Alcohol Reduction Among People With TB and HIV in India

NCT04230395 | Recruiting DMC

• 2 other identifiers: IRB00235134R01AA027974
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Tuberculosis; HIV

Keywords

Alcohol Use; HIV; Tuberculosis

Outcome Measures

Primary Outcomes (1)

• PEth

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

  6 months

Secondary Outcomes (9)

• Change in Alcohol Use as assessed by change in Drinking days

  3 months and 12 months

• Change in Alcohol Use as assessed by change in heavy Drinking days

  3 months and 12 months

• Change in Alcohol Use as assessed by change in standard drinks per drinking days

  3 months and 12 months

• TB treatment failure, TB treatment default, or all-cause mortality

  12 months

• HIV-RNA Non-Suppression

  6 months

Other Outcomes (1)

• Change in Phosphatidyl Ethanol

  3, 6, 12 months

Study Arms (2)

HATHI

EXPERIMENTAL

The HATHI intervention is an up to 4-session alcohol reduction intervention that uses a combination of Motivational Enhancement Therapy and Cognitive Behavioral Therapy. The intervention will also include 3 booster sessions.

Behavioral: HATHI Intervention

Usual Care

OTHER

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

Other: Usual Care

Interventions

Usual Care OTHER

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

Usual Care

HATHI Intervention BEHAVIORAL

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

HATHI

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (2)

BJ Government Medical College and Sassoon General Hospital

Pune, Maharashtra, 4110001, India

RECRUITING

Dr. D. Y. Patil Medical College

Pune, Maharashtra, 411018, India

RECRUITING

MeSH Terms

Conditions

Tuberculosis; Alcohol Drinking

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Drinking Behavior; Behavior

Study Officials

• Amita Gupta, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amita Gupta

CONTACT

410-502-7696; agupta25@jhmi.edu

Geetanjali Chander

CONTACT

443-287-2030; gchander@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2020
• First Posted: January 18, 2020
• Study Start: September 22, 2022
• Primary Completion (Estimated): September 6, 2026
• Study Completion (Estimated): March 6, 2027
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

IN (2)