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
2 other identifiers
interventional
400
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2025
Typical duration for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 30, 2025
CompletedFirst Posted
Study publicly available on registry
October 31, 2025
CompletedStudy Start
First participant enrolled
November 24, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2028
February 4, 2026
February 1, 2026
2 years
October 30, 2025
February 2, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (20)
Percentage of participants that adhere to PrEP
6 and 12 months
Percentage of participants retaining on PrEP
6 and 12 months
HIV incidence
6 and 12 months
Percentage of participants that adhere to ART
6 and 12 months
ART retention
6 and 12 months
- +15 more secondary outcomes
Study Arms (2)
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.
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.
Interventions
Standard of care
Participants can select from a menu of options including brick and mortar services, Mobile Health Unit (MHU) or telehealth services.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- severe medical or psychiatric disability making participation unsafe;
- unable to provide consent.
- persons self-reporting pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
- National Institute on Drug Abuse (NIDA)collaborator
Study Sites (4)
Yale School of Medicine
New Haven, Connecticut, 06510, United States
College of Medicine at the University of Kentucky
Lexington, Kentucky, 40506, United States
University of Texas Southwestern Medical Center (UTSW)
Dallas, Texas, 75390, United States
Texas Christian University's (TCU) School of Medicine
Fort Worth, Texas, 76109, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sandra Springer, MD
Yale University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 30, 2025
First Posted
October 31, 2025
Study Start
November 24, 2025
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
June 1, 2028
Last Updated
February 4, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share