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

Primary Purpose

HIV/AIDS, Alcohol Abuse

Status
Recruiting
Phase
Not Applicable
Locations
South Africa
Study Type
Interventional
Intervention
Motivational Interviewing
Motivational Interviewing plus Breathalyzer
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for HIV/AIDS

Eligibility Criteria

18 Years - 49 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Human Sciences Research CouncilRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Enhanced Usual Care

Motivational Interviewing (MI)

Motivational Interviewing Plus Breathalyzer (MI Plus)

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Enrollment Rate
proportion of eligible couples who enroll in the study
Retention Rate
proportion of enrolled couples who remain at the end

Secondary Outcome Measures

Satisfaction with Intervention
proportion of participants who report being "satisfied" or "very satisfied" with the intervention at the two-month follow-up
Mid-point survey completion
proportion of couples who complete the two-month survey
Final survey completion
proportion of couples who complete the six-month survey
MI sessions completed
proportion of participants who attend all three intervention sessions
70% breathalyzer completion
proportion of participants who complete 70% of breathalyzer tests

Full Information

First Posted
February 21, 2023
Last Updated
September 19, 2023
Sponsor
University of California, San Francisco
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA), Human Sciences Research Council, City University of New York, School of Public Health
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1. Study Identification

Unique Protocol Identification Number
NCT05756790
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 13, 2023 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA), Human Sciences Research Council, City University of New York, School of Public Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS, Alcohol Abuse

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Couples will be randomized 1:1
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Enhanced Usual Care
Arm Type
No Intervention
Arm Description
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.
Arm Title
Motivational Interviewing (MI)
Arm Type
Experimental
Arm Description
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.
Arm Title
Motivational Interviewing Plus Breathalyzer (MI Plus)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Motivational Interviewing
Intervention Description
Counseling
Intervention Type
Behavioral
Intervention Name(s)
Motivational Interviewing plus Breathalyzer
Intervention Description
Counseling plus mobile breathalyzer/ app
Primary Outcome Measure Information:
Title
Enrollment Rate
Description
proportion of eligible couples who enroll in the study
Time Frame
Baseline (Time 0)
Title
Retention Rate
Description
proportion of enrolled couples who remain at the end
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Satisfaction with Intervention
Description
proportion of participants who report being "satisfied" or "very satisfied" with the intervention at the two-month follow-up
Time Frame
2 months
Title
Mid-point survey completion
Description
proportion of couples who complete the two-month survey
Time Frame
2 months
Title
Final survey completion
Description
proportion of couples who complete the six-month survey
Time Frame
6 months
Title
MI sessions completed
Description
proportion of participants who attend all three intervention sessions
Time Frame
2 months
Title
70% breathalyzer completion
Description
proportion of participants who complete 70% of breathalyzer tests
Time Frame
2 months
Other Pre-specified Outcome Measures:
Title
Exploratory: Alcohol Use
Description
Number of drinking days in the past 30 days (self-report)
Time Frame
2 months and 6 months
Title
Exploratory: Alcohol Use
Description
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)
Time Frame
2 months
Title
Exploratory: ART adherence
Description
Proportion of pills taken by HIV-infected participants in the past 30 days, using the bean count method (self-report) adapted from VAS
Time Frame
2 months and 6 months
Title
Exploratory: HIV viral load
Description
Proportion of HIV-infected participants who are virally suppressed by local lab normal ranges, as measured by dried blood spots (DBS)
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alastair van Heerden, Ph.D.
Phone
27 0 33 324 5000
Email
avanheerden@hrsc.ac.za
First Name & Middle Initial & Last Name or Official Title & Degree
Amy Conroy, Ph.D.
Phone
1 303 522 9439
Email
amy.conroy@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy Conroy, Ph.D.
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
Human Sciences Research Council
City
Pietermaritzburg
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alastair van Heerden, Ph.D.
Phone
27 033 324 5000
Email
avanheerden@hsrc.ac.za

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
There is a plan in place to share data with the NIAAA Data Archive.
IPD Sharing 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.
IPD Sharing Access Criteria
Users must apply for and receive permission from the NIH data archive.
IPD Sharing URL
https://nda.nih.gov/niaaa
Citations:
PubMed Identifier
30218319
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.
Results Reference
background
PubMed Identifier
30581887
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.
Results Reference
background
PubMed Identifier
30407888
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.
Results Reference
background
PubMed Identifier
29129192
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.
Results Reference
background
PubMed Identifier
26381193
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.
Results Reference
background
PubMed Identifier
31771655
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.
Results Reference
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Couple-Based Motivational Interviewing With Mobile Breathalyzers to Reduce Alcohol Use in South Africa

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