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

Not Applicable

Not yet recruiting

• Conditions: Substance Use Disorders

• Registration Number: NCT07223398
• Lead Sponsor: Yale University

Brief 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. 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.

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 Timeline

• Status Verified: 2025-10
• Study First Submitted: 2025-10-30
• Study First Submitted QC: 2025-10-30
• Last Update Submitted: 2025-10-30
• Study First Posted: 2025-10-31
• Last Update Posted: 2025-10-31
• Study Start: 2025-11-01
• Primary Completion: 2027-12
• Study Completion: 2028-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 400

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Percentage of participants that adhere to PrEP	6 and 12 months	Percentage of participants that adhere to PrEP
Percentage of participants retaining on PrEP	6 and 12 months	Percentage of participants retaining on PrEP
HIV incidence	6 and 12 months	HIV incidence \[binary\] for those testing negative using rapid point of care (POC) test over time
Percentage of participants that adhere to ART	6 and 12 months	Percentage of participants that adhere to ART
ART retention	6 and 12 months	For persons living with HIV (PLH), ART retention \[binary\]
Substance use treatment	6 and 12 months	Percentage of participants engaged in substance use disorder (SUD) treatment
HIV viral suppression	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
Retention in HIV PrEP/ART	6 months	Retention in HIV PrEP/ART care \[binary\]: defined as attending 2 or more visits in 6-months
Number of Participants Who Had Any Needle Sharing Activity to Assess HIV Risk Behavior	6 and 12 months	Number of Participants Who Had Any Needle Sharing Activity
Number of Participants Who Had Sex Without a Condom to assess HIV Risk Behavior	6 and 12 months	Number of Participants Who Had Vaginal or Anal Sex Without a Condom
Days of using opioids	6 and 12 months	Measured by Timeline Followback, which assesses self-reported alcohol and other drug use including opioid use
Number of participants with with overdose events	6 and 12 months	Number of participants with non-fatal and fatal overdose events
Percentage of participants with retention in SUD treatment	6 and 12 months	Retention in SUD treatment including but not exclusive to Medication for Opioid Use Disorder (MOUD) for Opioid Use Disorder (OUD)
Quality of Life assessed using PROMIS-PROPr	6 and 12 months	PROMIS-PROPr assesses general societal health. Total summary score ranges from -0.022, worse than dead, to 1, perfect health.
Change in Depression assessed using Patient Health Questionnaire-9 (PHQ-9)	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.
Recidivism: Reasons	6 and 12 months	Number of participants per reason for arrest/ incarceration/return-to-custody
Recidivism: Mean days in custody/incarcerated	6 and 12 months	Mean days in custody/incarcerated
Recidivism: Mean days to return	6 and 12 months	Mean days to return to custody/incarcerated
HIV and SU Stigma assessed using Substance Use Stigma Mechanisms Scale (SU-SMS)	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
Percentage of participants diagnosed with SUD	Baseline and 12 months	Percentage of participants diagnosed with SUD using DSM-5

Trial Locations

Locations (4)

Yale School of Medicine; 🇺🇸 New Haven, Connecticut, United States

College of Medicine at the University of Kentucky; 🇺🇸 Lexington, Kentucky, United States

University of Texas Southwestern Medical Center (UTSW); 🇺🇸 Dallas, Texas, United States

Texas Christian University's (TCU) School of Medicine; 🇺🇸 Fort Worth, Texas, United States