HEPATITIS C (HCV)NCT06605573
Lay User Evaluation of the Panbio™ HCV Self-Test
A study testing Panbio™ HCV Self Test in people with HEPATITIS C (HCV), run by Abbott Rapid Dx.
Trial 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). Read more about this study
- Who is it for?
- Ages 14 years and olderHealthy volunteers can take part
- Conditions the study is for
- HEPATITIS C (HCV)
- What is being tested?
- Panbio™ HCV Self Test
- How many people
- 1,185 participants
- Where
- No sites listed yet
- Study dates
- Oct 2024to Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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".
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Lay User Evaluation of the Panbio™ HCV Self Test: a Prospective, Multi-centre Observed Untrained User Study.
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).
Read the 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.
- Conditions
- HEPATITIS C (HCV)
- Being tested
- Panbio™ HCV Self Test
- Keywords
- diagnostics, rapid test, untrained user, hepatitis C, lateral flow test
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Panbio™ HCV Self TestDiagnostic test
Also called Fingerstick HIV testing (optional), Laboratory reference testing for HCV (immunoassays and PCR, CE marked)
Rapid diagnostic test (self-test and professional) plus laboratory reference tests
What is being measured
The primary outcome is the main question the study is designed to answer.
Lay user / professional user test result concordance
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.
Measured: 5 months
Lay user / laboratory test result concordance
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.
Measured: 5 months
Secondary outcomes (3)
Usability evaluation - lay user experience
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.
Measured: 5 months
Usability evaluation - Self-test observer records
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.
Measured: 5 months
Lay user / professional user results interpretation concordance
To assess the concordance between the self-test results (obtained by the self-tester) when interpreted by the lay user and by the observer.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2024
- Study startOct 2024 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HEPATITIS C (HCV)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group assessment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,185 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abbott Rapid Dx
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Aga Khan University, Clinic 553 Karachi, Ezintsha Clinical Research Center
- Responsible party
- Sponsor
- Investigators
- Huma Qureshi, MD, Principal investigator, Clinic 553Saeed Hamid, Pr, Principal investigator, Aga Khan UniversityMohammed Majam, BSc, MBA, Principal investigator, Ezintsha
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06605573
- Sponsor's protocol ID
- SDRD-I-030-P
- Status last verified
- Sep 2024
- First submitted
- 18 Sep 2024
- Last updated
- 20 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lay User Evaluation of the Panbio™ HCV Self Test: a Prospective, Multi-centre Observed Untrained User Study.
- ClinicalTrials.gov ID
- NCT06605573
- Acronym / sponsor ID
- SDRD-I-030-P
- Conditions
- HEPATITIS C (HCV)
- Keywords
- diagnostics, rapid test, untrained user, hepatitis C, lateral flow test
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,185 participants (estimated)
- Lead sponsor
- Abbott Rapid DxIndustry (pharma, biotech, devices)
- Collaborators
- Aga Khan University, Clinic 553 Karachi, Ezintsha Clinical Research Center
- Study start
- Oct 2024 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 20 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Model description
- Single group assessment
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Panbio™ HCV Self TestAlso: Fingerstick HIV testing (optional), Laboratory reference testing for HCV (immunoassays and PCR, CE marked)Rapid diagnostic test (self-test and professional) plus laboratory reference tests | Diagnostic test | – |
Primary outcome
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.
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.
3 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huma Qureshi, MD principal investigator
Clinic 553
Saeed Hamid, Pr principal investigator
Aga Khan University
Mohammed Majam, BSc, MBA principal investigator
Ezintsha
Questions about this trial
What is this clinical trial studying?
A study testing Panbio™ HCV Self Test in people with HEPATITIS C (HCV), run by Abbott Rapid Dx.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jocelyn Farge, MSc, MBA (+33666483563, jocelyn.farge@abbott.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lay user / professional user test result concordance (time frame: 5 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2024.