Reducing alcohol use in people with TB and HIV in India
Hybrid Trial for Alcohol Reduction Among People With TB and HIV in India (HATHI)
This study tests a new program to help people with TB and HIV in India cut down on alcohol use to see if it improves their overall health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 450 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 2 sites (Pune, Maharashtra and 1 other locations) |
| Trial ID | NCT04230395 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of a behavioral intervention called HATHI, designed to reduce unhealthy alcohol use among individuals with tuberculosis (TB) and HIV in India. The intervention consists of four sessions integrated into the standard care for TB and TB/HIV patients. By addressing alcohol use, the study seeks to improve health outcomes for these patients, who are at increased risk of complications due to their conditions. The study will assess both the reduction in alcohol consumption and the subsequent health improvements in TB and HIV management.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have active TB and HIV, and exhibit unhealthy alcohol use.
Not a fit: Patients who are already receiving treatment for unhealthy alcohol use or those with severe medical conditions that prevent participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve health outcomes for patients with TB and HIV by reducing alcohol use.
How similar studies have performed: Previous studies have shown that integrated behavioral interventions can effectively reduce alcohol use, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Pune, Maharashtra and 1 other locations
- BJ Government Medical College and Sassoon General Hospital — Pune, Maharashtra, India (Recruiting)
- Dr. D. Y. Patil Medical College — Pune, Maharashtra, India (Recruiting)
Study contacts
- Principal investigator: Amita Gupta, MD — Johns Hopkins University
- Study coordinator: Amita Gupta
- Email: agupta25@jhmi.edu
- Phone: 410-502-7696
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.