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Feasibility and Usability of COVID-19 Antigen RDTs in Uganda

NCT05630300 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1280

Last updated 2023-11-07

No results posted yet for this study

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.

Conditions

  • COVID-19 Pandemic

Interventions

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

Sponsors & Collaborators

  • PATH

    lead OTHER

Principal Investigators

  • Kimberly Green · PATH

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-01
Primary Completion
2023-08-30
Completion
2023-09-30

Countries

  • Uganda

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05630300 on ClinicalTrials.gov