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Not yet recruiting NCT06605573

Lay User Evaluation of the Panbio™ HCV Self-Test

No phase Interventional HEPATITIS C (HCV)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Panbio™ HCV Self Test.
Who it may be relevant to
Registry conditions: HEPATITIS C (HCV). Basic parameters: from 14 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Lay User Evaluation of the Panbio™ HCV Self Test: a Prospective, Multi-centre Observed Untrained User Study.

Overview

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.

Interventions

  • Diagnostic test Panbio™ HCV Self Test
    Rapid diagnostic test (self-test and professional) plus laboratory reference tests

Primary outcome measures

  • Lay user / professional user test result concordance [Time frame: 5 months]
  • Lay user / laboratory test result concordance [Time frame: 5 months]
Secondary outcome measures (3)
  • Usability evaluation - lay user experience [Time frame: 5 months]
  • Usability evaluation - Self-test observer records [Time frame: 5 months]
  • Lay user / professional user results interpretation concordance [Time frame: 5 months]

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".

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Single blind
Primary purpose
Diagnostic

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06605573 · SDRD-I-030-P

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗