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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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 /≥4 in women.

Locations
Other Locations
India
BJ Government Medical College and Sassoon General Hospital
RECRUITING
Pune
Dr. D. Y. Patil Medical College
RECRUITING
Pune
Contact Information
Primary
Amita Gupta
agupta25@jhmi.edu
410-502-7696
Backup
Geetanjali Chander
gchander@uw.edu
443-287-2030
Time Frame
Start Date: 2022-09-22
Estimated Completion Date: 2026-08-31
Participants
Target number of participants: 450
Treatments
Experimental: HATHI
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.
Other: Usual Care
Provider advice to reduce alcohol use per recommended standard of clinical care, and referral to treatment as indicated
Related Therapeutic Areas
Sponsors
Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Leads: Johns Hopkins University

This content was sourced from clinicaltrials.gov