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Abstract: Background and aims: Given the scarcity of alcohol prevention and alcohol use disorder treatments in many low and middle‐income countries, the World Health Organization launched an e‐health portal on alcohol and health that includes a Web‐based self‐help program. This paper presents the protocol for a multicentre randomized controlled trial (RCT) to test the efficacy of the internet‐based self‐help intervention to reduce alcohol use. Design: Two‐arm randomized controlled trial (RCT) with follow‐up 6 months after randomization. Setting: Community samples in middle‐income countries. Participants: People aged 18+, with Alcohol Use Disorders Identification Test (AUDIT) scores of 8+ indicating hazardous alcohol consumption. Intervention and comparator: Offer of an internet‐based self‐help intervention, ‘Alcohol e‐Health’, compared with a ‘waiting list’ control group. The intervention, adapted from a previous program with evidence of effectiveness in a high‐income country, consists of modules to reduce or entirely stop drinking. Measurements: The primary outcome measure is change in the Alcohol Use Disorders Identification Test (AUDIT) score assessed at 6‐month follow‐up. Secondary outcomes include self‐reported the numbers of standard drinks and alcohol‐free days in a typical week during the past 6 months, and cessation of harmful or hazardous drinking (AUDIT < 8). Analysis: Data analysis will be by intention‐to‐treat, using analysis of covariance to test if program participants will experience a greater reduction in their AUDIT score than controls at follow‐up. Secondary outcomes will be analysed by (generalized) linear mixed models. Complier average causal effect and baseline observations carried forward will be used in sensitivity analyses. Comments: If the Alcohol e‐Health program is found to be effective, the potential public health impact of its expansion into countries with underdeveloped alcohol prevention and alcohol use disorder treatment systems world‐wide is considerable. [ABSTRACT FROM AUTHOR]

Background: Given the scarcity of alcohol prevention and use disorder treatments in many low- and middle-income countries (LMICs), the World Health Organization has launched an eHealth portal that includes the web-based self-help program "Alcohol e-Health."Objective: We aimed to test the effectiveness of the Alcohol e-Health program in a randomized controlled trial.Methods: This was a two-arm, individually randomized, and controlled trial across four LMICs comparing the self-help program and a psychoeducation and internet access as usual waiting list. Participants were broadly recruited from community samples in Belarus, Brazil, India, and Mexico from January 2016 through January 2019. The primary outcome measure was change in the Alcohol Use Disorders Identification Test (AUDIT) score with a time frame of 6 months between baseline and follow-up. Secondary outcomes included self-reported numbers of standard drinks over the previous week and cessation of harmful or hazardous drinking (AUDIT score <8).Results: For this study, we recruited 1400 predominantly male (n=982, 70.1%) at least harmful or hazardous alcohol drinkers. The mean age was 37.6 years (SD 10.5). The participants were recruited from Brazil (n=587), Mexico (n=509), India (n=212), and Belarus (n=92). Overall, complete case analysis identified higher AUDIT changes in the intervention group (B=-4.18, 95% CI -5.42 to -2.93, P<.001, d=0.56) that were mirrored by changes in weekly standard drinks (B=-9.34, 95% CI -15.90 to -2.77, P=.005, d=0.28) and cessation rates for harmful or hazardous drinking (χ21=14.56, N=561, P<.001). The supplementary intention-to-treat analyses largely confirmed these initial results.Conclusions: The expansion of the Alcohol e-Health program to other LMICs with underdeveloped alcohol prevention and treatment systems for alcohol use disorders should be considered after successful replication of the present results.Trial Registration: ISRCTN ISRCTN14037475; https://www.isrctn.com/ISRCTN14037475.International Registered Report Identifier (irrid): RR2-10.1111/add.14034. [ABSTRACT FROM AUTHOR]