Feasibility and Usability of COVID-19 Antigen RDTs in Uganda

Sponsor
PATH (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05630300
Collaborator
(none)
1,460
4
6

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: PMC Sure Status COVID-19 Antigen Test
  • Diagnostic Test: Acon Flowflex COVID-19 Antigen Home Test
N/A

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. Thematic analysis of barriers, facilitators, user preferences, and acceptability to offering COVID-19 Ag-RDT professional use and self-administered kits in health facilities and community settings.

  • 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 Design

Study Type:
Interventional
Anticipated Enrollment :
1460 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Assessing the Feasibility and Usability of Implementing Professional Use and Self-administered COVID-19 Antigen RDTs in Uganda
Anticipated Study Start Date :
Dec 1, 2022
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

  1. Implementation success [6 months]

    Thematic analysis of the barriers, facilitators, user preferences, and acceptability to offering COVID-19 Ag-RDT professional and self-administered kits in health facilities and community settings.

  2. Demand - OPD [6 months]

    Proportion of COVID-19 OPD cases identified via professional use testing who accept self-testing kits for their contacts.

  3. Demand - Community [6 months]

    Proportion of FSWs, Boda boda drivers, and household contacts who use Ag-RDT COVID-19 self-tests and report their results.

Secondary Outcome Measures

  1. Usability [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • PATH

Investigators

  • Principal Investigator: Kimberly Green, PATH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
PATH
ClinicalTrials.gov Identifier:
NCT05630300
Other Study ID Numbers:
  • RES-00378
First Posted:
Nov 29, 2022
Last Update Posted:
Nov 29, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 29, 2022