Does cervical screening without a speculum increase screening uptake in women aged 50-64?

A pilot study to assess the feasibility and acceptability of offering cervical screening without a speculum to increase uptake in lapsed attenders aged 50-64

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN16007231

Enrollment

700

Registered

2020-08-04

Start date

2018-08-15

Completion date

Unknown

Last updated

2025-09-15

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

Conditions

Cervical screening Cancer Malignant neoplasm of cervix uteri

Interventions

This is a pilot study in primary care which will involve 10-12 GP practices within the Barts Health Catchment area. Eligible women are randomised by the GP practice using computer-generated random num

known as human papillomavirus (HPV) testing. HPV testing has introduced the possibility of new cervical screening approaches that are likely to be more acceptable to older women, as sampling from the

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Lapsed cervical screening attenders (i.e. at least 12 months overdue but have attended at least once in the past 15 years)

Exclusion criteria

Exclusion criteria: Women unable to provide informed consent

Design outcomes

Primary

Measure	Time frame
Cervical screening uptake: the proportion of women screened (according to GP records) at 4 months from randomisation	—

Secondary

Measure	Time frame
1. Cervical screening uptake measured using GP records at 12 months (i.e. long-term cervical screening coverage) 2. Acceptability of non-speculum sampling approaches for cervical screening among women aged 50-64 who are lapsed attendees, assessed using a patient questionnaire data at the time they take the sample 3. The proportion of women who undergo clinician-taken sampling without a speculum versus the proportion who request and return a self-sample, measured using data received from the lab (the number who undergo clinician-taken sampling without a speculum and number who return a self-sample) and coordinating centre data (the number who request a kit) at the end of the study (once data is collected and clean). 4. The proportion of eligible women who test HPV positive and a) attend for follow up (cytology or colposcopy) within 6 months of testing HPV positive on a non-speculum sample and b) who are treated for CIN2+, measured using GP record data at end of the study (once data is collected and clean). 5. Acceptability of non-speculum sampling for cervical screening among the clinical staff who took non-speculum samples from eligible women at GP practices participating in this study, assessed using a swab-taker questionnaire at the end of the study (once recruitment is complete)	—

Measure

Time frame

1. Cervical screening uptake measured using GP records at 12 months (i.e. long-term cervical screening coverage) 2. Acceptability of non-speculum sampling approaches for cervical screening among women aged 50-64 who are lapsed attendees, assessed using a patient questionnaire data at the time they take the sample 3. The proportion of women who undergo clinician-taken sampling without a speculum versus the proportion who request and return a self-sample, measured using data received from the lab (the number who undergo clinician-taken sampling without a speculum and number who return a self-sample) and coordinating centre data (the number who request a kit) at the end of the study (once data is collected and clean). 4. The proportion of eligible women who test HPV positive and a) attend for follow up (cytology or colposcopy) within 6 months of testing HPV positive on a non-speculum sample and b) who are treated for CIN2+, measured using GP record data at end of the study (once data is collected and clean). 5. Acceptability of non-speculum sampling for cervical screening among the clinical staff who took non-speculum samples from eligible women at GP practices participating in this study, assessed using a swab-taker questionnaire at the end of the study (once recruitment is complete)

—

Countries

England, United Kingdom

Outcome results

None listed

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