PrEPHotspotNCT06919419
HOTSPOT Study: Implement and Evaluate the PrEP (Pre-exposure Prophylaxis) Implementation Strategy
A study testing Multicomponent strategy in people with PrEP and HIV, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- PrEP, HIV, Incarceration
- What is being tested?
- Multicomponent strategy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,600 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2025to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Incarcerated in Dallas County Jail
Who cannot join
- Severe medical or psychiatric disability making participation unsafe
- Unable to provide consent
- Not remaining in the local area after release from custody
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Laura Hansen contact
United States1 site, 1 recruiting
- Recruiting
Dallas County Jail
Dallas, Texas, 75207
Barry-Lewis Harris, MD, barry-lewis.harris@phhs.org
About this study
Official title: 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.
Read the 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.
- Conditions
- PrEP, HIV, Incarceration
- Being tested
- Multicomponent strategy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicomponent strategyBehavioural
Identify patients for HIV/STI testing, engage in discussions around PrEP and navigate patients to PrEP after jail incarceration
| Study group | Role | What they receive |
|---|---|---|
| PrEP navigation | Other | 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 Receives: Behavioral: Multicomponent strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Linkage to PrEP care
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.
Measured: Within 90 days of release from jail
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start1 Mar 2025
- Primary completion1 Feb 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrEPStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients identified to be at elevated risk for HIV will meet with the PrEP navigator during incarceration
- Masking
- None (open label)
- Enrolment
- 3,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Parkland Health and Hospital System
- Responsible party
- Principal investigator, Ank Nijhawan, University of Texas Southwestern Medical Center
- Investigators
- Ank Nijhawan, MD, Principal investigator, University of Texas Southwestern Medical CenterDouglas Krakower, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06919419
- Sponsor's protocol ID
- STU-2024-1096
- Other IDs
- 1R01MH129185-01
- Acronym
- Hotspot
- Status last verified
- Aug 2026
- First submitted
- 21 Mar 2025
- Last updated
- 2 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: MPIs will consider de-identified data sharing upon reasonable request from other researchers
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The HOTSPOT Study Hybrid Implementation-effectiveness Study to Optimize HIV Testing and PrEP in a Southern Jail
- ClinicalTrials.gov ID
- NCT06919419
- Acronym / sponsor ID
- Hotspot / STU-2024-1096
- Conditions
- PrEP, HIV, Incarceration
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,600 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Parkland Health and Hospital System
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 9 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients identified to be at elevated risk for HIV will meet with the PrEP navigator during incarceration
| Arm | Type | Receives |
|---|---|---|
| PrEP navigation | Other | Behavioral: Multicomponent strategyThis 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years of age or older
- Incarcerated in Dallas County Jail
Key exclusion criteria (3 listed)
- Severe medical or psychiatric disability making participation unsafe
- Unable to provide consent
- Not remaining in the local area after release from custody
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multicomponent strategyIdentify patients for HIV/STI testing, engage in discussions around PrEP and navigate patients to PrEP after jail incarceration | Behavioural | PrEP navigation |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: No. MPIs will consider de-identified data sharing upon reasonable request from other researchers
Related trials for PrEP
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Laura Hansen contact
Ank Nijhawan, MD principal investigator
University of Texas Southwestern Medical Center
Douglas Krakower, MD principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multicomponent strategy in people with PrEP and HIV, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ank Nijhawan, MD (2146482777, ank.nijhawan@utsouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Linkage to PrEP care (time frame: Within 90 days of release from jail). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.