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

SARS-CoV2 Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05055492
• Other study ID #: 1000078377-2
• Status: Completed
• Phase: N/A
• Start date: September 14, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: May 2023
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 30, 2022
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• SARS-CoV2 Infection

Intervention

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.

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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