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NCT Number: NCT06919419

HOTSPOT Study: Implement and Evaluate the PrEP (Pre-exposure Prophylaxis) Implementation Strategy

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.

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Key information

Conditions

PreP HIV Incarceration

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dallas County Jail

Dallas, Texas, 75207, United States

Location status: Recruiting

Location contact

Barry-Lewis Harris, MD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multicomponent strategy

Behavioral

Identify patients for HIV/STI testing, engage in discussions around PrEP and navigate patients to PrEP after jail incarceration

Primary outcomes

  1. Linkage to PrEP care

    Time frame: Within 90 days of release from jail

    Measure the proportion of individuals (of those who stated that they were interested in PrEP and have been released from jail) who attended a clinic visit with a PrEP provider as confirmed by the PrEP patient navigator or through medical record review.

Study contacts

Contact information is provided by the study sponsor or research team.

Ank Nijhawan, MD

CONTACT

[email protected]

2146482777

Laura Hansen

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

The HOTSPOT Study Hybrid Implementation-effectiveness Study to Optimize HIV Testing and PrEP in a Southern Jail

Acronym: Hotspot

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 9, 2025
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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