Exploring cervical screening without a speculum in women aged 50-64
Not Applicable
Completed
- Conditions
- Human papillomavirus (HPV)Infections and Infestations
- Registration Number
- ISRCTN69709352
- Lead Sponsor
- King's College London
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 298
Inclusion Criteria
1. Women aged 50 - 64 years attending routine cervical screening in GP primary care
2. Women aged = 50 years attending colposcopy who are likely or known to be HPV positive (e.g. referred with a cytology result of moderate or worse or positive on HPV triage testing)
Exclusion Criteria
1. Women unable to provide informed consent
2. Women whose command of English is not sufficient to obtain informed consent.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Measured at a single time point:<br> 1. Sensitivity” as the proportion of non-speculum HPV positives among (i) speculum HPV positives and (ii) women with high-grade disease (CIN2+ on histology and/or moderate dyskaryosis or worse on cytology)<br> 2. Specificity” as the proportion of non-speculum HPV negatives among women attending routine screening who are not found to have high-grade disease who are speculum HPV negatives and cytology screen-negative women (normal/borderline/mild dyskaryosis on cytology)<br>
- Secondary Outcome Measures
Name Time Method There are no secondary outcome measures