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NCT06872307 · ClinicalTrials.gov registry record · NA
Intervention to Enhance PrEP Persistence
A NA study of HIV Prevention and HIV Infection Primary, sponsored by Brown University.
- Recruiting
- Registry status
- NA
- Development phase
- 300
- Enrollment target
- 3
- Study locations
NCT06872307 is a NA study of HIV Prevention and HIV Infection Primary that is actively recruiting participants, run by Brown University. The registered enrollment target is 300 participants, below the 372-participant average among 32 other HIV Prevention trials with a reported enrollment target (19% lower). The trial reports 3 study locations across 3 states.
The verdict
NCT06872307, a NA study of HIV Prevention and HIV Infection Primary, is actively recruiting participants, sponsored by Brown University.
- RECRUITING
- Registry status
- NA
- Development phase
- 300 participants
- Enrollment target
- 3
- Study locations
Study 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 ac
Conditions Studied
Interventions
- BEHAVIORAL RAMP-It-Up Initiation, Adherence, and Retention Intervention
Study Locations (3)
District of Columbia
- Whitman Walker Health - Washington D.C.
Mississippi
- University of Mississippi Medical Center - Jackson
Rhode Island
- The Rhode Island Public Health Institute - Providence
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2024-10-01 |
| Est. Completion | 2028-07-31 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06872307
The ClinicalTrials.gov registry entry for NCT06872307 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 372-participant average among 32 other HIV Prevention trials with a reported enrollment target (19% lower). The listed sponsor is Brown University, which has 231 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with HIV Prevention appearing as the primary indexed condition, and to 1 intervention - of which RAMP-It-Up Initiation, Adherence, and Retention Intervention is the first listed.
NCT06872307 reports 3 study locations spanning 3 distinct geographic areas - top geographies include District of Columbia, Mississippi, Rhode Island.
Frequently Asked Questions
What is clinical trial NCT06872307 about?
NCT06872307 is a clinical study titled "Intervention to Enhance PrEP Persistence". 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 dis...
What is the current status of trial NCT06872307?
This trial is currently recruiting. It is a NA study. The enrollment target is 300 participants. The study started on 2024-10-01. Estimated completion is 2028-07-31.
What conditions does trial NCT06872307 study?
This clinical trial studies the following conditions: HIV Prevention, HIV Infection Primary.
What interventions are being tested in trial NCT06872307?
The interventions under investigation include: RAMP-It-Up Initiation, Adherence, and Retention Intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT06872307?
This trial is sponsored by Brown University, which has 231 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06872307 being conducted?
This trial has 3 study locations across District of Columbia, Mississippi, Rhode Island. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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