Peer Activate: Trial of Peer-Delivered Behavioral Activation for Methadone Adherence

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the feasibility and effectiveness of a peer-led, brief, behavioral intervention to improve adherence to medication for opioid use disorder (MOUD) among low-income, minority individuals living with opioid use disorder (OUD) in Baltimore, Maryland. The intervention is based on behavioral activation (BA) and is specifically designed to be implemented by a trained peer recovery specialist. In this Type 1 hybrid effectiveness-implementation randomized controlled trial (RCT), we will evaluate the effectiveness and implementation of Peer Activate vs. treatment as usual (TAU) over six months.

Detailed Description
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The opioid use disorder (OUD) crisis disproportionately affects low-income, racial/ethnic minorities. There is a pressing need to improve retention in medication for opioid use disorder (MOUD), particularly among low-income, racial/ethnic minorities. Training peer recovery specialists (PRSs), individuals with their own lived experience with substance use disorder (SUD), in evidence-based interventions (EBIs) may be a promising strategy to improve MOUD retention for low-income, minority individuals with OUD. Yet, few EBIs have been evaluated for PRS delivery to promote MOUD retention. Behavioral activation (BA) may be a feasible, scalable, reinforcement-based approach for improving MOUD retention for low-income, minority individuals with OUD. By targeting increases in positive reinforcement, BA has been found to be effective for improving SUD treatment retention, preventing future relapse, and improving medication adherence (i.e., for HIV) among low-income, minority populations with SUD as well as depression, which is a barrier to MOUD retention. Importantly for implementation, BA also is feasible and cost-effective using lay counselor delivery. Following from this prior research, BA is an ideal EBI to evaluate for improving MOUD retention using a PRS-delivered model. This Type 1 hybrid effectiveness-implementation randomized controlled trial (RCT) builds upon our team's formative work, as well as our recent open label-pilot (R61AT010799) to develop and pilot the PRS-delivered BA approach. Guided by Aarons' stage model and Proctor's model of implementation, we proposed a mixed-methods, Type 1 hybrid effectiveness-implementation study to evaluate implementation and the effectiveness of the intervention on MT retention.

Official Title
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Peer-Delivered Behavioral Activation Intervention to Improve Adherence to MT Among Low-Income, Minority Individuals With OUD

Conditions
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Substance-Related Disorders, Opioid Medication Assisted Treatment, Opioid Use Disorder, Opioid Use, Opioid Addiction, Treatment Adherence, Retention in Care

Intervention / Treatment
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* Behavioral: Peer-Delivered Behavioral Activation (Peer Activate)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Initiated methadone at the study site in the past three months (and no less than two weeks prior to study enrollment) or demonstrated challenges with methadone adherence in the past three months as indicated by one or more of the following: a) at least one missing take-home bottle at the time of bottle return; b) screened negative for methadone in routinely administered clinic urinalysis tests; c) transitioned from an extended take-home bottle schedule to daily dosing schedule; or d) at least one missed methadone dose in the past 3 months as identified through clinic records Minimum of 18 years old Exclusion Criteria: Demonstrating active, unstable or untreated psychiatric symptoms, including mania and/or psychosis that would interfere with study participation Inability to understand the study and provide informed consent in English Positive pregnancy status at enrollment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomized in parallel to receive either the Peer Activate intervention or treatment as usual (TAU: weekly group and individual counseling with an addiction counselor in addition to referral to other available services in the community through study contact). Assessments will take place for both groups at baseline, at an approximately 3-month follow-up (or at completion/discontinuation of the intervention), and at an approximately 6-month follow-up (or at 3 months after completion/discontinuation of the intervention).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Peer-Delivered Behavioral Activation (Peer Activate)<br>Participants in the Peer Activate intervention will receive a PRS-delivered behavioral activation intervention to address barriers to retention in methadone treatment and increase substance-free, positive reinforcement to support retention. | Behavioral: Peer-Delivered Behavioral Activation (Peer Activate)<br>* The PRS-delivered Peer Activate intervention will consist of approximately four weekly core sessions (approximately 30 minutes-1 hour) with two additional sessions to reinforce core content, and then 6 optional booster sessions to reinforce skill practice. In Peer Activate sessions, participants will learn behavioral activation and problem-solving skills to assist in their retention and persistence in methadone treatment and incorporating value-driven, substance-free, rewarding activities into their daily life.<br>|
| No Intervention: Treatment As Usual<br>Participants in the TAU group will receive treatment as usual (weekly group and individual counseling with an addiction counselor in addition to referral to other available services in the community through study contact). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MT Retention | Defined dichotomously as retention (yes/no) in methadone treatment | Measured at final follow up (approximately six-months post-baseline assessment) | 
| MT Persistence | Calculated as the proportion retained on MT monthly (i.e., at least one methadone dose for each 30 day period) | Measured at final follow up (approximately six-months post-baseline) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intervention Feasibility Measured by Intervention Initiation | Feasibility, defined as the suitability and practicability of the approach, will be measured quantitatively as the % of patients who agree to participate in the intervention. We will also collect qualitative feedback relating to feasibility. | Assessed at the post-treatment follow-up (approximately 3-months post-baseline assessment) | 
| Intervention Acceptability Measured by Intervention Attendance | Acceptability, defined as satisfaction with or tolerability of the proposed approach, will be measured quantitatively by session attendance. Specifically, we will measure the % of patients enrolled who attend ≥75% sessions. We will also collect qualitative feedback relating to acceptability. | Assessed at the acute post-treatment follow-up (approximately 3-months post-baseline assessment) | 
| Intervention Fidelity Measured by Independent Rating | Fidelity, defined as the delivery of the intervention as intended, will be measured based on PRS adherence to the intervention delivery. A random selection of 20% of sessions will be rated for fidelity by an independent rater, and we will assess the % of intervention components delivered as intended. | Assessed at the acute posttreatment follow-up (approximately 3-months post-baseline assessment) | 
| MT Retention | Defined dichotomously as retention (yes/no) in methadone treatment | Measured at the acute posttreatment follow-up (approximately 3-months post-baseline assessment) | 
| MT Persistence | Calculated as the proportion retained on MT monthly (i.e., at least one methadone dose for each 30 day period) | Measured at the acute posttreatment follow-up (approximately 3-months post-baseline assessment) | 
| Changes in substance use | Assess prevalence of opioid use and other substance use (urinalysis and timeline follow back) | Assessed between the baseline assessment and the final follow-up (approximately 6 months post-baseline) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Disease, Substance-Related Disorders, Opioid-Related Disorders, Mental Disorders