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Intervention to Enhance PrEP Persistence

Sponsor: Brown University • ClinicalTrials.gov ID: NCT06872307

Registry updated: 2026-10-16

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Description

The investigators will conduct a fully powered randomized controlled trial (RCT) to test the effect of a patient navigation intervention on PrEP initiation, adherence and retention in care. 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. 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 men. The intervention was found to be highly acceptable 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 men in real-world community health center settings (CHCs). Specific Aim #2 will estimate the cost-effectiveness of RAMP-IT-UP among men 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 which will be relevant for CHCs across the US. The long-term goal of this work is to decrease HIV incidence , 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 and PrEP research in real-world clinical settings.

Interventions

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

Eligibility criteria

Inclusion Criteria: * Aged 18 years and older * Assigned male sex at birth * 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 * 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.

Conditions

HIV Prevention HIV Infection Primary

Locations

Emory University — Atlanta, Georgia, United States
University of Mississippi Medical Center — Jackson, Mississippi, United States
The Rhode Island Public Health Institute — Providence, Rhode Island, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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