Thomas 2017.

Study characteristics
Methods	Study design: Cluster randomized controlled trial Country: India Setting: Chennai City zones where TB investigations and treatment are offered through the Revised National Tuberculosis Control Programme (RNTCP) Eligibility criteria: Included were zones with TB investigations and treatment offered through the RNTCP in Chennai. Participants were included if they were new TB patients, 18 years and older who were registered for an anti‐tuberculosis treatment. Duration of follow‐up: 6‐months Informed consent: All participants provided written informed consent Ethical approvals: Study procedures were approved by the National Institute for Research in Tuberculosis, the Indian Council of Medical Research, and Chennai Corporation
Participants	Sample size: 298 (113 alcohol counseling, 185 usual care) Description of the target population: Patients with tuberculosis Age: 44 years Sex: Not reported Race/Ethnicity: Not reported Marital status: 72% married Harmful alcohol use (baseline): 37% hazardous alcohol use, 20% harmful use, 33% dependence Co‐occurring disorders: 76% were new cases of tuberculosis, 24% were retreatment cases
Interventions	Type: Non‐pharmacologic Description: Alcohol counseling including discussion of the relationship between alcohol and tuberculosis, and the effect of alcohol on physical health, family and society. Duration and frequency: Four 45‐60 minute sessions at 0, 2, 4, and 6 months Delivery and provider: Trained lay counselor Comparison group: Usual care for tuberculosis without alcohol counseling
Outcomes	Primary outcome(s): Alcohol consumption Primary outcome measurement tool(s): AUDIT Secondary outcome(s): Adherence to anti‐tuberculosis treatment Secondary outcome measurement tool(s): Regular adherence, irregular adherence, or lost to follow‐up Time points: 0 and 6 months
Notes	Study funding and conflicts of interest: UNAIDS Linked study records: None
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	"This was a pilot, two‐arm, parallel‐cluster randomised trial carried out in four zones (TB units) where TB investigations and treatment are offered through the Revised National Tuberculosis Control Programme (RNTCP). The four zones were divided into two strata, two of which were high‐prevalence and two were low‐prevalence zones. Within each stratum, one zone was allocated to the intervention arm and the other to the control arm. Here the zones were the units of randomisation (clusters)" Pg. 948
Allocation concealment (selection bias)	High risk	"For administrative purposes, Chennai City is divided into 10 corporation zones and 155 divisions. This was a pilot, two‐arm, parallel‐cluster randomised trial carried out in four zones (TB units) where TB investigations and treatment are offered through the Revised National Tuberculosis Control Programme (RNTCP). The four zones were divided into two strata, two of which were high‐prevalence and two were low‐prevalence zones. Within each stratum, one zone was allocated to the intervention arm and the other to the control arm. Here the zones were the units of randomisation (clusters)" Pg. 948
Blinding of participants and personnel (performance bias) All outcomes	High risk	Participants and personnel cannot be blinded for this type of intervention
Blinding of outcome assessment (detection bias) All outcomes	High risk	Outcomes reported by participant not blind to intervention
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	"Information on overall treatment adherence was available for 104 (92%) intervention group participants and for 173 (94%) control group participants." Pg. 950
Selective reporting (reporting bias)	High risk	Does not provide quantitative results by alcohol risk level.