Building Retention and Initiation Through Delivery of Peer-Guided Evidence-Based Practices (BRIDGE-SC)

Data-Driven Approaches for Opioid Use Disorder Treatment, Recovery, and Overdose Prevention in Rural Communities Via Mobile Health Clinics and Peer Support Services

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.

Study Overview

• Status: Recruiting
• Conditions: Opioid Use Disorder
• Intervention / Treatment: Behavioral: Certified Peer Support Specialist Intervention

Detailed Description

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. In this project phase, the study will conduct an RCT to examine the effectiveness of the PSS on medications for OUD (MOUD) initiation and retention among these at-risk populations; and extend and optimize the modeling framework to improve effectiveness and utility of the MHC-directed PSS intervention, including cost-effectiveness. The primary outcomes are MOUD initiation and retention.

The study aims to enroll 750 participants with moderate to severe OUD. Through a 1:1 ratio using a computer randomization algorithm, 375 participants will be enrolled in the MHC + PSS intervention condition, while 375 will receive the standard MHC protocol. The MHC + PSS intervention condition entails linkage, via potential participants' visiting of a MHC, of participants to PSS services. PSSs are individuals who have had a direct experience with and successful recovery from OUD. PSSs are trained to provide recovery support services according to the Assertive Community Engagement (ACE) model of recovery support. To consistently deliver the ACE model of recovery support, the PSSs use the PSS checklist, developed and validated by our team in the R61 phase. In the R33 phase (Aim 1), the MHC + PSS protocol will be delivered to communities identified by the modeling framework as optimal locations for MHC delivery. The control condition involves the standard MHC protocol. Through the opioid use surveillance metrics and modeling framework from R61 Aim 2, the MHC will be allocated to the communities that are determined to be at highest risk for OUD, opioid-related hospitalizations, and overdose. Participants in the standard of care condition will receive MHC services for OUD screening, treatment, and overdose prevention, including enrollment in MOUD treatment and provided with fentanyl test strips and take-home naloxone for overdose reversal, without the added PSS support. The R33 phase (Aim 2) will also develop a model to evaluate the population impact and cost-effectiveness of the PSS on preventing fatal overdose.

• Study Type: Interventional
• Enrollment (Estimated): 750
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ashley King, MSW; Phone Number: 7049369402; Email: ashley.king3@prismahealth.org
• Study Contact Backup: Name: Marisol Miranda; Email: marisol.miranda@prismahealth.org

Study Locations

• United States
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • Recruiting
      • Prisma Health Upstate
      • Contact: Alain Litwin, MD, MPH; Phone Number: (864) 430-0911; Email: alain.litwin@prismahealth.org
      • Contact: Ashley King, MSW; Phone Number: (704) 936-9402; Email: ashley.king3@prismahealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of Care; 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.
Experimental: Certified Peer Intervention Specialist; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to Buprenorphine	Medication Adherence Self-Report Inventory (MASRI)	Weekly; 24 weeks
Barriers to Healthcare	Social Determinations of Health (SDOH)	90 days
Frequency of Opioid Use	Addiction Severity Index (ASI-Lite) 0-1: No imminent problem, treatment not indicated. 2-3: Slight problem; treatment may not be necessary. 4-5: Moderate problem, a treatment plan should be considered. 6-7: Considerable difficulty, begin a treatment plan. 8-9: Extreme problem, treatment is vital.	Monthly; 24 weeks
Overdose	Questionnaire	Weekly; 24 weeks
Hospitalizations/Emergency Department Visits	Questionnaire	Weekly; 24 weeks
Engagement in other Recovery Support Services	Questionnaire	Weekly; 24 weeks
Naloxone/Narcan Administration	Questionnaire	Weekly; 24 weeks
Fentanyl Test Strip Use	Questionnaire	Weekly; 24 weeks
Recovery Capital	Brief Assessment of Recovery Capital (BARC-10) Total scores can range from a minimum of 10 to a maximum of 60m, with a higher score indicating higher recovery capital.	90 days
Social Support	Medical Outcome Study (MOS) n the original publication (Sherbourne and Stewart, 1991), scores were transformed to have a possible range of 0-100, with higher scores indicating more support. This transformation was the method used for all of the Medical Outcomes Study measures of functioning and well-being.	90 days
Depression symptoms	Patient Health Questionnaire (PHQ-9) Scores can range from 0-27. 0-4 indicates no-minimal depression; 5-9 indicates mild depression; 10-14 indicates moderate depression; 15-19 indicates moderately severe depression; and 20-27 indicates severe depression.	90 days
Anxiety symptoms	Generalized Anxiety Disorder (GAD-7) The GAD-7 is a 7-item self-report questionnaire used to screen for generalized anxiety disorder and assess severity over the past two weeks. Each item is scored from 0 (not at all) to 3 (nearly every day). Total scores range from 0 to 21, with higher scores indicating greater anxiety severity	90 days
Post-Traumatic Stress Disorder (PTSD) symptoms	PTSD Checklist (PCL-5) The PCL-5 is a 20-item self-report questionnaire assessing DSM-5 PTSD symptoms, with items rated from 0 ("Not at all") to 4 ("Extremely"). Total scores range from 0 to 80, with a score of 31-33 or higher typically indicating probable PTSD.	90 days

Collaborators and Investigators

• Sponsor: Prisma Health-Upstate
• Collaborators: Clemson University

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2026
• Primary Completion (Estimated): February 28, 2029
• Study Completion (Estimated): August 31, 2029

Study Registration Dates

• First Submitted: April 8, 2026
• First Submitted That Met QC Criteria: April 16, 2026
• First Posted (Actual): April 21, 2026

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Narcotic-Related Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Opioid-Related Disorders
• Other Study ID Numbers: 2399199

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No