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

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 High SARS-CoV-2 Incidence Regions

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.

Study Overview

• Status: Completed
• Conditions: SARS-CoV2 Infection
• Intervention / Treatment: Diagnostic test: Take home saliva kits

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X8
      • The Hospital for Sick Children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Diagnostic test: 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.
No Intervention: Control period; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SARS-CoV-2 Case identification	The number of cases positive for SARS-CoV-2 in a cohort per week per school	Weekly measurement over 7 week study period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Uptake of take-home saliva kits for testing	Frequency of use of take-home saliva kits per week per school	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	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	Over 7 week study period

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2021
• Primary Completion (Actual): November 1, 2021
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: September 20, 2021
• First Submitted That Met QC Criteria: September 20, 2021
• First Posted (Actual): September 24, 2021

Study Record Updates

• Last Update Posted (Actual): May 25, 2023
• Last Update Submitted That Met QC Criteria: May 24, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: School Testing
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 1000078377-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No