Study to Assess Effectiveness of Nonpharmaceutical Interventions (Handwashing, Face Mask Use) to Prevent Influenza Transmission in Households
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,920
- 试验地点
- 1
- 主要终点
- Secondary influenza infection in household members
研究概览
简要总结
The purpose of this study is to determine whether nonpharmaceutical interventions (i.e., handwashing and masks) reduce secondary transmission of influenza in households.
详细描述
HITS is a multi-year project that will prospectively identify laboratory-confirmed influenza infected children. Secondary influenza infection will then be examined among members of the child's household and effectiveness of non-pharmaceutical interventions to decrease secondary infection will be assessed. The pediatric influenza-infected index case will be identified by rapid influenza testing and their household will then be enrolled and randomized to one of three study arms: control, hand washing (Intervention 1), and hand washing and mask use (Intervention 2). Following enrollment, at days 0, 3 and 7, all household participants will be tested: the index case will be assessed for influenza viral shedding and household members will be assessed for secondary influenza infection. This study is being conducted at Queen Sirikit Institute for Child Health in Bangkok.
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
- None
入排标准
- 年龄范围
- 1 Month 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child, 1 month through 15 years of age
- •Resident of Bangkok Metropolitan Area
- •Outpatient of Queen Sirikit National Institute of Child Health Children's
- •Hospital seen during HITS' active study period
- •Positive influenza rapid test result from patient presenting with influenza-like illness
- •In addition to the index case, consent must be obtained from at least 2 household members ≥1 month of age who plan to sleep inside the house for a period of at least 21 days from the time of enrollment
排除标准
- •Illness onset 48 hours or more before presentation and influenza testing at Queen Sirikit National Institute of Child Health Children's Hospital
- •Treatment with influenza antiviral medications since it may decrease secondary attack rate
- •Children who are at high risk for severe influenza disease (e.g., chronic lung disease, renal disease, chemotherapy for cancer, long-term aspirin therapy)
- •A history of influenza-like illness in another household member that precedes the index case by 7 days or less will lead to exclusion of the household because the source of influenza infection for secondary cases is uncertain.
- •Receipt of influenza vaccine by any household member during the preceding 12 months.
- •Prior participation in HITS.
研究组 & 干预措施
Control
Control: nutrition, physical activity and smoking cessation education
Hand washing
Intervention 1: hand washing education and material
干预措施: Hand washing (Behavioral)
Hand washing and surgical mask
Intervention 2: hand washing education and material AND paper surgical face masks
干预措施: Hand washing and surgical mask (Device)
结局指标
主要结局
Secondary influenza infection in household members
时间窗: 21 days
To determine the secondary attack rate (SAR) in households with a child with laboratory-confirmed influenza infection.
次要结局
未报告次要终点