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

Primary Purpose

SARS-CoV2 Infection

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Take home saliva kit
Sponsored by
The Hospital for Sick Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for SARS-CoV2 Infection focused on measuring School Testing

Eligibility Criteria

2 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Secondary schools will be included in the evaluation if they are:

  • Considered a secondary school by the school board
  • Open for in-person learning during the study period
  • They have at least 100 students
  • Offer Grades 9-12 (secondary)

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.

Sites / Locations

  • The Hospital for Sick Children

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

control phase

Intervention phase

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

SARS-CoV-2 Case Identification
The number of cases positive for SARS-CoV-2 in a cohort per week per school (rate per cohort per week) in the intervention period compared to the control period.

Secondary Outcome Measures

Uptake of take-home saliva kits for testing
Frequency of use of take-home saliva kits per school per week
Impact on timing of test for symptomatic individuals
To assess whether availability of take-home saliva kits at school leads to earlier testing as measured by duration of symptoms before testing of the symptomatic case
Impact on secondary transmission
To assess whether the availability of take-home saliva testing leads to reduced transmission within exposed cohorts as measured by the number of secondary cases identified in exposed cohorts.

Full Information

First Posted
September 20, 2021
Last Updated
May 24, 2023
Sponsor
The Hospital for Sick Children
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1. Study Identification

Unique Protocol Identification Number
NCT05060510
Brief Title
The School SPIT Study - COVID-19 Testing in Secondary Schools
Official Title
The School SPIT Study (Saliva to Promote Improved Testing): A Prospective Evaluation of a Home Saliva Testing Program for COVID-19 Implemented With a Stepped-wedge Cluster Randomized Design in Secondary Schools.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
September 14, 2021 (Actual)
Primary Completion Date
November 1, 2021 (Actual)
Study Completion Date
June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS-CoV2 Infection
Keywords
School Testing

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
This is a prospective evaluation of a program that is being implemented using a stepped-wedge, cluster randomized design.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control phase
Arm Type
No Intervention
Arm Description
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.
Arm Title
Intervention phase
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Take home saliva kit
Intervention Description
Saliva kits will be made available at schools for pick up to support symptomatic testing using PCR for students, staff and family members.
Primary Outcome Measure Information:
Title
SARS-CoV-2 Case Identification
Description
The number of cases positive for SARS-CoV-2 in a cohort per week per school (rate per cohort per week) in the intervention period compared to the control period.
Time Frame
Weekly measurement over 7 week study period
Secondary Outcome Measure Information:
Title
Uptake of take-home saliva kits for testing
Description
Frequency of use of take-home saliva kits per school per week
Time Frame
Weekly measurement over 7 week study period
Title
Impact on timing of test for symptomatic individuals
Description
To assess whether availability of take-home saliva kits at school leads to earlier testing as measured by duration of symptoms before testing of the symptomatic case
Time Frame
Over 7 week study period
Title
Impact on secondary transmission
Description
To assess whether the availability of take-home saliva testing leads to reduced transmission within exposed cohorts as measured by the number of secondary cases identified in exposed cohorts.
Time Frame
Over 7 week study period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Secondary schools will be included in the evaluation if they are: Considered a secondary school by the school board Open for in-person learning during the study period They have at least 100 students Offer Grades 9-12 (secondary) 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.
Facility Information:
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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