A Non-Inferiority Trial of an Electronic vs Face-to-face Brief Intervention After Alcohol Screening in Two Countries

Summary

The goal of this clinical trial is to compare two different strategies to deliver brief interventions to people whose scores on the Alcohol Use Disorders Identification Test (AUDIT) suggest that their level of alcohol use may be unhealthy. Brief interventions typically seek to increase the awareness of people whose alcohol use may be unhealthy of the extent and potential adverse consequences of their substance use, and then to provide guidance and motivate them to reduce their consumption. Due to limitations in the use of traditional brief interventions delivered face-to-face by health care providers, applications have been developed to support the electronic delivery of brief interventions. The main question posed in this study is: Is an electronic brief intervention (eBI) delivered via an app on a handheld device at least as effective in reducing alcohol consumption as a traditional in-person brief intervention delivered by a facilitator, who is a trained health educator? We expect that eBI will not be significantly less effective than face-to-face brief intervention.

To test the efficacy of eBI compared to traditional in-person brief intervention, researchers will compare changes in average 30-day quantity and frequency of drinking alcohol, AUDIT scores, and in several additional measures of outcomes related to risky or hazardous alcohol use between participants who received an eBI and those who received a face-to-face brief intervention. In this non-inferiority trial, the intervention (i.e., electronic brief intervention via an app) will be considered effective if it yields reductions in participants' risky or hazardous alcohol use that are no less than those produced by the comparison condition (i.e., a traditional brief intervention through an in-person interaction).

Participants will:

* be invited to complete an alcohol screening using the AUDIT
* be invited to be in a study of alcohol use patterns over time if they have an AUDIT score of 8 or higher
* take a brief survey with demographic and additional recent alcohol use questions
* receive either an eBI or an in-person brief intervention
* complete two additional surveys at 3- and 6-month intervals after the first survey to collect information on alcohol use over time

Conditions

• Alcohol Use Disorder

Interventions

BEHAVIORAL

brief intervention

Provision of personal feedback on drinking risk level and guidance that encourages the patient to develop a realistic plan to reduce his or her alcohol consumption to a less risky level

Sponsors & Collaborators

• AB InBev Foundation

  collaborator UNKNOWN

• HBSA

  lead OTHER

Principal Investigators

• Ted R Miller, Ph.D. · Pacific Institute for Research and Evaluation

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-02-17

Primary Completion

2025-12-31

Completion

2025-12-31

Countries

• Mexico
• South Africa

Study Locations