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. ? ? ?

National Institute of Health (NIH)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Research Project (R01)
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Special Emphasis Panel (ZAA1-CC (60))
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Delany, Pete
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Brigham and Women's Hospital
United States
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