Papas 2011.

Study characteristics
Methods	Study design: Randomized controlled trial Country: Kenya Setting: HIV outpatient clinic Eligibility criteria: Included were adults 18+ years of age enrolled in a HIV outpatient clinic with hazardous alcohol use or binge drinking (AUDIT‐C>=3, 6+ drinks per occasion monthly or more frequently), alcohol use in the past 30 days, eligible for antiretroviral treatment or initiated in the past year, speaks Kiswahili, living within one hour from the clinic with no plans to move away during the study period, and available during weekly group time. Excluded were individuals with active psychosis or suicidality, who attended an existing alcohol peer support group in the past year, or had participated int he study's group cognitive behavioral therapy pre‐pilot development study. Duration of follow‐up: 4.5 months Informed consent: All participants provided written informed consent Ethical approvals: Approved by IRBs at all participated universities ‐ Brown University, Moi University, Indiana University, Yale University, Syracuse University
Participants	Sample size: 75 (42 intervention, 33 control) Description of the target population: Outpatients living with HIV Age: 37.07 years (SD=8.04) Sex: Not reported Race/Ethnicity: Not reported Marital status: 57.33% married Harmful alcohol use (baseline): 9.99 days of alcohol use in the past month (SD=7.89); 5.68 drinks per drinking day (SD=4.01) Co‐occurring disorders: HIV/AIDS
Interventions	Type: Non‐pharmacologic Description: Cognitive behavioral therapy (abstinence‐focused) Duration and frequency: 6 weekly 90‐minute gender‐specific group sessions Delivery and provider: Counselor with no prior experience with cognitive behavioral therapy and minimal to no counseling experience Comparison group: Usual care involving routine medical care, option to attend peer‐led HIV support group, assessment
Outcomes	Primary outcome(s): Alcohol consumption (percent drinking days) Primary outcome measurement tool(s): Timeline Followback Secondary outcome(s): Drinks per drinking day Secondary outcome measurement tool(s): Timeline Followback Time points: 1.5, 2.5, 3.5, 4.5‐months post‐treatment
Notes	Study funding and conflicts of interest: National Institute on Alcohol Abuse and Alcoholism (R21AA016884), a grant to the USAID‐AMPATH Partnership from the United States Agency for International Development as part of the President's Emergency Plan for Aid Relief, and by the Nationa Institute on Drug Abuse (P50DA09241) Linked study records: Papas 2009
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	"A stratified simple randomization procedure was used to form gender‐ stratified cohorts. Within gender‐based cohorts, participants were randomly assigned until a minimum was achieved of 7 CBT and 5 usual care participants, thereby creating some waiting time. A group of 7 was required for CBT to enhance participation, while fewer were required for the individual usual care condition to minimize waiting time before treatment initiation. Each participant was randomized after she or he drew from a jar a paper with the name of the condition. The papers were prepared by study administrators to conceal the name of the condition during the drawing, which was supervised by staff." Pg. 4
Allocation concealment (selection bias)	Low risk	"A stratified simple randomization procedure was used to form gender‐ stratified cohorts. Within gender‐based cohorts, participants were randomly assigned until a minimum was achieved of 7 CBT and 5 usual care participants, thereby creating some waiting time. A group of 7 was required for CBT to enhance participation, while fewer were required for the individual usual care condition to minimize waiting time before treatment initiation. Each participant was randomized after she or he drew from a jar a paper with the name of the condition. The papers were prepared by study administrators to conceal the name of the condition during the drawing, which was supervised by staff." Pg. 4
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	"Nonblinded research assistants both recruited and interviewed participants; none delivered study interventions" Pg. 4
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Not described
Selective reporting (reporting bias)	Unclear risk	Protocol not available