Home › NCT06872307

Intervention to Enhance PrEP Persistence

Intervention to Enhance Prep Persistence Among African American Men Who Have Sex with Men

Who can join

Ages 18 and older · Men · Healthy volunteers welcome

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.

About the study

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.

What is being tested

• RAMP-It-Up Initiation, Adherence, and Retention Intervention (behavioral)

Sponsor: Brown University · Participants: 300 · Started: Oct 1, 2024

Contact the study team

• Dr. Amy Nunn, ScD · Phone: 401-863-6568

Official record on ClinicalTrials.gov — NCT06872307

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.