NCT07541417

Brief Summary

This study will provide longitudinal data for 6-months on a target sample of patients with Opioid Use Disorder (OUD) recruited from Prisma Health Mobile Health Clinics in South Carolina. The goal of our study is to increase OUD treatment initiation and retention and maximize prevention of overdose deaths in underserved communities through development, testing, and delivery of a novel intervention targeting areas of optimal allocation of MHC with a Peer Support Specialist (PSS) intervention.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
750

participants targeted

Target at P75+ for not_applicable

Timeline
40mo left

Started Apr 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress2%
Apr 2026Aug 2029

First Submitted

Initial submission to the registry

April 8, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

April 8, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 21, 2026

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2029

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2029

Last Updated

April 28, 2026

Status Verified

April 1, 2026

Enrollment Period

2.9 years

First QC Date

April 8, 2026

Last Update Submit

April 23, 2026

Conditions

Opioid Use Disorder

Outcome Measures

Primary Outcomes (2)

  • Medications for Opioid Use Disorder (MOUD) Initiation

    MOUD initiation defined as receipt of first MOUD prescription within 3 months since baseline assessment.

    3 months

  • Medications for Opioid Use Disorder (MOUD) Retention

    MOUD retention at 6 months defined as receipt of 80% of MOUD prescriptions in first 6 months since baseline assessment.

    6 months

Secondary Outcomes (13)

  • Adherence to Buprenorphine

    Weekly; 24 weeks

  • Barriers to Healthcare

    90 days

  • Frequency of Opioid Use

    Monthly; 24 weeks

  • Overdose

    Weekly; 24 weeks

  • Hospitalizations/Emergency Department Visits

    Weekly; 24 weeks

  • +8 more secondary outcomes

Study Arms (2)

Standard of Care

NO INTERVENTION

The control condition involves the standard mobile recovery program (MRP) protocol. The MRP MOUD-specific capabilities are providing screening and assessments; induction monitoring; maintenance buprenorphine treatment; and follow-up care. The MRP is a facilitator of MOUD induction through partnerships with 340B pharmacies. Participants in both the standard of care condition and CPSS condition will receive MRP services for OUD screening, treatment, and overdose prevention, including enrollment in MOUD treatment and provision of take-home naloxone, fentanyl and/or xylazine test strips as needed.

Certified Peer Intervention Specialist

EXPERIMENTAL

The intervention includes standard of care described above and also involves a participant meeting with a certified peer support specialist (CPSS) throughout MOUD initiation and early maintenance phases (up to 24 weeks post-initiation). CPSS encounters may be in-person or virtual. CPSS will track their services provided throughout the study period utilizing the newly developed checklist, incorporated into REDCap.

Behavioral: Certified Peer Support Specialist Intervention

Interventions

Certified Peer Support Specialist InterventionBEHAVIORAL

Participants are recruited from mobile health clinics (MHC) delivered to communities using a predictive modeling framework to target areas for optimal MHC allocation to maximize prevention of overdose deaths. Patients randomized to the intervention arm are linked to a peer support specialist. Peer support specialists are Certified Peer Support Specialists (CPSS) who have lived experience with Opioid Use Disorder (OUD) and OUD recovery. Peer support specialists offer consistent personalized recovery support and generalized social support based on a peer support checklist. Peer support specialists will maintain contact and provide support for the participant for 6 months post-baseline, following a peer support manual.

Certified Peer Intervention Specialist

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18+
  • Have diagnosis of OUD
  • New mobile health MOUD patient

You may not qualify if:

  • Unable to read and comprehend the consent materials and other study materials
  • Currently working with a Certified Peer Support Specialist
  • Having severe medical or psychiatric disability that would hinder participation in the study, as determined by the clinical provider

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prisma Health Upstate

Greenville, South Carolina, 29605, United States

RECRUITING

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Central Study Contacts

Ashley King, MSW

CONTACT

7049369402ashley.king3@prismahealth.org

Marisol Miranda

CONTACT

marisol.miranda@prismahealth.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2026

First Posted

April 21, 2026

Study Start

April 8, 2026

Primary Completion (Estimated)

February 28, 2029

Study Completion (Estimated)

August 31, 2029

Last Updated

April 28, 2026

Record last verified: 2026-04

Locations

US(1)