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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
120
Saliva kits will be made available at schools for pick up to support symptomatic testing using PCR for students, staff and family members.
The Hospital for Sick Children
Toronto, Ontario, Canada
SARS-CoV-2 Case identification
The number of cases positive for SARS-CoV-2 in a cohort per week per school
Time frame: Weekly measurement over 7 week study period
Uptake of take-home saliva kits for testing
Frequency of use of take-home saliva kits per week per school
Time frame: Weekly measurement over 7 week study period
Impact on timing of test for symptomatic individuals
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
Time frame: Over study 7 week study period
Impact on Secondary Transmission
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
Time frame: Over 7 week study period
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