Unlocking PrEP: Peer health coaches to expand PrEP access during re-entry
Official title: Integration of Peer Health Navigation Into Comprehensive Re-entry Services: Improving PrEP Implementation for Justice-involved Individuals
Run by University of Texas Southwestern Medical Center · NCT07292792 · Data updated 2026-11-12
This project will try adding peer health coaches at a Dallas re-entry program to increase PrEP awareness and uptake among people with a history of justice involvement.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 99 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | University of Texas Southwestern Medical Center Academic / other |
| Locations | 1 site (Dallas, Texas) |
| Status | Recruiting |
| Started | May 21, 2025 |
| Main results expected | November 21, 2026 |
| Study ends | November 21, 2026 |
| Registry record updated | January 15, 2026 |
| Trial ID | NCT07292792 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are English-speaking adults (18+) who receive services at Unlocking Doors in Dallas, can provide informed consent, are HIV-negative, and are willing to discuss sexual health and PrEP.
✕Probably not a fit
People who are under 18, currently incarcerated, living with HIV, non-English speakers, or not receiving Unlocking Doors services are unlikely to receive benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Guided by the EPIS implementation framework, this 18-month observational project uses qualitative interviews with Unlocking Doors staff, clients, health coaches, and PrEP providers to identify barriers and facilitators to integrating a sexual health-focused peer coach. Rapid qualitative analysis will be used to adapt the health coach intervention and workflows for the local setting. The adapted model will be embedded in Unlocking Doors to offer general and sexual health discussions, PrEP education, HIV and syphilis testing, and linkage to PrEP care and other services. Up to 600 people will be screened/consented to reach a target of 100 intervention participants, with outcomes focused on feasibility, acceptability, appropriateness, and changes in PrEP knowledge, referrals, and uptake over time.
Why it matters
Potential benefit: If successful, this model could increase PrEP awareness and linkage to preventive care among justice-involved people, potentially reducing HIV risk in a high-need population.
How similar studies have gone: Peer navigation and health coach approaches have shown promise in improving HIV prevention and care engagement in marginalized groups, but embedding such models specifically within re-entry services is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 18 years or older 2. Client of Unlocking Doors 3. Able to provide informed consent 4. Willing to participate in discussions about general health, sexual health, HIV prevention, and PrEP 5. Willing to complete health screening and eligibility assessment 6. For qualitative interview participants: * Unlocking Doors staff, clients, or PrEP providers who agree to participate in a one-time interview. Exclusion Criteria: 1. Under 18 years of age 2. Unable to provide informed consent 3. Not receiving services at Unlocking Doors 4. Non-English speakers 5. Diagnosed with HIV 6. Incarcerated individuals at the time of recruitment
Where it's running
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UT Southwestern Medical Center
Dallas, Texas, United States Recruiting
Study contacts
- Principal investigator: Ank E Nijhawan, MD — University of Texas Southwestern Medical Center
- Study coordinator: Laura A Hansen, MA
- Email: Laura.Hansen@UTSouthwestern.edu
- Phone: 7133057882
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.