Clinical trial NCT05630300: Feasibility and Usability of COVID-19 Antigen RDTs in Uganda
Official title: Assessing the Feasibility and Usability of Implementing Professional Use and Self-administered COVID-19 Antigen RDTs in Uganda
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19 Pandemic
Lead sponsor: PATH
Sponsor class: OTHER
First posted: 2022-11-29
Enrollment: 1280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Implementation success
timeFrame: 6 months
measure: Demand - OPD
timeFrame: 6 months
measure: Demand - Community
timeFrame: 6 months
Secondary outcomes:
measure: Usability
timeFrame: 6 months
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Kisenyi Health Center IV
state: Central
city: Kampala
country: Uganda
facility: Kiswa Health Center III
state: Central
city: Luwero
country: Uganda
facility: Katikamu Health Center III
state: Central
city: Luwero
country: Uganda
facility: Luwero Hospital
state: Central
Study officials:
affiliation: PATH
name: Kimberly Green
role: PRINCIPAL_INVESTIGATOR
References: