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NCT06605573 | NOT YET RECRUITING | HEPATITIS C (HCV)

Lay User Evaluation of the Panbio™ HCV Self-Test
Sponsor:

Abbott Rapid Dx

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).

Condition or disease

HEPATITIS C (HCV)

Intervention/treatment

Panbio™ HCV Self Test

Phase

NA

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 1185 participants
Masking : SINGLE
Masking Description : The study staff member who interprets the lay user\'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.
Primary Purpose : DIAGNOSTIC
Official Title : Lay User Evaluation of the Panbio™ HCV Self Test: a Prospective, Multi-centre Observed Untrained User Study.
Actual Study Start Date : 2024-10
Estimated Primary Completion Date : 2025-03
Estimated Study Completion Date : 2025-03

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 14 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
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".
Lay User Evaluation of the Panbio™ HCV Self-Test

Location Details

NCT06605573

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How to Participate

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