Clinical trial NCT06605573: Lay User Evaluation of the Panbio™ HCV Self-Test
Official title: Lay User Evaluation of the Panbio™ HCV Self Test: a Prospective, Multi-centre Observed Untrained User Study.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: HEPATITIS C (HCV)
Keywords: diagnostics
rapid test
untrained user
hepatitis C
lateral flow test
Lead sponsor: Abbott Rapid Dx
Sponsor class: INDUSTRY
Collaborators: name: Aga Khan University
name: Clinic 553 Karachi
name: Ezintsha Clinical Research Center
First posted: 2024-09-20
Enrollment: 1185
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group assessment
Primary purpose: DIAGNOSTIC

Brief summary: This is a prospective, multi-centre study designed to evaluate the usability of the Panbio™ HCV Self Test, when performed by untrained lay users in an observed study setting. The Panbio™ HCV Self Test detects antibodies to Hepatitis C Virus (HCV). The study validation will be conducted in accordance with the World Health Organisation's technical guidance on Hepatitis C rapid diagnostic tests for professional use and/or self-testing (TSS-16).

Detailed description: Hepatitis C is a liver disease caused by the hepatitis C virus. The virus can cause both acute and chronic disease, ranging in severity from a mild illness lasting a few weeks to a serious, lifelong illness. Globally, Hepatitis C virus infects around 71 million people per year, resulting in 700,000 deaths. The WHO estimates that only 21% of individuals chronically infected with HCV are diagnosed, and the WHO HCV targets include increasing the diagnoses to 90% by 2030. WHO guidelines, published in 2021, strongly recommend offering self-testing for HCV as an additional approach to HCV testing services.

Eligibility criteria: Inclusion Criteria:

* Participant is aged 14 or over
* Participant agrees to all aspects of the study and is able and willing to provide informed consent / assent with parental consent.

Exclusion Criteria:

* Participant has already participated in this study on a previous occasion.
* Participant is aware of their HCV status
* Participant is deemed unfit for the study by the Investigator.
* Participant has a condition deemed unfit by the Investigator to safely perform or receive the test.
* Participant is a practising health-care professional or laboratory scientist / technician or has prior medical or laboratory training or experience
* Participant is currently enrolled in a study to evaluate an investigational drug or vaccine.
* Participant has a visual impairment that cannot be restored using glasses or contact lenses or is unable to read the Instructions for Use.
* Participant is unwilling or unable to provide informed consent.
* Participant has participated in the study "Lay user evaluation of the Panbio™ HCV Self Test: A prospective, multi-centre usability study to evaluate lay user labelling comprehension and test result interpretation".

Primary outcomes:
measure: Lay user / professional user test result concordance
timeFrame: 5 months
measure: Lay user / laboratory test result concordance
timeFrame: 5 months
Secondary outcomes:
measure: Usability evaluation - lay user experience
timeFrame: 5 months
measure: Usability evaluation - Self-test observer records
timeFrame: 5 months
measure: Lay user / professional user results interpretation concordance
timeFrame: 5 months
Other outcomes:
Locations:
Study officials:
affiliation: Clinic 553
name: Huma Qureshi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Aga Khan University
name: Saeed Hamid, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: Ezintsha
name: Mohammed Majam, BSc, MBA
role: PRINCIPAL_INVESTIGATOR
References: