Can talking therapy cut alcohol use and save lives in TB and HIV patients?
NCT ID NCT04230395
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a 4-session behavioral program to reduce alcohol use in 450 people with TB and HIV in India. Unhealthy drinking can worsen TB and HIV outcomes. The program is added to usual care, and researchers will check if it lowers alcohol use and improves health. The goal is to see if this approach is practical and cost-effective in real-world clinics.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- behavioral intervention (motivational enhancement therapy and cognitive behavioral therapy)
- What this could lead to
- If successful, this could provide an effective way to reduce alcohol use and improve TB and HIV treatment outcomes in India.
- What could go wrong
- This is a behavioral intervention, not a drug, so results depend on patient participation. The study is also specific to India, so findings may not apply elsewhere.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
About 450 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Sep 2022
- Expected to finish
-
Mar 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 80 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for HIV are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
BJ Government Medical College and Sassoon General Hospital
Pune, Maharashtra, 4110001, India
-
Dr. D. Y. Patil Medical College
Pune, Maharashtra, 411018, India
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can 'Queen Mothers' bring HIV testing to the doorstep?
- Can a Once-Daily HIV pill with food match Twice-Daily dosing during TB treatment?
- Scientists map HIV's hiding spots in early infection
- Can simple sputum and urine tests catch tuberculosis earlier?
- Can a common virus be turned into a TB vaccine? scientists test VIR-1778
- Can local clinics keep more people with HIV in care?