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

The University of Texas System (UT)

Status: Enrolling

Conditions: HIV Disease; HIV Prevention

Treatments: Behavioral: Health Coach Intervention

Study type: Observational

Funder types: Other

Identifiers

NCT07292792

STU-2024-0736

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

100 participants in 1 patient group

Health Coach Intervention Group

Description:

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.

Treatment:

Behavioral: Health Coach Intervention