The School SPIT Study - Elementary Schools in Low COVID-19 Incidence Regions

The Hospital for Sick Children120 enrolled

Overview

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 facility) 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 Toronto Region in low SARS-CoV-2 incidence regions (quintiles 1,2 or 3) 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

Eligibility

Sex: ALLMin age: 2 Years

Medical Language ↔ Plain English

Elementary schools will be included in the evaluation if they are: * Considered an elementary school by the school board * Open for in-person learning during the study period * They have at least 200 students * Offer at least 4 grades Exclusion Criteria: 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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

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 the duration of symptoms before testing of a symptomatic case

Time frame: Over 7 week study period

Impact on secondary transmission

To assess whether the availability of take-home saliva test kits at schools leads to reduced transmission within exposed cohorts, as measures by the number of secondary cases identified in exposed cohorts.