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HOTSPOT Study: Implement and Evaluate the PrEP Implementation Strategy (Hotspot)

The University of Texas System (UT) logo

The University of Texas System (UT)

Status

Enrolling

Conditions

HIV
Incarceration
PrEP

Treatments

Behavioral: Multicomponent strategy

Study type

Observational

Funder types

Other
NIH

Identifiers

NCT06919419
STU-2024-1096
1R01MH129185-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The goal of this study is to measure the implementation and effectiveness of a multicomponent strategy for PrEP for people who are incarcerated at the Dallas County Jail. Specifically, based on a patients risk score on an electronic medical record HIV prediction model, referrals from providers and/or patient self-referrals, a PrEP patient navigator will meet with individuals at the jail to discuss HIV risk, offer HIV/STI testing if not yet completed and offer education around PrEP with referrals to community-based PrEP providers.

Full description

The objective of Aim 3 is to deploy the multicomponent strategy that was refined in Aim 2 and evaluate its impact on PrEP implementation and related clinical outcomes using iterative quantitative and qualitative assessments. The investigators' approach will be to utilize the EPIS framework (Exploration, Preparation, Implementation, Sustainment) across the jail-to-community continuum. The investigators will use mixed-methods to evaluate implementation process measures and an interrupted time series design to measure clinical outcomes for PrEP evaluations and linkage, as well as HIV/STI testing and diagnoses. The investigators' expected outcome is to define a feasible, acceptable and effective PrEP implementation strategy for jails.

Enrollment

3,600 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 18 years of age or older
  • Incarcerated in Dallas County Jail

Exclusion criteria

  • Severe medical or psychiatric disability making participation unsafe
  • Unable to provide consent
  • Not remaining in the local area after release from custody

Trial contacts and locations

1

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Central trial contact

Laura Hansen; Ank Nijhawan, MD

Data sourced from clinicaltrials.gov

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