Exploring cervical screening without a speculum in women aged 50-64

A cross-sectional study to assess the test performance and acceptability of non-speculum HPV testing in older women

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN69709352

Enrollment

250

Registered

2020-08-04

Start date

2017-08-20

Completion date

Unknown

Last updated

2022-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Human papillomavirus (HPV) Infections and Infestations Human papillomavirus (HPV)

Interventions

Eligible women will be consented to allow the GP or nurse to take a non-speculum sample before their rotuine sample. Study samples will be collected using a flocked vaginal swab (this is like a long c

Eligibility

Sex/Gender

Female

Inclusion criteria

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

Exclusion criteria: 1. Women unable to provide informed consent 2. Women whose command of English is not sufficient to obtain informed consent.

Design outcomes

Primary

Measure	Time frame
Measured at a single time point: 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) 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)	—

Measure

Time frame

Measured at a single time point: 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) 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)

—

Secondary

Measure	Time frame
There are no secondary outcome measures	—

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026