Buprenorphine to Improve HIV Care Engagement and Outcomes: A Randomized Trial

描述（由申请人提供）：本提案的主要目的是比较两种阿片类药物依赖治疗提供模式对改善越南艾滋病毒护理参与和结果的影响。我们与越南的几家主要机构合作，提出了一项多中心、随机试验，比较基于HIV诊所的丁丙诺啡/纳洛酮（BUP/NX）（n=225）与美沙酮维持治疗（MMT）（n=225），用于治疗越南HIV流行中心河内和海防市5家HIV诊所新治疗的HIV感染患者的阿片类药物依赖。艾滋病毒提供者将接受培训，使用灵活的BUP/NX剂量和外卖时间表管理阿片类药物依赖。所有受试者都将接受基于诊所的咨询和艾滋病毒护理。将通过12个月的随访评估自我报告的药物使用、尿液药物筛查（UDS）以及艾滋病毒护理参与和结局的测量。第1年至第4年的定性访谈将确定经验教训，为扩大规模的国家BUP/NX指南提供信息。我们将评估12个月时基于临床的BUP/NX与MMT转诊对HIV病毒抑制和治疗参与（目标1）和阿片类药物使用（目标2）的影响。我们假设，与MMT转诊相比，随机分配至基于临床的BUP/NX的受试者在12个月时将具有更大的HIV病毒抑制（HIV-1 RNA pcr < 200拷贝/mL）、抗逆转录病毒治疗开始、HIV护理保留和阿片类药物使用减少。我们将使用混合逻辑回归模型来检验这些假设。与艾滋病毒诊所提供者，管理人员和患者的年度定性访谈将记录形成实施战略，挑战和最佳实践，以告知全国扩大基于诊所的BUP/NX。拟议的工作是第一个大规模的随机试验艾滋病毒临床为基础的BUP/NX与转介MMT在现实世界的艾滋病毒诊所设置。一项成功的研究可能会改变越南对同时发生阿片类药物依赖的患者的艾滋病毒治疗实践，并为美国和世界各地的实践提供信息。

DESCRIPTION (provided by applicant): The primary objective of this proposal is to compare the effect of two opioid dependence treatment delivery models on improving the HIV care engagement and outcomes in Vietnam. We partner with several key institutions in Vietnam to propose a multi-site, randomized trial of HIV clinic- based buprenorphine/naloxone (BUP/NX) (n=225) versus referral to methadone maintenance treatment (MMT) (n=225) for treatment of opioid dependence in HIV-infected patients new to care in 5 HIV clinics in Hanoi and Hai Phong-epicenters of the Vietnam HIV epidemic. HIV providers will be trained to manage opioid dependence using flexible BUP/NX dosing and take-out schedules. All subjects will receive clinic-based counseling and HIV care. Self-reported drug use, urine drug screens (UDS), and measures of HIV care engagement and outcomes will be assessed through 12 months follow-up. Qualitative interviews in years 1 through 4 will identify lessons-learned to inform national BUP/NX guidelines for scale-up. We will assess the effect of clinic-based BUP/NX versus MMT referral on HIV viral suppression and treatment engagement (Aim 1) and opioid use (Aim 2) at 12 months. We hypothesize that subjects randomized to clinic-based BUP/NX will have greater HIV viral suppression (HIV-1 RNA pcr < 200 copies/mL), antiretroviral therapy initiation, HIV care retention, and decreased opioid use at 12 months compared with MMT referral. We will test these hypotheses using mixed logistic regression models. Annual qualitative interviews with HIV clinic providers, administrators, and patients will document formative implementation strategies, challenges, and best practices to inform national scale-up of clinic-based BUP/NX. The proposed work is the first large-scale randomized trial of HIV clinic-based BUP/NX versus referral for MMT in real-world HIV clinic settings. A successful study is likely to change HIV treatment practices in Vietnam for patients with co-occurring opioid dependence and inform practices in the United States and worldwide.