NCT04230395Active, not recruiting
Alcohol Reduction Among People With TB and HIV in India
Hybrid Trial for Alcohol Reduction Among People With TB and HIV in India (HATHI)
Source: ClinicalTrials.gov · Last updated 15 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 450 (estimated)
- First submitted
- 14 Jan 2020
- Start date
- 22 Sept 2022
- Primary completion date
- 31 Mar 2027
- Lead sponsor
- Johns Hopkins University
- Diseases
- Tuberculosis, HIV
- NCT number
- NCT04230395
What you commit to
- Study type: Interventional
- Planned participants: 450
- From 22 Sept 2022 to the primary completion date, 31 Mar 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- unable to participate in intervention sessions either due to severity of medical illness, cognitive dysfunction or active psychosis;
- Patients reported to have Drug Resistant TB, Multidrug-Resistant Tuberculosis (MDR-TB) and Extrapulmonary tuberculosis (EPTB) if they are in only TB cohort.
Other
- already in treatment for unhealthy alcohol use;
- pregnant (will refer directly to alcohol treatment)
- household member of current study participant
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dr. D. Y. Patil Medical College Coordinator of this site? Confirm its status | Pune | India | Unknown status |
| BJ Government Medical College and Sassoon General Hospital Coordinator of this site? Confirm its status | Pune | India | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.