Effectiveness of Rapid Antigen Testing of Students for COVID-19 in Reducing Absences From Schools in Bangladesh

NCT05668078 | Completed

• 1 other identifier: PR-21078
• Study Type: interventional
• Target: 1,141
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

School Absenteeism

Outcome Measures

Primary Outcomes (1)

• The number of days absent

  Daily data on school absence was collected prospectively from the school authorities and the cause of absence was collected from the students.

  10 Weeks

Secondary Outcomes (1)

• COVID-19 positivity

  10 Weeks

Study Arms (3)

School-type 1, intervention school-1

EXPERIMENTAL

We will test all symptomatic students, teachers, and support staff ; and track students symptoms and absenteeism

Diagnostic Test: Rapid Antigen Testing (RAT) for COVID-19

School-type 2, intervention school-2

EXPERIMENTAL

We will test all students, teachers, and support staff every 3 days, irrespective of symptoms (also test whenever develops symptoms) and track students symptoms and absenteeism

Diagnostic Test: Rapid Antigen Testing (RAT) for COVID-19

In School-type 3, control school

EXPERIMENTAL

We will not do any test, only track the students for symptom notification and absenteeism

Diagnostic Test: Rapid Antigen Testing (RAT) for COVID-19

Interventions

Rapid Antigen Testing (RAT) for COVID-19 DIAGNOSTIC_TEST

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.

In School-type 3, control school; School-type 1, intervention school-1; School-type 2, intervention school-2

Eligibility Criteria

• Age: 13 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• A day school (not residential), with at least 50 students per classroom that follows the national curriculum in either Bangla or English instruction
• Students of class Nine, Ten and Eight
• Providing written consent for participation (both student and Guardian)

You may not qualify if:

• Not providing written consent for participation (both student and Guardian)

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead
• Columbia University: collaborator

Study Sites (1)

Icddr,B

Dhaka, 1212, Bangladesh

Location

Study Officials

• Arifa Nazneen, MBBS, MPH

  International Centre for Diarrhoeal Disease Research, Bangladesh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2022
• First Posted: December 29, 2022
• Study Start: May 18, 2022
• Primary Completion: July 30, 2022
• Study Completion: July 30, 2022
• Last Updated: December 29, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)