Tests a patient navigation program to help men keep taking PrEP for HIV prevention
Tests a navigation program helping men start and stay on daily PrEP to prevent HIV.
Plain-language title generated from the registry record
Registry title: Intervention to Enhance PrEP Persistence
Key facts
- Where
- Atlanta, Jackson, and Providence, United StatesSee the 3 sites
Where in United States
- Emory UniversityAtlanta, United StatesTaking people
- University of Mississippi Medical CenterJackson, United StatesTaking people
- The Rhode Island Public Health InstituteProvidence, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Brown University
- Trial code
- NCT06872307
- Record updated
- 16 October 2026
- Original 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.Read full original descriptionShow less
Intervention to Enhance Prep Persistence Among Men
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.
Inclusion: 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: HIV-positive or inconclusive HIV status based on antibody testing at the time of enrollment; 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; 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.