NCT05630300

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. 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,280

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 21, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 29, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

November 7, 2023

Status Verified

November 1, 2022

Enrollment Period

6 months

First QC Date

November 21, 2022

Last Update Submit

November 2, 2023

Conditions

COVID-19 Pandemic

Outcome Measures

Primary Outcomes (3)

  • Implementation success

    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

  • Demand - OPD

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

    6 months

  • Demand - Community

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

    6 months

Secondary Outcomes (1)

  • Usability

    6 months

Study Arms (4)

Facility-based Ag-RDT COVID-19 testing - reactive

EXPERIMENTAL

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

Facility-based Ag-RDT COVID-19 testing - non-reactive

EXPERIMENTAL

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 Ag-RDT self-testing - agree to self-test

EXPERIMENTAL

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 Ag-RDT self-testing - refuse to self-test

NO INTERVENTION

Participants who receive but refuse to take a COVID-19 Ag-RDT self-test (female sex workers, Boda boda drivers, household contacts)

Interventions

PMC Sure Status COVID-19 Antigen TestDIAGNOSTIC_TEST

COVID-19 professional use kit in out-patient departments

Facility-based Ag-RDT COVID-19 testing - non-reactiveFacility-based Ag-RDT COVID-19 testing - reactive
Acon Flowflex COVID-19 Antigen Home TestDIAGNOSTIC_TEST

COVID-19 self-test kits

COVID-19 Ag-RDT self-testing - agree to self-test

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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.
  • 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)
  • 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.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Kisenyi Health Center IV

Kampala, Central Region, 7404, Uganda

Location

Kiswa Health Center III

Kampala, Central Region, 7404, Uganda

Location

Katikamu Health Center III

Luwero, Central Region, 7404, Uganda

Location

Luwero Hospital

Luwero, Central Region, 7404, Uganda

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Kimberly Green

    PATH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2022

First Posted

November 29, 2022

Study Start

March 1, 2023

Primary Completion

August 30, 2023

Study Completion

September 30, 2023

Last Updated

November 7, 2023

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

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.

Locations

UG(4)