Lay User Evaluation of the Panbio™ HCV Self-Test

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

1185 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-31

Study Completion Date

2025-03-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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HEPATITIS C (HCV)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single group assessment

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

The study staff member who interprets the lay user\&#39;s result will be blinded to the lay user\'s reference test results and medical status. The study staff member who conducts the Panbio™ HCV Self Test for the lay user will also be blinded to the lay user\'s reference test results and medical status as well as the self-test results.

Interventions

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Panbio™ HCV Self Test

Rapid diagnostic test (self-test and professional) plus laboratory reference tests

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Fingerstick HIV testing (optional) Laboratory reference testing for HCV (immunoassays and PCR, CE marked)

Eligibility Criteria

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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".

Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes