Hybrid trial for Alcohol reduction among people with TB and HIV in India (HATHI)

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The highest incidence of tuberculosis disease (TB) in the world is in India, accounting for 27% of all new cases globally, with approximately 86,000 among persons with HIV (PWH). Unhealthy alcohol use triples the risk of TB in the general population, increasing susceptibility to primary infection and reactivation, and also leads to poor TB outcomes including decreased treatment adherence, treatment failure, default and death. Among PWH, unhealthy alcohol use is associated with decreased use of and adherence to antiretroviral therapy (ART), lower viral suppression and increased mortality. Our work in India demonstrates not only high prevalence of unhealthy alcohol use among patients with TB, but also that it is one of the major reasons for treatment default, failure, and mortality. With the high prevalence of unhealthy alcohol use and its association with adverse TB and HIV treatment outcomes in low and middle income countries (LMIC), it is imperative to test scalable, culturally relevant, evidence-based alcohol interventions and measure implementation factors to facilitate more rapid integration of effective interventions into TB and HIV/TB care. To this end, we propose HATHI (Hybrid trial for Alcohol reduction among people with TB and HIV in India). This 2-arm hybrid type 1 effectiveness-implementation RCT will examine the effectiveness of CAP (Counseling on Alcohol Problems), a four-session combined Cognitive Behavioral Therapy/Motivational Enhancement Therapy alcohol reduction intervention integrated into HIV/TB and TB care, compared with usual care (provider advice, referral to treatment as needed). Patients (n=450) with TB (n=225) and HIV/TB co-infection (n=225) and unhealthy alcohol use will be recruited from TB and HIV clinics at 2 large, well-established research and care centers in Pune, Maharashtra India. Effectiveness outcomes measured at 3, 6 and 12 months include 1) self-reported alcohol use and phosphatidyl ethanol (PEth), an alcohol biomarker, and 2) TB and HIV clinical outcomes including TB and HIV medication adherence, HIV viral suppression, TB sputum/culture conversion and the composite outcome of TB treatment failure, default or death. Using the RE-AIM implementation framework, we will use mixed methods to assess barriers and facilitators to alcohol treatment integration in TB and HIV/TB clinical settings and the incremental costs of this intervention strategy. This hybrid effectiveness- implementation study addresses the huge burden of unhealthy alcohol use among persons with TB and TB/HIV in India, the country with the highest burden of TB, 3rd highest burden of HIV, and where unhealthy alcohol use is a significant contributor to unfavorable treatment outcomes. Our multidisciplinary team of epidemiologists, clinicians, health economists and behavioral scientists has a successful track record for conducting clinical trials and alcohol interventions in the US and India. Our research will provide much-needed evidence to inform local and global policy, and improve outcomes for persons most affected by HIV, TB, and unhealthy alcohol use.