Peer-Delivered Behavioral Activation Intervention to Improve Adherence to MT Among Low-Income, Minority Individuals With OUD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- MT Retention
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
At the approximately 3-Month (or at completion/discontinuation of intervention) and approximately 6-Month Follow-Up assessments (or approximately 3 months after 3-month follow up assessment or at discontinuation of intervention), a trained and blinded member of the research team will complete assessments with the participant.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
MT Retention
时间窗: Measured at final follow up (approximately six-months post-baseline assessment)
Defined dichotomously as retention (yes/no) in methadone treatment
MT Persistence
时间窗: 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)
次要结局
- 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))