Hepatitis C Clinical Trial
Official title:
A Controlled, Observed Trial of Hepatitis C Self-Testing in the Hands of Untrained Lay Users
This is a controlled study intended to evaluate the usability, label comprehension and performance of the INSTI® HCV Self Test in the hands of untrained lay users using fingerstick blood, with instructions for use specifically designed for a lay person who has not used any hepatitis C rapid self test prior to the study and to assess "lay" users ability to comprehend key concepts and information provided on the outside of the pouch and in the accompanying Instructions for Use. Comprehension will be assessed without product familiarization (demonstration/training) by a healthcare professional.
Status | Recruiting |
Enrollment | 1400 |
Est. completion date | April 22, 2024 |
Est. primary completion date | November 17, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - =18 years of age - Understand and sign the written informed Consent Form in English - Have unknown HCV serology status, i.e., never tested for HCV or tested negative but the last testing was done at least 6 months before the enrolment date. - Able to complete the required testing on the allocated testing day[s] - Agree to provide accurate medical history, required specimens of finger prick blood samples for self-test devices, and up to 3.5ml of blood by venipuncture for laboratory testing. - Able to speak and read English. Exclusion Criteria: - Do not meet all of the inclusion criteria. - Are known HCV positive. - Have received any experimental HCV vaccine. - Have participated in any prior, or concurrent studies of self-testing including any blood based RDTs. - A practicing medical healthcare professional (doctor, nurse or Counsellor that performs testing with RDTs) - Any condition which, in the opinion of the facilitator, would make the participant unsuitable or unsafe for enrolment or could interfere with the completion of the assessment, consent form and questionnaire etc. or bias the outcome, i.e., being unable to see / read by forgetting to bring reading glasses, being intoxicated or acute sickness. |
Country | Name | City | State |
---|---|---|---|
South Africa | Ezintsha, a division of Wits Health Consortium (Pty) Ltd | Parktown |
Lead Sponsor | Collaborator |
---|---|
bioLytical Laboratories |
South Africa,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical sensitivity and specificity of INSTI HCV Self Test | To evaluate the concordance between the results obtained by untrained lay users self-test to those results obtained by the HCP using another self-test device and lab-based confirmatory test and to ascertain the clinical sensitivity and specificity of the HCV Self-Test when compared to an approved state-of-the-art laboratory test. | 6 Months | |
Secondary | To assess the usability and label comprehension of the INSTI HCV Self Test | To assess the usability and label comprehension of the self-testing device and the ability of the participant to correctly comprehend the Instruction For Use of the self-test by observation of the self-testing procedure and documenting effectiveness and efficiency, i.e., successful / unsuccessful completion and difficulty of the critical steps as per the Instructions for Use. The label comprehension scoring spans from exceptionally satisfactory (score 5) to completely unsatisfactory (score 1). | 1 month |
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