Can Face Masks Reduce Transmission of SARS-CoV-2 in Bangladesh? A Cluster Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 350,000
- 试验地点
- 1
- 主要终点
- Symptomatic SARS-CoV2 infection
研究概览
简要总结
The primary goal of the village-level intervention is to assess whether mask-wearing reduces community-level COVID-19 seroconversion. The individual experiment assess whether masks protect against COVID-19 seroconversion. It also assesses the efficacy of high-quality cloth vs. surgical masks.
详细描述
This study intends to answer the following research questions:
Can mask distribution and mask promotion at homes, mosques, markets and other public areas successfully change community mask-wearing norms to increase mask-wearing?
Can community mask-wearing reduce COVID-19 seroconversions?
Can mask wearing reduce COVID-19 seroconversions for the wearer?
Are high-quality cloth or "surgical" masks more effective in reducing COVID-19 seroconversions?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
盲法说明
The intervention involves wearing a face mask so participants will know if they are in the intervention group. The investigators will be blinded as to intervention assignment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Community experiment: Live in selected village
- •Individual experiment: Work in selected market
排除标准
- 未提供
研究组 & 干预措施
Mask Intervention
Communities and individuals randomized to the intervention arm will be given masks and behavior change communication to motivate proper mask use.
In the community experiment, every adult in communities randomized to the intervention arm will be encouraged to wear a mask when outside their housing compound and around other people.
In the individual experiment, individuals randomized to the intervention arm will not be asked to recommend masks to others, but will also not be discouraged from recommending mask use to others.
干预措施: Face mask (Device)
Mask Intervention
Communities and individuals randomized to the intervention arm will be given masks and behavior change communication to motivate proper mask use.
In the community experiment, every adult in communities randomized to the intervention arm will be encouraged to wear a mask when outside their housing compound and around other people.
In the individual experiment, individuals randomized to the intervention arm will not be asked to recommend masks to others, but will also not be discouraged from recommending mask use to others.
干预措施: Face mask awareness (Behavioral)
Control
Control individuals will receive no masks or behavior change communication.
结局指标
主要结局
Symptomatic SARS-CoV2 infection
时间窗: 12 weeks
Symptomatic SARS-CoV2 infection, assessed via antibody testing 12 weeks after baseline, among individuals who report symptoms consistent with COVID-19 at 5 weeks or 9 weeks after baseline
次要结局
- Observed prevalence of proper mask wearing(intervention weeks 0, 1, 2, 4, 6, 8, and 12 in the community experiment and intervention weeks 0, 1, 2, 4, and 6 in the individual experiment)
- SARS-CoV2 infection(12 weeks)
- Respiratory infection prevalence(5 and 9 weeks)