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

描述(由申请人提供)：本提案的主要目标是比较两种阿片依赖治疗提供模式在改善越南艾滋病毒护理参与度和结果方面的效果。我们与越南的几个主要机构合作，提出了一项多点随机试验，以艾滋病毒诊所为基础的丁丙诺啡/纳洛酮(BUP/NX)(n=225)和转介美沙酮维持治疗(MMT)(n=225)，用于治疗在越南河内和海防的5家艾滋病毒诊所新护理的艾滋病毒感染者的阿片类药物依赖。艾滋病毒提供者将接受培训，以使用灵活的BUP/NX剂量和取出时间表管理阿片类药物依赖。所有受试者都将接受以诊所为基础的咨询和艾滋病毒护理。将通过12个月的跟踪评估自我报告的药物使用情况、尿液药物筛查(UDS)以及艾滋病毒护理参与度和结果的衡量标准。从第1年到第4年的定性访谈将确定经验教训，为国家BUP/NX扩大规模指导方针提供参考。我们将在12个月时评估基于临床的BUP/NX转诊与MMT转诊对HIV病毒抑制和治疗参与(AIM 1)和阿片类药物使用(AIM 2)的影响。我们假设，与MMT转介患者相比，随机接受基于临床的BUP/NX的受试者在12个月时将有更强的HIV病毒抑制(HIV-1RNA PCR和200拷贝/毫升)、抗逆转录病毒治疗开始、HIV护理保留和阿片类药物的使用减少。我们将使用混合Logistic回归模型来检验这些假设。对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性实施战略、挑战和最佳实践，以向全国推广以诊所为基础的BUP/NX。这项拟议的工作是第一次大规模的基于HIV诊所的BUP/NX与现实世界HIV诊所环境中MMT转诊的随机试验。一项成功的研究可能会改变越南对阿片类药物依赖患者的艾滋病毒治疗做法，并为美国和世界各地的做法提供借鉴。

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.