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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06919419
Acronym
Hotspot
Enrollment
3600
Registered
2025-04-09
Start date
2025-03-01
Completion date
2027-08-31
Last updated
2026-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV, Incarceration, PrEP

Brief summary

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.

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.

Interventions

BEHAVIORALMulticomponent strategy

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

Sponsors

University of Texas Southwestern Medical Center
Lead SponsorOTHER
National Institute of Mental Health (NIMH)
CollaboratorNIH
Parkland Health and Hospital System
CollaboratorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Patients identified to be at elevated risk for HIV will meet with the PrEP navigator during incarceration

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Linkage to PrEP careWithin 90 days of release from jailMeasure 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.

Countries

United States

Contacts

CONTACTAnk Nijhawan, MD
ank.nijhawan@utsouthwestern.edu2146482777
CONTACTLaura Hansen
laura.Hansen@utsouthwestern.edu
PRINCIPAL_INVESTIGATORAnk Nijhawan, MD

University of Texas Southwestern Medical Center

PRINCIPAL_INVESTIGATORDouglas Krakower, MD

Beth Israel Deaconess Medical Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 3, 2026