The School SPIT Study (Saliva to Promote Improved Testing): A Prospective Evaluation of a Home Saliva Testing Program for COVID-19 Implemented With a Stepped-wedge Cluster Randomized Design in Secondary Schools.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- SARS-CoV-2 Case Identification
研究概览
简要总结
This study will conduct an evaluation of a program that is being implemented SickKids / Toronto Public health that provides take-home saliva testing kits in schools. Operationally, there is a planned randomization so that all schools have an equitable chance to receive the intervention at various time periods during the planned operational roll-out, which will require a staggered implementation consistent with the stepped-wedge study design. The study will leverage this chance implementation to do a robust evaluation of the public health intervention. Schools that are not being rolled out to week one, will begin in the "control phase" (testing at an assessment center) and transition to the program "intervention phase" (take home saliva kits available at schools) at a randomly assigned time (wedge) over a 6-week period with all schools receiving the program by the end of the study. The investigators will evaluate the impact of the program on SARS-CoV-2 case identification in schools.
详细描述
This is a prospective evaluation of a program that is being implemented using a stepped-wedge, cluster randomized design.
Eligible secondary public schools in Toronto Region will be randomized. The study will occur over a 7-week period with a minimum of one-week of baseline data (control phase - testing at an assessment center, primary care or acute care center) and then schools will start the program in a stepwise manner (10 crossovers per week) with take-home saliva being available to all 60 schools by the end of the study period. The primary objective of the study is to assess whether the availability of take home saliva kits at schools for symptomatic PCR testing leads to increased diagnosis of COVID-19 cases in the school.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Schools that are middle schools only, that are not open for in-person learning, have fewer than 100 students or are not a complete secondary school (i.e. adult learning schools, schools offering independent courses, prep schools with 1-2 grades, secondary schools with < 4 grades) will be excluded.
结局指标
主要结局
SARS-CoV-2 Case Identification
时间窗: Weekly measurement over 7 week study period
The number of cases positive for SARS-CoV-2 in a cohort per week per school (rate per cohort per week) in the intervention period compared to the control period.
次要结局
- Impact on timing of test for symptomatic individuals(Over 7 week study period)
- Impact on secondary transmission(Over 7 week study period)
- Uptake of take-home saliva kits for testing(Weekly measurement over 7 week study period)
研究者
Michelle Science
Principal Investigator
The Hospital for Sick Children