Project-0027. Lay User Usage Study

Study Overview
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Brief Summary
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Study volunteers will be required to conduct a home pregnancy test (HPT) at the trial centre and provide a sample of urine from the same void for further testing. Volunteers will then complete a product usage questionnaire and leaflet comprehension questionnaire at site. Follow-up information will be required from all volunteers as both additional urine sample(s) and pregnancy information to establish true pregnancy status at the study visit.

Detailed Description
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Eligible volunteers will be recruited into the study and provide informed consent. Volunteers will then test their urine sample with the investigational HPT according to the device Instructions for use and record their result onto the results sheet. A sample of urine from the same void will be obtained for further testing by the study technicians. The technician will then test the volunteer's sample with a second investigational HPT, a professional use pregnancy test and a Clearblue Digital HPT, the results of which will be used to provide the volunteer with her pregnancy test result. During technician testing, the volunteer will complete the device usability and leaflet comprehension questionnaires. At the end of the study visit, all volunteers will be provided with materials to allow follow-up for the determination of pregnancy status. The majority of volunteers will be requested to provide one additional urine sample, collected 2 days after the study visit. If early pregnancy is suspected the volunteer will be requested to provide an additional 7 daily urine samples following the study visit. All volunteers will be required to provide details of pregnancy status (documented menses or pregnancy confirmation by health care professional) after the study visit. True pregnancy status will be determined by laboratory tests and clinical information. The study will continue until a minimum of 300 pregnant and 300 not pregnant volunteers have completed the study.

Official Title
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Project-0027 Lay User Usage Study

Conditions
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Pregnancy

Intervention / Treatment
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* Other: Clearblue Investigational Pregnancy test
* Other: Professional pregnancy test
* Other: Clearblue Marketed Pregnancy test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female Aged 18 or over Willing to conduct a personal pregnancy test and reveal their pregnancy status Willing to give informed consent Exclusion Criteria: Currently or previously employed by SPD Development Company Ltd. (SPD), Alere, Unipath, Procter and Gamble (P&G), or affiliates. Has an immediate relative* currently or previously employed by SPD, Alere, Unipath or P&G or affiliates Previously used the investigational HPT within the last six months Healthcare professionals (HCP's) with professional experience either using lateral flow based devices or conducting near patient testing Confirmed to be pregnant by a healthcare professional and beyond the first trimester Taken a hormonal preparation containing human chorionic gonadotropin (hCG) in the last month, e.g. Pregnyl®

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Pregnancy test<br>Clearblue investigational Pregnancy test Clearblue Marketed pregnancy test Professional pregnancy test | Other: Clearblue Investigational Pregnancy test<br>* Clearblue Investigational Pregnancy test<br>Other: Professional pregnancy test<br>* Alere Professional use pregnancy test<br>Other: Clearblue Marketed Pregnancy test<br>* Clearblue Marketed Pregnancy test<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants recording the correct pregnancy test result when testing their own urine sample with the investigational HPT referenced to confirmed pregnancy status | The accuracy of the investigational HPT in volunteer hands compared to pregnancy status | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants recording the same pregnancy test result as a laboratory technician when testing their own urine sample with the investigational HPT. | The agreement between volunteer and technician results using the investigational HPT | 3 months | 
| Number of participants recording a false positive or false negative pregnancy test result when testing their own urine sample with the investigational HPT referenced to confirmed pregnancy status. | The estimated sensitivity and specificity of the investigational HPT | 3 months | 
| Calculation of the level of certainty a user can have if the device gives a pregnant (positive predictive value (PPV)) or not pregnant result (Negative predictive value(NPV)). | The estimated NPV and PPV of the investigational HPT | 3 months | 
| Number of participants correctly answering questions about the product when referencing the instructions for use (IFU) leaflet. | Volunteer leaflet comprehension of the IFU | 3 months | 
| Participants opinion on using the product. | Volunteer usability of the IFU | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregnancy