The Impact of SARS-CoV-2 Rapid Antigen Testing Kit Screening in Bangkok Community

January 12, 2023 updated by: Gasit Saksirisampant, Mahidol University

Our current focus is to reduce the spread of COVID through distribution of Rapid Antigen Test Kits (ATKs) to low-income, high-risk communities across Bangkok.

Hospitals across Thailand have been operating over capacity for many months, both in receiving the high number of cases as well as in testing for COVID. RT PCR, although highly sensitive, requires potentially infectious people to travel to testing sites, wait in line, and takes 1-2 days to return results, leading to further spread of COVID through increased contact with other high-risk individuals.

On the contrary, testing via an Antigen Test Kit (ATK) can be done by everyone at home with the potential to test more frequently than the PCR test due to much cheaper cost. This means that ATK testing can be mixed into people's daily lifestyle, but another underlying reason is that ATKs only show test results as positive only when an infected person is contagious. Another key advantage is the rapid results, which helps people identify risks quickly, limiting spread even faster.

Our trial therefore aims to achieve the following primary objective:

To monitor the results of freely distribute ATKs in real environments to measure its effectiveness in reducing COVID spread in communities by comparing the incidence of COVID-19 between communities with rapid antigen tests and without rapid antigen tests.

Secondary objectives are:

  1. To compare the incidence of severe COVID-19 between communities with rapid antigen tests and without rapid antigen tests.
  2. To study the decrease in incidence of community-acquired COVID-19 in communities with rapid antigen tests.
  3. To study factors affecting community-acquired COVID-19 in these communities.
  4. To campaign for the government to recognize the importance and effectiveness of weekly testing, and propose suitable strategies to fight COVID.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The cluster randomized controlled trial will be conducted in Bangkok communities supported by Thaicare. A total number of 70,000 participants will be enrolled from 70 clusters. (1,000 from each cluster). Participants from each area will be divided into three groups according to the accommodation type. The rational between intervention group 1 to intervention group 2 and control group will be 1:1:1. The characteristics of population in each stratum will be reproduced as closely as possible. Cluster randomization by software will be used to blind the order of randomization. Demographic data (i.e., age, gender, weight, height, body mass index), concomitant diseases, income, type of accommodation, vaccination profile) of the control and intervention groups will be collected. The collection of data and the obtaining of the consent will be conducted by Socialgiver volunteers. There will be 2 intervention groups. Group 1 will receive 4 rapid antigen kits at the beginning of the study and will be asked to conduct a weekly self-test for 3 weeks. Group 2 will receive 7 rapid antigen kits at the beginning of the study and will be asked to conduct a twice-weekly self-test for 3 weeks (total of 6 tests)

Study Type

Interventional

Enrollment (Actual)

70000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10330
        • Provincial Community Housing Complex
      • Chiang Mai, Thailand
        • Rural Community
      • Chiang Rai, Thailand
        • Rural Community
      • Mae Hong Son, Thailand
        • Rural Community
      • Phang Nga, Thailand
        • Rural Community
      • Ranong, Thailand
        • Rural Community

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria (community level): every Bangkok community under Thai Care. Exclusion criteria (community level): any Bangkok community in which the community coordinator cannot participate in the study.

Inclusion criteria (individual level): anyone who are over 10 years old. Exclusion criteria (individual level): anyone who are not consent or unable to give consents. Those who are known to be COVID-19 positive or currently treated with favipiravir

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rapid antigen testing kit use once weekly

Community will use rapid antigen testing kit once weekly every Monday and will be asked to conduct a weekly self-test for 3 weeks.

This research use COVID-19 Saliva Antigen Rapid Test from Tigsun COVID-19 Speichel Antigen-Schnelltest from Beijing Tigsun Diagnostics
Diagnostic test: Rapid antigen testing kit
COVID-19 Saliva Antigen Rapid Test Tigsun COVID-19 Speichel Antigen-Schnelltest
Experimental: Rapid antigen testing kit use twice weekly
Community will use rapid antigen testing kit twice weekly every Monday and Thursday and will be asked to conduct a twice-weekly self-test for 3 weeks This research use COVID-19 Saliva Antigen Rapid Test from Tigsun COVID-19 Speichel Antigen-Schnelltest from Beijing Tigsun Diagnostics
Diagnostic test: Rapid antigen testing kit
COVID-19 Saliva Antigen Rapid Test Tigsun COVID-19 Speichel Antigen-Schnelltest
No Intervention: Control
Did not routinely use Rapid antigen testing kit

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence rate of COVID19 infection
Time Frame: 3 week
Incidence rate of COVID19 infection in intervention group and control group
3 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence rate of severe COVID19 infection
Time Frame: 3 week
severe COVID19 infection defined as ICU admission, on mechanical ventilator in intervention group and control group
3 week
Incidence of COVID19 infection in COVID19 vaccinated and non vaccinated people
Time Frame: 3 week
3 week
sensitivity and specificity of rapid antigen testing kit
Time Frame: 3 week
compare with standard PCR
3 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Collaborators

Chulalongkorn University
Ministry of Health, Thailand
Yuvabadhana foundation
Zero COVID Thailand

Investigators

  • Principal Investigator: Gasit Saksirisampant, MD, Mahidol University
  • Study Chair: Dhammika Leshan Wannigama, MD.PhD, Chulalongkorn University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2021

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

January 13, 2023

Study Registration Dates

First Submitted

September 6, 2021

First Submitted That Met QC Criteria

September 16, 2021

First Posted (Actual)

September 17, 2021

Study Record Updates

Last Update Posted (Estimate)

January 16, 2023

Last Update Submitted That Met QC Criteria

January 12, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COA. MURA2021/711

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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