NCT07292792

The Unlocking PrEP Study: Integration of Peer Health Navigation Into Comprehensive Re-entry Services

Integration of Peer Health Navigation Into Comprehensive Re-entry Services: Improving PrEP Implementation for Justice-involved Individuals

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Accepted

Summary

This 18-month study, "Integration of peer health navigation into comprehensive re-entry services: improving PrEP implementation for justice-involved individuals," aims to increase PrEP awareness and uptake among people with a history of justice involvement in Dallas, primarily clients of Unlocking Doors.

Detailed description

This 18-month study, "Integration of peer health navigation into comprehensive re-entry services: improving PrEP implementation for justice-involved individuals," aims to increase PrEP awareness and uptake among people with a history of justice involvement in Dallas, primarily clients of Unlocking Doors. Guided by the EPIS (Exploration, Preparation, Implementation, Sustainment) framework, the study will: Conduct qualitative interviews with Unlocking Doors staff, clients, health coaches, and PrEP providers to identify barriers and facilitators to integrating a health coach focused on sexual health, HIV testing, and PrEP. Use rapid qualitative analysis to adapt the health coach intervention and workflows. Implement a health coach model embedded in Unlocking Doors to offer general and sexual health discussions, PrEP education, HIV/syphilis testing, and linkage to PrEP care and other services. Enroll up to 600 consented/screened individuals to achieve a target of 100 participants in the intervention. Assess feasibility, acceptability, and appropriateness of the model, as well as changes in PrEP knowledge, interest, referrals, and uptake over time. The study is led by PI: Ank Nijhawan in UTSW Infectious Diseases.

Conditions

• HIV Disease
• HIV Prevention

Interventions

Type	Name	Description
BEHAVIORAL	Health Coach Intervention	The intervention integrates a PrEP-focused health coach into Unlocking Doors' re-entry services. The health coach provides clients with general health guidance, sexual health education, HIV and syphilis testing, PrEP education, PrEP eligibility screening, and linkage to PrEP care. The coach also offers ongoing navigation and referrals to medical, behavioral health, and re-entry services as needed. The aim of the intervention is to increase PrEP awareness, interest, and uptake among justice-involved individuals while assessing feasibility, acceptability, and appropriateness of embedding a health coach within legal re-entry services.

Timeline

• Start date: 2025-05-21
• Primary completion: 2026-11-21
• Completion: 2026-11-21
• First posted: 2025-12-18
• Last updated: 2026-01-15

Locations

1 site across 1 country: United States