Intervention to Enhance Prep Persistence Among African American Men Who Have Sex with Men
Brown University
Summary
The investigators will conduct a fully powered randomized controlled trial (RCT) to test the effect of a patient navigation intervention for Black/African American (B/AA) men who have sex with men (MSM) on PrEP initiation, adherence and retention in care. B/AA men who have sex with men (MSM) are disproportionately impacted by the HIV/AIDS epidemic in the United States. Pre-exposure prophylaxis (PrEP), a once daily medication, can dramatically reduce HIV acquisition risk. However, social and structural barriers have contributed to suboptimal PrEP initiation, adherence, and retention in care among B/AA MSM. Our prior NIH-funded pilot study (R34MH109371; MPI: Nunn, Chan, Mena) developed and evaluated an Intervention to Retain and Adhere MSM in PrEP (RAMP-IT-UP), a brief strengths-based patient navigation program to enhance PrEP care outcomes among young B/AA MSM. The intervention was found to be highly acceptable among B/AA MSM and demonstrated preliminary effectiveness. Compared to control participants, RAMP-IT-UP participants were statistically more likely to initiate PrEP and adhere to PrEP based on pharmacy fill data and PrEP blood levels. Additionally, RAMP-IT-UP participants were more likely to be retained in PrEP care at the 3-month and 6-month clinical visits. Specific Aim #1 of this study will conduct a fully powered randomized controlled trial (RCT to estimate the effectiveness of RAMP-IT-UP in improving PrEP adherence and care outcomes among B/AA MSM in real-world community health center settings (CHCs). Specific Aim #2 will estimate the cost-effectiveness of RAMP-IT-UP among B/AA MSM attending CHCs compared to standard of care. The investigators will also determine the cost-effectiveness of differing levels of intensity of navigation services to prevent HIV based on data collected in Specific Aim #1. Our goal is to develop a cost-effective intervention that enhances PrEP care outcomes and reduces HIV incidence for B/AA MSM which will be relevant for CHCs across the US. The long-term goal of this work is to decrease HIV incidence among B/AA MSM, which aligns with federal Ending the HIV Epidemic and National HIV/AIDS Strategy goals. This application is led by an experienced team of investigators with a proven track record conducting HIV, PrEP and disparities research in real-world clinical settings.
Description
Black/African American (B/AA) gay, bisexual, and other men who have sex with men (MSM) are at high risk for HIV acquisition in the United States (US). Although B/AA MSM account for less than 1% of the US population, they comprise 26% of new HIV infections. An estimated 41% of B/AA MSM acquire HIV during their lifetimes. HIV pre-exposure prophylaxis (PrEP) can dramatically reduce HIV incidence for B/AA MSM. B/AA MSM have poorer outcomes at every stage of the PrEP care continuum. B/AA MSM are less likely to initiate PrEP, and be retained in care than non-Hispanic White MSM. PrEP care outcomes a…
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- Yes
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…
Interventions
- BehavioralRAMP-It-Up Initiation, Adherence, and Retention Intervention
The intervention arm will receive facilitated strengths-based case management (SBCM)-delivered by trained interventionists-to help navigate the PrEP medical care system and support the participant and health care staff in meeting the challenges faced with obtaining PrEP medication (e.g., overcoming insurance barriers or barriers with co-pays). This also includes facilitated integration into the PrEP clinic and obtaining monthly PrEP prescription refills
Locations (3)
- Whitman Walker HealthWashington D.C., District of Columbia
- University of Mississippi Medical CenterJackson, Mississippi
- The Rhode Island Public Health InstituteProvidence, Rhode Island