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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-14

Study Completion Date

2022-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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SARS-CoV2 Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

This is a prospective evaluation of a program that is being implemented using a stepped-wedge, cluster randomized design.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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control phase

Schools will start in the control phase (SARS-CoV-2 diagnostic testing at an assessment center, primary care office or acute care center) and transition to the intervention phase at a randomly assigned time point over the course of the study.

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention phase

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.

Group Type ACTIVE_COMPARATOR

Take home saliva kits

Intervention Type DIAGNOSTIC_TEST

Saliva kits will be made available at schools for pick up to support symptomatic testing using PCR for students, staff and family members.

Interventions

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Take home saliva kits

Saliva kits will be made available at schools for pick up to support symptomatic testing using PCR for students, staff and family members.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.

Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No