Study protocol for a non-inferiority trial of electronic versus face-to-face brief intervention following alcohol screening in Zacatecas-Guadalupe, Mexico and Alexandra Township, South Africa

Abstract

We describe the rationale for and design of a non-inferiority trial to evaluate the relative effectiveness of electronic alcohol screening with in-person vs. electronic brief intervention (BI) approaches implemented in Alexandra Township, South Africa, and Zacatecas-Guadalupe, Mexico. The purpose of screening and brief intervention is to identify individuals whose responses to the Alcohol Use Disorders Identification Test (AUDIT) indicate risky drinking patterns and offer them information and advice to help them reduce their drinking. We seek to determine whether a BI comprising information and advice delivered electronically, along with the opportunity to schedule an appointment with a health care professional at a later time, is not significantly worse than a more labor-intensive traditional BI provided through a face-to-face interaction with a health professional immediately following screening. Selected patients visiting participating health clinics in Alexandra and Zacatecas-Guadalupe will be asked to complete the AUDIT screening using an online app accessed via a handheld device. Those whose scores indicate risky alcohol consumption will be invited to participate in the study. Participants at the clinics will be allocated in alternate weeks to either a customary in-person BI or an electronic BI. Based on power analyses taking attrition and nesting within clinics into account, the target sample sizes are 680 in Alexandra and 560 in Zacatecas-Guadalupe. Measures of 30-day alcohol consumption and AUDIT scores will be obtained at baseline, 3 months, and 6 months. The primary outcome will be the past 30-day quantity-frequency of alcohol consumption. Outcomes will be compared for the two study conditions using mixed effects multilevel regression analyses to account for nesting of observations within participants and participants within clinics. Potential socio-demographic covariates include gender, age, marital status, the highest completed level of education, family’s primary native language (a proxy for ethnicity/culture), presence of household members younger than 16, and subjective economic status (Trial ID: NCT07150156. Clinical trial platform: ClinicalTrials.gov Protocol Registration and Results System. Web address: https://clinicaltrials.gov).

Keywords

alcohol / screening / brief intervention / electronic / non-inferiority trial

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