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Completed

NCT Number: NCT05098795

FOREward Together: Training Peer Recovery Coaches to Promote Retention and Adherence to MOUD

This project aims to implement a peer-led intervention to support retention and adherence to medications for opioid use disorder among low-income adults in Detroit, as well as a training manual for peer recovery coaches serving similar populations. The approach will serve as a guide to coaches in providing positive reinforcement and helping those in treatment to schedule and engage in valued activities. Researchers will examine the effectiveness of the intervention, supervision and training models, and share results with policymakers and treatment programs.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Detroit Recovery Project

Detroit, Michigan, 48203, United States

About this study

Low-income and racial/ethnic minorities suffer disproportionately from the opioid use disorder (OUD) crisis, evidencing consistently lower rates of critical treatment outcomes, including medication for OUD (MOUD) engagement and retention. While these individuals exhibited a need for evidence-based care prior to the pandemic, low-income, racial/ethnic minority populations have been disproportionately affected by COVID-19, as have persons with SUDs.

Peer Recovery Coaches (PRC) are individuals with lived-experiences with substance use who have been certified by the state to assist in treatment recovery. Because of similarities between PRCs and substance use clients, PRCs can overcome many of the barriers that clients face to engaging and staying in MOUD treatment, such as stigma. goal of the current project is to conduct an open-label pilot trial to examine the feasibility, acceptability and accessibility of a PRC-led intervention to support retention in MOUD care.

This project proposes to develop a novel and sustainable model for improving retention in MOUD treatment by training PRCs to deliver an evidence-based intervention (EBI), Behavioral Activation (BA). BA seeks to increase the positive reinforcement patients experience from their natural environment by promoting prosocial and valued experiences. BA has been found to improve substance use treatment retention and adherence, as well as medication adherence in low-income individuals with HIV/AIDS. To that end, the following goal is proposed: to evaluate the preliminary feasibility, acceptability, and effectiveness of the PRC- delivered BA approach. An open-label pilot trial (n=40) of the adapted PRC-delivered BA intervention and training protocol in a representative agency in Detroit, MI serving a low-income, predominantly African-American population will be conducted. Findings from this phase of the project will be used to re-adapt the manual and training procedures.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Participants must (1) be receiving or referred to MOUD; and (2) be over the age of 18.

Exclusion criteria

  • Exclusion criteria will be (1) demonstrating active, unstable or untreated psychiatric symptoms, including mania and/or psychosis; or (2) inability to understand the study and give informed consent in English Active, Unstable or Untreated Psychiatric Symptoms: The study team is committed to recruiting a sample that reflects the complexity and likely comorbidity of people with moderate to severe OUD in this setting. Therefore, only people whose concurrent mental health issues preclude ability to participate with the procedures in this study will be excluded. Throughout the study, researchers will monitor for active, unstable or untreated psychiatric symptoms as the presence of these symptoms during study procedures would interfere with participation. Monitoring for exclusionary psychiatric symptoms can include reviewing data in medical chart (per protocol-approved access to medical records), observation during assessments and intervention sessions, and/or current symptoms detected on the MINI modules for psychosis and mania.

Inability to complete informed consent/ study in English. This study/intervention will be implemented in English only. Therefore, the capacity and willingness to give written informed consent in English, to understand the study and inclusion and exclusion criteria in English.

Treatment and study plan

Behavioral Activation (BA)

Behavioral

BA seeks to increase the positive reinforcement patients experience from their natural environment by promoting prosocial and valued experiences. BA has been found to improve substance use treatment retention and adherence, as well as medication adherence in low-income individuals with HIV/AIDS.

Primary outcomes

  1. MOUD Retention Rate

    Time frame: Measured between participants' completion of baseline assessment and completion of the follow-up assessment (approximately 8-12 weeks following the intervention date).

    Average number of days a participant missed an MOUD appointment between receiving the intervention and completing the follow-up assessment (approximately 8-12 weeks following the intervention date), averaged across all participants with available data.

  2. Intervention Fidelity: Proportion of Intervention Components Delivered as Intended

    Time frame: The number of days between starting the intervention and completing the intervention (approximately 8-10 weeks).

    Defined as the proportion of all 24 intervention components in the total intervention that were delivered with fidelity by the interventionist (ranging from 0 to 1.0 with higher proportion reflecting more fidelity).

Secondary outcomes

  1. Intervention Acceptability: Percentage of Patients Enrolled Who Attend ≥75% Sessions

    Time frame: The number of days between starting the intervention and completing the intervention (approximately 8-10 weeks).

    Defined as the percentage of participants who started the intervention who then finish the intervention (defined as completing 8 total sessions)

  2. Intervention Feasibility: Percentage of Patients Who Consents Who Started BA

    Time frame: The number of days between starting providing consent and starting BA (approximately 1-5 weeks).

    Defined as the percentage of participants who started BA sessions relative to those who enrolled in the program

Sponsors and collaborators

Lead sponsor

Henry Ford Health System

Other

Collaborators

  • University of Maryland, College Park

Registry information

Official study title

Training Peer Recovery Coaches to Promote Retention and Adherence to Medications for Opioid Use Disorder Among Low-Income Adults

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 28, 2021
Registry last updated
Mar 14, 2025

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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