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

项目摘要 马来西亚大多数艾滋病毒携带者(PLWH)也有阿片类药物使用障碍(OUD)，但只有少数人 接受抗逆转录病毒治疗，导致死亡率和艾滋病毒发病率增加。建议的务实， 多点、实施和有效性研究将评估改善艾滋病毒治疗的战略 结果(接受抗逆转录病毒治疗的患者的病毒学抑制率增加，治疗保留率提高， 艺术坚持)与OUD的PLWH。与马来西亚的4个大型区域艾滋病毒/艾滋病治疗中心合作， 在研究地点逐步推出研究方案，以随机顺序 站点启动，研究将评估实施改进的护理模式的障碍和促进者 将在临床试验中评估该模型的相对有效性。在每个研究地点，个人 检测HIV阳性的人也有OUD(n=4x70)将被登记接受同时接受ART和MMT的治疗 按照通常的护理标准。他们的患者水平的结果将与符合相同条件的个人进行比较 纳入标准(n=4x70)，并在拟议的改进模式下处理(实施后评价)。 通常的护理标准将包括提供抗逆转录病毒治疗和对艾滋病毒和其他医疗艾滋病毒的医疗护理。 在艾滋病毒/艾滋病治疗中心提供的疾病，并迅速和便利地转介到美沙酮 维持治疗(MMT)。改进后的护理模式将包括常规护理，并辅之以 对艾滋病毒/艾滋病和MMT诊所的医务人员进行继续教育和辅导，并提供额外的 基于同伴的咨询干预侧重于患者可以学习和使用的行为技能和策略 师父不间断地长期参与艺术治疗，同时通过 MMT。主要的结果衡量标准是两组中病毒抑制患者的比率(20拷贝/毫升) 护理模式将在24周时进行评估。同样追踪了24周的次要结果将包括 通过客观测量(替诺福韦干血点、临床记录)和自我报告来衡量ART依从性； 以阿片类药物尿毒学结果阴性率和自我报告率衡量的非法阿片类药物使用减少；以及 改善其他与健康相关和功能状况的结果。在统计上显著影响 支持改进护理模式的主要结果和对次要结果有临床意义的影响 都是假设的。同时在每个研究地点，采用实施科学混合方法进行研究 工具和与当地主要利益攸关方(治疗提供者、患者、他们的家人和社区)的接触 活动人士)，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 在马来西亚和马来西亚实施有效的寻找-测试-治疗和保留PLWH和OUD模式 为其他医疗资源有限的中低收入国家和地区的医疗政策提供信息。

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.