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NCT Number: NCT06605573

Lay User Evaluation of the Panbio™ HCV Self-Test

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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Key information

Conditions

HEPATITIS C (HCV) Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

14 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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".

Treatment and study plan

Panbio™ HCV Self Test

Diagnostic Test

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

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

Primary outcomes

  1. Lay user / professional user test result concordance

    Time frame: 5 months

    To assess the concordance between the Panbio™ HCV Self Test, as performed by lay users based on self-collected finger-stick samples, and the Panbio™ HCV Self Test performed by a trained health care worker, who also will collect the finger-stick sample required for the test and perform the test.

  2. Lay user / laboratory test result concordance

    Time frame: 5 months

    To establish clinical performance (concordance with the reference test) for the Panbio™ HCV Self Test, as performed by lay users using finger-stick whole blood samples, when compared to reference testing using venous plasma samples.

Secondary outcomes

  1. Usability evaluation - lay user experience

    Time frame: 5 months

    To assess the usability of the Panbio™ HCV Self Test, as performed by lay users, based on a participant questionnaire evaluation by the lay user participant. The participant questionnaire includes questions to assess the lay users' experience when performing the test. Most questions have a Yes / No answer option, with free text possible. Some questions require a free text answer.

  2. Usability evaluation - Self-test observer records

    Time frame: 5 months

    To assess the usability of the Panbio™ HCV Self Test, as performed by lay users based on a questionnaire evaluation by the study staff observer. In the observer questionnaire, particular attention will be paid to compliance regarding factors considered critical for the test, such as reading the IFU/ QRG and applying the correct test volume. The observer questionnaire is not reporting scores on a scale, but is recording observations regarding how the users complete each step. For each step, a question is asked whether the user conducted a certain procedure, and a Yes / No answer is requested, with Monitor Notes when applicable.

  3. Lay user / professional user results interpretation concordance

    Time frame: 5 months

    To assess the concordance between the self-test results (obtained by the self-tester) when interpreted by the lay user and by the observer.

Study contacts

Contact information is provided by the study sponsor or research team.

Camilla S Forssten, PhD

CONTACT

[email protected]

+447792902244

Jocelyn Farge, MSc, MBA

CONTACT

[email protected]

+33666483563

Sponsors and collaborators

Lead sponsor

Abbott Rapid Dx

Industry

Collaborators

  • Aga Khan University
  • Clinic 553 Karachi
  • Ezintsha Clinical Research Center

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 20, 2024
Registry last updated
Sep 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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