HIV/AIDSNCT05756790

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

A study testing Motivational Interviewing and Motivational Interviewing plus Breathalyzer in people with HIV/AIDS and Alcohol Abuse, run by University of California, San Francisco at 1 site in South Africa.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 49 yearsHealthy volunteers can take part
Conditions the study is for: HIV/AIDS, Alcohol Abuse
What is being tested?: Motivational Interviewing and Motivational Interviewing plus Breathalyzer
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 186 participants
Where: 1 siteSouth Africa
Study dates: 15 Mar 2023to 30 Aug 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 49 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

South Africa1 site

Human Sciences Research Council
Pietermaritzburg

Other trials in South Africa

About this study

Read the 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
Being tested: Motivational Interviewing, Motivational Interviewing plus Breathalyzer
Medical subject headings: Acquired Immunodeficiency Syndrome, Alcoholism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Motivational InterviewingBehavioural
Counseling
Motivational Interviewing plus BreathalyzerBehavioural
Counseling plus mobile breathalyzer/ app

Study groups in NCT05756790
Study group	Role	What they receive
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. Receives: 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. Receives: Behavioral: Motivational Interviewing; Behavioral: Motivational Interviewing plus Breathalyzer

What is being measured

The primary outcome is the main question the study is designed to answer.

Enrollment Rate
Number of eligible individuals who enroll in the study
Measured: Baseline (Time 0)
Retention Rate
Number of enrolled individuals who completed the final follow-up survey (6-months post baseline)
Measured: 6 months

Secondary outcomes (10)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Mar 202330 Aug 2024

First posted6 Mar 2023
Study start15 Mar 2023
Primary completion20 Jun 2024
Study completion30 Aug 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (8)Papers the sponsor has linked to this study.
Other trials for HIV/AIDSStudies of the same condition, open and under way.
More trials run by University of California, San FranciscoThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Model description: Couples will be randomized 1:1
Masking: None (open label)
Enrolment: 186 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05756790
Sponsor's protocol ID: P0551145
Other IDs: R34AA029649
Status last verified: Jul 2025
First submitted: 21 Feb 2023
Last updated: 7 Aug 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: There is a plan in place to share data with the NIAAA Data Archive.

Publications

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.
PubMed 30218319
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.
PubMed 30581887
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.
PubMed 30407888
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.
PubMed 29129192
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.
PubMed 26381193
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.
PubMed 31771655
Conroy AA, Butterfield RM, Chibi B, Msimango L, Starks TJ. Trial experiences with dyadic breathalyzer technology for alcohol monitoring and feedback among couples living with HIV in South Africa. Addict Sci Clin Pract. 2026 Mar 12;21(1):32. doi: 10.1186/s13722-026-00659-1.
PubMed 41821038
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.
PubMed 38296300

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Couple-Based Motivational Interviewing With Mobile Breathalyzers to Reduce Alcohol Use in South Africa
ClinicalTrials.gov ID: NCT05756790
Acronym / sponsor ID: P0551145
Conditions: HIV/AIDS, Alcohol Abuse
Study type: Interventional
Recruitment status: Completed
Enrolment: 186 participants (actual)
Lead sponsor: University of California, San FranciscoUniversity, hospital or other
Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA), The City College of New York, Human Sciences Research Council
Study start: 15 Mar 2023 (actual)
Primary completion: 20 Jun 2024 (actual)
Study completion: 30 Aug 2024 (actual)
First posted: 6 Mar 2023 (actual)
Results: Posted 7 Aug 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: Couples will be randomized 1:1

Arm	Type	Receives
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	Behavioral: Motivational InterviewingCouples 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.
Motivational Interviewing Plus Breathalyzer (MI Plus)	Experimental	Behavioral: Motivational Interviewing, Behavioral: Motivational Interviewing plus BreathalyzerIn 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.

Who may qualify

Ages: 18 to 49 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Motivational InterviewingCounseling	Behavioural	Motivational Interviewing (MI), Motivational Interviewing Plus Breathalyzer (MI Plus)
Motivational Interviewing plus BreathalyzerCounseling plus mobile breathalyzer/ app	Behavioural	Motivational Interviewing Plus Breathalyzer (MI Plus)

Primary outcome

Enrollment Rate
Time frame: Baseline (Time 0)
Number of eligible individuals who enroll in the study
Retention Rate
Time frame: 6 months
Number of enrolled individuals who completed the final follow-up survey (6-months post baseline)

10 secondary outcomes

Satisfaction With Intervention
Time frame: 2 months
Mid-point Survey Completion
Time frame: 2 months
Final Survey Completion
Time frame: 6 months
Number of Participants Who Attended All Intervention Sessions
Time frame: 2 months
70% Breathalyzer Completion
Time frame: 2 months
Exploratory: ART Adherence
Time frame: 6 months
Exploratory: Alcohol Use- Number of Drinking Days
Time frame: 6 months
Exploratory: Alcohol Use- Score on AUDIT at 2 Months
Time frame: 2 months
Exploratory: HIV Viral Load
Time frame: 2 months
Exploratory: Alcohol Use- Score on AUDIT at 6 Months
Time frame: 6 months

Results and safety

Results posted to the registry on 7 Aug 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Enhanced Usual Care- Heavy Drinkers	31	30
Enhanced Usual Care (EUC)- Partners	31	30
Motivational Interviewing (MI) - Heavy Drinkers	31	29
Motivational Interviewing (MI) - Partners	31	29
Motivational Interviewing Plus Breathalyzer (MI Plus) - Heavy Drinkers	31	29
Motivational Interviewing Plus Breathalyzer (MI Plus) - Partners	31	29

Primary outcome: Enrollment Rate

Time frame: Baseline (Time 0). Count of participants. Unit: Participants

Measure	Enhanced Usual Care (EUC)- Heavy Drinkers n = 31	Enhanced Usual Care (EUC) - Partners n = 31	Motivational Interviewing (MI) - Heavy Drinkers n = 30	Motivational Interviewing (MI)- Partners n = 30	Motivatinal Interviewing Plus (MI Plus)- Heavy Drinkers n = 29	Motivational Interviewing Plus (MI Plus)- Partners n = 29
Value	31	31	30	30	29	29

Population analysed: All couples who were eligible after screening enrolled in the study (i.e., engaged in the informed consent process, completed the baseline questionnaire, and were randomized). No one refused participation after randomization either.

Primary outcome: Retention Rate

Time frame: 6 months. Count of participants. Unit: Participants

Measure	Enhanced Usual Care (EUC)- Heavy Drinkers n = 31	Enhanced Usual Care (EUC) - Partners n = 31	Motivational Interviewing (MI) - Heavy Drinkers n = 30	Motivational Interviewing - Partners n = 30	Motivational Interviewing Plus Breathalyzer (MI Plus)- Heavy Drinkers n = 29	Motivational Interviewing Plus (MI Plus)- Partners n = 29
Value	30	30	29	29	29	29

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were collected for 1 year.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Enhanced Usual Care (EUC)- Heavy Drinkers	0 of 31 (0%)	0 of 31 (0%)	0 of 31
Enhanced Usual Care (EUC) - Partners	0 of 31 (0%)	0 of 31 (0%)	0 of 31
Motivational Interviewing (MI) - Heavy Drinkers	0 of 30 (0%)	0 of 30 (0%)	0 of 30
Motivational Interviewing (MI) - Partners	0 of 30 (0%)	0 of 30 (0%)	0 of 30
Motivational Interviewing Plus Breathalyzer (MI Plus) - Heavy Drinkers	0 of 29 (0%)	0 of 29 (0%)	0 of 29
Motivational Interviewing Plus Breathalyzer (MI Plus) - Partners	0 of 29 (0%)	0 of 29 (0%)	0 of 29

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 30218319Conroy 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.
Background: PubMed 30581887Starks 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.
Background: PubMed 30407888Woolf-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.
Background: PubMed 29129192Aharonovich 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.
Background: PubMed 26381193Hahn 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.
Background: PubMed 31771655Lauckner 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.
Derived from this study: PubMed 41821038Conroy AA, Butterfield RM, Chibi B, Msimango L, Starks TJ. Trial experiences with dyadic breathalyzer technology for alcohol monitoring and feedback among couples living with HIV in South Africa. Addict Sci Clin Pract. 2026 Mar 12;21(1):32. doi: 10.1186/s13722-026-00659-1.
Derived from this study: PubMed 38296300Msimango 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.
Individual participant dataSharing planned: Yes. There is a plan in place to share data with the NIAAA Data Archive.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Amy Conroy, Ph.D. principal investigator

University of California, San Francisco

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Enrollment Rate (time frame: Baseline (Time 0)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05756790, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2025.