Shared Decision Making for Substance Use Disorders

Overseen By Cynthia Frank, PhD, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Disqualifiers: Severe disability, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

30 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Sandra Springer, MD

Principal Investigator

Yale University

Eligibility Criteria

This trial is for individuals with substance use disorders who are involved in the justice system. It aims to help them start treatment for HIV prevention (PrEP/ART) and manage their substance use or disorder.

Inclusion Criteria

Have a current DSM-5 SUD (opioid and/or stimulant)

Able to provide written informed consent in English or Spanish

Willing to have HIV testing to determine negative or positive status

Exclusion Criteria

Severe medical or psychiatric disability making participation unsafe

I am unable to give my consent.

Persons self-reporting pregnancy

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pilot Study

Development and pilot testing of the patient choice menu of options for PrEP/ART and SUD treatment services

12 months

3 focus group visits

Follow-up

Participants are monitored for access to and receipt of PrEP/ART services, and engagement in SUD treatment

3 months

Treatment Details

Interventions

• Patient Choice
• Standard PN

Trial Overview The study compares two types of support: Standard Patient Navigation (PN), which guides patients through treatment, versus Patient Choice (PC), where patients pick from a menu of community health services.

Participant Groups

Group I: PN + Patient Choice (PC) (PN+PC) Experimental Treatment 2 Interventions

PNs working in the PN + PC arm will be trained to engage participants in selecting from the menu of options developed in the pilot. This menu of SUD and HIV prevention and treatment service delivery options will be created through bolstering and working with our CAB.

Group II: Standard Patient Navigation (PN) Active Control 1 Intervention

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 appointment scheduling to brick and mortar services only, and not to MHU or telehealth services.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+