COVID-19 (SARS-CoV-2 infection) Infections and Infestations
Conditions
Interventions
The intervention will use SARS-CoV-2 antigen rapid diagnostic tests (Ag-RDT) approved for self-testing by ANVISA in Brazil at the time of study start. Close contacts of confirmed positive cases of COV
after completing the contact elicitation interview, index cases will be followed up for 10 days and asked to complete a short survey each day.
Sponsors
PATH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participants will be confirmed COVID-19 cases (index cases) and their associated close contacts. 2. Index cases will be 7 years of age or older. 3. Primary exposure close contacts will be enrolled in the main study, including children aged 7 and older. 4. Secondary exposure close contacts (household members of primary exposure close contacts enrolled in Arm 2) will be given self-tests to use in the observational sub-study. 5. A subset of patients/primary exposure close contacts, caregivers of primary exposure close contacts, health unit workers, and other key stakeholders will also have the option of participating in a usability workshop and/or focus group discussions. These participants will be aged 18 years and older
Exclusion criteria
Exclusion criteria: 1. Study site employee who is involved in the protocol and may have access to study-related data 2. Inappropriate to enroll 3. Previous study participant 4. Contraindication to nasal swab
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of primary exposure close contacts who test positive per index case measured using COVID-19 Ag-RDT result reported on daily follow-up questionnaire Days 1-10. Self-reported COVID-19 self-test result reporting to a public health authority on daily follow-up questionnaire Days 1-10. Use of COVID-19 self-test by secondary exposures reported on optional anonymous survey upon use of self-test. Number of critical errors incurred during supervised self-test, measured per manufacturer instructions for use at baseline visit. Supervised self-test result and professionally-administered self-test result at baseline visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured as per the primary outcome measure: 1. Proportion of Ag-RDT positive contacts per index case who report adhering to recommended treatment, quarantine, or isolation guidelines at the time study is running 2. Proportion of exposed contacts in the self-testing group (Arm 2) who report test results as per local guidelines 3. Number of self-tests used by individuals with secondary exposures 4. Proportion of exposed contacts who perform a self-test per manufacturer instructions without critical errors, under supervision 5. Concordance of self-test result with professional use Ag-RDT test result | — |
Countries
Brazil
Contacts
Public ContactEmily Gerth-Guyette
Outcome results
None listed