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Recruiting NCT07292792

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

— Observational HIV Disease HIV Prevention

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Health Coach Intervention.
Who it may be relevant to
Registry conditions: HIV Disease, HIV Prevention. Basic parameters: 18 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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-invol

Primary outcome measures

  • Feasibility of Integrating a PrEP-Focused Health Coach [Time frame: 18 Months]
  • Acceptability of the Health Coach Model [Time frame: 18 Months]
  • Appropriateness of the Health Coach Model [Time frame: 18 Months]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • UT Southwestern Medical Center — Dallas

Identifiers

NCT: NCT07292792 · STU-2024-0736

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗