Effectiveness of Rapid Antigen Testing of Students for COVID-19 in Reducing Absences From Schools in Bangladesh
Condition: School Absenteeism
Study type: Interventional

Summary: 
      The goal of this trial is to evaluate the impact of different testing strategies with Rapid
      Antigen Testing (RAT) on reduction of school absences. RATs are relatively inexpensive, fast,
      and can be performed at the point of care. Provision of testing in schools will allow rapid
      identification and isolation of individuals infected with Covid-19. This will likely reduce
      COVID-19 transmission, as well as allow symptomatic COVID-19 negative students to return to
      classroom, avoiding the 10-days isolation period. If proven successful, the lessons from this
      study can be translated to schools in similar settings. While several testing strategies have
      been proposed and evaluated in developed countries, no studies have evaluated the role of
      testing for safe operation of schools or reducing absenteeism in developing country
      contexts.The lessons learned from this study is likely to inform government policy regarding
      the provision of testing in school.

      Study design: Cluster randomized trial

      School types: Three types based on testing:

        -  Intervention school-1: Test all symptomatic students, teachers, and support staff ; and
           track symptoms and absenteeism

        -  Intervention school-2: Test all students, teachers, and support staff every 3 days,
           irrespective of symptoms (also test whenever develops symptoms) and track symptoms and
           absenteeism

        -  Control school: Only track the students for symptom notification and absenteeism
    

Detailed description: 
      Research Design and Methods Study design: Cluster randomized trial School types: Three types
      based on testing

      ● School-type 1, intervention school-1: Test all symptomatic participants; and track symptoms
      and absenteeism

      ● School-type 2, intervention school-2: Test all participants every three days, irrespective
      of symptoms (also test whenever develops symptoms), and track symptoms and absenteeism

      ● In School-type 3, control school: Only track the symptom notification and absenteeism

      Trigger testing:

      Enrolled students, teachers, and staff will be tested if they are absent from school due
      COVID-19 like symptoms such as cough, fever, fatigue/ tiredness, headache, loss of taste
      /loss of smell, sore throat, diarrhoea, shortness of breath/dyspnoea (a person with at least
      one of the mentioned signs/symptoms at present or within the last five days). These symptoms
      will be based on the self-report of the individuals. Once a student or staff is absent from
      school, they will be called to assess their symptoms. If they report COVID-19-like symptoms,
      they will be asked to come to the testing booth adjacent to their school. If a student
      arrives at school with any COVID-19-like symptoms or experiences any symptoms during school
      hours, he/she will be tested immediately.

      Study site: Schools in Dhaka, Bangladesh. Selected nine schools

      Study Population:

        -  Students of 9th and 10th grade

        -  Teachers and support staff Length of data collection: 3 months

      Data collection:

      Investigator will select three schools meeting the inclusion criteria for the study. Selected
      schools will be non-residential. The investigator will communicate with the school
      authorities to confirm their participation prior to the inception of the study. Then invite
      all the students of classes 9 and 10 and all the teachers and other support staff of the
      selected school to participate. When the investigator confirms the participant's
      participation by written consent, collect socio-demographic and health-related information at
      baseline and begin to follow up with students and teachers.

      Sample collection and testing:

      Whenever any participant develops any COVID-19-like symptoms, study team will immediately
      arrange to test their nasal swab samples by Rapid Antigen Test (RAT) on-site and inform them
      of the result soon after testing. The team will collect two swabs, one for antigen tests and
      the other for Reverse Transcription Polymerase Chain Reaction (RT-PCR), in case the antigen
      test is negative. Sample collection to testing completion of RAT may require one hour.
      Samples that test negative by antigen tests will be tested by RT-PCR, which may take up to 24
      hours to get results. Students will stay home until they receive their RT-PCR test results.
      Swabs will be collected by trained medical technicians of the research team who will be
      available in school during and after school hours. Sick students will be asked to come to the
      testing site near the school gate after school hours for testing. The team will collect
      detailed data on the current signs and symptoms during sample collection. They will also
      collect information on the current practice of mask use, social distancing, hand washing,
      travel history, and contact information for the last 14 days from the participants.

      Sample testing booth for RAT:

      The investigator will select a separate area near the school gate for an on-site sample
      testing booth. The testing booth area would preferably be inside the school near one side of
      the school gate, but it can be outside the gate if an arrangement of a booth inside the gate
      is not suitable. The sample collection booth will remain open after school hours to collect
      samples who missed school. Two trained medical technologists (MT) of the study team will
      collect the sample and complete the testing procedure. Both MTs will wear Full PPE during
      sample collection and ensure standard bio-safety measures while collecting and testing the
      samples.

      If any participants become COVID-19 positive, investigator will recommend ten days of
      isolation of the positive participant. If the participant is tested negative for RAT and
      RT-PCR, he/she will continue to attend the school after getting the test result if their
      health condition permits.

      Everyone will be tested routinely in the intervention arm assigned to serial testing,
      irrespective of their symptoms. In between, if anyone develops symptoms, the team will
      arrange their sample test immediately.

      Communication of test results:

      Investigator will send an SMS to the participants immediately with their test results, and
      positive test results will be communicated via phone and SMS. If anyone needs individual test
      results, investigator will arrange a hard copy /soft copy of the test report later.
      Investigator will also send the test results to the school authority by email and or send a
      hard copy list of test results for their documentation.

      RAT testing Kit: "Pnbio COVID-19 AG Papid Tests Device 25T NS".

      Outcomes:

        1. School absence days due to influenza-like symptoms

        2. Episodes of Influenza-like illness (ILI)/COVID-19-like illness Data Analysis
           Investigator will compare the socio-demographic characteristics between the control and
           intervention schools using the chi-square test for binary variables and the student's
           t-test for continuous variables. Each outcome will be undertaken on an
           'intention-to-treat (ITT) basis, i.e., all participants with a recorded outcome will be
           included in the analyses and will be analyzed according to the intervention arm they
           were allocated. Investigator will model absenteeism rates (number of ill days per
           student) as a Poisson variable. Investigator will use generalized estimating equations
           to compare absenteeism rates and COVID-19 incidence between intervention and control
           schools while accounting for the clustering in the data from each classroom. This
           comparison will be made in unadjusted and adjusted analyses using multivariate
           regression models for potential confounders, including SES, family size, health status,
           mask use, etc
    

Intervention name(s): Rapid Antigen Testing (RAT) for COVID-19
Intervention type(s): Diagnostic Test
Intervention description(s): COVID-19 RAT intervention done among the school students to see if RAT test can play a role in reducing absenteeism. School type-1-only for symptomatic participants, School type-2-Serial testing at three days interval for all participants and School type-3 got no testing.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention