Hybrid trial for Alcohol reduction among people with TB and HIV in India (HATHI): Protocol for a Hybrid Type 1 Effectiveness-Implementation Randomized Controlled Trial

Abstract Background The highest incidence of tuberculosis disease (TB) in the world is in India, accounting for 26% of all new cases globally, with approximately 48,000 among persons with HIV (PWH). Unhealthy alcohol use can worsen the health of people who have TB or HIV and those who have both TB and HIV. Behavioral interventions that target alcohol use and are integrated into TB and HIV care may lead to better outcomes. This paper describes the protocol for HATHI, H ybrid trial for A lcohol reduction among people with T B and H IV in I ndia, a Hybrid Type 1 effectiveness-implementation trial, that tests if a behavioral intervention integrated into TB and HIV treatment, compared to usual care, results in lower alcohol use and improved TB and HIV health outcomes among people with unhealthy alcohol use in Pune, India. Methods HATHI is a randomized controlled trial that will recruit 450 people with unhealthy alcohol use from TB and HIV clinics in Pune, India. The aims of HATHI are to: (1) test if a four session behavioral intervention integrated into TB and HIV care results in lower alcohol use among persons with TB, HIV and TB/HIV coinfection compared to usual care as measured by phosphatidyl ethanol (PEth), an alcohol biomarker (primary outcome); (2) test if the same intervention also leads to improved 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; (3) evaluate barriers and facilitators to integrating the intervention into TB and HIV care, and (4) determine the incremental costs of delivering the intervention in these clinical settings. We hypothesize that the HATHI intervention will result in lower alcohol use compared to standard of care use at 6 months among people and superior TB and HIV clinical outcomes at 12 months. Discussion This intervention addresses unhealthy alcohol use, a known barrier to optimal TB and HIV treatment outcomes. If HATHI proves effective, insights into barriers and facilitators for integration will inform future scale-up of this behavioral alcohol intervention in TB and HIV clinical settings. Trial registration ClinicalTrials.gov NCT04230395 (first submission 1/18/2020, most recently update 2/17/25) and India Clinical trial Registry CTRI/2020/03/024141