COVID-19 PandemicNCT05630300
Feasibility and Usability of COVID-19 Antigen RDTs in Uganda
A study testing PMC Sure Status COVID-19 Antigen Test and Acon Flowflex COVID-19 Antigen Home Test in people with COVID-19 Pandemic, run by PATH at 4 sites in Uganda.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Pandemic
- What is being tested?
- PMC Sure Status COVID-19 Antigen Test and Acon Flowflex COVID-19 Antigen Home Test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,280 participants
- Where
- 4 sitesUganda
- Study dates
- 1 Mar 2023to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- 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).
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- Willing and able to provide informed consent.
- 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.
Who cannot join
- 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
- Contraindication to nasal swab.
- Had a nasopharyngeal swab in the last 8 hours.
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- 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)
- 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.
Trial locations and contacts
4 sites in 1 country.
Uganda4 sites
Kisenyi Health Center IV
Kampala, Central Region, 7404
Kiswa Health Center III
Kampala, Central Region, 7404
Katikamu Health Center III
Luwero, Central Region, 7404
Luwero Hospital
Luwero, Central Region, 7404
About this study
Official title: 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:
Read more
- 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.
- 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.
Read the 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
- Being tested
- PMC Sure Status COVID-19 Antigen Test, Acon Flowflex COVID-19 Antigen Home Test
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PMC Sure Status COVID-19 Antigen TestDiagnostic test
COVID-19 professional use kit in out-patient departments
Acon Flowflex COVID-19 Antigen Home TestDiagnostic test
COVID-19 self-test kits
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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) Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Demand - OPD
Proportion of COVID-19 OPD cases identified via professional use testing who accept self-testing kits for their contacts.
Measured: 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.
Measured: 6 months
Secondary outcomes (1)
Usability
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).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2022
- Study start1 Mar 2023
- Primary completion30 Aug 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PandemicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,280 participants (actual)
Sponsor and investigators
- Lead sponsor
- PATH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kimberly Green, Principal investigator, PATH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05630300
- Sponsor's protocol ID
- RES-00378
- Status last verified
- Nov 2022
- First submitted
- 21 Nov 2022
- Last updated
- 7 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Feasibility and Usability of Implementing Professional Use and Self-administered COVID-19 Antigen RDTs in Uganda
- ClinicalTrials.gov ID
- NCT05630300
- Acronym / sponsor ID
- RES-00378
- Conditions
- COVID-19 Pandemic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,280 participants (actual)
- Lead sponsor
- PATHUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 29 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Facility-based Ag-RDT COVID-19 testing - reactive | Experimental | Diagnostic Test: PMC Sure Status COVID-19 Antigen TestOut-patient department patients who utilized a COVID-19 Ag-RDT professional-use test in an OPD clinical setting with reactive test result |
| Facility-based Ag-RDT COVID-19 testing - non-reactive | Experimental | Diagnostic Test: PMC Sure Status COVID-19 Antigen TestOut-patient department patients who utilized a COVID-19 Ag-RDT professional-use test in an OPD clinical setting with non-reactive test result |
| COVID-19 Ag-RDT self-testing - agree to self-test | Experimental | Diagnostic Test: Acon Flowflex COVID-19 Antigen Home TestParticipants who receive and take a COVID-19 Ag-RDT self-test (female sex workers, Boda boda drivers, household contacts) |
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
- 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).
Key exclusion criteria (12 listed)
- 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
- Contraindication to nasal swab.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PMC Sure Status COVID-19 Antigen TestCOVID-19 professional use kit in out-patient departments | Diagnostic test | Facility-based Ag-RDT COVID-19 testing - non-reactive, Facility-based Ag-RDT COVID-19 testing - reactive |
| Acon Flowflex COVID-19 Antigen Home TestCOVID-19 self-test kits | Diagnostic test | COVID-19 Ag-RDT self-testing - agree to self-test |
Primary outcome
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.
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.
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.
1 secondary outcome
Usability
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kimberly Green principal investigator
PATH
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PMC Sure Status COVID-19 Antigen Test and Acon Flowflex COVID-19 Antigen Home Test in people with COVID-19 Pandemic, run by PATH at 4 sites in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implementation success (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023; AzTrials last refreshed its copy on 7 Nov 2026.