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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 186

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)	Number of eligible individuals who enroll in the study
Retention Rate	6 months	Number of enrolled individuals who completed the final follow-up survey (6-months post baseline)

Secondary Outcome Measures

Name	Time	Method
Satisfaction With Intervention	2 months	number of participants who report being "satisfied" or "very satisfied" with the intervention at the two-month follow-up
Final Survey Completion	6 months	number of couples who complete the six-month survey
70% Breathalyzer Completion	2 months	number of participants in the MI Plus - Heavy Drinker arm who complete 70% of breathalyzer tests
Exploratory: HIV Viral Load	2 months	Number of HIV-infected index patients who are virally suppressed by local lab normal ranges, as measured by dried blood spots (DBS)
Mid-point Survey Completion	2 months	number of participants who complete the two-month survey
Exploratory: Alcohol Use- Score on AUDIT at 2 Months	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.
Number of Participants Who Attended All Intervention Sessions	2 months	Number of participants who attend all three intervention sessions
Exploratory: ART Adherence	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
Exploratory: Alcohol Use- Number of Drinking Days	6 months	Number of drinking days in the past 30 days (self-report)
Exploratory: Alcohol Use- Score on AUDIT at 6 Months	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.