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: 9926436
• 负责人: Giang M Le
• 金额: $ 47.65万
• 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/9926436
• 关键词: Achievement; Adoption; Alcohol or Other Drugs use; 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; Hybrids; 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; 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; 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.

研究摘要 我们建议开发和评估最佳的循证干预措施（EBIS）的最佳组合 改善艾滋病毒结局并减少阿片类药物使用障碍（OUD）的甲基苯丙胺的使用 在越南的美沙酮维持治疗（MMT）中（Star-OM研究）。在过去的十年中， MMT的扩展有助于阻止HIV和阿片类药物流行病。但是，上升 甲基苯丙胺的使用威胁到这些成就。阿片类药物和 在美国和其他国家，还报告了甲基苯丙胺的使用。建立我们的飞行员工作 河内的MMT患者，通过与当地MMT提供者和患者的合作工作，我们将完善 适应EBIS开发了一种自适应设计，该设计提供了个性化的治疗方法。适应性 设计包括：（1）两项前线干预：6周的CM，然后每周6周的小组教育 会话（低强度CM）和12周CM（高强度CM）； （2）一个（短期）裁缝结果： 在第11周和第12周中，甲基代谢产物阴性的尿液测试均被视为对前线的反应 干预措施； （3）三种替代干预措施：那些阳性结果的干预措施将移至12周 维护阶段，并收到两个每日SMS提醒以及每周一次的自我监控评估 信息。非响应者将移至12周增强的治疗阶段，并随机分配给任何一个 仅矩阵小组咨询或矩阵小组咨询加上CM。我们将比较两个 前线干预措施和四个自适应干预措施，并具有顺序多重分配随机化 在200 HIV+中试验（HCMC的150个；来自河内的50）和400 HIV-（每个城市的200个）MMT患者 报告具有基于平板电脑的辅助和/或尿液的中度和高风险甲基甲基苯丙胺在自我筛查上使用 甲基苯丙胺代谢产物阳性。在每个位置，研究将根据HIV状态将参与者分类 在将它们随机进行两种一线干预措施之一之前。主要结果 - 包括HIV病毒 抑制，艾滋病毒风险行为和使用甲基甲基苯丙胺（报告和尿液测试）将在12、24和48评估 几周。我们将计算比较成本效益的增量成本效益比（ICER） 两种前线干预以及四种自适应策略。最后，重要的是，我们也进行 民族志观察和MMT诊所经理，临床人员和MMT患者的深入访谈 （n = 60，30，每个城市30）确定影响采用和扩展的结构，提供者和患者级别的因素 自适应干预措施。这项研究的发现，I型混合设计以评估 有效性实施将提供有价值的证据，以开发资源和 资源受限的设置与阿片类药物和甲基苯丙胺使用的双胞胎流行相遇 由于滥用毒品而激发艾滋病毒流行的背景。