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.

Study Overview

• Status: Active, not recruiting
• Conditions: HIV/AIDS; Alcohol Abuse
• Intervention / Treatment: Behavioral: Motivational Interviewing; Behavioral: Motivational Interviewing plus Breathalyzer

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 Type: Interventional
• Enrollment (Actual): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alastair van Heerden, Ph.D.; Phone Number: 27 0 33 324 5000; Email: avanheerden@hrsc.ac.za
• Study Contact Backup: Name: Amy Conroy, Ph.D.; Phone Number: 1 303 522 9439; Email: amy.conroy@ucsf.edu

Study Locations

• South Africa
  • Pietermaritzburg, South Africa
    • Human Sciences Research Council
    • Contact: Alastair van Heerden, Ph.D.; Phone Number: 27 033 324 5000; Email: avanheerden@hsrc.ac.za

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Enhanced Usual Care; 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); 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; Counseling
Experimental: Motivational Interviewing Plus Breathalyzer (MI Plus); 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; Counseling; Behavioral: Motivational Interviewing plus Breathalyzer; Counseling plus mobile breathalyzer/ app

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory: Alcohol Use	Number of drinking days in the past 30 days (self-report)	2 months and 6 months
Exploratory: Alcohol Use	Non-heavy drinking determined by self-report (Alcohol Use Disorders Identification Test - Consumption [AUDIT-C], prior 3 months, negative) and phosphatidylethanol (PEth) <35 ng/mL (composite measure)	2 months
Exploratory: ART adherence	Proportion of pills taken by HIV-infected participants in the past 30 days, using the bean count method (self-report) adapted from VAS	2 months and 6 months
Exploratory: HIV viral load	Proportion of HIV-infected participants who are virally suppressed by local lab normal ranges, as measured by dried blood spots (DBS)	2 months

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA); Human Sciences Research Council; City University of New York, School of Public Health
• Investigators: Principal Investigator: Amy Conroy, Ph.D., University of California, San Francisco

Publications and helpful links

General Publications

• Hahn JA, Emenyonu NI, Fatch R, Muyindike WR, Kekiibina A, Carrico AW, Woolf-King S, Shiboski S. Declining and rebounding unhealthy alcohol consumption during the first year of HIV care in rural Uganda, using phosphatidylethanol to augment self-report. Addiction. 2016 Feb;111(2):272-9. doi: 10.1111/add.13173. Epub 2015 Nov 5.
• Conroy AA, McKenna SA, Ruark A. Couple Interdependence Impacts Alcohol Use and Adherence to Antiretroviral Therapy in Malawi. AIDS Behav. 2019 Jan;23(1):201-210. doi: 10.1007/s10461-018-2275-2.
• Starks TJ, Millar BM, Doyle KM, Bertone P, Ohadi J, Parsons JT. Motivational interviewing with couples: A theoretical framework for clinical practice illustrated in substance use and HIV prevention intervention with gay male couples. Psychol Sex Orientat Gend Divers. 2018 Dec;5(4):490-502. doi: 10.1037/sgd0000297. Epub 2018 Jun 25.
• Woolf-King SE, Conroy AA, Fritz K, Johnson MO, Hosegood V, van Rooyen H, Darbes L, McGrath N. Alcohol use and relationship quality among South African couples. Subst Use Misuse. 2019;54(4):651-660. doi: 10.1080/10826084.2018.1531428. Epub 2018 Nov 8.
• Aharonovich E, Stohl M, Cannizzaro D, Hasin D. HealthCall delivered via smartphone to reduce co-occurring drug and alcohol use in HIV-infected adults: A randomized pilot trial. J Subst Abuse Treat. 2017 Dec;83:15-26. doi: 10.1016/j.jsat.2017.09.013. Epub 2017 Sep 29.
• Lauckner C, Taylor E, Patel D, Whitmire A. The feasibility of using smartphones and mobile breathalyzers to monitor alcohol consumption among people living with HIV/AIDS. Addict Sci Clin Pract. 2019 Nov 26;14(1):43. doi: 10.1186/s13722-019-0174-0.

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2023
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): August 31, 2024

Study Registration Dates

• First Submitted: February 21, 2023
• First Submitted That Met QC Criteria: February 21, 2023
• First Posted (Actual): March 6, 2023

Study Record Updates

• Last Update Posted (Estimated): December 20, 2023
• Last Update Submitted That Met QC Criteria: December 18, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Alcoholism
• Other Study ID Numbers: P0551145; R34AA029649 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: There is a plan in place to share data with the NIAAA Data Archive.
• IPD Sharing Time Frame: Data will be uploaded to the NIAAA Data Archive two times per year while data are being collected. It will be available indefinitely.
• IPD Sharing Access Criteria: Users must apply for and receive permission from the NIH data archive.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No