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

January 13, 2026 updated by: Ank Nijhawan, University of Texas Southwestern Medical Center

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75390
        • Recruiting
        • UT Southwestern Medical Center
        • Contact:
          • Ank E Nijhawan, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of Integrating a PrEP-Focused Health Coach
Time Frame: 18 Months
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
Time Frame: 18 Months
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
Time Frame: 18 Months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas Southwestern Medical Center

Collaborators

Unlocking Doors

Investigators

  • Principal Investigator: Ank E Nijhawan, MD, University of Texas Southwestern Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 21, 2025

Primary Completion (Estimated)

November 21, 2026

Study Completion (Estimated)

November 21, 2026

Study Registration Dates

First Submitted

November 21, 2025

First Submitted That Met QC Criteria

December 5, 2025

First Posted (Estimated)

December 18, 2025

Study Record Updates

Last Update Posted (Actual)

January 15, 2026

Last Update Submitted That Met QC Criteria

January 13, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU-2024-0736

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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