Implementation of Seek, Test, Treat & Retain Strategies among People Who Inject Drugs in Malaysia

项目摘要 马来西亚的大多数艾滋病毒感染者（PLWH）也患有阿片类药物使用障碍（OUD），但只有少数人 接受抗逆转录病毒疗法和口服避孕药治疗，导致死亡率和艾滋病毒发病率上升。建议务实， 多地点、实施和有效性研究将评估改善艾滋病毒治疗的战略 结果（ART患者的病毒学抑制率增加，治疗保留率提高， ART依从性）。在马来西亚建立4个大型区域艾滋病毒/艾滋病治疗中心， 在研究中心逐步推出研究方案，以随机顺序偏移一年， 研究中心启动时，研究将评估实施改进护理模式的障碍和促进因素， 将在临床试验中评估该模型的相对有效性。在每个研究中心， 将入组同时患有OUD的HIV检测阳性患者（n= 4x 70），接受基于ART和MMT的同步治疗 一般的护理标准。他们的患者水平结果将与满足相同条件的个人进行比较。 入选标准（n= 4x 70），并根据拟议的改进模型（实施后评价）进行处理。 通常的护理标准将包括提供抗逆转录病毒疗法和艾滋病毒医疗护理以及其他艾滋病毒医疗护理， 在艾滋病毒/艾滋病治疗中心提供的发病率，快速和便利地转诊到美沙酮 维持治疗（MMT）。改进后的护理模式将包括常规护理， 对艾滋病毒/艾滋病诊所和MMT诊所的医务人员进行继续教育和辅导， 以同伴为基础的咨询干预，重点是患者可以学习的行为技能和策略， 掌握实现不间断的，长期的ART治疗参与，同时继续OUD恢复， MMT。主要结果指标，两组中病毒学抑制（< 20拷贝/mL）患者的比率， 将在24周时评估护理模式。次要结局也随访24周，包括 通过客观测量（替诺福韦干血斑、诊所记录）和自我报告测量抗逆转录病毒治疗依从性; 通过阿片类药物阴性尿液毒理学结果和自我报告的比率测量的非法阿片类药物使用减少;以及 其他健康相关和功能状态结果的改善。在统计学上， 主要结局和对次要结局有临床意义的影响，有利于改善护理模式 都是假设的同时在各研究点，采用实施科学混合方法研究 工具和参与关键的当地利益相关者（治疗提供者、患者、他们的家人和社区） 活动家），并评估临床和医疗保健数据，该研究将评估现有的障碍（组织， 人员和社区层面的因素），并发现可用的资源和促进者， 实施改进的护理模式。这项研究将提供至关重要的证据， 在马来西亚全国范围内为感染者和残疾人实施有效的“寻求-测试-治疗”和“保留”模式， 为其他医疗资源有限中低收入国家和地区的医疗保健政策提供信息。

Project Summary Most people living with HIV (PLWH) in Malaysia also have an opioid use disorder (OUD), yet only a minority receive ART and OUD treatment, resulting in increased mortality and HIV incidence. The proposed pragmatic, multisite, implementation and effectiveness research will evaluate a strategy to improve HIV treatment outcomes (increased rates of patients on ART with virological suppression, improved treatment retention and ART adherence) for PLWH with OUD. Engaging 4 large regional HIV/AIDS treatment centers in Malaysia, with a stepped rollout of the study protocol across the study sites, offset by one year with a random order of the sites initiation, the study will evaluate barriers and facilitators for implementation of improved care model and will evaluate the comparative effectiveness of the model in a clinical trial. At each of the study sites, individuals testing HIV positive who also have OUD (n=4x70) will be enrolled to receive concurrent ART and MMT based on the usual care standards. Their patient level outcomes will be compared with individuals meeting the same inclusion criteria (n=4x70) and treated under the proposed improved model (post implementation evaluation). The usual care standard will consist of provision of ART and medical care for HIV and other medical HIV co- morbidities provided at the HIV/AIDS treatment center with an expedited and facilitated referral to a methadone maintenance treatment (MMT). The improved care model will include the usual care supplemented by continuing education and coaching of medical staff at HIV/AIDS and MMT clinics and by provision of additional peer-based counseling intervention focused on behavioral skills and strategies that patients can learn and master to achieve uninterrupted, long-term ART treatment participation while continuing OUD recovery through MMT. The primary outcome measure, rates of patients with virologic suppression (< 20 copies/mL) in the two care models will be assessed at 24 weeks. The secondary outcomes, also followed for 24 weeks, will include ART adherence measured by objective measures (tenofovir dried blood spots, clinic records) and self-report; decreased illicit opioid use measured by rates of opioid negative urine toxicology results and self-report; and improvements on other health-related and functional status outcomes. A statistically significant effect on the primary outcome and clinically meaningful effects on secondary outcomes favoring the improved care model are hypothesized. Concurrently at each study site, using implementation science mixed methods research tools and engaging key local stakeholders (treatment providers, patients, their families, and community activists), and evaluating clinical and healthcare data, the study will assess existing barriers (organizational, personnel, and community level factors) and uncover available resources and facilitators for a successful implementation of the improved care model. The research will provide critically important evidence for implementation of effective Seek-Test-Treat, and Retain models for PLWH and OUD throughout Malaysia and inform healthcare policy in other low to middle income countries and regions with limited healthcare resources.