The School SPIT Study - Elementary Schools in High COVID-19 Incidence Regions
- Conditions
- SARS-CoV2 Infection
- Interventions
- Diagnostic Test: Take home saliva kits
- Registration Number
- NCT05055492
- Lead Sponsor
- The Hospital for Sick Children
- Brief Summary
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. This 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, primary care or acute care 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.
- Detailed Description
This is a prospective evaluation of a program that is being implemented using a stepped-wedge, cluster randomized design.
Eligible elementary public schools high SARS-CoV-2 incidence regions (quintiles 4 and 5) in Toronto 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 (20 crossovers per week) with take-home saliva being available to all 120 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 testing leads to increased diagnosis of SARS-CoV-2 cases in the school.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
Not provided
Schools that are middle schools only, that are not open for in-person learning, have fewer than 200 students or are not a complete elementary school (i.e. schools offering independent courses, prep schools with 1-2 grades, elementary schools with < 4 grades) will be excluded.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Intervention phase Take home saliva kits Schools will have take home saliva kits available at the school to support SARS-CoV-2 diagnostic testing. Schools will transition to the intervention phase at a randomly assigned time (wedge) over a 6-week period with all schools receiving the program by the end of the study.
- Primary Outcome Measures
Name Time Method SARS-CoV-2 Case identification Weekly measurement over 7 week study period The number of cases positive for SARS-CoV-2 in a cohort per week per school
- Secondary Outcome Measures
Name Time Method Impact on timing of test for symptomatic individuals Over study 7 week study period To assess whether availability of take-home saliva kits at schools leads to earlier testing as measured by duration of symptoms before testing of the symptomatic case
Uptake of take-home saliva kits for testing Weekly measurement over 7 week study period Frequency of use of take-home saliva kits per week per school
Impact on Secondary Transmission Over 7 week study period To assess whether the availability of take-home saliva kits at schools leads to reduced transmission within exposed cohorts as measured by number of secondary cases identified in exposed cohorts
Trial Locations
- Locations (1)
The Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada