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RECRUITING
NCT04230395
NA

Alcohol Reduction Among People With TB and HIV in India

Sponsor: Johns Hopkins University

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

450

Start Date

2022-09-22

Completion Date

2027-03-06

Last Updated

2026-03-09

Healthy Volunteers

No

Conditions

Interventions

BEHAVIORAL

HATHI Intervention

4-session combination Motivational Enhancement Therapy and Cognitive Behavioral Therapy alcohol reduction intervention. The intervention will also include 3 booster sessions.

OTHER

Usual Care

Provider advice to reduce alcohol use per recommended standard of clinical care, and referral to treatment as indicated

Locations (2)

BJ Government Medical College and Sassoon General Hospital

Pune, Maharashtra, India

Dr. D. Y. Patil Medical College

Pune, Maharashtra, India