Status:
NOT_YET_RECRUITING
Lay User Evaluation of the Panbio™ HCV Self-Test
Lead Sponsor:
Abbott Rapid Dx
Collaborating Sponsors:
Aga Khan University
Clinic 553 Karachi
Conditions:
HEPATITIS C (HCV)
Eligibility:
All Genders
14+ years
Phase:
NA
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...
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 i...
Eligibility Criteria
Inclusion
- 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
- 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".
Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2025
Estimated Enrollment :
1185 Patients enrolled
Trial Details
Trial ID
NCT06605573
Start Date
October 1 2024
End Date
March 1 2025
Last Update
September 20 2024
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