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临床试验/NCT03885024
NCT03885024已完成不适用

The Peer-Based Retention of People Who Use Drugs in Rural Research

Oregon Health and Science University6 个研究点 分布在 1 个国家目标入组 850 人开始时间: 2020年8月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
850
试验地点
6
主要终点
12 Month Retention Rate

研究概览

简要总结

The purpose of this study is to, through several aims, test the effectiveness of peer-driven intervention and inform methods to optimize engagement in research in people who use drugs (PWUD) in rural America.

详细描述

This study builds on the National Rural Opioids Initiative (NROI), a multi-state consortium studying access to care, overdose, and infectious consequences of opioid use disorder (OUD) in Rural America. It includes counties in rural Oregon and Appalachian Kentucky and Ohio with high rates of drug overdose.

Aim 1: Conduct a randomized trial to evaluate the effectiveness of a peer-driven study retention intervention for retaining PWUD in Kentucky, Ohio, and Oregon Rural Opioid Initiative sites.

Aim 2: Elicit preferences of PWUD in the Kentucky, Ohio, and Oregon Rural Opioid Initiative sites Aim 2a: Administer baseline survey of discrete choice experiment preferences for participating in clinical trials of potential medical innovations (e.g. new treatments for OUD, HIV, and HCV vaccination). Aim 2a will be accomplished as part of the NROI studies. The data will then be merged for PROUD-R² analyses.

Aim 2b: Compare participant survey preferences regarding willingness to participate in clinical trials at baseline, 6, and 12 months.

Aim 3: Explore participant perceptions of clinical research participation and retention among PWUD in rural America.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • NROI eligibility criteria: Participants are eligible to enroll in the NROI if they 1) live in the study area, 2) have recently injected drugs or report opioid use to get high without injection, and 3) are age 18 or older.
  • NROI participants enrolled after April 2019 are eligible to participate in the PROUD R2 study.
  • Participants enrolling as study buddies will be eligible if they 1) live in the study area, 2) are age 18 or older; they do not need to have recent or past substance use to qualify.
  • No eligible participants are excluded.

排除标准

  • Under 18 years of age

结局指标

主要结局

12 Month Retention Rate

时间窗: 12 months

Participants receiving the peer retention intervention will have 20% higher retention at 12 months (primary outcome) than those receiving the standard retention approach, alone.

次要结局

  • 6 Month Retention Rate(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

P. Todd Korthuis, MD

Professor

Oregon Health and Science University

研究点 (6)

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