Alcohol reduction intervention study for TB and/ HIV patients in India
Not Applicable
- Conditions
- Health Condition 1: Z918- Other specified personal risk factors, not elsewhere classifiedHealth Condition 2: A150- Tuberculosis of lung
- Registration Number
- CTRI/2020/03/024141
- Lead Sponsor
- ational Institute on Alcohol Abuse and Alcoholism NIAAA National Institutes of Health NIH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
already in alcohol treatment
severe medical illness,
cognitive dysfunction or active psychosis,
pregnant
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - 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). <br/ ><br>- 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. <br/ ><br>Timepoint: Measured at 6 and 12 months
- Secondary Outcome Measures
Name Time Method To understand multi-level factors that influence alcohol reduction intervention integration into these clinical settings. <br/ ><br>a) evaluate patient, provider and organizational barriers and facilitators to integrated alcohol treatment in TB and HIV/TB settings, and <br/ ><br>b) measure incremental costs from health system and societal perspectives, and to estimate their incremental cost-effectiveness, compared to treatment as usual. <br/ ><br>Timepoint: during the study period for 5 years