Couple-Based Motivational Interviewing With Mobile Breathalyzers to Reduce Alcohol Use in South Africa
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 186
- 试验地点
- 1
- 主要终点
- Enrollment Rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 49 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Report severe intimate partner violence in the past 3 months and/or fear that their safety would be at risk (reported during screening)
结局指标
主要结局
Enrollment Rate
时间窗: Baseline (Time 0)
Number of eligible individuals who enroll in the study
Retention Rate
时间窗: 6 months
Number of enrolled individuals who completed the final follow-up survey (6-months post baseline)
Enrollment Rate
时间窗: Baseline (Time 0)
Number of eligible individuals who enroll in the study
Retention Rate
时间窗: 6 months
Number of enrolled individuals who completed the final follow-up survey (6-months post baseline)
次要结局
- Satisfaction With Intervention(2 months)
- Final Survey Completion(6 months)
- 70% Breathalyzer Completion(2 months)
- Exploratory: HIV Viral Load(2 months)
- Mid-point Survey Completion(2 months)
- Exploratory: Alcohol Use- Score on AUDIT at 2 Months(2 months)
- Number of Participants Who Attended All Intervention Sessions(2 months)
- Exploratory: ART Adherence(6 months)
- Exploratory: Alcohol Use- Number of Drinking Days(6 months)
- Exploratory: Alcohol Use- Score on AUDIT at 6 Months(6 months)
