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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Connecticut
Yale School of Medicine
RECRUITING
New Haven
Kentucky
College of Medicine at the University of Kentucky
RECRUITING
Lexington
Texas
University of Texas Southwestern Medical Center (UTSW)
NOT_YET_RECRUITING
Dallas
Texas Christian University's (TCU) School of Medicine
RECRUITING
Fort Worth
Contact Information
Primary
Sandra Springer, MD
Sandra.springer@yale.edu
203-687-6680
Backup
Cynthia Frank, PhD, RN
Cyndi.frank@yale.edu
203-745-8630
Time Frame
Start Date: 2025-11-24
Estimated Completion Date: 2028-06
Participants
Target number of participants: 400
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute on Drug Abuse (NIDA)
Leads: Yale University

This content was sourced from clinicaltrials.gov