Feasibility and Usability of COVID-19 Antigen RDTs in Uganda

November 2, 2023 updated by: PATH

Assessing the Feasibility and Usability of Implementing Professional Use and Self-administered 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:

  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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

1280

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Uganda
    • Central
      • Kampala, Central, Uganda, 7404
        • Kisenyi Health Center IV
      • Kampala, Central, Uganda, 7404
        • Kiswa Health center III
      • Luwero, Central, Uganda, 7404
        • Katikamu Health Center III
      • Luwero, Central, Uganda, 7404
        • Luwero Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

OPD patients (index cases) for professional use testing

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).
  • 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-testing

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).
  • 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 Criteria

  • Contraindication 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Facility-based Ag-RDT COVID-19 testing - reactive
Out-patient department patients who utilized a COVID-19 Ag-RDT professional-use test in an OPD clinical setting with reactive test result
Diagnostic test: PMC Sure Status COVID-19 Antigen Test
COVID-19 professional use kit in out-patient departments
Experimental: Facility-based Ag-RDT COVID-19 testing - non-reactive
Out-patient department patients who utilized a COVID-19 Ag-RDT professional-use test in an OPD clinical setting with non-reactive test result
Diagnostic test: PMC Sure Status COVID-19 Antigen Test
COVID-19 professional use kit in out-patient departments
Experimental: COVID-19 Ag-RDT self-testing - agree to self-test
Participants who receive and take a COVID-19 Ag-RDT self-test (female sex workers, Boda boda drivers, household contacts)
Diagnostic test: Acon Flowflex COVID-19 Antigen Home Test
COVID-19 self-test kits
No Intervention: COVID-19 Ag-RDT self-testing - refuse to self-test
Participants who receive but refuse to take a COVID-19 Ag-RDT self-test (female sex workers, Boda boda drivers, household contacts)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demand - OPD
Time Frame: 6 months
Proportion of COVID-19 OPD cases identified via professional use testing who accept self-testing kits for their contacts.
6 months
Demand - Community
Time Frame: 6 months
Proportion of FSWs, Boda boda drivers, and household contacts who use Ag-RDT COVID-19 self-tests and report their results.
6 months
Implementation success
Time Frame: 6 months
Proportion of focus group discussion responses on the barriers, facilitators, user preferences, and acceptability to offering COVID-19 Ag-RDT professional and self-administered kits in health facilities and community settings through thematic analysis.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Usability
Time Frame: 6 months
Proportion of assisted self-testers compared to unassisted self-testers who self-report their comfort with correctly using the test and return the results, stratified by population group (OPD patients, household contacts of OPD patients, FSWs, and Boda boda drivers).
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PATH

Investigators

  • Principal Investigator: Kimberly Green, PATH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Actual)

August 30, 2023

Study Completion (Actual)

September 30, 2023

Study Registration Dates

First Submitted

November 21, 2022

First Submitted That Met QC Criteria

November 21, 2022

First Posted (Actual)

November 29, 2022

Study Record Updates

Last Update Posted (Actual)

November 7, 2023

Last Update Submitted That Met QC Criteria

November 2, 2023

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RES-00378

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The investigators do not plan to share any individual participant data, as study data will be aggregated into the study database for analysis and further dissemination of results.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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