Intervention to Enhance PrEP Persistence
Recruiting · NCT06872307 · Interventional (participants receive a specific treatment) · Lead sponsor: Brown University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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 it is running
3 locations listed across 3 US states.
- Whitman Walker Health - Washington D.C., District of Columbia, United States
- University of Mississippi Medical Center - Jackson, Mississippi, United States
- The Rhode Island Public Health Institute - Providence, Rhode Island, United States