The Impact of SARS-CoV-2 Rapid Antigen Testing Kit Screening in Bangkok Community
Phase: NA
Conditions: Covid19, SARS-CoV-2, Community Transmissions, Coronavirus Infections
Sponsor: Mahidol University

Study Protocol and Statistical Analysis Plan 
 
 
The cluster randomized controlled trial will be conducted in Bangkok communities 
supported by Thaicare. A total number of 30,000 participants will be enrolled from 10 areas. 
(3,000 from each area). Participants from each area will be divided into three groups according 
to the accommodation type. The ratio 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). This is illustrated 
in Fig 1.  
Patients with inclusion criteria
Patients are informed consent
Patients are random 1:1:1 and test with rapid 
antigen test as protocol
Data collection

 
Fig 1. Self-tests schedule of each group. 
 
Categorical variables will be presented in percent and frequency and analyzed by Chi 
square. Continuous variables will be presented in medians and interquartile range. Mixed effect 
logistic regression and incidence rate ratio will be used to model the difference in COVID-19 
infection between the intervention and control groups, and between the two intervention 
groups. Statistically significant will be achieved at < 0.05 (P-values <0.05). Statistical Package for 
Social Sciences (SPSS) software (version 27, SPSS, Inc, Chicago, IL, USA) will be used.