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（AUDs）和结核病（TB）。AUDs在与结核病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-短期化疗），但俄罗斯的许多结核病项目都不成功，这在很大程度上是由于AUDs对不依从性的压倒性影响，最终导致治疗结果不佳。然而，在俄罗斯，结核病患者并发AUDs的管理一直被忽视。因此，我们的目的是研究两种已证实的酒精干预措施在俄罗斯托木斯克合并结核病和AUDs的患者中作为常规结核病治疗的一部分时的有效性。提供这些酒精干预措施的一个重要方面是将其纳入直接督导下的短程化疗结核病护理服务，利用直接观察治疗、病例保留策略和频繁路线监测的优势。我们建议进行一项III期临床试验，比较结核病和酒精滥用/依赖患者的酒精和结核病治疗结果，这些患者被随机分配到以下干预措施之一：行为咨询干预（BCI）由结核病医生在每月患者评估加上常规治疗（TAU）时提供；2. 纳曲酮直接观察治疗加TAU；3. BCI、纳曲酮、TAU；或4。τ。如果证明有效，在结核病卫生保健模式中提供酒精干预措施的卫生服务方面的这种创新可能对俄罗斯的公共卫生产生重大影响。我们的研究团队经验丰富

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.