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

NCT05055505 | Completed DMC

• 1 other identifier: 1000078377-1
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

SARS-CoV2 Infection

Keywords

School Testing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Uptake of take-home saliva kits for testing

  Weekly measurement over 7 week study period

• Impact on timing of test for symptomatic individuals

  Over 7 week study period

• Impact on secondary transmission

  Over 7 week study period

Study Arms (2)

control phase

NO INTERVENTION

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.

Intervention phase

ACTIVE COMPARATOR

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

Interventions

Take home saliva kits 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.

Intervention phase

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M8Y1W5, Canada

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

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

Study Record Dates

• First Submitted: September 20, 2021
• First Posted: September 24, 2021
• Study Start: September 14, 2021
• Primary Completion: November 1, 2021
• Study Completion: June 30, 2022
• Last Updated: May 25, 2023

Record last verified: 2023-05

Locations

CA (1)