Epidemiology, University of Kentucky, Lexington, Kentucky, USA
Center on Drug and Alcohol Research, University of Kentucky, Lexington, Kentucky, USA.
BMJ Open. 2022 Jun 15;12(6):e064400. doi: 10.1136/bmjopen-2022-064400.
Rural communities bear a disproportionate share of the opioid and methamphetamine use disorder epidemics. Yet, rural people who use drugs (PWUD) are rarely included in trials testing new drug use prevention and treatment strategies. Numerous barriers impede rural PWUD trial engagement and advancing research methods to better retain rural PWUD in clinical trials is needed. This paper describes the Peer-based Retention Of people who Use Drugs in Rural Research (PROUD-R) study protocol to test the effectiveness of a peer-driven intervention to improve study retention among rural PWUD.
The PROUD-R study is being implemented in 21 rural counties in three states (Kentucky, Ohio and Oregon). People who are 18 years or older, reside in the study area and either used opioids or injected any drug to get high in the past 30 days are eligible for study inclusion. Participants are allocated in a 1:1 ratio to two arms, stratified by site to assure balance at each geographical location. The trial compares the effectiveness of two retention strategies. Participants randomised to the control arm provide detailed contact information and receive standard retention outreach by study staff (ie, contacts for locator information updates, appointment reminders). Participants randomised to the intervention arm are asked to recruit a 'study buddy' in addition to receiving standard retention outreach. Study buddies are invited to participate in a video training and instructed to remind their intervention participant of follow-up appointments and encourage retention. Assessments are completed by intervention, control and study buddy participants at 6 and 12 months after enrolment.
The protocol was approved by a central Institutional Review Board (University of Utah). Results of the study will be disseminated in academic conferences and peer-reviewed journals, online and print media, and in meetings with community stakeholders.
NCT03885024.
农村社区承担着阿片类药物和冰毒使用障碍流行的不成比例的部分。然而，农村吸毒者（PWUD）很少被纳入测试新的药物预防和治疗策略的试验中。许多障碍阻碍了农村 PWUD 参与试验，并需要推进研究方法，以便更好地将农村 PWUD 纳入临床试验。本文描述了基于同伴的农村研究中吸毒者保留研究（PROUD-R）研究方案，以测试一种同伴驱动的干预措施对改善农村 PWUD 研究保留率的有效性。
PROUD-R 研究正在三个州（肯塔基州、俄亥俄州和俄勒冈州）的 21 个农村县实施。年龄在 18 岁或以上，居住在研究区域内，并且在过去 30 天内使用过阿片类药物或注射过任何药物来获得快感的人有资格参加研究。参与者按照 1:1 的比例分为两组，按地点分层，以确保每个地理位置的平衡。试验比较了两种保留策略的有效性。随机分配到对照组的参与者提供详细的联系信息，并接受研究人员的标准保留外展（即，定位信息更新、预约提醒的联系方式）。随机分配到干预组的参与者除了接受标准保留外展外，还被要求招募一名“研究伙伴”。研究伙伴被邀请参加视频培训，并被指示提醒他们的干预参与者随访预约并鼓励保留。干预、对照和研究伙伴参与者在入组后 6 个月和 12 个月时完成评估。
该方案已获得中央机构审查委员会（犹他大学）的批准。研究结果将在学术会议和同行评议期刊、在线和印刷媒体以及与社区利益相关者的会议上进行传播。
NCT03885024。
