Antigen Rapid Diagnostic Tests for Community Identification of Severe Acute Respiratory Syndrome Coronavirus 2

NCT05458557 | Completed

• 1 other identifier: EG0278
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Background: Testing with antigen-detecting rapid diagnostic tests (Ag-RDTs), including in asymptomatic individuals, has the potential to promptly identify more Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infections and consequently decrease spread of coronavirus-19 disease at the community level. In addition, rapid test results are important for immediate clinical management and isolation of patients with SARS-CoV-2 infection, and for contact tracing and quarantining of contacts. Data on SARS-CoV-2 infection rates, the acceptability of Ag-RDT, and the cost of conducting widespread testing in these communities are limited in Africa. Study Aim and Objectives: To generate evidence evaluating the use of Ag-RDTs for community identification of SARS-CoV-2 infections within large gathering venues such as work places, schools, places of worship, and markets. The primary objective is to determine the SARS-CoV-2 case detection rate through a mass testing approach in large gatherings. Secondary objectives include determining the proportion of asymptomatic and symptomatic infections detected, acceptance of mass SARS-CoV-2 Ag-RDT testing, the prevalence of circulating variants, and the cost of implementing this community testing strategy. Study Design: The investigators propose a serial cross-sectional study design targeting approximately 15,000 persons, who will be offered testing in up to 50 different high attendance venues of Kiambu County that will be identified as possible points of community-based transmission. The study will follow an opt-in consent approach, with those accepting to participate providing additional information to the trained research assistant and/or health worker. Outcome: Evidence will be generated to provide recommendations to the Kenya Ministry of Health, and more broadly to inform the field on the use of Ag-RDTs for large scale community screening by identifying best practices and stratifying risk areas for community transmission based on rates of infections detected within various settings.

Conditions

Severe Acute Respiratory Syndrome Coronavirus 2 Infection

Outcome Measures

Primary Outcomes (1)

• SARS-CoV-2 case detection rate

  Will determine the proportion of SARS-CoV-2 infections detected per 100 individuals tested) in high volume community venues using SARS-CoV-2 Ag-RDT, overall and disaggregated by venue type.

  This will be done in a period of 4 months of study enrolment

Secondary Outcomes (5)

• Proportion testing positive across the cascade

  4 months

• Positive cases by type

  4months

• Factors

  4 months

• SARS-COV-2 variants

  4 months

• Costing

  4months

Interventions

Rapid Antigen Testing DIAGNOSTIC_TEST

Community testing for SARS-COV-2 using rapid Antigen test

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be composed of all persons attending the selected venue where testing is offered on the day of the testing campaign, including all ages \> 2 years regardless of presence of coronavirus-19 symptoms. This population will include people from different economic and social backgrounds.

You may qualify if:

• Age \> 2 years
• Agrees to Undergo testing with SARS-CoV-2-Ag RDT on the day of testing campaign
• Ability and willingness to provide written consent/assent for participation in an interview following the test

You may not qualify if:

• \. Positive SARS-CoV-2 test done 1 to 14 days before the current testing campaign

Sponsors & Collaborators

• Elizabeth Glaser Pediatric AIDS Foundation: lead
• Find: collaborator
• Kiambu County: collaborator

Study Sites (1)

Kiambu County

Kiambu, Kenya

Location

Biospecimen

Retention: NONE RETAINED

naso-pharyngial swabs collected for purposes of identification of SARS-COV-2

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 Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Director Public Health Evaluations

Study Record Dates

• First Submitted: July 7, 2022
• First Posted: July 14, 2022
• Study Start: June 20, 2022
• Primary Completion: September 30, 2022
• Study Completion: December 16, 2022
• Last Updated: April 19, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

KE (1)