D.C., District of Columbia, United States (Recruiting)
- University of Mississippi Medical Center — Jackson, Mississippi, United States (Recruiting)
- The Rhode Island Public Health Institute — Providence, Rhode Island, United States (Recruiting)
Study contacts
- Study coordinator: Dr. Amy Nunn, ScD
- Email: amy_nunn@brown.edu
- Phone: 401-863-6568
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.