Feasibility and Usability of COVID-19 Antigen RDTs in Uganda

This study will assess the feasibility and usability of COVID-19 professional and self-administered Antigen-Rapid Diagnostic Tests (Ag-RDTs) through health facility outpatient services and community settings in Kampala and Luwero districts in Uganda.There are two components to this study:Facility-based COVID-19 Ag-RDT professional use testing which will include people seeking care at outpatient departments and household contacts of index participants diagnosed at outpatient departments in four health facilities in Kampala and Luwero districts.Community-based COVID-19 Ag-RDT self-testing which will include at-risk populations such as female sex workers (FSW) and Boda boda drivers (motorcyclists) at points of mass throughfare in Kampala and Luwero districts.Key outcomes target the implementation's success, demand, and usability of professional and self-administered Ag-RDTs.

OPD patients (index cases) for professional use testingInclusion Criteria:18 years of age or older or below 18 years and meets the qualification of an emancipated minor (heads a family, takes care of his/herself, pregnant/has children, cohabiting or married).Exhibits signs and symptoms of a COVID-19 infection.Positive screening result for COVID-19 infection using -Ag-RDT self-test or Ag-RDT professional-use test.Willing and able to provide informed consent to participate and comply with study requirements.Exclusion Criteria:Any study site employees who are involved in the protocol or may have access to study-related data.Treating clinician deems inappropriate to enroll.Those who do not have a telephone contact to report results and be interviewed on phone.Household contacts of OPD patients for self-testingInclusion Criteria:18 years of age or older or below 18 years and meets the qualification of an emancipated minor (heads a family, takes care of his/herself, pregnant/has children, cohabiting or married).Exposure to COVID-19 (i.e., being within 6ft/1 meter of the index case for more than 15 minutes or physical contact with the index case within the 2 days before symptom onset of the confirmed COVID-19 case (index case).Willing and able to provide informed consent.Exclusion CriteriaContraindication to nasal swab.Had a nasopharyngeal swab in the last 8 hours.Any study site employees who are involved in the protocol or may have access to study-related data.Already enrolled in this study.Community-based self-testing participants (FSWs and Boda boda drivers)Inclusion criteria:18 years of age or older or below 18 years and meets the qualification of an emancipated minor (heads a family, takes care of his/herself, pregnant/has children, cohabiting or married).Must identify as a FSW or Boda boda driver.Ability to provide informed consent.Must be a resident or working in Kampala or Luwero districts.Exclusion Criteria:Unwilling or unable to provide informed consent.Not a part of the population group outlined above.Has no cell phone to convey results and for interview.