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Completed

NCT Number: NCT05047900

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

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.

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Key information

Conditions

Covid19 COVID-19 Communicable Diseases Community Transmissions Coronaviridae Infections Coronavirus Infections Disease Attributes Infections Lung Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections SARS-CoV-2 Virus Diseases

Age range

10 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Provincial Community Housing Complex, Bangkok, Thailand

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About this study

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)

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Rapid antigen testing kit

Diagnostic Test

COVID-19 Saliva Antigen Rapid Test Tigsun COVID-19 Speichel Antigen-Schnelltest

Primary outcomes

  1. Incidence rate of COVID19 infection

    Time frame: 3 week

    Incidence rate of COVID19 infection in intervention group and control group

Secondary outcomes

  1. 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

  2. Incidence of COVID19 infection in COVID19 vaccinated and non vaccinated people

    Time frame: 3 week

  3. sensitivity and specificity of rapid antigen testing kit

    Time frame: 3 week

    compare with standard PCR

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Collaborators

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

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Sep 17, 2021
Registry last updated
Jan 17, 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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