Clinical trial NCT05047900: 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
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
SARS-CoV-2
Community Transmissions
Coronavirus Infections
Keywords: ATK
Covid19
Rapid antigen testing kit
Screening
Community transmissions
SARS-CoV-2
Coronavirus
Infectious diseases
Lead sponsor: Mahidol University
Sponsor class: OTHER
Collaborators: name: Yuvabadhana foundation
name: Zero COVID Thailand
name: Chulalongkorn University
name: Ministry of Health, Thailand
First posted: 2021-09-17
Enrollment: 70000
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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)

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

Primary outcomes:
measure: Incidence rate of COVID19 infection
timeFrame: 3 week
Secondary outcomes:
measure: Incidence rate of severe COVID19 infection
timeFrame: 3 week
measure: Incidence of COVID19 infection in COVID19 vaccinated and non vaccinated people
timeFrame: 3 week
measure: sensitivity and specificity of rapid antigen testing kit
timeFrame: 3 week
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Provincial Community Housing Complex
city: Chiang Mai
country: Thailand
facility: Rural Community
city: Chiang Rai
country: Thailand
facility: Rural Community
city: Mae Hong Son
country: Thailand
facility: Rural Community
city: Phang Nga
country: Thailand
facility: Rural Community
city: Ranong
country: Thailand
facility: Rural Community
Study officials:
affiliation: Mahidol University
name: Gasit Saksirisampant, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chulalongkorn University
name: Dhammika Leshan Wannigama, MD.PhD
role: STUDY_CHAIR
affiliation: Ministry of Health, Thailand
name: Katika Akksilp, MD
role: STUDY_DIRECTOR
References:
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