MaxART: The Effect of Early Access to ART for All in Swaziland on Economic Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3,019
- 主要终点
- Total healthcare expenditures (for hospitalization and primary care)
研究概览
简要总结
The purpose of this study is to evaluate the impact of offering early antiretroviral therapy to HIV-positive individuals in government-managed health facilities in Swaziland on a range of economic outcomes
详细描述
The MaxART study is a three-year stepped-wedge randomized trial with open enrollment for all adults 18 years and older across 14 rural health facilities in Swaziland's Hhohho Region. The main trial registration is accessible at: https://clinicaltrials.gov/ct2/show/record/NCT02909218.
This registration is specific to the economic evaluation of the MaxART study which aims to quantify the causal impacts of early ART initiation (compared to national standard care) on a range of key economic outcomes, including healthcare expenditures, productivity, and household wealth.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Health Services Research
- 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
- 否
入选标准
- •All HIV-positive individuals who are aged 18 years or older, are ART naïve and attend the health facilities included in the study
排除标准
- •All HIV-positive individuals who are <18 years of age
- •All HIV-positive pregnant or breastfeeding women
- •All HIV-positive individuals who did not consent to participate
研究组 & 干预措施
National HIV Treatment Guidelines
HIV-positive individuals are offered ART per Swaziland's national treatment guidelines
Early Access to ART for All
HIV-positive individuals who are aged 18 years or older are initiated on ART regardless of client's immunological and clinical staging (excluding pregnant or breastfeeding women)
干预措施: Early Access to ART for All (Other)
结局指标
主要结局
Total healthcare expenditures (for hospitalization and primary care)
时间窗: 12 months
Including direct health care costs (e.g., surgery, medication, consultation) and indirect costs (e.g., transport to clinic, payment for someone to look after children, salary lost for time off...)
Total productivity hours
时间窗: 24 hours
Total Hours per day spent on income generation activities
次要结局
- Household Assets Ownership and Living Standards Index(At study completion, an average of 1.5 years)
- Rate of participants with current employment(At study completion, an average of 1.5 years)
- Total sum of self-reported monthly expenditures of the participant's household(12 months)
研究者
Till Bärnighausen
University Hospital Heidelberg
University Hospital Heidelberg