Exploring the potential of non-speculum HPV testing in older women
Research type
Research Study
Full title
A cross-sectional study to assess the test performance and acceptability of non-speculum HPV testing in older women
IRAS ID
228847
Contact name
Anita Lim
Contact email
Sponsor organisation
Kings College London
Duration of Study in the UK
1 years, 2 months, 0 days
Research summary
Women aged >65 account for almost half of all cervical cancer deaths, most are in women not adequately screened when aged 50-64. Smears can become uncomfortable after the menopause and this can put some women off coming for cervical screening. One of the main causes of discomfort is the speculum (the instrument used to hold the walls of the vagina open). It is now possible to do cervical screening by testing for the virus that causes cervical cancer; human papillomavirus (HPV). An advantage of HPV testing is that samples can be taken without a speculum. Women can even collect a sample themselves (self-testing). Unfortunately, over half of women who take a self-test worry about not taking a good sample. Another option is to do HPV testing on a sample taken by a clinician without a speculum (non-speculum). Women would have the reassurance of having a clinician take the sample but with much less discomfort. This has not been tried before.
This study will assess the test performance and acceptability of non-speculum clinician samples for HPV testing in women aged 50+. There are 2 parallel studies; (i) GP primary care - women aged 50-64 attending routine cervical screening (to assess if non-speculum clinician samples can correctly identify women without disease) and (ii) colposcopy - women aged 50+ being investigated for possible cervical disease (to assess if non-speculum clinician samples can correctly identify women with disease).
In both studies a non-speculum clinician sample will be collected followed by a speculum clinician sample (in the GP study the second sample will be the routine smear). HPV test results from non-speculum samples will be compared with results from speculum samples and routine screening tests. Women in the GP study will complete a short questionnaire asking them about their experiences with the test.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
17/NE/0268
Date of REC Opinion
3 Aug 2017
REC opinion
Favourable Opinion