NCT04230395: HATHI

Alcohol Reduction Among People With TB and HIV in India

Recruiting now NA Last updated 9 March 2026

What this trial tests

NA trial testing HATHI Intervention in Tuberculosis in 450 participants. Currently enrolling.

Timeline

22 September 2022

Primary endpoint
6 September 2026

6 March 2027

Quick facts

Lead sponsor	Johns Hopkins University
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	450
Start date	22 September 2022
Primary completion	6 September 2026
Estimated completion	6 March 2027
Sites	2 locations across India

Drugs / interventions tested

• HATHI Intervention
• Usual Care

Conditions studied

• Tuberculosis — all drugs for Tuberculosis →
• HIV — all drugs for HIV →

Sponsor

Johns Hopkins University

Who can join

Adults 18 to 80, any sex, with Tuberculosis or HIV. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 can worsen the health of people who have Tuberculosis (TB), HIV and people who have both TB and HIV. Behavioral interventions that 1) target alcohol use and 2) are integrated into TB and TB/HIV and HIV care may lead to better outcomes. The goal of this study is to test if a behavioral alcohol reduction intervention integrated into TB, TB/HIV and HIV treatment can reduce alcohol use and improve TB and HIV health outcomes among people with unhealthy alcohol use. The aims of the HATHI study are: Aim 1: To test if a 4 session behavioral alcohol reduction intervention, called HATHI, integrated into TB and TB/HIV and HIV Care can decrease unhealthy alcohol use among persons with TB and TB/HIV coinfection and HIV. Aim 2: To test if the HATHI intervention, integrated into TB and TB/HIV and HIV care can improve TB and HIV clinical outcomes; Aim 3: To evaluate barriers and facilitators to integrating HATHI intervention into TB and TB/HIV and HIV care, and to determine the incremental costs of delivering HATHI intervention in TB and HIV clinical settings. Investigators hypothesize that HATHI intervention will reduce alcohol use among persons with TB and TB with HIV and HIV, and that its delivery in the TB and HIV setting will be acceptable to patients and providers and feasible.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. 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
   Chander G, Suryavanshi N, Gupte N, Dhumal G, et al · · 2026 · DOI 10.21203/rs.3.rs-8759034/v1