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临床试验/NCT05756790
NCT05756790已完成不适用

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

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 186 人开始时间: 2023年3月15日最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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