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

NCT ID: NCT05756790

Last Updated: 2025-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 186 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-15
• Study Completion Date: 2024-08-30

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.

Conditions

HIV/AIDS; Alcohol Abuse

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Motivational Interviewing

Intervention Type: BEHAVIORAL

Counseling

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.

Group Type: EXPERIMENTAL

Motivational Interviewing

Intervention Type: BEHAVIORAL

Counseling

Motivational Interviewing plus Breathalyzer

Intervention Type: BEHAVIORAL

Counseling plus mobile breathalyzer/ app

Interventions

Motivational Interviewing

Counseling

Intervention Type: BEHAVIORAL

Motivational Interviewing plus Breathalyzer

Counseling plus mobile breathalyzer/ app

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

The City College of New York

OTHER

Sponsor Role: collaborator

Human Sciences Research Council

OTHER_GOV

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amy Conroy, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

Human Sciences Research Council

Pietermaritzburg, , South Africa

Countries

South Africa

References

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.

Reference Type: BACKGROUND

PMID: 30218319 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30581887 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30407888 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29129192 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26381193 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31771655 (View on PubMed)

Msimango L, Butterfield R, Starks TJ, van Heerden A, Neilands TB, Hahn JA, Chibi B, Humphries H, Conroy AA. Couples motivational interviewing with mobile breathalysers to reduce alcohol use in South Africa: a pilot randomised controlled trial of Masibambisane. BMJ Open. 2024 Jan 30;14(1):e083390. doi: 10.1136/bmjopen-2023-083390.

Reference Type: DERIVED

PMID: 38296300 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

R34AA029649

Identifier Type: NIH

Identifier Source: secondary_id

View Link

P0551145

Identifier Type: -

Identifier Source: org_study_id