Clinical trial NCT05098795: FOREward Together: Training Peer Recovery Coaches to Promote Retention and Adherence to MOUD
Official title: Training Peer Recovery Coaches to Promote Retention and Adherence to Medications for Opioid Use Disorder Among Low-Income Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Use
Keywords: Medications for opioid use disorder
Peer recovery coach
Substance use
Behavioral activation
Task sharing
Treatment retention
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
Collaborators: name: University of Maryland, College Park
First posted: 2021-10-28
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: MOUD Retention Rate
timeFrame: Measured between participants' completion of baseline assessment and completion of the follow-up assessment (approximately 8-12 weeks following the intervention date).
measure: Intervention Fidelity: Proportion of Intervention Components Delivered as Intended
timeFrame: The number of days between starting the intervention and completing the intervention (approximately 8-10 weeks).
Secondary outcomes:
measure: Intervention Acceptability: Percentage of Patients Enrolled Who Attend ≥75% Sessions
timeFrame: The number of days between starting the intervention and completing the intervention (approximately 8-10 weeks).
measure: Intervention Feasibility: Percentage of Patients Who Consents Who Started BA
timeFrame: The number of days between starting providing consent and starting BA (approximately 1-5 weeks).
Other outcomes:
Locations:
city: Detroit
country: United States
facility: The Detroit Recovery Project
state: Michigan
Study officials:
affiliation: Henry Ford Health System
name: Julia Felton, PhD.
role: PRINCIPAL_INVESTIGATOR
References: