Intervention to Enhance PrEP Persistence

Recruiting now · Not applicable

Conditions studied: HIV Prevention, HIV Infection Primary

In brief

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.

Key facts

Study ID

NCT06872307

Run by

Brown University

People needed

300

Starts

2024-10-01

Expected to finish

2028-07-31

Last updated by the study team

2025-03-12

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

• Whitman Walker Health — Washington D.C., District of Columbia, United States (enrolling)
• University of Mississippi Medical Center — Jackson, Mississippi, United States (enrolling)
• The Rhode Island Public Health Institute — Providence, Rhode Island, United States (enrolling)

Full record on ClinicalTrials.gov

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