Human Sciences Research Council
Pietermaritzburg, South Africa
NCT Number: NCT05756790
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.
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Notify Me18 year–49 year
All sexes
Interventional
Not applicable
Pietermaritzburg, South Africa
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Counseling
Counseling plus mobile breathalyzer/ app
Time frame: Baseline (Time 0)
Number of eligible individuals who enroll in the study
Time frame: 6 months
Number of enrolled individuals who completed the final follow-up survey (6-months post baseline)
Time frame: 2 months
number of participants who report being "satisfied" or "very satisfied" with the intervention at the two-month follow-up
Time frame: 2 months
number of participants who complete the two-month survey
Time frame: 6 months
number of couples who complete the six-month survey
Time frame: 2 months
Number of participants who attend all three intervention sessions
Time frame: 2 months
number of participants in the MI Plus - Heavy Drinker arm who complete 70% of breathalyzer tests
Time frame: 6 months
Percentage of pills taken by HIV-infected participants in the past 30 days, using the bean count method (self-report) adapted from VAS
Time frame: 6 months
Number of drinking days in the past 30 days (self-report)
Time frame: 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.
Time frame: 2 months
Number of HIV-infected index patients who are virally suppressed by local lab normal ranges, as measured by dried blood spots (DBS)
Time frame: 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.
University of California, San Francisco
Other
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