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Completed

NCT Number: NCT05055505

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

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 facility) 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.

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Key information

Conditions

SARS-CoV2 Infection COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

2 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hospital for Sick Children

Toronto, Ontario, M8Y1W5, Canada

About this study

This is a prospective evaluation of a program that is being implemented using a stepped-wedge, cluster randomized design.

Eligible elementary public schools Toronto Region in low SARS-CoV-2 incidence regions (quintiles 1,2 or 3) 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Take home saliva kits

Diagnostic Test

Saliva kits will be made available at schools for pick up to support symptomatic testing using PCR for students, staff and family members.

Primary outcomes

  1. SARS-CoV-2 Case identification

    Time frame: Weekly measurement over 7 week study period

    The number of cases positive for SARS-CoV-2 in a cohort per week per school

Secondary outcomes

  1. Uptake of take-home saliva kits for testing

    Time frame: Weekly measurement over 7 week study period

    Frequency of use of take-home saliva kits per week per school

  2. Impact on timing of test for symptomatic individuals

    Time frame: Over 7 week study period

    To assess whether availability of take-home saliva kits at schools leads to earlier testing as measured by the duration of symptoms before testing of a symptomatic case

  3. Impact on secondary transmission

    Time frame: Over 7 week study period

    To assess whether the availability of take-home saliva test kits at schools leads to reduced transmission within exposed cohorts, as measures by the number of secondary cases identified in exposed cohorts.

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Official study 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 Low SARS-CoV-2 Incidence Regions

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Sep 24, 2021
Registry last updated
May 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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