Hybrid Trial for Alcohol Reduction Among People With TB and HIV in India (HATHI)

In 2017, over 10 million people worldwide developed tuberculosis disease (TB), with 9% of cases among people with HIV (PWH). In that same year, there were 1.6 million deaths from TB, with 300,000 among PWH. The highest incidence of TB is in India, accounting for 27% of all new cases globally, with approximately 86,000 among PWH. Unhealthy alcohol use triples the risk of TB in the general population, increasing susceptibility to primary infection and reactivation. Among PWH, unhealthy alcohol use is associated with decreased use of and adherence to antiretroviral therapy (ART), lower viral suppression and increased mortality. Treatment for TB presents a unique opportunity to address unhealthy alcohol use among people with TB and TB/HIV coinfection and HIV given the frequent contact participants have with healthcare providers and the deleterious effects of unhealthy use on both HIV and TB clinical outcomes. Although combined cognitive behavioral therapy (CBT) and motivational enhancement therapy (MET) can be effective in reducing alcohol use, access to and implementation of such interventions is limited in high-need, under-resourced low and middle income (LMIC) settings. Even in settings where formal treatment is available, alcohol-related stigma and cost of treatment may prevent individuals from seeking care. Integrating treatment for unhealthy alcohol use into TB and TB/HIV and HIV care may overcome barriers to alcohol treatment for such individuals at risk for poor health outcomes. HATHI (Hybrid trial for Alcohol reduction among people with TB, TB/HIV and HIV in India), is a 2-arm hybrid type 1 effectiveness-implementation randomized controlled trial (RCT) examining the effectiveness of a four-session combined CBT/MET alcohol reduction intervention (HATHI), followed by three intervention boosters, integrated into TB and TB/HIV and TB care, compared with usual care (provider advice, referral to treatment as needed). There will be 3 phases. In Phase 1) investigators will tailor the intervention based on results from a) focus groups (FG) with patients with TB and HIV, medical and clinical staff, and the intervention counselors (IC) and b) individual intervention testing with a subgroup of patients with TB and HIV. In Phase 2) investigators will conduct an RCT in which participants will be randomized to HATHI intervention or to usual care. Investigators will stratify persons with TB/HIV coinfection by HIV status to ensure balance of HIV between the groups. Effectiveness outcomes measured at 3, 6 and 12 months will include 1) phosphatidyl ethanol (PEth), an alcohol biomarker (primary), and self reported alcohol use (secondary) 2) TB and HIV clinical outcomes. In Phase 3, evaluating trial participants, counselors, clinical and organizational staff, investigators will use the RE-AIM implementation framework using mixed methods to assess barriers and facilitators to alcohol treatment integration in TB and HIV clinical settings and to assess the incremental costs of this intervention strategy.

Setting: All phases of the study will take place at two sites in India: the Byramjee Jeejeebhoy Government Medical College (BJGMC) and Dr. DY Patil Medical College, Pune (DYPMC).

Objectives/Aims:

Aim 1: In a randomized controlled trial (RCT), to examine the effectiveness of CBT/MET integrated into TB, TB/HIV and HIV care compared to usual care on alcohol use.

Aim 2: In a RCT, to examine the effectiveness of CBT/MET integrated into TB, TB/HIV and HIV care compared to usual care on TB and HIV treatment outcomes.