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

NCT07292792 | Recruiting

• 1 other identifier: STU-2024-0736
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV Disease; HIV Prevention

Keywords

PrEP

Outcome Measures

Primary Outcomes (3)

• Feasibility of Integrating a PrEP-Focused Health Coach

  Feasibility will be assessed by the proportion of Unlocking Doors clients who engage with the health coach. This indicator reflects whether the health coach can be effectively integrated into existing re-entry workflows.

  18 Months

• Acceptability of the Health Coach Model

  Acceptability will be assessed using custom questions developed by our team and modified question items from the Scales for Participant Alliance with Recovery Coach (SPARC) scale, and which will be asked of clients and staff. These questions will assess satisfaction, comfort, and perceived usefulness of health coach interactions. Response options will be rated on a Likert scale ranging from 1 - 5, with higher scores indicating better perceptions of acceptability. Qualitative feedback will supplement these ratings to capture overall acceptability.

  18 Months

• Appropriateness of the Health Coach Model

  Appropriateness will be assessed using custom questions developed by our team and modified question items from the Scales for Participant Alliance with Recovery Coach (SPARC) scale. These questions assess perceived relevance, fit, and value of integrating a health coach into Unlocking Doors' services, as well as how well the model aligns with client needs. Response options will be rated on a Likert scale ranging from 1 - 5, with higher scores indicating better perceptions of appropriateness. Qualitative feedback will supplement these ratings to capture overall appropriateness.

  18 Months

Study Arms (1)

Health Coach Intervention Group

Participants in this group are clients of Unlocking Doors who meet eligibility criteria and choose to enroll in the study. They receive the health coach intervention, which includes general health and sexual health discussions, HIV and syphilis testing, PrEP education, PrEP eligibility screening, linkage to PrEP care, and referrals to other health or re-entry services. Their PrEP knowledge, interest, and engagement, as well as feasibility and acceptability of the model, are assessed throughout the study.

Behavioral: Health Coach Intervention

Interventions

Health Coach Intervention BEHAVIORAL

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.

Health Coach Intervention Group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults (18+) receiving re-entry services at Unlocking Doors, including justice-involved individuals and staff participating in qualitative interviews. Participants are engaged in general health, sexual health, and PrEP-related discussions with a health coach as part of the intervention.

You may qualify if:

• Age 18 years or older
• Client of Unlocking Doors
• Able to provide informed consent
• Willing to participate in discussions about general health, sexual health, HIV prevention, and PrEP
• Willing to complete health screening and eligibility assessment
• For qualitative interview participants:
• Unlocking Doors staff, clients, or PrEP providers who agree to participate in a one-time interview.

You may not qualify if:

• Under 18 years of age
• Unable to provide informed consent
• Not receiving services at Unlocking Doors
• Non-English speakers
• Diagnosed with HIV
• Incarcerated individuals at the time of recruitment

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Unlocking Doors: collaborator

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Ank E Nijhawan, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura A Hansen, MA

CONTACT

7133057882; Laura.Hansen@UTSouthwestern.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor- Internal Medicine

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: December 18, 2025
• Study Start: May 21, 2025
• Primary Completion (Estimated): November 21, 2026
• Study Completion (Estimated): November 21, 2026
• Last Updated: January 15, 2026

Record last verified: 2026-01

Locations

US (1)