Shared Decision Making to Treat Or Prevent (STOP) HIV in Justice Populations (R33)

STOP (Shared Decision Making to Treat Or Prevent) HIV in Justice 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.

Study Overview

• Status: Recruiting
• Conditions: Substance Use Disorders
• Intervention / Treatment: Behavioral: Standard PN; Behavioral: Patient Choice

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.

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sandra Springer, MD; Phone Number: 203-687-6680; Email: Sandra.springer@yale.edu
• Study Contact Backup: Name: Alysse Schultheis, MA; Phone Number: 203-231-2454; Email: alysse.schultheis@yale.edu

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Recruiting
      • Yale School of Medicine
      • Principal Investigator: Sandy Springer, MD
  • Kentucky
    • Lexington, Kentucky, United States, 40506
      • Recruiting
      • College of Medicine at the University of Kentucky
      • Principal Investigator: Michele Staton, PhD, MSW
  • Texas
    • Dallas, Texas, United States, 75390
      • Recruiting
      • University of Texas Southwestern Medical Center (UTSW)
      • Principal Investigator: Ank Nijhawan, MD, MPH
    • Fort Worth, Texas, United States, 76109
      • Recruiting
      • Texas Christian University's (TCU) School of Medicine
      • Principal Investigator: Kevin Knight,, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 6 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 meet CDC PrEP eligibility criteria in past 6 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 6 months within the community.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Patient Navigation (PN); PNs 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.	Behavioral: Standard PN; Standard of care
Experimental: PN + Patient Choice (PC) (PN+PC); PNs 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.	Behavioral: Standard PN; Standard of care; Behavioral: Patient Choice; Participants can select from a menu of options including brick and mortar services, Mobile Health Unit (MHU) or telehealth services.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 months
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	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 months
Percentage of participants that adhere to PrEP	Percentage of participants that adhere to PrEP	6 and 12 months
Percentage of participants retaining on PrEP	Percentage of participants retaining on PrEP	6 and 12 months
HIV incidence	HIV incidence [binary] for those testing negative using rapid point of care (POC) test over time	6 and 12 months
Percentage of participants that adhere to ART	Percentage of participants that adhere to ART	6 and 12 months
ART retention	For persons living with HIV (PLH), ART retention [binary]	6 and 12 months
Substance use treatment	Percentage of participants engaged in substance use disorder (SUD) treatment	6 and 12 months
Retention in HIV PrEP/ART	Retention in HIV PrEP/ART care [binary]: defined as attending 2 or more visits in 6-months	6 months
Number of Participants Who Had Any Needle Sharing Activity to Assess HIV Risk Behavior	Number of Participants Who Had Any Needle Sharing Activity	6 and 12 months
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	6 and 12 months
Days of using opioids	Measured by Timeline Followback, which assesses self-reported alcohol and other drug use including opioid use	6 and 12 months
Number of participants with with overdose events	Number of participants with non-fatal and fatal overdose events	6 and 12 months
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)	6 and 12 months
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.	6 and 12 months
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.	6 and 12 months
Recidivism: Reasons	Number of participants per reason for arrest/ incarceration/return-to-custody	6 and 12 months
Recidivism: Mean days in custody/incarcerated	Mean days in custody/incarcerated	6 and 12 months
Recidivism: Mean days to return	Mean days to return to custody/incarcerated	6 and 12 months
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	6 and 12 months
Percentage of participants diagnosed with SUD	Percentage of participants diagnosed with SUD using DSM-5	Baseline and 12 months

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Sandra Springer, MD, Yale University

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: October 30, 2025
• First Submitted That Met QC Criteria: October 30, 2025
• First Posted (Actual): October 31, 2025

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 24, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Health Services Administration; Delivery of Health Care; Health Care Economics and Organizations; Patient Care Management; Social Control, Formal; Financing, Organized; Economics; Insurance, Health; Insurance; Managed Care Programs; Legislation as Topic; Patient Freedom of Choice Laws
• Other Study ID Numbers: 2000037052_a; 4R33DA060625-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No