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， 在阿片类药物使用障碍（OUD）患者中改善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（MMT）（STAR-OM研究）。在过去的十年里， MMT的扩展有助于遏制艾滋病毒和阿片类药物的流行。然而， 甲基安非他明的使用威胁到这些成就。阿片类药物和 美国和其他国家也报告了甲基苯丙胺的使用情况。基于我们的试点工作， 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以开发一种自适应设计，提供个性化的治疗方法。自适应 设计包括：（1）两项一线干预：6周CM，然后6周每周小组教育 会话（低强度CM）和12周CM（高强度CM）;（2）一个（短期）定制结果： 在第11周和第12周的尿检中甲基代谢物均为阴性， （3）三种替代干预措施：那些有积极成果的将移至12周 并收到两个每日短信提醒和一个每周自我监测评估 留言该无应答者将进入12周强化治疗阶段，并随机分配至 矩阵小组咨询或矩阵小组咨询加CM。我们将比较两个 一线干预和四种适应性干预，采用序贯多重分配随机化 在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患者中进行的试验， 报告中度和高度风险的甲基使用自我筛选与片剂为基础的ASSIST和/或有尿 甲基苯丙胺代谢物检测呈阳性在每个地点，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种一线干预措施中的一种。主要结果-包括艾滋病毒 抑制，艾滋病毒的危险行为，和甲基使用（报告和尿检）-将在12，24和48评估 周我们将计算增量成本效益比（ICER）， 两项一线干预措施以及四项适应性战略。最后，重要的是，我们还 对MMT诊所管理者、临床工作人员和MMT患者进行民族志观察和深入访谈 （N=60，每个城市30个），以确定影响采用和扩大规模的结构性、提供者和患者层面的因素 适应性干预措施。使用I型混合设计评价本研究的结果 实施将提供有价值的证据，以开发资源丰富和 在资源有限的情况下应对非洲使用类阿片和甲基苯丙胺这一孪生流行病 在吸毒导致艾滋病毒流行病激增的背景下。

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.