NCT05055492

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: The Hospital for Sick Children · Academic / Other
• Sex: All
• Age: 2 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• SARS-CoV2 Infection

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-09-14
• Primary completion: 2021-11-01
• Completion: 2022-06-30
• First posted: 2021-09-24
• Last updated: 2023-05-25

Locations

1 site across 1 country: Canada