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

Key facts

Where
Dallas, Fort Worth, Lexington, and New Haven, United StatesSee the 4 sites

Where in United States

  • University of Texas Southwestern Medical Center (UTSW)Dallas, United StatesTaking people
  • Texas Christian University's (TCU) School of MedicineFort Worth, United StatesTaking people
  • College of Medicine at the University of KentuckyLexington, United StatesTaking people
  • Yale School of MedicineNew Haven, United StatesTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
Yale University
Trial code
NCT07223398
Record updated
20 October 2026
Original description
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 full original descriptionShow less

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.

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

ClinicalTrials.gov NCT07223398