Skip to main content
OpenTrials
Completed

NCT Number: NCT05756790

Couple-Based Motivational Interviewing With Mobile Breathalyzers to Reduce Alcohol Use in South Africa

This project aims to develop and pilot test an intervention using couple-based motivational interviewing (MI) and mobile breathalyzers to reduce heavy alcohol use with couples living with HIV in South Africa.

Completed

Looking for future studies?

Notify Me

Key information

About this study

This project aims to develop and test an alcohol intervention using couple-based motivational interviewing (MI) and mobile breathalyzers to build dyadic support around drinking in HIV-affected couples in South Africa. Specifically, the study aims to: 1) To develop a couple-based MI intervention with mobile breathalyzer technology to deliver real-time feedback on BAC levels. We will target heavy alcohol users with HIV and enroll their primary partner; 2) to develop and pilot test the study procedures for a future randomized controlled trial (RCT) of the couple-based intervention; and 3) to determine the feasibility and acceptability (F&A) of couple-based MI as a standalone intervention and when combined with mobile breathalyzers to provide real-time feedback and support to couples. We will also conduct qualitative interviews with a subset of 15 couples to contextualize F&A data and refine our procedures. Our goal is to demonstrate a proof-of-concept for the proposed intervention, which if shown to be feasible and acceptable, may provide a scalable intervention to reduce heavy alcohol consumption and improve HIV treatment outcomes for couples in South Africa.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • in a primary relationship for at least 6 months
  • aged 18-49
  • have at least one partner (the "index patient") with a positive AUDIT-C screen score
  • has been on antiretroviral therapy (ART) for at least 6 months
  • has disclosed HIV status to their partner

Exclusion criteria

  • Report severe intimate partner violence in the past 3 months and/or fear that their safety would be at risk (reported during screening)

Treatment and study plan

Motivational Interviewing

Behavioral

Counseling

Motivational Interviewing plus Breathalyzer

Behavioral

Counseling plus mobile breathalyzer/ app

Primary outcomes

  1. Enrollment Rate

    Time frame: Baseline (Time 0)

    Number of eligible individuals who enroll in the study

  2. Retention Rate

    Time frame: 6 months

    Number of enrolled individuals who completed the final follow-up survey (6-months post baseline)

Secondary outcomes

  1. Satisfaction With Intervention

    Time frame: 2 months

    number of participants who report being "satisfied" or "very satisfied" with the intervention at the two-month follow-up

  2. Mid-point Survey Completion

    Time frame: 2 months

    number of participants who complete the two-month survey

  3. Final Survey Completion

    Time frame: 6 months

    number of couples who complete the six-month survey

  4. Number of Participants Who Attended All Intervention Sessions

    Time frame: 2 months

    Number of participants who attend all three intervention sessions

  5. 70% Breathalyzer Completion

    Time frame: 2 months

    number of participants in the MI Plus - Heavy Drinker arm who complete 70% of breathalyzer tests

  6. Exploratory: ART Adherence

    Time frame: 6 months

    Percentage of pills taken by HIV-infected participants in the past 30 days, using the bean count method (self-report) adapted from VAS

  7. Exploratory: Alcohol Use- Number of Drinking Days

    Time frame: 6 months

    Number of drinking days in the past 30 days (self-report)

  8. Exploratory: Alcohol Use- Score on AUDIT at 2 Months

    Time frame: 2 months

    Mean score on the Alcohol Use Disorders Identification Test- AUDIT prior 3 months. The AUDIT is a 10-item scale that assesses drinking behavior with a range of 0-40 (higher scores indicate higher alcohol use). A score of 8 or more may indicate hazardous or harmful drinking in both men and women.

  9. Exploratory: HIV Viral Load

    Time frame: 2 months

    Number of HIV-infected index patients who are virally suppressed by local lab normal ranges, as measured by dried blood spots (DBS)

  10. Exploratory: Alcohol Use- Score on AUDIT at 6 Months

    Time frame: 6 months

    Mean score on the Alcohol Use Disorders Identification Test- AUDIT prior 3 months. The AUDIT is a 10-item scale that assesses drinking behavior with a range of 0-40 (higher scores indicate higher alcohol use). A score of 8 or more may indicate hazardous or harmful drinking in both men and women.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Human Sciences Research Council
  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  • The City College of New York

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 6, 2023
Registry last updated
Aug 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.