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Alcohol reduction intervention study for TB and/ HIV patients in India

HATHI (Hybrid trial for Alcohol reduction among people with TB and HIV in India) - HATHI

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/03/024141
Enrollment
450
Registered
2020-03-20
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: Z918- Other specified personal risk factors, not elsewhere classified Health Condition 2: A150- Tuberculosis of lung

Interventions

Intervention1: Counseling for Alcohol Problem (CAP) - It includes Cognitive Behavioral Therapy (CBT) and Motivational Enhancement Therapy (MET): In the CAP intervention, 4 session of combined CBT/MET

Sponsors

National Institute on Alcohol Abuse and Alcoholism NIAAA National Institutes of Health NIH
Lead Sponsor
BJ Govt Medical College
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Active TB, 18+ years Starting TB treatment, Known HIV status, AUDIT score more than equal to 8 if male, AUDIT score more than equal to 4 if female

Exclusion criteria

Exclusion criteria: already in alcohol treatment severe medical illness, cognitive dysfunction or active psychosis, pregnant

Design outcomes

Primary

MeasureTime frame
- Intervention will result in a greater reduction in drinking days, heavy drinking days and drinks per drinking day, and lower levels of PEth (which is dried blood spot test to confirm alcohol use). - Intervention will result in 1) decreased TB treatment default, failure or death (primary), 2) increased TB medication adherence, 3) increased retention in TB care; and among PWH/TB, 4) increased HIV-RNA suppression and 5) increased ART adherence and 6) increased retention in HIV care. Timepoint: Measured at 6 and 12 months

Secondary

MeasureTime frame
To understand multi-level factors that influence alcohol reduction intervention integration into these clinical settings. a) evaluate patient, provider and organizational barriers and facilitators to integrated alcohol treatment in TB and HIV/TB settings, and b) measure incremental costs from health system and societal perspectives, and to estimate their incremental cost-effectiveness, compared to treatment as usual. Timepoint: during the study period for 5 years

Countries

India

Contacts

Public ContactProf Shashikala Sangle

B.J. Government Medical College and Sassoon General Hospital

hathi.bjgmc.dpu.2019@gmail.com9822874712

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026