Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05668078 |
| Other study ID # |
PR-21078 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 18, 2022 |
| Est. completion date |
July 30, 2022 |
Study information
| Verified date |
December 2022 |
| Source |
International Centre for Diarrhoeal Disease Research, Bangladesh |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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
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
