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

研究摘要 我们建议开发和评估循证干预(EBI)的最佳组合，以 改善阿片使用障碍(OUD)患者的艾滋病毒结果并减少甲基苯丙胺的使用 在越南接受美沙酮维持治疗(STAR-OM研究)。在过去的十年里， MMT的扩大有助于遏制艾滋病毒和阿片类药物的流行。然而，上升 冰毒的使用威胁到了这些成就。阿片类药物和阿片类药物的孪生流行 在美国和其他国家也有甲基苯丙胺的使用报告。在我们的试点工作的基础上 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EBIS以开发一种适应性设计，提供个性化的治疗方法。自适应的 设计包括：(1)两个一线干预：6周的CM和6周的小组教育 疗程(低强度CM)和12周CM(高强度CM)；(2)一次(短期)量身定制结果： 在第11周和第12周的尿检中，冰毒代谢物均呈阴性，被认为对前线有反应。 干预措施；(3)三种替代干预措施：那些结果积极的将转移到12周 维护阶段，每天收到两次短信提醒，外加一次每周自我监控评估 留言。无反应者将进入为期12周的强化治疗阶段，并被随机分配到 仅矩阵小组咨询或矩阵小组咨询加CM。我们将比较两种方法的有效性 序贯多任务随机化的一线干预和四种适应性干预 在200名HIV+患者(150名来自HCMC；50名来自河内)和400名HIV-MMT患者(每个城市200名)中进行试验 报告在使用片剂辅助和/或有尿液的自我筛查中使用中风险和高风险冰毒 甲基苯丙胺代谢产物呈阳性。在每个地点，这项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个一线干预中的一个。主要结果--包括艾滋病毒病毒 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岁进行评估 几周。我们将计算增量成本效益比(ICER)，将成本效益与 两项前线干预措施以及四项适应性战略。最后，但重要的是，我们还进行了 人种学观察和对MMT诊所经理、临床工作人员和MMT患者的深入访谈 (n=60，每个城市30个)，以确定影响采用和扩展的结构、提供商和患者层面的因素 适应性干预措施。这项研究的结果使用I型杂交设计来评估 有效性-实施将提供宝贵的证据，以开发治疗资源和 资源有限的环境，以应对阿片类药物和甲基苯丙胺使用的孪生流行 毒品滥用导致艾滋病毒流行激增的背景下。

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.