STAMPS: South Carolina Buprenorphine Treatment Initiation, Adherence, and Retention Utilizing Mobile Health Units and Peer Support Specialists

October 21, 2025 updated by: Prisma Health-Upstate

Development, Refinement, and Validation of a Peer Support Specialist Checklist for Individuals With Opioid Use Disorder / STAMPS: South Carolina Buprenorphine Treatment Initiation, Adherence, and Retention Utilizing Mobile Health Units and Peer Support Specialists

The study is a 1-arm prospective interventional cohort quasi-experimental with retrospective control group. Enrolled participants will be compared to previously established mobile health patients, who did not work with a peer recovery coach, for buprenorphine treatment and adherence outcomes. 90 patients will be recruited from the mobile health units in rural counties in Upstate South Carolina. Visits consist of a baseline and 3 month follow up.

The study will focus to develop, deliver, and evaluate an innovative 1) Peer Support Specialist (PSS) intervention to increase Medications for Opioid Use Disorder (MOUD) initiation and retention rates in rural populations and underserved communities, and 2) dynamic modeling framework to prioritize at-risk communities for delivery of Mobile Health Clinics. the interventions will be developed in the R61 phase and implemented in a pilot study to determine the effectiveness on initiation and retention. With opioid overdose deaths continuing to rise in South Carolina (SC) and nationally, our sustainable framework has potential to prevent hundreds to thousands of opioid overdoses in SC and can be scaled up in other regions to save many more lives.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Over 100,000 lives were lost due to drug overdose in the past year, of which 80% involved opioids.The majority of opioid-related deaths were due to fentanyl, an illicit opioid that has been labeled the single deadliest drug threat ever encountered in the United States.With opioid overdose deaths doubling in the past two years, there are no current signs that the epidemic is slowing down. Despite the effectiveness of medications for opioid use disorder (MOUD) at reducing opioid use, only 10% of those in need receive treatment. Furthermore, treatment retention is low (30-50%). Low treatment initiation and retention rates for Opioid Use Disorder (OUD) are especially concerning for rural and underserved communities, who rarely have access to clinicians prescribing MOUD and experience substantial barriers to care, including lack of insurance, social isolation, homelessness, transportation issues, and stigma. Given these populations are also at an elevated risk of overdose due to many of these same factors,interventions to increase MOUD initiation, retention, and overdose prevention in rural and underserved communities are urgently needed.

Our proposal aims to improve medication for opioid use disorder (MOUD) treatment rates and prevent overdose deaths in underserved communities using mobile health clinics (MHC). This will be achieved by developing, testing, delivering, and evaluating two key components: 1) a Peer Support Specialist (PSS) intervention to enhance MOUD initiation and retention, and 2) a modeling framework to identify high-risk communities for MHC delivery of opioid use disorder (OUD) interventions, based on the prevention of overdose deaths in those areas. Previous research has shown that such modeling tools can significantly enhance the efficiency of resource allocation across different health issues.

In the initial R61 phase, we will develop the PSS intervention and modeling framework.

The primary goal of aim 1 in the R61 phase is to assess the early fidelity, acceptability, and effectiveness of the PSS Service Delivery in boosting MOUD initiation and retention in rural and underserved populations. This intervention will draw from the successful assertive community engagement (ACE) model PSS interventions for substance use disorders and will be crafted based on qualitative interviews with PSS and OUD patients, as well as pilot data.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Clinton, South Carolina, United States, 29325
        • Prisma Addiction Medicine Center - Mobile Health Clinic
      • Seneca, South Carolina, United States, 29672
        • Prisma - Addiction Medicine Center Mobile Health Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Study Population

Participants diagnosed with opioid use disorder

Description

Inclusion Criteria:

  • Age 18+
  • Have diagnosis of OUD
  • New patient of the mobile clinic

Exclusion Criteria:

  • Currently prescribed MOUD
  • Currently working with a PSS
  • Current suicidal ideation, as verified through the Patient Health Questionnaire-9 (PHQ-9)
  • Having a severe medical or psychiatric disability that would hinder participation in the study, as determined by nurse practitioner
  • Unable to read/speak English
  • Unable to read and comprehend the consent materials and other study materials

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Peer Support Specialist Intervention
Eligible participants will be 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. Peer support specialists will maintain contact and provide support for the participant for 3 months post-baseline utilizing the newly validated checklist.
Behavioral: Peer Support Checklist
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. Peer support specialists will maintain contact and provide support for the participant for six-months post-baseline. CPSS will utilize the newly developed checklist from earlier phases of the project to provide patient support.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medication for Opioid Use Disorder (MOUD) Initiation
Time Frame: 3 months
MOUD initiation is defined as receipt of first MOUD prescription within the 3-month study period
3 months
MOUD Retention
Time Frame: 3 months
MOUD retention is defined as receipt of 75% of weekly MOUD prescriptions in first 3 months since MOUD initiation
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prisma Health-Upstate

Collaborators

National Institute on Drug Abuse (NIDA)
Clemson University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2024

Primary Completion (Actual)

July 31, 2025

Study Completion (Actual)

July 31, 2025

Study Registration Dates

First Submitted

April 22, 2024

First Submitted That Met QC Criteria

April 22, 2024

First Posted (Actual)

April 25, 2024

Study Record Updates

Last Update Posted (Estimated)

October 23, 2025

Last Update Submitted That Met QC Criteria

October 21, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2130836
  • R61DA059892-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Study data will be shared as described in the Data Management and Sharing Plan.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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