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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: Recruiting NA study of HIV Prevention and HIV Infection Primary, sponsored by Brown University.

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. According to ClinicalTrials.gov, the official US trial registry.

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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

Primary Outcome

The primary outcome will be PrEP adherence, given adherence is the definitive marker associated with protection from HIV infection. Adherence will be measured using pharmacy fill data in order to determine whether participants have picked up their prescription on a monthly basis.

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

FieldValue
Enrollment Target 300 participants
Start Date 2024-10-01
Est. Completion 2028-07-31
Phase NA
Brown University

231 total trials

What NCT06872307 shows while recruiting

NCT06872307 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, below the 372-participant average among 32 other HIV Prevention trials with a reported enrollment target (19% lower).

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 a single indexed study location in 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.

Similar trials for HIV Prevention

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06872307's enrollment target sits among peer trials

300 10th of 32 higher than 22 of 32 other HIV Prevention trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other HIV Prevention trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06872307, the US trial registry maintained by the National Library of Medicine. NCT06872307 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.