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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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HIV/AIDS, Alcohol Abuse

Intervention / Treatment
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* Behavioral: Motivational Interviewing
* Behavioral: Motivational Interviewing plus Breathalyzer


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Couples will be randomized 1:1
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Enhanced Usual Care<br>Couples in this condition will receive the standard of care for alcohol use in addition to a brief alcohol counseling session modeled after WHO guidelines and Dr. Conroy's intervention in Malawi, which uses participants' baseline AUDIT scores for messaging around alcohol reduction and lasts 5-10 minutes. | |
| Experimental: Motivational Interviewing (MI)<br>Couples will have three MI sessions over a 60-day period. These sessions will focus on communication between the couple, alcohol consumption patterns, and setting goals for alcohol-use reduction. | Behavioral: Motivational Interviewing<br>* Counseling<br>|
| Experimental: Motivational Interviewing Plus Breathalyzer (MI Plus)<br>In addition to three MI sessions, drinkers in this condition will be prompted via SMS message twice per day to use a mobile app and a breathalyzer to test their blood alcohol levels (BAC). Both the drinker and their partner will receive real-time feedback about alcohol use. | Behavioral: Motivational Interviewing<br>* Counseling<br>Behavioral: Motivational Interviewing plus Breathalyzer<br>* Counseling plus mobile breathalyzer/ app<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Enrollment Rate | proportion of eligible couples who enroll in the study | Baseline (Time 0) | 
| Retention Rate | proportion of enrolled couples who remain at the end | 6 months | 

Secondary Outcome Measures

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