Peer-Delivered Behavioral Activation Intervention to Improve Adherence to MT Among Low-Income, Minority Individuals With OUD
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Substance-Related Disorders
- Sponsor
- University of Maryland, College Park
- Enrollment
- 200
- Locations
- 2
- Primary Endpoint
- MT Retention
- Status
- Completed
- Last Updated
- 6 months ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
MT Retention
Time Frame: Measured at final follow up (approximately six-months post-baseline assessment)
Defined dichotomously as retention (yes/no) in methadone treatment
MT Persistence
Time Frame: Measured at final follow up (approximately six-months post-baseline)
Calculated as the proportion retained on MT monthly (i.e., at least one methadone dose for each 30 day period)
Secondary Outcomes
- MT Persistence(Measured at the acute posttreatment follow-up (approximately 3-months post-baseline assessment))
- Intervention Feasibility Measured by Intervention Initiation(Assessed at the post-treatment follow-up (approximately 3-months post-baseline assessment))
- Intervention Acceptability Measured by Intervention Attendance(Assessed at the acute post-treatment follow-up (approximately 3-months post-baseline assessment))
- Intervention Fidelity Measured by Independent Rating(Assessed at the acute posttreatment follow-up (approximately 3-months post-baseline assessment))
- MT Retention(Measured at the acute posttreatment follow-up (approximately 3-months post-baseline assessment))
- Changes in substance use(Assessed between the baseline assessment and the final follow-up (approximately 6 months post-baseline))