None listed
Conditions
Brief summary
SCoPE2 is evaluating different methods of self-collection to determine is alternative methods can be used with new HPV nucleic acid based assays to facilitate a wider range of options for HPV-based cervical screening. There is a lot of evidence demonstrating that self-collection is as good as clinician-collected for HPV-based cervical screening. SCoPE2 is looking to assess whether the method in this study produces similar results showing that self-collection is equivalent to clinician-collected samples for HPV-based cervical screening.
Interventions
The study will ask participants to take two self-collected vaginal samples using two different devices and compare them against the standard of care clinician-collected specimen from the cervix for the detection of Human Papillomavirus (HPV) using any colposcopy biopsy findings as the reference for sensitivity and specificity for cervical disease. Particiapnts who have been referred to colposcopy would not be routinely tested for HPV as this is a risk stratification rather than diagnostic test. The two devices are the Copan FLOQSwab and the Rovers Viba-brush. The Copan FLOQSwab is a thin swab (similar to the swabs used for collection of a sample for COVID19 PCR testing. The Viba-brush is a simpler version of the Evalyn brush which is a device designed specifically for self-collection for HPV-based cervical screening and consists of a head with a soft plastic broom-like head on a plastic shaft. Both are commonly used in self-collection and have regulatory approval for self-collection for HPV-based cervical screening and collection would take less than one minute for each device. Both devices will be collected at the same time in a private space while waiting for the patient's colposcopy appointment, Collection with both devices would be completed is less than five minutes total time .
Sponsors
Study design
Eligibility
Inclusion criteria
Over 18 years of age, attending colposcopy clinic, gave informed consent
Exclusion criteria
Pregnancy, unable to give informed consent