The Impact of SARS-CoV-2 Rapid Antigen Testing Kit Screening in Bangkok Community
Study Details
Study Description
Brief 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:
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To compare the incidence of severe COVID-19 between communities with rapid antigen tests and without rapid antigen tests.
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To study the decrease in incidence of community-acquired COVID-19 in communities with rapid antigen tests.
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To study factors affecting community-acquired COVID-19 in these communities.
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To campaign for the government to recognize the importance and effectiveness of weekly testing, and propose suitable strategies to fight COVID.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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 |
Outcome Measures
Primary Outcome Measures
- Incidence rate of COVID19 infection [3 week]
Incidence rate of COVID19 infection in intervention group and control group
Secondary Outcome Measures
- Incidence rate of severe COVID19 infection [3 week]
severe COVID19 infection defined as ICU admission, on mechanical ventilator in intervention group and control group
- Incidence of COVID19 infection in COVID19 vaccinated and non vaccinated people [3 week]
- sensitivity and specificity of rapid antigen testing kit [3 week]
compare with standard PCR
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Mahidol University
- Yuvabadhana foundation
- Zero COVID Thailand
- Chulalongkorn University
- Ministry of Health, Thailand
Investigators
- Principal Investigator: Gasit Saksirisampant, MD, Mahidol University
- Study Chair: Dhammika Leshan Wannigama, MD.PhD, Chulalongkorn University
- Study Director: Katika Akksilp, MD, Ministry of Health, Thailand
Study Documents (Full-Text)
More Information
Publications
- Agulló V, Fernández-González M, Ortiz de la Tabla V, Gonzalo-Jiménez N, García JA, Masiá M, Gutiérrez F. Evaluation of the rapid antigen test Panbio COVID-19 in saliva and nasal swabs in a population-based point-of-care study. J Infect. 2021 May;82(5):186-230. doi: 10.1016/j.jinf.2020.12.007. Epub 2020 Dec 9.
- Hirotsu Y, Maejima M, Shibusawa M, Nagakubo Y, Hosaka K, Amemiya K, Sueki H, Hayakawa M, Mochizuki H, Tsutsui T, Kakizaki Y, Miyashita Y, Yagi S, Kojima S, Omata M. Comparison of automated SARS-CoV-2 antigen test for COVID-19 infection with quantitative RT-PCR using 313 nasopharyngeal swabs, including from seven serially followed patients. Int J Infect Dis. 2020 Oct;99:397-402. doi: 10.1016/j.ijid.2020.08.029. Epub 2020 Aug 12.
- Mak GC, Cheng PK, Lau SS, Wong KK, Lau CS, Lam ET, Chan RC, Tsang DN. Evaluation of rapid antigen test for detection of SARS-CoV-2 virus. J Clin Virol. 2020 Aug;129:104500. doi: 10.1016/j.jcv.2020.104500. Epub 2020 Jun 8.
- Pavelka M, Van-Zandvoort K, Abbott S, Sherratt K, Majdan M; CMMID COVID-19 working group; Inštitút Zdravotných Analýz, Jarčuška P, Krajčí M, Flasche S, Funk S. The impact of population-wide rapid antigen testing on SARS-CoV-2 prevalence in Slovakia. Science. 2021 May 7;372(6542):635-641. doi: 10.1126/science.abf9648. Epub 2021 Mar 23.
- Yue H, Bai X, Wang J, Yu Q, Liu W, Pu J, Wang X, Hu J, Xu D, Li X, Kang N, Li L, Lu W, Feng T, Ding L, Li X, Qi X; Gansu Provincial Medical Treatment Expert Group of COVID-19. Clinical characteristics of coronavirus disease 2019 in Gansu province, China. Ann Palliat Med. 2020 Jul;9(4):1404-1412. doi: 10.21037/apm-20-887. Epub 2020 Jul 13.
- COA. MURA2021/711