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

NCT07150156 | Recruiting

• 1 other identifier: HBSA
• Study Type: interventional
• Target: 1,200
• Locations: 2 countries
• Sites: 2

Brief 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

Keywords

alcohol use disorder; screening; brief intervention; electronic

Outcome Measures

Primary Outcomes (1)

• Average daily quantity X frequency within last 30 days

  In the past 30 days, on how many days did you have a whole drink, more than a sip or taste, of any alcoholic beverage? In the past 30 days, on the days when you drank alcohol, about how many whole drinks did you typically have?

  3 months and 6 months

Secondary Outcomes (3)

• Maximum quantity x frequency within last 30 days

  3 months and 6 months

• 30-day frequency of 6+ drinks

  3 months and 6 months

• Past 3 months total 10-item AUDIT score

  3 months and 6 months

Study Arms (2)

Intervention group

EXPERIMENTAL

Participants receive an electronic brief intervention via an app accessed on a handheld device

Behavioral: brief intervention

Comparison group

ACTIVE COMPARATOR

Participants receive an in-person brief intervention via a personal discussion with a trained facilitator

Behavioral: brief intervention

Interventions

brief intervention BEHAVIORAL

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

Comparison group; Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 and above
• AUDIT screening score of 8 or more

You may not qualify if:

• Having been screened for alcohol use within the past 6 months

Sponsors & Collaborators

• HBSA: lead
• AB InBev Foundation: collaborator

Study Sites (2)

IMSS Bienestar

Zacatecas City, Zacatecas, Mexico

ACTIVE NOT RECRUITING

Friends for Life

Johannesburg, Gauteng, South Africa

RECRUITING

MeSH Terms

Conditions

Alcoholism

Interventions

Crisis Intervention

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Ted R Miller, Ph.D.

  Pacific Institute for Research and Evaluation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Deborah A Fisher, Ph.D.

CONTACT

301-755-2716; fisher@pire.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2025
• First Posted: September 2, 2025
• Study Start: February 17, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: All data will be made available within six months following the publication of a manuscript detailing the study's main findings. These data will be available indefinitely.
• Access Criteria: All data will be made available to interested researchers upon written request to the GSDG Data Library. The GSDG Data Library is an independent, external warehouse designed to help advance knowledge, science, and the field of public health by making all data sourced in the pursuit of the Global Smart Drinking Goals initiative available for scientific use. HBSA, the external evaluator of the GSDG Initiative, oversees the collection, coordination, measurement, and evaluation of all data collected as well as its analysis and assessment. Scientific researchers can apply to access GSDG Data Library data to replicate evaluation results, conduct their own research, and plan programs to reduce harmful alcohol consumption

Locations

ZA (1); ME (1)