Project-0027. Lay User Usage Study

Project-0027 Lay User Usage Study

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy
• Intervention / Treatment: Other: Clearblue Investigational Pregnancy test; Other: Professional pregnancy test; Other: Clearblue Marketed Pregnancy test

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 943
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Chester
    • Macclesfield, Chester, United Kingdom, SK11 7QJ
      • Illingworth Research Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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®

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Pregnancy test; Clearblue investigational Pregnancy test Clearblue Marketed pregnancy test Professional pregnancy test	Other: Clearblue Investigational Pregnancy test; Clearblue Investigational Pregnancy test; Other: Professional pregnancy test; Alere Professional use pregnancy test; Other: Clearblue Marketed Pregnancy test; Clearblue Marketed Pregnancy test

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: SPD Development Company Limited
• Collaborators: Illingworth Research Ltd
• Investigators: Principal Investigator: Juliet Hulse, Illingworth Research Ltd

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: October 20, 2015
• First Submitted That Met QC Criteria: December 16, 2015
• First Posted (Estimate): December 21, 2015

Study Record Updates

• Last Update Posted (Estimate): December 21, 2015
• Last Update Submitted That Met QC Criteria: December 16, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: Pregnancy
• Other Study ID Numbers: PROTOCOL-0772