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

Not Applicable

Completed

• Conditions: Covid19; SARS-CoV-2; Coronavirus Infections; Community Transmissions
• Interventions: Diagnostic Test: Rapid antigen testing kit

• Registration Number: NCT05047900
• Lead Sponsor: Mahidol University

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.

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 Timeline

• Study First Submitted: 2021-09-06
• Study First Submitted QC: 2021-09-16
• Study First Posted: 2021-09-17
• Study Start: 2021-11-01
• Primary Completion: 2022-12-31
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-12
• Study Completion: 2023-01-13
• Last Update Posted: 2023-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rapid antigen testing kit use twice weekly	Rapid antigen testing kit	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
Rapid antigen testing kit use once weekly	Rapid antigen testing kit	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

Primary Outcome Measures

Name	Time	Method
Incidence rate of COVID19 infection	3 week	Incidence rate of COVID19 infection in intervention group and control group

Secondary Outcome Measures

Name	Time	Method
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
Incidence rate of severe COVID19 infection	3 week	severe COVID19 infection defined as ICU admission, on mechanical ventilator in intervention group and control group

Trial Locations

Locations (2)

Provincial Community Housing Complex; 🇹🇭 Bangkok, Thailand

Rural Community; 🇹🇭 Ranong, Thailand