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临床试验/NCT04906616
NCT04906616已完成不适用

An Economic and Relationship-strengthening Intervention for HIV-affected Couples Who Drink Alcohol in Malawi

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 156 人开始时间: 2021年5月31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
156
试验地点
1
主要终点
Enrollment Rate

研究概览

简要总结

A couples-based alcohol-reduction and economic and relationship-strengthening intervention for HIV-affected couples in Malawi.

详细描述

This project aims to develop and pilot test a combined economic and relationship-strengthening intervention to redirect funds spent on alcohol into financial investments (e.g., education, income-generating business) and to improve couple relationships and adherence to ART. The study hypothesizes that engaging couples to work together on alcohol use and financial goals-equipped with financial, communication, and problem-solving skills-will decrease alcohol use, and improve relationship dynamics and adherence to ART. Specifically, the project aims: (1) to adapt and integrate two proven interventions, Suubi and Uthando Lwethu, using the ADAPT-ITT method, into a combined intervention for HIV-affected couples with a heavy alcohol user (to be called Mlambe); (2) to develop and pilot test the study procedures to evaluate Mlambe; and (3) to assess the feasibility and acceptability of Mlambe through a pilot study. In the formative phase, the study will develop a draft of the intervention manual and conduct five focus group discussions with couples and key stakeholders to obtain input on the intervention. In the pilot phase, 80 HIV-affected couples with a heavy alcohol user will be enrolled and randomized to either Mlambe or the comparison arm (regular HIV care plus brief advice on alcohol use). The study will conduct qualitative interviews with a subset of 20 couples to contextualize feasibility and acceptability data, and then will analyze the mixed- methods feasibility and acceptability data to refine intervention and procedures for a future trial.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • in a married or cohabitating union
  • have at least one partner with a positive AUDIT-C screen in prior 3 months who is also currently on ART for at least 6 months who has disclosed their HIV status to their partner

排除标准

  • severe intimate partner violence reported in previous 3 months and/or fear that safety would be at risk by participation in the study (reported at screening)

结局指标

主要结局

Enrollment Rate

时间窗: Baseline (Time 0)

Percentage of eligible couples enrolled in the study.

Retention Rate

时间窗: 15 months

Percentage of enrolled and randomized participants retained at the end of the study

次要结局

  • 100% Intervention Completion(10 months)
  • 75% Intervention Completion(10 months)
  • Percentage of Couples Who Are "Satisfied" or "Very Satisfied" With the Intervention at 10 Months(10 months)
  • Percentage of Couples Who Are Satisfied With the Intervention at 15 Months(15 months)
  • 10 Month Follow up Survey Completion(10 months)
  • 15 Month Follow up Survey Completion(15 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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