Screen, Treat and Retain Meth-Using People with Opioid Use Disorders at MMT Clinics (STAR-OM)

在 MMT 诊所筛查、治疗和保留患有阿片类药物使用障碍的冰毒吸食者 (STAR-OM)

• 批准号: 10171837
• 负责人: Giang M Le
• 金额: $ 47.3万
• 依托单位: HANOI MEDICAL UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-06-01 至 2025-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10171837
• 关键词: Achievement; Adoption; Asia; Buprenorphine; Cities; Clinic; Clinical; Collaborations; Country; Development; Disease; Drug abuse; Enrollment; Ensure; Epidemic; Ethnography; Evidence based intervention; Funding; HIV; HIV risk; Healthcare Systems; Heroin; Injecting drug user; Intervention; Interview; Location; Maintenance; Methamphetamine; Modeling; Monitor; National Institute of Drug Abuse; North America; Outcome; Participant; Patients; Provider; Public Health; Randomized; Reporting; Research; Research Personnel; Resources; Risk; Risk Behaviors; Sequential Multiple Assignment Randomized Trial; Structure; Tablets; Technology Transfer; Testing; Twin Multiple Birth; United States Substance Abuse and Mental Health Services Administration; Urine; Vietnam; Viral; Work; adaptive intervention; addiction; base; comparative cost effectiveness; compare effectiveness; contingency management; cost effective; cost-effectiveness ratio; design; effectiveness evaluation; group counseling; high risk; hybrid type 1 design; improved; incremental cost-effectiveness; individual response; methadone treatment; methamphetamine use; motivational enhancement therapy; multidisciplinary; opioid epidemic; opioid injection; opioid use; opioid use disorder; opioid user; personalized approach; primary outcome; recruit; response; scale up; screening; stem; substance use; therapy design; treatment strategy; trial design

Research Abstracts We propose to develop and evaluate optimal combinations of evidence-based interventions (EBIs) to improve HIV outcomes and reduce methamphetamine use among people with opioid use disorder (OUD) who are in methadone maintenance therapy (MMT) in Vietnam (STAR-OM study). Over the past decade, the expansion of MMT has contributed to stemming both HIV and opioid epidemics. However, rising methamphetamine use threatens these achievements. The twinned epidemics of opioid and methamphetamine use have also been reported in the US and other countries. Building on our pilot work with MMT patients in Hanoi, through collaborative work with local MMT providers and patients, we will refine adapted EBIs to develop an adaptive design that offers an individualized approach to treatment. The adaptive design includes: (1) Two frontline interventions: 6 weeks of CM then 6 weeks of weekly group educational sessions (low intensity CM) and 12 weeks of CM (high intensity CM); (2) One (short-term) tailoring outcome: urine tests negative with meth metabolites in both week 11 and 12 are considered responsive to frontline interventions; (3) Three alternative interventions: those with positive outcomes will move to 12-week maintenance stage and receive two daily SMS reminders plus one weekly self-monitoring assessment message. Non-responders will move to 12-week enhanced treatment stage and are randomized to either Matrix group counseling only or Matrix group counseling plus CM. We will compare effectiveness of two frontline interventions and four adaptive interventions with a Sequential Multiple Assignment Randomization Trial in 200 HIV+ (150 from HCMC; 50 from Hanoi) and 400 HIV- (200 from each city) MMT patients who report moderate- and high-risk meth use on self-screening with tablet-based ASSIST and/or have urine positive with methamphetamine metabolites. In each location, the study will stratify participants by HIV status before randomizing them to one of two frontline interventions. Primary outcomes - including HIV viral suppression, HIV risk behaviors, and meth use (reported and urine tests) - will be assessed at 12, 24 and 48 weeks. We will calculate the incremental cost effectiveness ratio (ICER) comparing cost-effectiveness between two frontline interventions as well as among four adaptive strategies. Finally yet importantly, we also conduct ethnographic observations and in-depth interviews with MMT clinic managers, clinical staff and MMT patients (N=60, 30 per city) to identify structural, provider and patient-level factors that influence adoption and scale-up of the adaptive interventions. Findings from this study with Type I Hybrid design to evaluate EFFECTIVENESS-Implementation will provide valuable evidence to develop treatments in resourced and resourced-constrained settings to confront the twinned epidemics of opioid and methamphetamine use in the context of surging HIV epidemic due to drug abuse.

研究文摘 我们建议开发和评估基于证据的干预措施（EBI）的最佳组合，以 改善阿片类药物使用障碍 (OUD) 患者的艾滋病毒结果并减少甲基苯丙胺的使用 正在越南接受美沙酮维持治疗 (MMT)（STAR-OM 研究）。在过去的十年里， MMT 的推广有助于遏制艾滋病毒和阿片类药物的流行。然而，不断上升 甲基苯丙胺的使用威胁到这些成就。阿片类药物和阿片类药物的孪生流行病 美国和其他国家也有使用甲基苯丙胺的报道。以我们的试点工作为基础 河内的 MMT 患者，通过与当地 MMT 提供者和患者的合作，我们将完善 调整 EBI 来开发适应性设计，提供个性化的治疗方法。适应性 设计包括： (1) 两次一线干预：6 周的 CM，然后 6 周的每周小组教育 疗程（低强度 CM）和 12 周 CM（高强度 CM）； (2) 一项（短期）定制成果： 第 11 周和第 12 周，尿液检测呈冰毒代谢物阴性，被认为对前线治疗有反应 干预措施； (3) 三种替代干预措施：效果积极的将进入 12 周 维护阶段，每天收到两次短信提醒以及每周一次自我监控评估 信息。无反应者将进入为期 12 周的强化治疗阶段，并被随机分配至 仅 Matrix 团体咨询或 Matrix 团体咨询加 CM。我们将比较两者的有效性 前线干预措施和四种采用序贯多重分配随机化的适应性干预措施 试验对象为 200 名 HIV+（150 名来自胡志明市；50 名来自河内）和 400 名 HIV-（每个城市 200 名）MMT 患者。 在使用基于片剂的 ASSIST 进行自我筛查时报告中度和高风险的冰毒使用情况和/或进行尿液检查 甲基苯丙胺代谢物呈阳性。在每个地点，该研究将根据艾滋病毒状况对参与者进行分层 然后将他们随机分配到两项前线干预措施之一。主要结果 - 包括 HIV 病毒 抑制、艾滋病毒危险行为和冰毒使用（报告和尿检） - 将在 12、24 和 48 进行评估 几周。我们将计算增量成本效益比（ICER），比较之间的成本效益 两项一线干预措施以及四种适应性策略。最后但重要的是，我们还进行 对 MMT 诊所管理者、临床工作人员和 MMT 患者进行人种学观察和深入访谈 （N=60，每个城市 30 个）以确定影响采用和扩大规模的结构、提供者和患者层面的因素 的适应性干预措施。本研究的结果采用 I 型混合设计进行评估 有效性——实施将为在资源丰富和资源丰富的地区开发治疗方法提供宝贵的证据。 在资源有限的环境下应对阿片类药物和甲基苯丙胺使用的双重流行 由于药物滥用导致艾滋病毒流行激增的背景。