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

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT07223398
Status
Recruiting
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Conditions

  • Substance Use Disorders

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Nov 24, 2025
Status verified
Apr 2026
Primary completion
Dec 31, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

Percentage of participants who initiate or re-initiate PrEP [ Time Frame: 6 months ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Yale School of MedicineNew HavenConnecticut06510
Sandy Springer, MD (PRINCIPAL_INVESTIGATOR)
College of Medicine at the University of KentuckyLexingtonKentucky40506
Michele Staton, PhD, MSW (PRINCIPAL_INVESTIGATOR)
University of Texas Southwestern Medical Center (UTSW)DallasTexas75390
Ank Nijhawan, MD, MPH (PRINCIPAL_INVESTIGATOR)
Texas Christian University's (TCU) School of MedicineFort WorthTexas76109
Kevin Knight,, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in New Haven, CT

By research site
Yale School of Medicine· New Haven, CTCollege of Medicine at the University of Kentucky· Lexington, KYUniversity of Texas Southwestern Medical Center (UTSW)· Dallas, TXTexas Christian University's (TCU) School of Medicine· Fort Worth, TX

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