An interventional study of Certified Peer Support Specialist Intervention in Opioid Use Disorder, sponsored by Prisma Health-Upstate. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-28.
Sponsored by Prisma Health-Upstate · Not applicable, Interventional, and Treatment
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.
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.
1,472 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.
This study's planned enrollment of 750 is above the median of 63 across 1,166 interventional studies indexed under Opioid-Related Disorders.
Browse Opioid-Related Disorders studies →Prisma Health-Upstate is the lead sponsor of 76 studies on the registry; 7 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 10 (83%) have results posted.
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Exclusion Criteria:
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.
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.
Medications for Opioid Use Disorder (MOUD) Initiation
MOUD initiation defined as receipt of first MOUD prescription within 3 months since baseline assessment.
Time frame: 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.
Time frame: 6 months
Adherence to Buprenorphine
Medication Adherence Self-Report Inventory (MASRI)
Time frame: Weekly; 24 weeks
Barriers to Healthcare
Social Determinations of Health (SDOH)
Time frame: 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.
Time frame: Monthly; 24 weeks
Overdose
Questionnaire
Time frame: Weekly; 24 weeks
Hospitalizations/Emergency Department Visits
Questionnaire
Time frame: Weekly; 24 weeks
Engagement in other Recovery Support Services
Questionnaire
Time frame: Weekly; 24 weeks
Naloxone/Narcan Administration
Questionnaire
Time frame: Weekly; 24 weeks
Fentanyl Test Strip Use
Questionnaire
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 90 days
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