PETAHG
Research type
Research Study
Full title
Performance of tampons as a biospecimen collection tool for the detection of Human Papillomavirus in a colposcopy setting
IRAS ID
333185
Contact name
Iva Lazarova
Contact email
Sponsor organisation
Tampon Innovations Ltd (Daye)
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 11 months, 30 days
Research summary
Cervical screening is now based on detection of Human Papillomavirus (HPV). HPV testing in the UK is routinely performed on samples taken by a trained health care worker but increasing evidence suggests that HPV can be detected in self taken sample sometimes referred to as "self sampling". The use of self sampling to deliver cervical screening is increasing globally as it can overcome both emotional (e.g. embarrassment, fear of pain) and practical (e.g. difficulty making appointments) barriers to cervical screening. This all said, when it comes to "what device?" is optimal for self sampling, studies show that (1) the acceptability of different devices may be dependent on the people approached (2) not all devices perform equally. Having a set of well researched and validated options/devices for self sampling will help give women a choice. This in turn should help facilitate and enhance engagement
Tampons are familiar devices to many, however, compared to other self sampling options such as vaginal swabs, there is relatively little information on their use to capture a sample for HPV testing. To address this, we aim to deliver a study where the performance of a self-administered tampon for detection of HPV infection is assessed. The HPV result on the tampon will be compared to a sample taken by a health care worker. Our plan is to invite women attending for routine colposcopy (visual examination of the cervix) to participate and the tampon (self taken) would be compared to a sample taken by a health care worker. The information obtained at colposcopy will support assessment of the relative accuracy of the tampon compared with the sample taken by the health care worker.REC name
East Midlands - Derby Research Ethics Committee
REC reference
24/EM/0028
Date of REC Opinion
27 Feb 2024
REC opinion
Further Information Favourable Opinion