NCT05098795

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2021

Geographic Reach
1 country

1 active site

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

October 7, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

October 28, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 14, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 14, 2023

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

March 14, 2025

Completed
Last Updated

March 14, 2025

Status Verified

February 1, 2025

Enrollment Period

1.7 years

First QC Date

October 7, 2021

Results QC Date

August 11, 2024

Last Update Submit

February 22, 2025

Conditions

Keywords

Medications for opioid use disorderPeer recovery coachSubstance useBehavioral activationTask sharingTreatment retention

Outcome Measures

Primary Outcomes (2)

  • MOUD Retention Rate

    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.

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

  • Intervention Fidelity: Proportion of Intervention Components Delivered as Intended

    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).

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

Secondary Outcomes (2)

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

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

  • Intervention Feasibility: Percentage of Patients Who Consents Who Started BA

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

Study Arms (1)

Peer-delivered Behavioral Activation

EXPERIMENTAL

Adults 18 years or older on MOUD or referred to MOUD will receive Behavioral Activation (BA) an evidence-based intervention (EBI) by trained Peer Recovery Coaches (PRC)

Behavioral: Behavioral Activation (BA)

Interventions

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.

Peer-delivered Behavioral Activation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Detroit Recovery Project

Detroit, Michigan, 48203, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Limitations and Caveats

None noted.

Results Point of Contact

Title
Dr. Julia Felton
Organization
Henry Ford Health

Study Officials

  • Julia Felton, PhD.

    Henry Ford Health System

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Scientist

Study Record Dates

First Submitted

October 7, 2021

First Posted

October 28, 2021

Study Start

December 1, 2021

Primary Completion

August 14, 2023

Study Completion

August 14, 2023

Last Updated

March 14, 2025

Results First Posted

March 14, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will share

After all primary analyses are complete, de-identified data will be available per request of outside individual

Locations