Face Masks to Reduce Symptomatic and Asymptomatic SARS-CoV-2 Infections in Bangladesh
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Asymptomatic and asymptomatic SARS-CoV-2 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 asymptomatic and symptomatic SARS-CoV-2 infections, assessed via PCR testing. The study also examines if community-based activation through values or individual activation through information results in higher mask-wearing.
详细描述
Detailed Description:
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, even years into a pandemic?
Can community mask-wearing reduce SARS-CoV-2 infections (both symptomatic and asymptomatic)?
Is increased prevalence of community-level mask-wearing associated with decreased physical distancing?
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Live in selected village
排除标准
- 未提供
研究组 & 干预措施
Mask intervention
Communities randomized to the intervention arm will be given masks and behavior change communication to motivate proper mask use. 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 arms randomized to school promotion, secondary school children will also be encouraged to wear masks both inside and outside of school.
干预措施: Face mask (Device)
Mask intervention
Communities randomized to the intervention arm will be given masks and behavior change communication to motivate proper mask use. 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 arms randomized to school promotion, secondary school children will also be encouraged to wear masks both inside and outside of school.
干预措施: Face mask awareness (Behavioral)
Mask intervention
Communities randomized to the intervention arm will be given masks and behavior change communication to motivate proper mask use. 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 arms randomized to school promotion, secondary school children will also be encouraged to wear masks both inside and outside of school.
干预措施: Face mask promotion through community values or individual information (Behavioral)
Control
Control individuals will receive no masks or behavior change communication.
结局指标
主要结局
Asymptomatic and asymptomatic SARS-CoV-2 infection
时间窗: approximately weekly for 4 weeks; may be lengthened if the intervention is extended due to low than estimated seroprevalence at the start of the intervention
Asymptomatic and asymptomatic SARS-CoV-2 infection, assessed using PCR testing every 6-10 days after baseline, among individuals regardless of whether they report symptoms of COVID-19
次要结局
- Respiratory infection prevalence(approximately weekly for 4 weeks; may be lengthened if the intervention is extended due to low than estimated seroprevalence at the start of the intervention)
- Physical distancing(Intervention weeks 0, 2, and 4; end line and midline timepoints may be adjusted if the intervention is extended due to low than estimated seroprevalence at the start of the intervention.)
- Observed prevalence of mask-wearing(Intervention weeks 0, 2, and 4; end line and midline timepoints may be adjusted if the intervention is extended due to low than estimated seroprevalence at the start of the intervention.)