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

HIV/AIDS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05756790
• Other study ID #: P0551145
• Secondary ID: R34AA029649
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 13, 2023
• Est. completion date: August 31, 2024

Study information

• Verified date: December 2023
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 180
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 49 Years

Eligibility

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)

Related Conditions & MeSH terms

• Alcohol Abuse
• Alcoholism
• HIV/AIDS

Intervention

Behavioral:
• Motivational Interviewing
Counseling
• Motivational Interviewing plus Breathalyzer
Counseling plus mobile breathalyzer/ app

Locations

Country	Name	City	State
South Africa	Human Sciences Research Council	Pietermaritzburg

Sponsors (4)

Lead Sponsor	Collaborator
University of California, San Francisco	City University of New York, School of Public Health, Human Sciences Research Council, National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

South Africa, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory: Alcohol Use	Number of drinking days in the past 30 days (self-report)	2 months and 6 months
Other	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
Other	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
Other	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
Primary	Enrollment Rate	proportion of eligible couples who enroll in the study	Baseline (Time 0)
Primary	Retention Rate	proportion of enrolled couples who remain at the end	6 months
Secondary	Satisfaction with Intervention	proportion of participants who report being "satisfied" or "very satisfied" with the intervention at the two-month follow-up	2 months
Secondary	Mid-point survey completion	proportion of couples who complete the two-month survey	2 months
Secondary	Final survey completion	proportion of couples who complete the six-month survey	6 months
Secondary	MI sessions completed	proportion of participants who attend all three intervention sessions	2 months
Secondary	70% breathalyzer completion	proportion of participants who complete 70% of breathalyzer tests	2 months