The School SPIT Study - COVID-19 Testing in Secondary Schools

NCT ID: NCT05060510

Last Updated: 2023-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-14
• Study Completion Date: 2022-06-30

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. The 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) 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 secondary public schools in Toronto Region 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 (10 crossovers per week) with take-home saliva being available to all 60 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 PCR testing leads to increased diagnosis of COVID-19 cases in the school.

Conditions

SARS-CoV2 Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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 kit

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

Take home saliva kit

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

Exclusion Criteria

Schools that are middle schools only, that are not open for in-person learning, have fewer than 100 students or are not a complete secondary school (i.e. adult learning schools, schools offering independent courses, prep schools with 1-2 grades, secondary schools with < 4 grades) will be excluded.

• Minimum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Hospital for Sick Children

OTHER

Sponsor Role: lead

Responsible Party

Michelle Science

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Hospital for Sick Children

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

1000078377-3

Identifier Type: -

Identifier Source: org_study_id