NCT05630300

Feasibility and Usability of COVID-19 Antigen RDTs in Uganda

Assessing the Feasibility and Usability of Implementing Professional Use and Self-administered COVID-19 Antigen RDTs in Uganda

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,280 (actual)
• Sponsor: PATH · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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: 1. 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. 2. 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.

Detailed description

This study seeks to understand the feasibility and usability of COVID-19 Ag-RDT self-tests among Boda boda drivers and FSWs in community-based settings in two districts of Uganda. Ag-RDT COVID-19 professional use tests will also be assessed, among patients soliciting OPD services in health facilities, to support public-sector screening when qRT-PCR testing services are limited or unavailable. Feasibility for the purposes of this intervention refers to core factors affecting implementation success (i.e., barriers, facilitators, user preferences, and acceptability of Ag-RDT use and implementation) and demand (the measure of actual use of professional and self-administered Ag-RDTs in the population). Usability is defined as the extent to which FSWs, Boda boda drivers, and OPD patients, and household contacts of OPD patients self-report their comfort with performing critical self-testing procedures (sample collection, sample processing, and results interpretation) autonomously. Primary Research Objective • To assess the feasibility of using professional and self-administered COVID-19 Ag-RDTs in facility OPD and community settings in Uganda. Secondary Research Objective • Determine usability of Ag-RDT COVID-19 self-tests among FSWs, Boda boda drivers, OPD patients, and household contacts of OPD patients. Primary outcomes: Feasibility of professional and self-administered COVID-19 Ag-RDT use. * Implementation success. Number of people who report COVID 19 self-testing and professional COVID 19 testing acceptable and preferred. * Demand. Proportion of COVID-19 OPD cases identified via professional use testing who accept to take self-testing kits for their contacts. * Demand. Proportion of FSWs, Boda boda drivers, and household contacts who use Ag-RDT COVID-19 self-tests and report their findings. Secondary outcomes: Usability of Ag-RDT self-administered tests. • Usability. Proportion of assisted self-testers compared to unassisted self-testers who self-report that they feel comfortable using the test and return the results, stratified by population group (OPD patients, household contacts of OPD patients, FSWs, and Boda boda drivers).

Conditions

• COVID-19 Pandemic

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	PMC Sure Status COVID-19 Antigen Test	COVID-19 professional use kit in out-patient departments
DIAGNOSTIC_TEST	Acon Flowflex COVID-19 Antigen Home Test	COVID-19 self-test kits

Timeline

• Start date: 2023-03-01
• Primary completion: 2023-08-30
• Completion: 2023-09-30
• First posted: 2022-11-29
• Last updated: 2023-11-07

Locations

4 sites across 1 country: Uganda