Recruiting

Patient Navigation & Patient Choice

Sponsor:

Yale University

Code:

NCT07223398

Conditions

Substance Use Disorders

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Standard PN

Patient Choice

Study Details

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.

Conditions

Substance Use Disorders

Study ID

NCT07223398

Start date

Nov 24, 2025

Status verified date

Jun, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 12 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 have a PrEP indication in past 12 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 12 months within the community.

Exclusion Criteria:

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

Study Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Standard PN

Standard of care

Patient Choice

Participants can select from a menu of options including brick and mortar services, Mobile Health Unit (MHU) or telehealth services.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Sandra Springer, MD

203-687-6680Sandra.springer@yale.edu

Alysse Schultheis, MA

203-231-2454alysse.schultheis@yale.edu

Locations

Yale School of Medicine

Recruiting

New Haven, Connecticut, United States, 06510

Principal Investigator:

Sandy Springer, MD

College of Medicine at the University of Kentucky

Recruiting

Lexington, Kentucky, United States, 40506

Principal Investigator:

Michele Staton, PhD, MSW

University of Texas Southwestern Medical Center (UTSW)

Recruiting

Dallas, Texas, United States, 75390

Principal Investigator:

Ank Nijhawan, MD, MPH

Texas Christian University's (TCU) School of Medicine

Recruiting

Fort Worth, Texas, United States, 76109

Principal Investigator:

Kevin Knight,, PhD

More Information

Sponsor

Yale University

Last update posted

Jun 25, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Yale University on 2026-06-25.