Clinical trial NCT05055505: The School SPIT Study - Elementary Schools in Low COVID-19 Incidence Regions
Official title: The School SPIT Study (Saliva to Promote Improved Testing): A Prospective Evaluation of a Home Saliva Testing Program Implemented With a Stepped-wedge Cluster Randomized Design in Elementary Schools in Low SARS-CoV-2 Incidence Regions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: SARS-CoV2 Infection
Keywords: School Testing
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2021-09-24
Enrollment: 120
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: This is a prospective evaluation of a program that is being implemented using a stepped-wedge, cluster randomized design.
Primary purpose: DIAGNOSTIC

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 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.

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: SARS-CoV-2 Case identification
timeFrame: Weekly measurement over 7 week study period
Secondary outcomes:
measure: Uptake of take-home saliva kits for testing
timeFrame: Weekly measurement over 7 week study period
measure: Impact on timing of test for symptomatic individuals
timeFrame: Over 7 week study period
measure: Impact on secondary transmission
timeFrame: Over 7 week study period
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
References: