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Substance Use DisordersNCT07223398

Shared Decision Making to Treat Or Prevent (STOP) HIV in Criminal Legal Involved Populations (R33)

A study testing Standard PN and Patient Choice in people with Substance Use Disorders, run by Yale University at 4 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study seeks to compare the effectiveness of two Patient Navigation models of care to evaluate the proportion who initiate PrEP/ART and substance use/substance use disorder (SU/SUD) treatment. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Substance Use Disorders
What is being tested?
Standard PN and Patient Choice
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
4 sitesUnited States
Study dates
24 Nov 2025to 1 Jun 2028
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • able to provide written informed consent in English or Spanish;
  • living in the community of Western, CT, Dallas and Tarrant Counties in TX and Madison County, KY (potential for Fayette county as well);
  • Those with current justice involvement (with in the past 12 months) (e.g., prison, jail, community supervision);
  • willing to have HIV testing to determine negative or positive status;
  • persons with HIV who report not currently taking ART in past 6 months OR persons who test negative for HIV who report not taking PrEP that have a PrEP indication in past 12 months, including (i) condomless sexual intercourse; and/or (ii) sharing IDU equipment with HIV positive or unknown status partner; and/or (iii) bacterial STI and;
  • Having a history of opioid and/or stimulant use in the last 12 months within the community.

Who cannot join

  • severe medical or psychiatric disability making participation unsafe;
  • unable to provide consent.
  • persons self-reporting pregnancy

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Sandra Springer, MD contact

203-231-2454

Sandra.springer@yale.edu

Alysse Schultheis, MA contact

203-231-2454

alysse.schultheis@yale.edu

United States4 sites, 4 recruiting

  • University of Texas Southwestern Medical Center (UTSW)

    Dallas, Texas, 75390

    Ank Nijhawan, MD, MPH

    Recruiting

  • Texas Christian University's (TCU) School of Medicine

    Fort Worth, Texas, 76109

    Kevin Knight,, PhD

    Recruiting

  • College of Medicine at the University of Kentucky

    Lexington, Kentucky, 40506

    Michele Staton, PhD, MSW

    Recruiting

  • Yale School of Medicine

    New Haven, Connecticut, 06510

    Sandy Springer, MD

    Recruiting

Other trials in United States

About this study

Official title: STOP (Shared Decision Making to Treat Or Prevent) HIV in Criminal Legal Involved Populations

This study seeks to compare the effectiveness of two Patient Navigation models of care to evaluate the proportion who initiate PrEP/ART and substance use/substance use disorder (SU/SUD) treatment. A standardized Patient Navigation (PN) arm will be compared with a shared decision-making model in the form of Patient Choice (PC) through the offer of a menu of existing community-based health service delivery options. This design will offer providers, correctional and public health authorities, payers and policy makers' timely and relevant data to assess the effectiveness of Patient Navigation and Patient Choice models of care as potentially useful re-entry and relapse prevention treatment options.

Read the detailed description

This study will be done in two phases. Aim 1, the R61 portion of the project will be a Pilot Study, and Aim 2, the R33 portion of the project will be a Randomized Controlled Trail informed by the pilot.

The focus of this registration is Aim 2, the randomized controlled trial. The Aim 1 (R61) portion is registered with NCT06439329. In Aim 2 (R33), investigators will evaluate standard PN compared to PN+PC on participant outcomes, implementation outcomes and costs associated with implementing the study.

Being tested
Standard PN, Patient Choice
Medical subject headings
Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard PNBehavioural

    Standard of care

  • Patient ChoiceBehavioural

    Participants can select from a menu of options including brick and mortar services, Mobile Health Unit (MHU) or telehealth services.

Study groups in NCT07223398
Study groupRoleWhat they receive
Standard Patient Navigation (PN)Active comparatorPNs are "near-peer" professionals who have shared lived experiences with participants and help them overcome barriers to accessing and engaging in quality care. PNs are trained and linked to PrEP/ART and SUD services. This manualized PN approach provides a complete assessment of participant needs, goal setting, and help with appointment scheduling.
Receives: Behavioral: Standard PN
PN + Patient Choice (PC) (PN+PC)ExperimentalPNs working in the PN + PC arm will be trained to engage participants in selecting from a menu of service options in their community. This menu of SUD and HIV prevention and treatment service delivery options will be created through bolstering and working with our Community Advisory Boards (CAB). PNs will also be trained to discuss sexual and substance use history with participants in order to provide education and motivation towards starting PrEP/ART and SUD treatment.
Receives: Behavioral: Standard PN; Behavioral: Patient Choice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of participants who initiate or re-initiate PrEP

    Percentage of participants not living with HIV who initiate or re-initiate PrEP within the 6-month intervention period by self report

    Measured: 6 months

  2. Percentage of participants who initiate or re-initiate ART

    Percentage of participants living with HIV who initiate or re-initiate ART within the 6-month intervention period by self report

    Measured: 6 months

Secondary outcomes (20)

  1. Percentage of participants that adhere to PrEP

    Percentage of participants that adhere to PrEP

    Measured: 6 and 12 months

  2. Percentage of participants retaining on PrEP

    Percentage of participants retaining on PrEP

    Measured: 6 and 12 months

  3. HIV incidence

    HIV incidence [binary] for those testing negative using rapid point of care (POC) test over time

    Measured: 6 and 12 months

  4. Percentage of participants that adhere to ART

    Percentage of participants that adhere to ART

    Measured: 6 and 12 months

  5. ART retention

    For persons living with HIV (PLH), ART retention [binary]

    Measured: 6 and 12 months

  6. Substance use treatment

    Percentage of participants engaged in substance use disorder (SUD) treatment

    Measured: 6 and 12 months

  7. HIV viral suppression

    For PLH, HIV viral suppression, for those with HIV at time of randomization: the percent who maintain or achieve HIV viral load < 200 copies/mL at 6 months

    Measured: 6 months

  8. Retention in HIV PrEP/ART

    Retention in HIV PrEP/ART care [binary]: defined as attending 2 or more visits in 6-months

    Measured: 6 months

  9. Number of Participants Who Had Any Needle Sharing Activity to Assess HIV Risk Behavior

    Number of Participants Who Had Any Needle Sharing Activity

    Measured: 6 and 12 months

  10. Number of Participants Who Had Sex Without a Condom to assess HIV Risk Behavior

    Number of Participants Who Had Vaginal or Anal Sex Without a Condom

    Measured: 6 and 12 months

  11. Days of using opioids

    Measured by Timeline Followback, which assesses self-reported alcohol and other drug use including opioid use

    Measured: 6 and 12 months

  12. Number of participants with with overdose events

    Number of participants with non-fatal and fatal overdose events

    Measured: 6 and 12 months

  13. Percentage of participants with retention in SUD treatment

    Retention in SUD treatment including but not exclusive to Medication for Opioid Use Disorder (MOUD) for Opioid Use Disorder (OUD)

    Measured: 6 and 12 months

  14. Quality of Life assessed using PROMIS-PROPr

    PROMIS-PROPr assesses general societal health. Total summary score ranges from -0.022, worse than dead, to 1, perfect health.

    Measured: 6 and 12 months

  15. Change in Depression assessed using Patient Health Questionnaire-9 (PHQ-9)

    Depression will be assessed using the PHQ-9. PHQ-9 is a 9-item validated questionnaire used to screen for depression with a range of scores from 0-45. A cumulative score of ≥10 is considered positive with lower scores indicating no or mild anxiety.

    Measured: 6 and 12 months

  16. Recidivism: Reasons

    Number of participants per reason for arrest/ incarceration/return-to-custody

    Measured: 6 and 12 months

  17. Recidivism: Mean days in custody/incarcerated

    Mean days in custody/incarcerated

    Measured: 6 and 12 months

  18. Recidivism: Mean days to return

    Mean days to return to custody/incarcerated

    Measured: 6 and 12 months

  19. HIV and SU Stigma assessed using Substance Use Stigma Mechanisms Scale (SU-SMS)

    Mean score for Enacted (6 items), Anticipated (6 items), and Internalized (6 items) scales. Each scale is scored 1-5, with higher scores indicating greater endorsement of substance use stigma

    Measured: 6 and 12 months

  20. Percentage of participants diagnosed with SUD

    Percentage of participants diagnosed with SUD using DSM-5

    Measured: Baseline and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Oct 2025
  2. Study start24 Nov 2025
  3. Primary completion30 Dec 2027 (estimated)
  4. Study completion1 Jun 2028 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07223398
Sponsor's protocol ID
2000037052_a
Other IDs
4R33DA060625-02
Status last verified
Oct 2026
First submitted
30 Oct 2025
Last updated
20 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Standard PN and Patient Choice in people with Substance Use Disorders, run by Yale University at 4 sites 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 6 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 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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 Sandra Springer, MD (203-231-2454, Sandra.springer@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of participants who initiate or re-initiate PrEP (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07223398.

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 20 Oct 2026.

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