Electronic versus in-person brief intervention after alcohol screening
Study Protocol for a Non-inferiority Trial of Electronic Versus Face-to-face Brief Intervention Following Alcohol Screening in Zacatecas, Mexico and Alexandra Township, South Africa
NA · HBSA · NCT07150156
This trial tests whether an app-delivered brief counseling is at least as effective as in-person counseling for adults who screen positive for unhealthy drinking on the AUDIT.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 1200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | HBSA (other) |
| Locations | 2 sites (Zacatecas City, Zacatecas and 1 other locations) |
| Trial ID | NCT07150156 on ClinicalTrials.gov |
What this trial studies
This randomized non-inferiority interventional study compares an electronic brief intervention (eBI) delivered via an app on a handheld device to a traditional in-person brief intervention delivered by a trained facilitator for adults with AUDIT scores indicating unhealthy drinking. Participants aged 18 and older who score 8 or more on the AUDIT are enrolled and randomized, with people screened in the past six months excluded. The primary outcome is reduction in alcohol consumption and related harms measured at predefined follow-up points using standard alcohol-use measures. The trial is conducted at sites in Zacatecas, Mexico and Johannesburg, South Africa to evaluate performance across different real-world healthcare settings.
Who should consider this trial
Good fit: Adults aged 18 and older with an AUDIT screening score of 8 or more who have not been screened for alcohol use within the past six months are the intended participants.
Not a fit: People with severe alcohol dependence who need more intensive treatment, those recently screened in the last six months, or individuals without access to or comfort using a smartphone may not benefit from the interventions tested.
Why it matters
Potential benefit: If successful, the app could make brief alcohol counseling more accessible, private, and easier to scale so more people can reduce risky drinking.
How similar studies have performed: Screening and brief interventions have substantial evidence for reducing risky drinking, and prior digital brief-intervention trials have shown promising but mixed results compared with face-to-face approaches.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged 18 and above * AUDIT screening score of 8 or more Exclusion Criteria: • Having been screened for alcohol use within the past 6 months
Where this trial is running
Zacatecas City, Zacatecas and 1 other locations
- IMSS Bienestar — Zacatecas City, Zacatecas, Mexico (ACTIVE_NOT_RECRUITING)
- Friends for Life — Johannesburg, Gauteng, South Africa (RECRUITING)
Study contacts
- Principal investigator: Ted R Miller, Ph.D. — Pacific Institute for Research and Evaluation
- Study coordinator: Deborah A Fisher, Ph.D.
- Email: fisher@pire.org
- Phone: 301-755-2716
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Alcohol Use Disorder, alcohol use disorder, screening, brief intervention, electronic