NCT06872307 Intervention to Enhance PrEP Persistence
| NCT ID | NCT06872307 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Brown University |
| Condition | HIV Prevention |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2024-10-01 |
| Primary Completion | 2028-07-31 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 300 participants in total. It began in 2024-10-01 with a primary completion date of 2028-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06872307 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying HIV Prevention. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06872307 currently recruiting?
Yes, NCT06872307 is actively recruiting participants. Contact the research team at amy_nunn@brown.edu for enrollment information.
Where is the NCT06872307 trial being conducted?
This trial is being conducted at Washington D.C., United States, Jackson, United States, Providence, United States.
Who is sponsoring the NCT06872307 clinical trial?
NCT06872307 is sponsored by Brown University. The trial plans to enroll 300 participants.
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