HIV DiseaseNCT07292792
The Unlocking PrEP Study: Integration of Peer Health Navigation Into Comprehensive Re-entry Services
An observational study of HIV Disease and HIV Prevention, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
This 18-month study, "Integration of peer health navigation into comprehensive re-entry services: improving PrEP implementation for justice-involved individuals," aims to increase PrEP awareness and uptake among people with a history of justice involvement in Dallas, primarily clients of Unlocking Doors. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Disease, HIV Prevention
- What is being tested?
- Health Coach Intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 21 May 2025to 21 Nov 2026
- Phase
- Observational
- 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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults (18+) receiving re-entry services at Unlocking Doors, including justice-involved individuals and staff participating in qualitative interviews. Participants are engaged in general health, sexual health, and PrEP-related discussions with a health coach as part of the intervention.
Who may be able to join
- Age 18 years or older
- Client of Unlocking Doors
- Able to provide informed consent
- Willing to participate in discussions about general health, sexual health, HIV prevention, and PrEP
- Willing to complete health screening and eligibility assessment
- For qualitative interview participants:
- Unlocking Doors staff, clients, or PrEP providers who agree to participate in a one-time interview.
Who cannot join
- Under 18 years of age
- Unable to provide informed consent
- Not receiving services at Unlocking Doors
- Non-English speakers
- Diagnosed with HIV
- Incarcerated individuals at the time of recruitment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UT Southwestern Medical Center
Dallas, Texas, 75390
Ank E Nijhawan, MD
About this study
Official title: Integration of Peer Health Navigation Into Comprehensive Re-entry Services: Improving PrEP Implementation for Justice-involved Individuals
This 18-month study, "Integration of peer health navigation into comprehensive re-entry services: improving PrEP implementation for justice-involved individuals," aims to increase PrEP awareness and uptake among people with a history of justice involvement in Dallas, primarily clients of Unlocking Doors.
Read the detailed description
This 18-month study, "Integration of peer health navigation into comprehensive re-entry services: improving PrEP implementation for justice-involved individuals," aims to increase PrEP awareness and uptake among people with a history of justice involvement in Dallas, primarily clients of Unlocking Doors. Guided by the EPIS (Exploration, Preparation, Implementation, Sustainment) framework, the study will:
Conduct qualitative interviews with Unlocking Doors staff, clients, health coaches, and PrEP providers to identify barriers and facilitators to integrating a health coach focused on sexual health, HIV testing, and PrEP.
Use rapid qualitative analysis to adapt the health coach intervention and workflows.
Implement a health coach model embedded in Unlocking Doors to offer general and sexual health discussions, PrEP education, HIV/syphilis testing, and linkage to PrEP care and other services.
Enroll up to 600 consented/screened individuals to achieve a target of 100 participants in the intervention.
Assess feasibility, acceptability, and appropriateness of the model, as well as changes in PrEP knowledge, interest, referrals, and uptake over time.
The study is led by PI: Ank Nijhawan in UTSW Infectious Diseases.
- Conditions
- HIV Disease, HIV Prevention
- Being tested
- Health Coach Intervention
- Keywords
- PrEP
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Coach InterventionBehavioural
The intervention integrates a PrEP-focused health coach into Unlocking Doors' re-entry services. The health coach provides clients with general health guidance, sexual health education, HIV and syphilis testing, PrEP education, PrEP eligibility screening, and linkage to PrEP care. The coach also offers ongoing navigation and referrals to medical, behavioral health, and re-entry services as needed. The aim of the intervention is to increase PrEP awareness, interest, and uptake among justice-involved individuals while assessing feasibility, acceptability, and appropriateness of embedding a health coach within legal re-entry services.
| Study group | Role | What they receive |
|---|---|---|
| Health Coach Intervention Group | Participants in this group are clients of Unlocking Doors who meet eligibility criteria and choose to enroll in the study. They receive the health coach intervention, which includes general health and sexual health discussions, HIV and syphilis testing, PrEP education, PrEP eligibility screening, linkage to PrEP care, and referrals to other health or re-entry services. Their PrEP knowledge, interest, and engagement, as well as feasibility and acceptability of the model, are assessed throughout the study. Receives: Behavioral: Health Coach Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Integrating a PrEP-Focused Health Coach
Feasibility will be assessed by the proportion of Unlocking Doors clients who engage with the health coach. This indicator reflects whether the health coach can be effectively integrated into existing re-entry workflows.
Measured: 18 Months
Acceptability of the Health Coach Model
Acceptability will be assessed using custom questions developed by our team and modified question items from the Scales for Participant Alliance with Recovery Coach (SPARC) scale, and which will be asked of clients and staff. These questions will assess satisfaction, comfort, and perceived usefulness of health coach interactions. Response options will be rated on a Likert scale ranging from 1 - 5, with higher scores indicating better perceptions of acceptability. Qualitative feedback will supplement these ratings to capture overall acceptability.
Measured: 18 Months
Appropriateness of the Health Coach Model
Appropriateness will be assessed using custom questions developed by our team and modified question items from the Scales for Participant Alliance with Recovery Coach (SPARC) scale. These questions assess perceived relevance, fit, and value of integrating a health coach into Unlocking Doors' services, as well as how well the model aligns with client needs. Response options will be rated on a Likert scale ranging from 1 - 5, with higher scores indicating better perceptions of appropriateness. Qualitative feedback will supplement these ratings to capture overall appropriateness.
Measured: 18 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start21 May 2025
- Primary completion21 Nov 2026 (estimated)
- Study completion21 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV DiseaseStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Unlocking Doors
- Responsible party
- Principal investigator, Ank Nijhawan, University of Texas Southwestern Medical Center
- Investigators
- Ank E Nijhawan, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07292792
- Sponsor's protocol ID
- STU-2024-0736
- Status last verified
- Jan 2026
- First submitted
- 21 Nov 2025
- Last updated
- 15 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integration of Peer Health Navigation Into Comprehensive Re-entry Services: Improving PrEP Implementation for Justice-involved Individuals
- ClinicalTrials.gov ID
- NCT07292792
- Acronym / sponsor ID
- STU-2024-0736
- Conditions
- HIV Disease, HIV Prevention
- Keywords
- PrEP
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Unlocking Doors
- Study start
- 21 May 2025 (actual)
- Primary completion
- 21 Nov 2026 (estimated)
- Study completion
- 21 Nov 2026 (estimated)
- First posted
- 18 Dec 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.
This 18-month study, "Integration of peer health navigation into comprehensive re-entry services: improving PrEP implementation for justice-involved individuals," aims to increase PrEP awareness and uptake among people with a history of justice involvement in Dallas, primarily clients of Unlocking Doors.
Detailed description
This 18-month study, "Integration of peer health navigation into comprehensive re-entry services: improving PrEP implementation for justice-involved individuals," aims to increase PrEP awareness and uptake among people with a history of justice involvement in Dallas, primarily clients of Unlocking Doors. Guided by the EPIS (Exploration, Preparation, Implementation, Sustainment) framework, the study will:
Conduct qualitative interviews with Unlocking Doors staff, clients, health coaches, and PrEP providers to identify barriers and facilitators to integrating a health coach focused on sexual health, HIV testing, and PrEP.
Use rapid qualitative analysis to adapt the health coach intervention and workflows.
Implement a health coach model embedded in Unlocking Doors to offer general and sexual health discussions, PrEP education, HIV/syphilis testing, and linkage to PrEP care and other services.
Enroll up to 600 consented/screened individuals to achieve a target of 100 participants in the intervention.
Assess feasibility, acceptability, and appropriateness of the model, as well as changes in PrEP knowledge, interest, referrals, and uptake over time.
The study is led by PI: Ank Nijhawan in UTSW Infectious Diseases.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Health Coach Intervention Group | – | Behavioral: Health Coach InterventionParticipants in this group are clients of Unlocking Doors who meet eligibility criteria and choose to enroll in the study. They receive the health coach intervention, which includes general health and sexual health discussions, HIV and syphilis testing, PrEP education, PrEP eligibility screening, linkage to PrEP care, and referrals to other health or re-entry services. Their PrEP knowledge, interest, and engagement, as well as feasibility and acceptability of the model, are assessed throughout the study. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults (18+) receiving re-entry services at Unlocking Doors, including justice-involved individuals and staff participating in qualitative interviews. Participants are engaged in general health, sexual health, and PrEP-related discussions with a health coach as part of the intervention.
Key inclusion criteria (7 listed)
- Age 18 years or older
- Client of Unlocking Doors
- Able to provide informed consent
- Willing to participate in discussions about general health, sexual health, HIV prevention, and PrEP
- Willing to complete health screening and eligibility assessment
Key exclusion criteria (6 listed)
- Under 18 years of age
- Unable to provide informed consent
- Not receiving services at Unlocking Doors
- Non-English speakers
- Diagnosed with HIV
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 |
|---|---|---|
| Health Coach InterventionThe intervention integrates a PrEP-focused health coach into Unlocking Doors' re-entry services. The health coach provides clients with general health guidance, sexual health education, HIV and syphilis testing, PrEP education, PrEP eligibility screening, and linkage to PrEP care. The coach also offers ongoing navigation and referrals to medical, behavioral health, and re-entry services as needed. The aim of the intervention is to increase PrEP awareness, interest, and uptake among justice-involved individuals while assessing feasibility, acceptability, and appropriateness of embedding a health coach within legal re-entry services. | Behavioural | Health Coach Intervention Group |
Primary outcome
Feasibility of Integrating a PrEP-Focused Health Coach
Time frame: 18 Months
Feasibility will be assessed by the proportion of Unlocking Doors clients who engage with the health coach. This indicator reflects whether the health coach can be effectively integrated into existing re-entry workflows.
Acceptability of the Health Coach Model
Time frame: 18 Months
Acceptability will be assessed using custom questions developed by our team and modified question items from the Scales for Participant Alliance with Recovery Coach (SPARC) scale, and which will be asked of clients and staff. These questions will assess satisfaction, comfort, and perceived usefulness of health coach interactions. Response options will be rated on a Likert scale ranging from 1 - 5, with higher scores indicating better perceptions of acceptability. Qualitative feedback will supplement these ratings to capture overall acceptability.
Appropriateness of the Health Coach Model
Time frame: 18 Months
Appropriateness will be assessed using custom questions developed by our team and modified question items from the Scales for Participant Alliance with Recovery Coach (SPARC) scale. These questions assess perceived relevance, fit, and value of integrating a health coach into Unlocking Doors' services, as well as how well the model aligns with client needs. Response options will be rated on a Likert scale ranging from 1 - 5, with higher scores indicating better perceptions of appropriateness. Qualitative feedback will supplement these ratings to capture overall appropriateness.
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 15 Jan 2026.
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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.
Ank E Nijhawan, MD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Disease and HIV Prevention, 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 7 inclusion and 6 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 15 Jan 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 Laura A Hansen, MA (7133057882, Laura.Hansen@UTSouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Integrating a PrEP-Focused Health Coach (time frame: 18 Months). The study lists 3 primary outcomes in all. 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 15 Jan 2026.