Clinical Trials Logo

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. 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05060510
Study type Interventional
Source The Hospital for Sick Children
Contact
Status Active, not recruiting
Phase N/A
Start date September 14, 2021
Completion date June 30, 2022

See also
  Status Clinical Trial Phase
Recruiting NCT04979858 - Reducing Spread of COVID-19 in a University Community Setting: Role of a Low-Cost Reusable Form-Fitting Fabric Mask N/A
Not yet recruiting NCT04999098 - Clinical Study to Assess the Antiviral Properties of Echinaforce Reducing Oropharyngeal Concentration and Infectivity of SARS-CoV2 Phase 4
Not yet recruiting NCT04978038 - Third Dose of COVID-19 Vaccine in LTCF Residents Phase 4
Active, not recruiting NCT05055505 - The School SPIT Study - Elementary Schools in Low COVID-19 Incidence Regions N/A
Active, not recruiting NCT05055492 - The School SPIT Study - Elementary Schools in High COVID-19 Incidence Regions N/A
Recruiting NCT05054218 - COVID-19 Immunogenicity of a Third Dose of mRNA-1273 Vaccine Among Cancer Patients
Recruiting NCT05076253 - Efficacy of Ivermectin in COVID-19 Phase 1/Phase 2
Not yet recruiting NCT04528771 - S-Nitrosylation Therapy of COVID-19 Phase 1
Not yet recruiting NCT05067946 - Evaluation of Efficacy, Safety and Immunogenicity of GX-19N in Healthy Individuals Who Have Received COVID-19 Vaccines Phase 2/Phase 3
Not yet recruiting NCT05077969 - Leidos-Enabled Adaptive Protocol (LEAP-CT) for Evaluation of Post-exposure Prophylaxis for Newly-infected COVID-19 Patients (Addendum 2) Phase 2
Not yet recruiting NCT05030974 - RECOVAC Booster Vaccination Study Phase 4
Not yet recruiting NCT05013034 - Exploratory Regimen of Basiliximab for Treatment of Pulmonary Cytokine Storm in SARS-CoV-2 Hospitalized Adult Patients Phase 2
Not yet recruiting NCT05073718 - Acetylsalicylic Acid in COVID-19 (ASA-SARS) Phase 3
Not yet recruiting NCT05047783 - Masitinib in Patients With Symptomatic Mild to Moderate COVID-19 Phase 2
Not yet recruiting NCT04590222 - Impact of a Monoamine Oxidase Inhibitor on the Phenotype of Blood Mononucleated Cells in Patients With COVID-19
Active, not recruiting NCT04953039 - Use of Saliva for COVID-19 Diagnosis
Not yet recruiting NCT05074121 - NAC for Attenuation of COVID-19 Symptomatology Phase 2
Not yet recruiting NCT05083130 - Awake Prone Positioning in Moderate to Severe COVID-19 N/A
Recruiting NCT04918797 - COVAXIN in a Pediatric Cohort Phase 2/Phase 3
Completed NCT04893694 - the Prevalence of Oral Manifestation in Patients With SARS-CoV2 Infection