Effectiveness of Alcohol Interventions Among TB Patients in Tomsk, Russia

描述（由申请人提供）：俄罗斯的两个主要公共卫生问题是酒精使用障碍（AUD）和结核病（TB）。AUDs在与TB相关的发病率和死亡率中发挥协同作用。尽管实施了世界卫生组织认可的DOTS（直接观察治疗-短程化疗），但俄罗斯的许多结核病项目都没有成功，这在很大程度上是由于AUD对不依从性的巨大影响，最终导致治疗效果不佳。然而，俄罗斯结核病患者并发AUDs的管理一直被忽视。因此，我们的目的是检查两种经证实的酒精干预措施的有效性时，整合作为常规结核病护理的一部分，在俄罗斯托木斯克合并结核病和AUDs的患者。提供这些酒精干预措施的一个重要方面是将其纳入DOTS结核病护理服务，利用直接观察治疗，病例保持策略和频繁的路由监测的优势。我们提出了一项III期临床试验，在结核病和酒精滥用/依赖患者中比较酒精和结核病治疗结果，这些患者随机接受以下干预措施之一：1.由结核病医生在每月患者评估时提供的行为咨询干预（BCI）加上常规治疗（TAU）; 2.在直接观察治疗加TAU下施用纳洛酮; 3. BCI、纳洛酮和TAU;或4.τ的如果被证明是有效的，这种在结核病卫生保健模式内提供酒精干预的卫生服务创新可能会对俄罗斯的公共卫生产生重大影响。我们的研究团队拥有丰富的经验 在酒精和其他物质依赖患者的研究中。我们也有一个牢固的 计划和研究存在于托木斯克，与我们的托木斯克同事的独特关系，将确保这项研究的可行性。最后，我们有一个多元化的跨学科团队，能够制定一个综合的生物社会和文化适当的方法来治疗这一人群中的AUD。

DESCRIPTION (provided by applicant): Two major public health issues in Russia are alcohol use disorders (AUDs) and tuberculosis (TB). AUDs play a synergistic role in the morbidity and mortality associated with TB. Despite the implementation of DOTS (Directly Observed Therapy - Short Course Chemotherapy) endorsed by the World Health Organization, many TB programs in Russia have been unsuccessful, in large part due to the overwhelming impact of AUDs on nonadherence and, ultimately, poor treatment outcomes. Yet, management of concurrent AUDs among TB patients in Russia has been neglected. Therefore, we aim to examine the effectiveness of two proven alcohol interventions when integrated as part of routine TB care among patients with co-occurring TB and AUDs in Tomsk, Russia. An important aspect of the delivery of these alcohol interventions will be their incorporation into DOTS TB care services, utilizing the strengths of directly observed therapy, case holding strategies, and frequent routing monitoring. We propose a Phase III clinical trial comparing alcohol and TB treatment outcomes among individuals with TB and alcohol abuse/dependence who are randomized to one of the following interventions: 1. Behavioral Counseling Intervention (BCI) delivered by TB physicians at monthly patient evaluations plus treatment as usual (TAU); 2. Naltrexone administered under directly observed therapy plus TAU; 3. BCI, naltrexone and TAU; or 4. TAU. If proven effective, such innovations in health service delivery of alcohol interventions within the TB health care model could have a major public health impact in Russia. Our research team has extensive experience in research on alcohol and other substance-dependent patients. We also have a firmly established programmatic and research presence in Tomsk, with unique relations with out Tomsk colleagues that will ensure the feasibility of this study. Finally, we have a diverse interdisciplinary team that has been able to formulate an integrated biosocial and culturally-appropriate approach to treating AUDs in this population.