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

Sponsor
Mahidol University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05047900
Collaborator
Yuvabadhana foundation (Other), Zero COVID Thailand (Other), Chulalongkorn University (Other), Ministry of Health, Thailand (Other)
70,000
Enrollment
3
Arms
1
Anticipated Duration (Months)

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:
  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.

Condition or DiseaseIntervention/TreatmentPhase
  • Diagnostic Test: Rapid antigen testing kit
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

Study Type:
Interventional
Anticipated Enrollment :
70000 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Screening
Official Title:
The Impact of SARS-CoV-2 Rapid Antigen Testing Kit Screening in Bangkok Community
Anticipated Study Start Date :
Oct 1, 2021
Anticipated Primary Completion Date :
Nov 1, 2021
Anticipated Study Completion Date :
Nov 1, 2021

Arms and Interventions

ArmIntervention/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

  1. Incidence rate of COVID19 infection [3 week]

    Incidence rate of COVID19 infection in intervention group and control group

Secondary Outcome Measures

  1. Incidence rate of severe COVID19 infection [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 [3 week]

  3. sensitivity and specificity of rapid antigen testing kit [3 week]

    compare with standard PCR

Eligibility Criteria

Criteria

Ages Eligible for Study:
10 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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

Responsible Party:
Gasit Saksirisampant, Principal Investigator, Mahidol University
ClinicalTrials.gov Identifier:
NCT05047900
Other Study ID Numbers:
  • COA. MURA2021/711
First Posted:
Sep 17, 2021
Last Update Posted:
Oct 19, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Gasit Saksirisampant, Principal Investigator, Mahidol University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 19, 2021