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

Not Applicable

Completed

• Conditions: HIV/AIDS; Alcohol Abuse

• Registration Number: NCT05756790
• Lead Sponsor: University of California, San Francisco

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2023-02-21
• Study First Submitted QC: 2023-02-21
• Study First Posted: 2023-03-06
• Study Start: 2023-03-13
• Primary Completion: 2024-06-20
• Study Completion: 2024-08-30
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-16
• Last Update Posted: 2024-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Enrollment Rate	Baseline (Time 0)	proportion of eligible couples who enroll in the study
Retention Rate	6 months	proportion of enrolled couples who remain at the end

Secondary Outcome Measures

Name	Time	Method
Satisfaction with Intervention	2 months	proportion of participants who report being "satisfied" or "very satisfied" with the intervention at the two-month follow-up
Final survey completion	6 months	proportion of couples who complete the six-month survey
MI sessions completed	2 months	proportion of participants who attend all three intervention sessions
70% breathalyzer completion	2 months	proportion of participants who complete 70% of breathalyzer tests
Mid-point survey completion	2 months	proportion of couples who complete the two-month survey

Trial Locations

Locations (1)

Human Sciences Research Council; 🇿🇦 Pietermaritzburg, South Africa