Peer-based Retention of people who Use Drugs in Rural Research (PROUD-R2)

在农村研究中基于同伴的吸毒者保留 (PROUD-R2)

• 批准号: 10238785
• 负责人: Philip Todd Korthuis
• 金额: $ 103.37万
• 依托单位: OREGON HEALTH & SCIENCE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-18 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10238785
• 关键词: Appalachian Region; Baseline Surveys; Behavior assessment; Clinical Research; Clinical Trials; Clinical Trials Network; Clinical and Translational Science Awards; Cluster randomized trial; Country; County; Drug user; Elements; Enrollment; Epidemiology; Fostering; Frequencies; Future; HIV Infections; HIV/HCV; Health Services Accessibility; Hepatitis C; Hepatitis C Vaccination; Incentives; Infrastructure; Intervention; Interview; Kentucky; Medical; Methods; National Institute of Drug Abuse; Network-based; Ohio; Opioid; Oregon; Outcome; Overdose; Participant; Perception; Pharmaceutical Preparations; Population; Positioning Attribute; Protocols documentation; Randomized; Reporting; Research; Research Infrastructure; Research Methodology; Research Personnel; Resources; Respondent; Risk Behaviors; Rural; Rural Community; Sample Size; Sampling; Site; Special Population; Structure; Surveys; Techniques; Telephone; Testing; Text Messaging; Time; Training; Training Support; Translational Research; Travel; Visit; arm; base; clinical trial implementation; cohort; disease transmission; effectiveness evaluation; experimental study; improved; injection drug use; innovation; novel strategies; opioid epidemic; opioid use; opioid use disorder; outreach; overdose prevention; peer; preference; prescription opioid; primary outcome; randomized trial; recruit; research study; retention rate; rural America; rural area; rural setting; secondary outcome; social culture; treatment arm; trend; trial comparing; urban setting; willingness

ABSTRACT The epidemics of opioid prescribing, injection drug use, overdose, and infectious disease transmission intersect in rural America. Clinical trials methods have not yet caught up with shifting trends in Opioid Use Disorder (OUD) and its consequences. Research methods to study People Who Use Drugs (PWUD) were crafted in urban settings, and cannot simply be imported to rural communities which differ demographically, socioculturally, and in infrastructure. Optimal strategies for recruiting and retaining people with OUD in clinical research in rural America remain unknown. The proposed Peer-based Retention Of people who Use Drugs in Rural Research (PROUD-R2) study tests strategies to improve retention of PWUD in research in rural communities, and fosters facilitation of rural participants into clinical trials. This study leverages the national Rural Opioids Initiative infrastructure in Oregon and Appalachian Kentucky and Ohio. The Rural Opioids Initiative is a multi-state consortium studying access to care and prevention of overdose and infectious consequences of opioid use in rural America. The initiative recruits PWUD in rural settings using harmonized respondent-driven sampling (RDS) for risk behavior assessments. RDS is a widely used network-based sampling technique for hard-to-reach populations in which purposively sampled initial participants are given a limited number of referral coupons to recruit peers, who in turn recruit more peers until the desired sample size is reached. Peers can successfully reach and engage hard-to-reach populations in treatment, but their potential to improve integration of special populations in clinical trial implementation and retention has been largely untapped. Clinical and Translational Science Award (CTSA) sites and the NIDA Clinical Trials Network are well-positioned to partner with Rural Opioids Initiative investigators to determine optimal practices for recruiting and retaining rural PWUD in research and transferring clinical research innovations to PWUD in rural communities. PROUD-R2 uses a rigorous, two-arm, cluster-randomized trial of RDS chains to receive brief video training and support in peer retention techniques. Intervention arm participants are tasked with and incentivized for retaining recruited peers at 6- and 12-months (n=685 participants) in addition to standard retention strategies. Control RDS chains receive standard retention strategies including a harmonized staff outreach approach (e.g., phone calls, text message reminders) (n=685 participants). We compare study retention at 6 and 12-months (primary outcome) (Aim 1), assess preferences and willingness to participate in future clinical trials using a survey including discrete choice experiments (Aim 2), and explore perceptions of research participation and retention using in-depth qualitative interviews (Aim 3). The project informs methods to optimize engagement in research for PWUD in rural America and has the potential to transform retention strategies in clinical trials. PROUD-R2 aligns with NCATS priorities to improve retention of difficult to reach populations in rural areas of the country most impacted by OUD.

摘要 阿片类药物处方、注射药物使用、过量和传染病传播的流行 在美国农村有交集临床试验方法尚未赶上阿片类药物使用的变化趋势 疾病（OUD）及其后果。研究吸毒者的方法是： 在城市环境中制作，不能简单地引入人口统计学上不同的农村社区， 社会文化和基础设施。招募和留住临床OUD患者的最佳策略 美国农村的研究仍然未知。提议的基于同伴的保留吸毒的人， 农村研究（PROUD-R2）研究测试策略，以提高农村研究中的PWUD保留率 社区，并促进农村参与者进入临床试验。这项研究利用了国家 俄勒冈州、阿巴拉契亚肯塔基州和俄亥俄州的农村阿片类药物倡议基础设施。农村鸦片 倡议是一个多个国家的财团研究获得护理和预防过量和传染性 阿片类药物在美国农村使用的后果。该倡议在农村地区招募残疾人， 响应者驱动抽样（RDS）用于风险行为评估。RDS是一种广泛使用的基于网络的 针对难以接触人群的抽样技术，其中有目的地抽样的初始参与者被给予一个 有限数量的推荐券，用于招募同行，同行反过来招募更多的同行，直到达到所需的样本量 已经到达。同行可以成功地接触到难以接触到的人群并使其参与治疗，但他们的 在临床试验实施和保留中改善特殊人群整合的潜力， 大部分尚未开发临床和转化科学奖（CTSA）地点和NIDA临床试验网络 有能力与农村阿片类药物倡议调查人员合作，以确定最佳做法， 招募和留住农村的PWUD参与研究，并将临床研究创新转移给农村的PWUD 社区. PROUD-R2使用了一项严格的、双臂的、随机分组的RDS链试验， 视频培训和同伴保持技巧方面的支持。干预组参与者的任务是， 在6个月和12个月（n=685名参与者）时，除了标准治疗外， 保留策略。控制RDS链接受标准的保留策略，包括统一的员工 外展方法（例如，电话、短信提醒）（n=685名参与者）。我们比较研究 6个月和12个月时的保留率（主要结局）（目标1），评估参与 未来的临床试验，使用包括离散选择实验（目标2）的调查，并探讨对 研究参与和保留使用深入的定性访谈（目标3）。该项目提供了方法 优化美国农村地区PWUD研究的参与，并有可能改变保留 临床试验中的策略。PROUD-R2与NCATS的优先事项保持一致，以提高难以达到的保留率 农村地区受OUD影响最大的人口。