Research on Community Based ATK Test Study to Control Spread of COVID-19 in Migrant Community

Study Overview
=================
Brief Summary
-----------------
Thousands of migrants from Myanmar have arrived in Thailand for their safety, better living standards and employment opportunities. They are often in Thailand illegally and have poor access to the Thai health care system. This underutilization not only puts their health at risk but may also put the general public's health at risk. During the COVID-19 pandemic, migrants often have no access to diagnostic tests even though global health actors are focused on accelerating access to COVID-19 testing. SARS-CoV-2 testing is one of the most effective and necessary means of mitigating the COVID-19 pandemic. The overarching goal of this study is to provide evidence on effectiveness and feasibility of community-based SARS-CoV-2 antigen rapid diagnostic test (Ag-RDT) application in the Myanmar migrant community, Tak Province along the Thai Myanmar border as part of test-trace-isolation strategies to fight COVID-19. After the study has been completed, the study team will have evidence to inform policymakers on whether community based SARS-CoV-2 Ag-RDT test-trace-isolate strategy is effective and feasible to fight COVID-19 where there is limited or no access to COVID-19 testing in the Myanmar migrant communities.

Detailed Description
-----------------
This study plan to recruit people who are living in the Maramat and Pohphra Myanmar migrant community or returning to community from outside. This study includes seroprevalence survey (secondary objective) at the beginning and at the post-intervention of study to estimate the percentage of people in a population who have antibodies against SARS-CoV-2 by capillary blood collection from finger prick. This secondary objective will be achieved through a substudy. In the substudy, 427 participants will be studied from 7 clusters that will be randomly sampled from the parent study for the Ag RDT arm and similarly 427 participants will be studied from 7 clusters that will be randomly sampled from the parent study for the No Ag RDT arm. There will be two cross-sectional surveys in each of these two arms one at baseline and the other at post-intervention. The aim will be to compare the post-intervention percentage of people in a population who have antibodies against SARS-CoV-2 by capillary blood collection from finger prick between the two arms. The two arms of the substudy will be managed as follows: One arm (Arm 1): Symptomatic /suspected COVID-19 participant or close contact/family members of COVID-19 patient will be tested with Ag RDT and also involve in awareness-raising campaign with mask distribution. One arm (Arm 2): No community based Ag RDT testing but there has routine ATK or RT-PCR test by Thai health authorities if local health volunteer finds symptomatic or suspected COVID-19 or close contact with positive cases in their villages. The participant also involves in awareness-raising campaign with mask distribution. Ten focus group discussion (FGD) with community members will be conducted to find out the attitudes and perception of community members on the use of community based SAR COV2 Ag-RDTs testing in Myanmar migrant community for prevention control of COVID-19 in the study area. The overarching goal of this study is to provide evidence on effectiveness and feasibility of community-based SARS-CoV-2 antigen rapid diagnostic test (Ag-RDT) application in the Myanmar migrant community, Tak Province along the Thai Myanmar border for test-trace-isolation strategies to fight COVID-19. After the study has been completed, depending upon the study finding, study team believe that study team can propose to policymakers to recognize the effectiveness and feasibility of community-based SARS-CoV-2 Ag-RDT's test-trace-isolate strategies to fight COVID-19 where there is limited or no access to COVID-19 testing in the Myanmar migrant communities This study was funded by The Foundation for Innovative New Diagnostics (FIND). The grant reference number is U-2208

Official Title
-----------------
Evaluating the Effectiveness and Feasibility of Community Based SARS-CoV-2 Antigen Rapid Diagnostic Testing (Ag-RDT) in the Myanmar Migrant Community, Tak Province Along the Thai Myanmar Border for Controlling Coronavirus Transmission

Conditions
-----------------
COVID-19 Pandemic

Intervention / Treatment
-----------------
* Device: STANDARD Q COVID-19 Ag Test


Participation Criteria
=================
Eligibility Criteria
-----------------
For Ag RDT arm (primary objective) Inclusion Criteria *Symptomatic COVID-19 patient/suspected COVID-19 or **close contact/family members of COVID-19 patient Participant at any age living in chosen clusters of Maramat and Pohphra Myanmar migrant community Participant or parent/guardian/caretaker is willing and able to give informed consent for participation in the study. Exclusion Criteria Known history of a COVID-19 positive test result within the last 21 days For No Ag RDT arm (primary objective) Inclusion Criteria Participant at any age living in chosen cluster of Maramat and Pohphra Myanmar migrant community Symptomatic COVID-19 patient/suspected COVID-19 or **close contact/family members of COVID-19 patient who agrees to go for routine Thai COVID-19 ATK or RT-PCR test Participant or parent/guardian/caretaker is willing and able to give informed consent for participation in the study Exclusion Criteria Not living in chosen clusters in Maramat and Pohphra Myanmar migrant community note: *Symptomatic or suspected COVID-19: Acute onset of ANY THREE OR MORE of the following signs or symptoms: Fever, cough, general weakness/fatigue1, headache, myalgia, sore throat, coryza, dyspnoea, anorexia/nausea/vomiting1, diarrhoea, altered mental status (1 Signs separated with slash (/) are to be counted as one sign) Reference: WHO-2019-nCoV-Surveillance_Case_Definition-2020.2-eng (5).pdf note: **1 Person who stayed close to or had conversation with COVID-19 patient(s) for >5 minutes, or was exposed to the patient's cough or sneeze; 2 Individual who stayed in enclosed spaces with poor ventilation together with COVID-19 patient(s) for >30 minutes, for instance, in air-conditioned bus, commuter vane, or air-conditioned room; Reference: g_HCWs_3Mar22.pdf (moph.go.th) For seroprevalence survey (secondary objective) Inclusion Criteria Participant at any age living in chosen clusters of Maramat and Pohphra Myanmar migrant community Participant or parent/guardian/caretaker is willing and able to give informed consent for participation in the study. Exclusion Criteria Refusal to give informed consent, or contraindication to venepuncture For Focus group discussion (FGD) Inclusion Criteria Age 18 years and above Living in chosen clusters of Maramat and Pohphra migrant communities Participant is willing and able to give informed consent for participation in the study. Exclusion Criteria Not living in chosen clusters of Maramat and Pohphra migrant communities
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: For primary objective (Ag-RDT (arm 1) and no Ag-RDT (arm 2)) 74 clusters (37 in each arm) Approximate 5,500 participants in arm 1 and 5,500 participants in arm 2
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ag-RDT (arm 1)<br>Symptomatic /suspected COVID-19 participant or close contact/family members of COVID-19 patient will be tested with Ag RDT and also involve in awareness-raising campaign with mask distribution. | Device: STANDARD Q COVID-19 Ag Test<br>* Device Name: STANDARD Q COVID-19 Ag Test Manufactured by SD Biosensor, Inc., Korea Purpose: To detect COVID-19 (Its manufacture specification sensitivity was at 84.97% and specificity 98.4%)<br>|
| No Intervention: No Ag-RDT (arm 2)<br>No community based Ag RDT testing but there has routine ATK or RT-PCR test by Thai health authorities if local health volunteer finds symptomatic or suspected COVID-19 or close contact with positive cases in their villages. The participant also involves in awareness-raising campaign with mask distribution. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the differences in number of cases detected per 1,000 people between the Ag-RDT and No Ag-RDT intervention arms. | The number of cases per 1,000 will be estimated and summarised per group/arm and will compared between groups | through study completion, an average of 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the seroprevalence of SAR COV2 antibody between Ag-RDT Arm (1) and No Ag-RDT Arm (2) | Seroprevalence of SAR COV2 antibody in each of the groups at baseline and at post-intervention surveys. | through study completion, an average of 3 months | 
| Find out about the attitudes of community members on the use of community based SAR COV2 Ag-RDTs testing in Myanmar migrant community | Attitudes of community participants towards community base SAR COV2 Ag-RDTs use. | through study completion, an average of 3 months | 
| Find out about the perception of community members on the use of community based SAR COV2 Ag-RDTs testing in Myanmar migrant community | Perception of community participants towards community base SAR COV2 Ag-RDTs use. | through study completion, an average of 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19, Thailand, ATK, SARS-CoV-2 antigen rapid diagnostic testing