NCT06384781

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2024

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 25, 2024

Completed
7 days until next milestone

Study Start

First participant enrolled

May 2, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

October 23, 2025

Status Verified

October 1, 2025

Enrollment Period

1.2 years

First QC Date

April 22, 2024

Last Update Submit

October 21, 2025

Conditions

Keywords

peer support specialistpeer recovery coachOUDopioid use disordermobile health clinicrural

Outcome Measures

Primary Outcomes (2)

  • Medication for Opioid Use Disorder (MOUD) Initiation

    MOUD initiation is defined as receipt of first MOUD prescription within the 3-month study period

    3 months

  • MOUD Retention

    MOUD retention is defined as receipt of 75% of weekly MOUD prescriptions in first 3 months since MOUD initiation

    3 months

Study Arms (1)

Peer Support Specialist Intervention

EXPERIMENTAL

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

Interventions

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.

Peer Support Specialist Intervention

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 patient of the mobile clinic

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Prisma Addiction Medicine Center - Mobile Health Clinic

Clinton, South Carolina, 29325, United States

Location

Prisma - Addiction Medicine Center Mobile Health Clinic

Seneca, South Carolina, 29672, United States

Location

Related Links

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2024

First Posted

April 25, 2024

Study Start

May 2, 2024

Primary Completion

July 31, 2025

Study Completion

July 31, 2025

Last Updated

October 23, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations