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.
Study Summary
This is a prospective, multi-centre study designed to evaluate ability of lay users to understand product labelling of the Panbio™ HCV Self Test and to be able to correctly interpret contrived Panbio™ HCV Self Test results. 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).
Background and Rationale
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.
Investigational Device Description
The Panbio™ HCV Self Test is lateral flow test, designed for the qualitative detection of antibodies specific to HCV in finger-stick whole blood. The test is designed to be used by lay users and uses a sample volume of 10 µL. The professional use version test (Bioline HCV Test) is commercially available and has previously been clinically validated by the manufacturer, demonstrating a sensitivity of 99.3-100% and a specificity of 98.1-100%.
Lay User Participants and Observers
Lay User Participant: Refers to a lay user who will conduct the labelling comprehension, questionnaire-based evaluation and / or the contrived (static) results interpretation evaluation.
Observer: A study staff member (trained healthcare worker) who observes the lay-user conducting the labelling comprehension and / or the results interpretation evaluation. The observer and other study staff members can be either a laboratory technician or a non-laboratory healthcare professional (nurse, MD) or a non-certified, but trained healthcare worker (as per WHO definition).
Objectives
The primary objectives of this study are:
- To evaluate lay users’ Panbio™ HCV Self Test labelling comprehension. 200 literate adult participants, 30 literate adolescents (14-17 years old) and 50 illiterate participants (14 years old and older will be enrolled in the studyThis evaluation will assess the lay users’ understanding of the key messages from the Panbio™ HCV Self Test product packaging and labelling. The evaluation will be questionnaire based and will comprise evaluation of the lay users’ understanding of
- The proper self-selection and whether the test would be suitable for them
- The key warnings and test limitations and/or restrictions
- The test procedure
- The test result interpretation.
- To evaluate the ability of lay users to interpret Panbio™ HCV Self Test results (n=280 participants). This evaluation will assess the lay users’ ability to interpret contrived, static Panbio™ HCV Self Test results. The results will comprise a range of test results, including weak positive results and tests with failed control lines. Each lay user will interpret five different test results, in randomised order.
Study Eligibility Criteria
Participants aged 14 or over, who agree to all aspects of the study and are able and willing to provide written informed consent, will be prospectively enrolled.
The study will aim to enrol some participants without any previous experience of rapid diagnostic testing. However, other participants will likely have been tested professionally/self-testing for e.g. malaria, hepatitis C, or HIV.
Participants with prior self-testing experience outside a clinical trial will be considered representative of the general population and will not be excluded. However, efforts will be made to enrol participants without prior self-testing experience.
Participants will be enrolled from low and high prevalence settings. Participants will also be enrolled from both HCV low-risk and high-risk groups from the low and high prevalence settings.
Statistically sufficient numbers of participants from various categories regarding educational level, economic status, gender and age will be enrolled.
Participants meeting any of the following criteria will be excluded from the study:
- Participant has already participated in this study on a previous occasion.
- Participant is deemed unfit for the study by the Investigator.
- Participant is a practising health-care professional or laboratory scientist / technician or has prior medical or laboratory training or experience.
- Participant has a visual impairment that cannot be restored using glasses or contact lenses or is unable to read the Instructions for Use (Literate cohort).
- 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 observed untrained user study.”
Study Design
This study will be conducted at sites in Pakistan and South Africa.
At least 280 participants, representative of the product intended users, will perform the labelling comprehension evaluation.
At least 200 literate adult participants will perform the results interpretation evaluation. These participants will comprise at least 100 participants of approximately equal numbers from 2 high-prevalence (> 2%) and geographically diverse populations, and at least 100 subjects from a low-prevalence (<2%) population. The participants from the high-prevalence population will be enrolled in Pakistan, and the participants from the low prevalence population will be enrolled in South Africa. In addition, 30 literate adolescents (14-17 years old) and 50 illiterate participants (14 years old and older) will be enrolled in the study. Each participant in the results interpretation study will interpret five different test results in randomised order.
Participants will be enrolled to evaluate both the labelling comprehension and the results interpretation. However, the study population in this labelling comprehension / results interpretation study cannot overlap with the study population in the separate untrained user evaluation study.
Eligible participants presenting at a participating clinical site for routine medical care, or by invitation to the study, will be approached for enrolment. The enrolment may also occur in Outreach study settings. The purpose of the study and its potential risks and benefits will be explained to potential study participants. Each participant will be enrolled in the study only after giving written informed consent or consent with a thumb impression in the presence of an impartial witness who also signs the consent form. For participants 14-17 years, parental / caregiver consent will be collected; this can be either a signature or a thumb impression in the presence of an impartial witness who also signs the consent form. After confirming that a participant is eligible for study participation and obtaining written informed consent, a study-specific participant identification number (ID) will be assigned to the participant. Participant demographics will be collected.
The participant will subsequently participate in the labelling comprehension evaluation and the results interpretation evaluation, as described below.
- Labelling comprehension evaluation: The participant will be provided with a Panbio™ HCV Self Test, including the Instructions for Use / Quick Reference Guide. The Instructions for Use will include a QR code with a link to an instructional video, which the participants may choose to access. No additional training will be provided to the participant. The participant will also be provided with a questionnaire to evaluate the labelling comprehension. Each participant will be asked to complete the questionnaire. A study staff member (observer) will be present during the participants’ labelling comprehension evaluation, including the questionnaire completion, but will not assist the participant.
- Results interpretation evaluation: Panbio™ HCV Self Tests with pre-printed, static results will be provided to the study participants in the results interpretation evaluation. The result interpretation will be communicated by the participant to the study staff member (observer) who will record the results. The observer will not assist the participant in the result interpretation. Each lay user will interpret five different test results, in randomised order.
All study data will be recorded on case report forms (CRFs) and transferred into an electronic data capture (EDC) database.
All other aspects of the participant’s care will remain the same with no deviation from prescribed practice.
The Panbio™ HCV Self Test validation will be conducted in accordance with the World Health Organisation’s TSS-16 guidance on Hepatitis C rapid diagnostic tests for professional use and/or self-testing (2021 update), ISO 20916 (In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice), IEC 62366-1:2015, AMD1:2020 (Medical devices – Part 1: Application of usability engineering to medical devices), the study protocol, Good Clinical Practice and the respective local medical device laws.
Duration of Participant’s Study Participation and Total Study Duration
Each participant’s involvement in the study will last approximately 1 hour. The study enrolment is anticipated to occur during 3-4 months.
Statistical analysis
The questionnaires will be evaluated using descriptive statistics.
The positive agreement, negative agreement and overall agreement (total concordance), with their 95% confidence intervals, will be reported for the interpretation of the contrived test results. The agreement for invalid test interpretation, with 95% confidence intervals, will also be reported.
