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

NCT05756790 | Completed Results DMC

• 2 other identifiers: P0551145R34AA029649
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV/AIDS; Alcohol Abuse

Outcome Measures

Primary Outcomes (2)

• Enrollment Rate

  Number of eligible individuals who enroll in the study

  Baseline (Time 0)

• Retention Rate

  Number of enrolled individuals who completed the final follow-up survey (6-months post baseline)

  6 months

Secondary Outcomes (10)

• Satisfaction With Intervention

  2 months

• Mid-point Survey Completion

  2 months

• Final Survey Completion

  6 months

• Number of Participants Who Attended All Intervention Sessions

  2 months

• 70% Breathalyzer Completion

  2 months

Study Arms (3)

Enhanced Usual Care

NO INTERVENTION

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.

Motivational Interviewing (MI)

EXPERIMENTAL

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

Motivational Interviewing Plus Breathalyzer (MI Plus)

EXPERIMENTAL

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; Behavioral: Motivational Interviewing plus Breathalyzer

Interventions

Motivational Interviewing BEHAVIORAL

Counseling

Motivational Interviewing (MI); Motivational Interviewing Plus Breathalyzer (MI Plus)

Motivational Interviewing plus Breathalyzer BEHAVIORAL

Counseling plus mobile breathalyzer/ app

Motivational Interviewing Plus Breathalyzer (MI Plus)

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Report severe intimate partner violence in the past 3 months and/or fear that their safety would be at risk (reported during screening)

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator
• The City College of New York: collaborator
• Human Sciences Research Council: collaborator

Study Sites (1)

Human Sciences Research Council

Pietermaritzburg, South Africa

Location

Related Publications (7)

• 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.

  PMID: 30218319 BACKGROUND

• 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.

  PMID: 30581887 BACKGROUND

• 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.

  PMID: 30407888 BACKGROUND

• 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.

  PMID: 29129192 BACKGROUND

• 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.

  PMID: 26381193 BACKGROUND

• 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.

  PMID: 31771655 BACKGROUND

• 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.

  PMID: 38296300 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Alcoholism

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Dr. Amy Conroy
• Organization: University of California San Francisco

amy.conroy@ucsf.edu

303-522-9439

Study Officials

• Amy Conroy, Ph.D.

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Couples will be randomized 1:1

Study Record Dates

• First Submitted: February 21, 2023
• First Posted: March 6, 2023
• Study Start: March 15, 2023
• Primary Completion: June 20, 2024
• Study Completion: August 30, 2024
• Last Updated: August 7, 2025
• Results First Posted: August 7, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• 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.
• Access Criteria: Users must apply for and receive permission from the NIH data archive.

Locations

ZA (1)