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Hybrid Trial for Alcohol Reduction among People with TB and HIV in India
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).
Primary aims and hypothesis
Specific Aim 1: To examine the effectiveness of CBT/MET integrated into TB and HIV/TB care compared to usual care on alcohol reduction.
Hypothesis: We hypothesize that compared to usual care, CBT/MET will result in a greater reduction in drinking days, heavy drinking days and drinks per drinking day, and lower levels of PEth;
Specific Aim 2: To examine the effectiveness of CBT/MET integrated into TB and HIV/TB care compared to usual care on TB and HIV treatment outcomes.
Hypothesis: We hypothesize that compared to usual care, CBT/MET will result in 1) decreased TB treatment default, failure or death (primary), 2) increased TB medication adherence, 3) increased retention in TB care; and among PWH/TB, 4) increased HIV-RNA suppression and 5) increased ART adherence and 6) increased retention in HIV care.
Specific Aim 3: Guided by the RE-AIM implementation framework, and using mixed methods, to 3a) evaluate patient, provider and organizational barriers and facilitators to integrated alcohol treatment in TB and HIV/TB settings, and 3b) measure incremental costs from health system and societal perspectives, and to estimate their incremental cost-effectiveness, compared to treatment as usual. The primary implementation outcome domains for aim 3 include: 3a) intervention Reach, Effectiveness, Adoption (Feasibility, Acceptability, Appropriateness), Implementation (Fidelity), and Maintenance (Sustainability); and 3b) costs defined as estimated incremental cost per incremental Disability Adjusted Life Years (DALY) averted.