NCT05060510

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

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (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. 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

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	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.

Timeline

• Start date: 2021-09-14
• Primary completion: 2021-11-01
• Completion: 2022-06-30
• First posted: 2021-09-29
• Last updated: 2023-05-25

Locations

1 site across 1 country: Canada