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

Primary Purpose

Covid19, SARS-CoV-2, Community Transmissions

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Rapid antigen testing kit
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Covid19 focused on measuring ATK, Covid19, Rapid antigen testing kit, Screening, Community transmissions, SARS-CoV-2, Coronavirus, Infectious diseases

Eligibility Criteria

10 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Provincial Community Housing Complex
  • Rural Community
  • Rural Community
  • Rural Community
  • Rural Community
  • Rural Community

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Rapid antigen testing kit use once weekly

Rapid antigen testing kit use twice weekly

Control

Arm Description

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

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

Did not routinely use Rapid antigen testing kit

Outcomes

Primary Outcome Measures

Incidence rate of COVID19 infection
Incidence rate of COVID19 infection in intervention group and control group

Secondary Outcome Measures

Incidence rate of severe COVID19 infection
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
sensitivity and specificity of rapid antigen testing kit
compare with standard PCR

Full Information

First Posted
September 6, 2021
Last Updated
January 12, 2023
Sponsor
Mahidol University
Collaborators
Yuvabadhana foundation, Zero COVID Thailand, Chulalongkorn University, Ministry of Health, Thailand
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1. Study Identification

Unique Protocol Identification Number
NCT05047900
Brief Title
The Impact of SARS-CoV-2 Rapid Antigen Testing Kit Screening in Bangkok Community
Official Title
The Impact of SARS-CoV-2 Rapid Antigen Testing Kit Screening in Bangkok Community
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
January 13, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mahidol University
Collaborators
Yuvabadhana foundation, Zero COVID Thailand, Chulalongkorn University, Ministry of Health, Thailand

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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: To compare the incidence of severe COVID-19 between communities with rapid antigen tests and without rapid antigen tests. To study the decrease in incidence of community-acquired COVID-19 in communities with rapid antigen tests. To study factors affecting community-acquired COVID-19 in these communities. 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, SARS-CoV-2, Community Transmissions, Coronavirus Infections
Keywords
ATK, Covid19, Rapid antigen testing kit, Screening, Community transmissions, SARS-CoV-2, Coronavirus, Infectious diseases

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
70000 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rapid antigen testing kit use once weekly
Arm Type
Experimental
Arm Description
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
Arm Title
Rapid antigen testing kit use twice weekly
Arm Type
Experimental
Arm Description
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
Arm Title
Control
Arm Type
No Intervention
Arm Description
Did not routinely use Rapid antigen testing kit
Intervention Type
Diagnostic Test
Intervention Name(s)
Rapid antigen testing kit
Intervention Description
COVID-19 Saliva Antigen Rapid Test Tigsun COVID-19 Speichel Antigen-Schnelltest
Primary Outcome Measure Information:
Title
Incidence rate of COVID19 infection
Description
Incidence rate of COVID19 infection in intervention group and control group
Time Frame
3 week
Secondary Outcome Measure Information:
Title
Incidence rate of severe COVID19 infection
Description
severe COVID19 infection defined as ICU admission, on mechanical ventilator in intervention group and control group
Time Frame
3 week
Title
Incidence of COVID19 infection in COVID19 vaccinated and non vaccinated people
Time Frame
3 week
Title
sensitivity and specificity of rapid antigen testing kit
Description
compare with standard PCR
Time Frame
3 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gasit Saksirisampant, MD
Organizational Affiliation
Mahidol University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dhammika Leshan Wannigama, MD.PhD
Organizational Affiliation
Chulalongkorn University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Katika Akksilp, MD
Organizational Affiliation
Ministry of Health, Thailand
Official's Role
Study Director
Facility Information:
Facility Name
Provincial Community Housing Complex
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
Rural Community
City
Chiang Mai
Country
Thailand
Facility Name
Rural Community
City
Chiang Rai
Country
Thailand
Facility Name
Rural Community
City
Mae Hong Son
Country
Thailand
Facility Name
Rural Community
City
Phang Nga
Country
Thailand
Facility Name
Rural Community
City
Ranong
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32692208
Citation
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.
Results Reference
background
PubMed Identifier
33758017
Citation
Pavelka M, Van-Zandvoort K, Abbott S, Sherratt K, Majdan M; CMMID COVID-19 working group; Institut Zdravotnych Analyz; Jarcuska P, Krajci 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.
Results Reference
background
PubMed Identifier
32800855
Citation
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.
Results Reference
background
PubMed Identifier
32585619
Citation
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.
Results Reference
background
PubMed Identifier
33309541
Citation
Agullo V, Fernandez-Gonzalez M, Ortiz de la Tabla V, Gonzalo-Jimenez N, Garcia JA, Masia M, Gutierrez 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. No abstract available.
Results Reference
background

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

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