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Project STAMINA (Syringe Service Telemedicine Access for Medication-assisted Intervention Through NAvigation)

NCT04575324 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 275

Last updated 2024-07-09

Study results available
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Summary

Project STAMINA is a clinical trial that seeks to establish effectiveness of a telemedicine approach for linking syringe exchange clients to medications for opioid use disorder. This pilot study aims to recruit n=275 people and utilizes two study arms: (1) a treatment arm consisting of immediate telemedicine linkage and (2) a control arm consisting of standard referral to treatment. Half of the study participants will be randomly enrolled in each arm. The study will utilize qualitative and quantitative data, including questionnaire data, drug test results, and administrative treatment data, at multiple time points to determine what effect telemedicine linkage has on clients in relation to the comparison group.

Conditions

  • Opioid-use Disorder

Interventions

BEHAVIORAL

Telemedicine Linkage Intervention

Participants will be immediately linked to telemedicine care provided by an FQHC provider waivered to prescribe buprenorphine and naltrexone or able to refer patients to methadone treatment. Participants will have their vitals checked and be virtually connected to the provider. The research assistant will share the vitals with the provider, and the provider will provide personalized care during which they discuss treatment options with the participant. If a medication for opioid use disorder is prescribed or if a methadone referral is made, transportation assistance will be provided to the participant as part of the intervention. Transportation to pick up the prescription or complete the first appointment will be provided via a HIPAA compliant ride-share company, and a bus pass will be provided to the participant for the return trip.

Sponsors & Collaborators

  • University of Illinois at Chicago

    collaborator OTHER

  • Chestnut Health Systems

    lead OTHER

Principal Investigators

  • Dennis P Watson, PhD · Chestnut Health Systems

  • James A Swartz, PhD · University of Illinois at Chicago

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-08-24
Primary Completion
2022-12-30
Completion
2022-12-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04575324 on ClinicalTrials.gov