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NCT Number: NCT07541417

Building Retention and Initiation Through Delivery of Peer-Guided Evidence-Based Practices

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Certified Peer Support Specialist Intervention

Behavioral

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.

Primary outcomes

  1. Medications for Opioid Use Disorder (MOUD) Initiation

    Time frame: 3 months

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

  2. Medications for Opioid Use Disorder (MOUD) Retention

    Time frame: 6 months

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

Secondary outcomes

  1. Adherence to Buprenorphine

    Time frame: Weekly; 24 weeks

    Medication Adherence Self-Report Inventory (MASRI)

  2. Barriers to Healthcare

    Time frame: 90 days

    Social Determinations of Health (SDOH)

  3. Frequency of Opioid Use

    Time frame: Monthly; 24 weeks

    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.

  4. Overdose

    Time frame: Weekly; 24 weeks

    Questionnaire

  5. Hospitalizations/Emergency Department Visits

    Time frame: Weekly; 24 weeks

    Questionnaire

  6. Engagement in other Recovery Support Services

    Time frame: Weekly; 24 weeks

    Questionnaire

  7. Naloxone/Narcan Administration

    Time frame: Weekly; 24 weeks

    Questionnaire

  8. Fentanyl Test Strip Use

    Time frame: Weekly; 24 weeks

    Questionnaire

  9. Recovery Capital

    Time frame: 90 days

    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.

  10. Social Support

    Time frame: 90 days

    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.

  11. Depression symptoms

    Time frame: 90 days

    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.

  12. Anxiety symptoms

    Time frame: 90 days

    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

  13. Post-Traumatic Stress Disorder (PTSD) symptoms

    Time frame: 90 days

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ashley King, MSW

CONTACT

[email protected]

7049369402

Marisol Miranda

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Prisma Health-Upstate

Other

Collaborators

  • Clemson University

Registry information

Official study title

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

Acronym: BRIDGE-SC

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Apr 21, 2026
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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