Feasibility and Usability of COVID-19 Antigen RDTs in Uganda

COVID-19 Pandemic Clinical Trial

Official title:

Assessing the Feasibility and Usability of Implementing Professional Use and Self-administered COVID-19 Antigen RDTs in Uganda

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05630300
• Other study ID #: RES-00378
• Status: Completed
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: September 30, 2023

Study information

• Verified date: November 2022
• Source: PATH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1280
• Est. completion date: September 30, 2023
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Pandemic

Intervention

Diagnostic Test:
• PMC Sure Status COVID-19 Antigen Test
COVID-19 professional use kit in out-patient departments
• Acon Flowflex COVID-19 Antigen Home Test
COVID-19 self-test kits

Locations

Country	Name	City	State
Uganda	Kisenyi Health Center IV	Kampala	Central
Uganda	Kiswa Health Center III	Kampala	Central
Uganda	Katikamu Health Center III	Luwero	Central
Uganda	Luwero Hospital	Luwero	Central

Sponsors (1)

Lead Sponsor	Collaborator
PATH

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Demand - OPD	Proportion of COVID-19 OPD cases identified via professional use testing who accept self-testing kits for their contacts.	6 months
Primary	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	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).	6 months