Clinical trial NCT05756790: Couple-Based Motivational Interviewing With Mobile Breathalyzers to Reduce Alcohol Use in South Africa
Official title: Couple-Based Motivational Interviewing With Mobile Breathalyzers to Reduce Alcohol Use in South Africa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Alcohol Abuse
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
name: The City College of New York
name: Human Sciences Research Council
First posted: 2023-03-06
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Couples will be randomized 1:1
Primary purpose: SUPPORTIVE_CARE

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.

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)

Primary outcomes:
measure: Enrollment Rate
timeFrame: Baseline (Time 0)
measure: Retention Rate
timeFrame: 6 months
Secondary outcomes:
measure: Satisfaction with Intervention
timeFrame: 2 months
measure: Mid-point survey completion
timeFrame: 2 months
measure: Final survey completion
timeFrame: 6 months
measure: MI sessions completed
timeFrame: 2 months
measure: 70% breathalyzer completion
timeFrame: 2 months
Other outcomes:
measure: Exploratory: Alcohol Use
timeFrame: 2 months and 6 months
measure: Exploratory: Alcohol Use
timeFrame: 2 months
measure: Exploratory: ART adherence
timeFrame: 2 months and 6 months
measure: Exploratory: HIV viral load
timeFrame: 2 months
Locations:
city: Pietermaritzburg
country: South Africa
facility: Human Sciences Research Council
Study officials:
affiliation: University of California, San Francisco
name: Amy Conroy, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.