NCT05047900

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70,000 (actual)
• Sponsor: Mahidol University · Academic / Other
• Sex: All
• Age: 10 Years
• Healthy volunteers: Not accepted

Summary

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.

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)

Conditions

• Covid19
• SARS-CoV-2
• Community Transmissions
• Coronavirus Infections

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Rapid antigen testing kit	COVID-19 Saliva Antigen Rapid Test Tigsun COVID-19 Speichel Antigen-Schnelltest

Timeline

• Start date: 2021-11-01
• Primary completion: 2022-12-31
• Completion: 2023-01-13
• First posted: 2021-09-17
• Last updated: 2023-01-17

Locations

6 sites across 1 country: Thailand