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NCT Number: NCT07223398

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

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.

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Key information

Conditions

Substance Use Disorders Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale School of Medicine, New Haven, Connecticut, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Standard PN

Behavioral

Standard of care

Patient Choice

Behavioral

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

Primary outcomes

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

    Time frame: 6 months

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

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

    Time frame: 6 months

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

Secondary outcomes

  1. Percentage of participants that adhere to PrEP

    Time frame: 6 and 12 months

    Percentage of participants that adhere to PrEP

  2. Percentage of participants retaining on PrEP

    Time frame: 6 and 12 months

    Percentage of participants retaining on PrEP

  3. HIV incidence

    Time frame: 6 and 12 months

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

  4. Percentage of participants that adhere to ART

    Time frame: 6 and 12 months

    Percentage of participants that adhere to ART

  5. ART retention

    Time frame: 6 and 12 months

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

  6. Substance use treatment

    Time frame: 6 and 12 months

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

  7. HIV viral suppression

    Time frame: 6 months

    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

  8. Retention in HIV PrEP/ART

    Time frame: 6 months

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

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

    Time frame: 6 and 12 months

    Number of Participants Who Had Any Needle Sharing Activity

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

    Time frame: 6 and 12 months

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

  11. Days of using opioids

    Time frame: 6 and 12 months

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

  12. Number of participants with with overdose events

    Time frame: 6 and 12 months

    Number of participants with non-fatal and fatal overdose events

  13. Percentage of participants with retention in SUD treatment

    Time frame: 6 and 12 months

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

  14. Quality of Life assessed using PROMIS-PROPr

    Time frame: 6 and 12 months

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

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

    Time frame: 6 and 12 months

    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.

  16. Recidivism: Reasons

    Time frame: 6 and 12 months

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

  17. Recidivism: Mean days in custody/incarcerated

    Time frame: 6 and 12 months

    Mean days in custody/incarcerated

  18. Recidivism: Mean days to return

    Time frame: 6 and 12 months

    Mean days to return to custody/incarcerated

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

    Time frame: 6 and 12 months

    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

  20. Percentage of participants diagnosed with SUD

    Time frame: Baseline and 12 months

    Percentage of participants diagnosed with SUD using DSM-5

Study contacts

Contact information is provided by the study sponsor or research team.

Alysse Schultheis, MA

CONTACT

[email protected]

203-231-2454

Sandra Springer, MD

CONTACT

[email protected]

203-687-6680

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Oct 31, 2025
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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