Community-led Distribution of HIV Self-tests: a Cluster Randomised Trial Investigating Uptake of HIV Testing and Linkage to Treatment and Prevention, Costs and Safety in Rural Malawi (HIV Self-Testing Africa [STAR])
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7,880
- 试验地点
- 1
- 主要终点
- Percentage of self-reported lifetime testing in adolescents aged 15-19 years old
研究概览
简要总结
The aim of this study is to determine the benefits, costs and safety of community-led delivery of HIV self-testing (HIVST) kits in rural Malawi, with a focus on testing and linkage to care and prevention services among defined population sub-groups: men, adolescents aged 15-19 years old, and adults aged 40 years or older.
详细描述
RESEARCH QUESTION
Can community-led delivery of HIV self-tests be used to maximise public health and social benefits and reduce costs without introducing social harms?
RESEARCH AIMS AND OBJECTIVES
The broad aim is to determine the benefits, costs and safety of community-led delivery of HIVST kits in rural Malawi, with a focus on testing and linkage to care and prevention services among defined population sub-groups: men, adolescents aged 15-19 years old, and adults aged 40 years or older.
The specific objectives are to conduct a cluster randomised controlled trial to:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged ≥ 15 years
- •Residence in GVH catchment areas included in the intervention arm
排除标准
- •Aged < 15 years old
- •Not resident in GVH catchment areas included in the intervention arm
结局指标
主要结局
Percentage of self-reported lifetime testing in adolescents aged 15-19 years old
时间窗: Measured 8-12 weeks post-intervention
次要结局
- Cumulative incidence of population-level ART uptake in adults aged ≥ 15 years over 6 months(Measured 6-months post-intervention)
- Measure of HIV testing stigma.(Measured 8-12 weeks post-intervention)
- Percentage of self-reported testing in last 3 months in adults aged ≥ 40 years(Measured 8-12 weeks post-intervention)
- Measure of knowledge of HIV prevention methods(Measured 8-12 weeks post-intervention)
- Percentage of self-reported testing in last 3 months in men aged ≥ 15 years(Measured 8-12 weeks post-intervention)