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

NCT05557513 | Completed

• 1 other identifier: VIR22002
• Study Type: interventional
• Target: 1,310
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19 Pandemic

Keywords

COVID-19; Thailand; ATK; SARS-CoV-2 antigen rapid diagnostic testing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Compare the seroprevalence of SAR COV2 antibody between Ag-RDT Arm (1) and No Ag-RDT Arm (2)

  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

  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

  through study completion, an average of 3 months

Study Arms (2)

Ag-RDT (arm 1)

ACTIVE COMPARATOR

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

No Ag-RDT (arm 2)

NO INTERVENTION

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.

Interventions

STANDARD Q COVID-19 Ag Test DEVICE

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%)

Ag-RDT (arm 1)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \*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.

You may not qualify if:

• Known history of a COVID-19 positive test result within the last 21 days
• For No Ag RDT arm (primary objective)
• 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
• 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)
• 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.
• Refusal to give informed consent, or contraindication to venepuncture
• For Focus group discussion (FGD)
• Age 18 years and above
• Living in chosen clusters of Maramat and Pohphra migrant communities

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

Shoklo Malaria Research Unit

Mae Sot, Changwat Tak, Thailand

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Dr Thaw Htwe MIn

  Shoklo Malaria Research Unit (SMRU) 69/30 Ban Tung Road, Maesot63110, Tak, Thailand Tel: +66-087-307-0971

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: June 15, 2022
• First Posted: September 28, 2022
• Study Start: August 18, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: April 11, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: For data and records will be retained for five years following completion of the study. Afterwards, all the identifiable data from source documents as well as the electronic database will be destroyed. De-identified data will be archived in SMRU for the purpose of pooled or secondary data analysis. Data may be used alone or in combination with data from related studies in secondary analyses. Any data published in the peer-reviewed medical literature will protect the identity of the participant.

Locations

TH (1)