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Search / Trial NCT04230395

Alcohol Reduction Among People With TB and HIV in India

Launched by JOHNS HOPKINS UNIVERSITY · Jan 14, 2020

Trial Information

Current as of August 29, 2025

Recruiting

Keywords

Alcohol Use Hiv Tuberculosis

ClinConnect Summary

**Summary of the Clinical Trial: Alcohol Reduction Among People With TB and HIV in India**

This clinical trial, called the HATHI study, is looking at how to help people with tuberculosis (TB), especially those who also have HIV, reduce their alcohol use. In India, where TB is a big health problem, using alcohol in unhealthy ways can make both TB and HIV worse. The study will test a program called CAP (Counseling on Alcohol Problems) that includes four sessions aimed at reducing alcohol use. The goal is to see if this program can help people with TB and HIV feel better and improve their health.

To participate in this study, you need to be at least 18 years old, have active TB, and show signs of unhealthy alcohol use. This means your alcohol use scores must be above a certain level. If you're currently receiving treatment for alcohol problems or have certain severe medical issues, you won't be eligible. Participants will attend several counseling sessions as part of their TB treatment, and the study will also look at how easy it is to include this program in TB care settings. Overall, the researchers hope this approach will be helpful for patients and feasible for healthcare providers.

Gender

ALL

Eligibility 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 /≥4 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.

About Johns Hopkins University

Johns Hopkins University, a prestigious research institution located in Baltimore, Maryland, is renowned for its commitment to advancing medical science and public health through innovative clinical trials. With a rich history of groundbreaking research and a multidisciplinary approach, the university's clinical trial initiatives focus on translating scientific discoveries into effective treatments and interventions. Leveraging state-of-the-art facilities and a collaborative network of experts, Johns Hopkins University conducts rigorous clinical studies that aim to improve patient outcomes and address critical health challenges. Its dedication to ethical standards and participant safety underscores its role as a leader in clinical research.

Locations

Pune, Maharashtra, India

Pune, Maharashtra, India

Patients applied

0 patients applied

Trial Officials

Amita Gupta, MD

Principal Investigator

Johns Hopkins University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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