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

Sponsor
University of California, San Francisco (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05756790
Collaborator
National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH), Human Sciences Research Council (Other), City University of New York, School of Public Health (Other)
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Motivational Interviewing
  • Behavioral: Motivational Interviewing plus Breathalyzer
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
180 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Couples will be randomized 1:1Couples will be randomized 1:1
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Couple-Based Motivational Interviewing With Mobile Breathalyzers to Reduce Alcohol Use in South Africa
Anticipated Study Start Date :
Mar 8, 2023
Anticipated Primary Completion Date :
May 30, 2024
Anticipated Study Completion Date :
May 30, 2024

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Enhanced Usual Care

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.

Experimental: Motivational Interviewing (MI)

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
Counseling

Experimental: Motivational Interviewing Plus Breathalyzer (MI Plus)

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
Counseling

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

Outcome Measures

Primary Outcome Measures

  1. Enrollment Rate [Baseline (Time 0)]

    proportion of eligible couples who enroll in the study

  2. Retention Rate [6 months]

    proportion of enrolled couples who remain at the end

Secondary Outcome Measures

  1. Satisfaction with Intervention [2 months]

    proportion of participants who report being "satisfied" or "very satisfied" with the intervention at the two-month follow-up

  2. Mid-point survey completion [2 months]

    proportion of couples who complete the two-month survey

  3. Final survey completion [6 months]

    proportion of couples who complete the six-month survey

  4. MI sessions completed [2 months]

    proportion of participants who attend all three intervention sessions

  5. 70% breathalyzer completion [2 months]

    proportion of participants who complete 70% of breathalyzer tests

Other Outcome Measures

  1. Exploratory: Alcohol Use [2 months and 6 months]

    Number of drinking days in the past 30 days (self-report)

  2. Exploratory: Alcohol Use [2 months]

    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)

  3. Exploratory: ART adherence [2 months and 6 months]

    Proportion of pills taken by HIV-infected participants in the past 30 days, using the bean count method (self-report) adapted from VAS

  4. Exploratory: HIV viral load [2 months]

    Proportion of HIV-infected participants who are virally suppressed by local lab normal ranges, as measured by dried blood spots (DBS)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 49 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Human Sciences Research Council Pietermaritzburg South Africa

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Amy Conroy, Ph.D., University of California, San Francisco

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT05756790
Other Study ID Numbers:
  • P0551145
  • R34AA029649
First Posted:
Mar 6, 2023
Last Update Posted:
Mar 10, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 10, 2023