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

February 6, 2026 updated by: Ank Nijhawan, University of Texas Southwestern Medical Center

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

3600

Phase

  • Not Applicable

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 Contact Backup

Study Locations

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

Study Population

Adults incarcerated at the Dallas County Jail

Description

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

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

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: PrEP navigation
This is a single arm study where people in the Dallas County Jail identified to be at elevated risk for HIV are offered a PrEP navigation visit
Behavioral: Multicomponent strategy
Identify patients for HIV/STI testing, engage in discussions around PrEP and navigate patients to PrEP after jail incarceration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Within 90 days of release from jail

Collaborators and Investigators

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

Sponsor

University of Texas Southwestern Medical Center

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Douglas Krakower, MD, Beth Israel Deaconess Medical Center
  • Principal Investigator: Ank 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)

March 1, 2025

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

August 31, 2027

Study Registration Dates

First Submitted

March 21, 2025

First Submitted That Met QC Criteria

April 1, 2025

First Posted (Actual)

April 9, 2025

Study Record Updates

Last Update Posted (Actual)

February 10, 2026

Last Update Submitted That Met QC Criteria

February 6, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

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

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

MPIs will consider de-identified data sharing upon reasonable request from other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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