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: 10011950
• 负责人: Philip Todd Korthuis
• 金额: $ 105.61万
• 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 2023-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10011950
• 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; Structure; Surveys; Techniques; Telephone; Testing; Text Messaging; Time; Training; Training Support; Translational Research; Travel; Visit; arm; base; cohort; disease transmission; effectiveness evaluation; experimental study; improved; injection drug use; innovation; named group; 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、注射吸毒、过量用药和传染病传播的流行 美国农村的交叉口。临床试验方法尚未跟上阿片类药物使用的变化趋势 混乱(OUD)及其后果。研究吸毒人群(PWUD)的研究方法是 在城市环境中制作，不能简单地输入到人口结构不同的农村社区， 在社会文化和基础设施方面。临床招聘和留住OUD患者的最优策略 在美国农村的研究仍然不为人所知。提议的以同伴为基础的保留吸毒者 农村研究(PROAD-R2)研究测试提高农村研究中PWUD留存率的策略 促进农村参与者参与临床试验。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类阿片倡议基础设施。乡村类阿片 倡议是一个多州联盟，研究获得护理以及预防服药过量和感染。 美国农村阿片类药物使用的后果。该计划在农村地区招募残疾人，使用Harmoned 用于风险行为评估的受访者驱动抽样(RDS)。RDS是一种广泛使用的基于网络的 难以到达人群的抽样技术，其中有目的地抽样的初始参与者被给予一个 有限数量的推荐优惠券来招募同行，而同行反过来又招募更多的同行，直到达到所需的样本量 已经到达了。同龄人可以成功地接触到难以接触到的人群并参与治疗，但他们的 在临床试验的实施和保留中改善特殊人群的整合的潜力 很大程度上没有开发。临床和翻译科学奖(CTSA)网站和NIDA临床试验网络 处于有利地位，可以与农村类阿片倡议调查人员合作，确定最佳做法 在研究中招募和留住农村PWUD，并将临床研究创新转移到农村PWUD 社区。Proud-R2使用RDS链的严格、双臂、集群随机试验来获得简要 视频培训和同伴保持技术方面的支持。干预组参与者的任务是 除标准外，在6个月和12个月(n=685名参与者)留住招聘同事时受到激励 保留策略。控制RDS连锁店收到标准的保留策略，包括统一的员工 外联办法(如电话、短信提醒)(n=685名参与者)。我们比较研究 保留6个月和12个月(主要结果)(目标1)，评估偏好和参与意愿 使用包括离散选择实验(目标2)的调查的未来临床试验，并探索对 使用深度定性访谈的研究参与和保留(目标3)。该项目通知方法 在美国农村地区优化PWUD研究的参与度，并有可能改变保留 临床试验中的策略。PROAD-R2与NCATS优先事项保持一致，以提高难以联系的客户的保留率 受艾滋病影响最严重的农村地区的人口。