Predictors 5.2
Research type
Research Study
Full title
Comparison of high risk HPV positivity of a vaginal self sample and urine sample with a clinician taken cervical sample taken at the same screening visit.
IRAS ID
311023
Contact name
Ranjit Manchanda
Contact email
Sponsor organisation
Queen Mary University of London
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
Women who test positive for high risk HPV may be at risk of developing cervical cancer. High risk HPV is associated with cervical cancer but most women clear the infection themselves and not develop cancer. We can test for HPV and in the future HPV testing is likely to replace cytology as the primary cervical screening test. It has the potential for self sampling as a woman can use a simple swab or a commercially designed swab kit to take a 'self sample' for HPV. The study aims to look at the non inferiority between the use of self sampling equipment compared to the standard clinician taken test. We aim to recruit 2000 women over a period of 12 months. Women will be approached at their GP clinic on the day of their regular cervical screening test. The GP admin team will send out information relating to the study prior to them attending so that they are aware that they may be approached on the day of their appointment about whether they wish to participate in the study.
Before their cervical screening test, women will be asked to sign a consent form confirming that they are happy to take part in the study, will be asked to provide a urine sample and take two self samples using vaginal swabs:
1) Digene Dacron Swab
2) Copans Floq Swab (like cotton bud).The women will be given an illustrated instruction sheet within the self test kits and the kits will contain both types of swabs and the urine collection device. The study team will make up the packs and two swabs will be taken in a pre specified order. This will all be documented within the instruction sheet. They will also be asked to fill out a short questionnaire about ease and acceptability.
REC name
London - Central Research Ethics Committee
REC reference
22/PR/1146
Date of REC Opinion
9 Nov 2022
REC opinion
Further Information Favourable Opinion