Alcohol Reduction Among People With TB and HIV in India

NCT04230395 · tracked via the Priya Life Science India tracker

Sponsor

Johns Hopkins University

Phase

Not applicable

Started

2022-09-22

Last updated

2026-06-15

Condition(s) studied

TuberculosisHIV

Investigational drug(s) / intervention(s)

HATHI InterventionUsual Care

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

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

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

Inclusion Criteria: * Active TB defined as either a) microbiologically confirmed TB (sputum AFB smear positive by microscopy or +GeneXpert at entry) or b) clinical TB that is subsequently confirmed by Acid-Fast Bacilli (AFB) culture; with or without concurrent HIV infection) * HIV infection * initiating TB therapy; * age ≥ 18 years of age; * AUDIT Score ≥ 8 in men /≥ 6 in women. Exclusion Criteria: * already in treatment for unhealthy alcohol use; * unable to participate in intervention sessions either due to severity of medical illness, cognitive dysfunction or active psychosis; * pregnant (will refer directly to alcohol treatment) * household member of current study participant * Patients reported to have Drug Resistant TB, Multidrug-Resistant Tuberculosis (MDR-TB) and Extrapulmonary tuberculosis (EPTB) if they are in only TB cohort.

Primary outcome measure(s)

PEth — 6 months
PEth biomarker will be used as a liner variable and log transformed if data are skewed

Trial sites (2)

Facility	City	Region	Status
BJ Government Medical College and Sassoon General Hospital	Pune	Maharashtra
Dr. D. Y. Patil Medical College	Pune	Maharashtra

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04230395 on ClinicalTrials.gov ↗ ← All trials in India