Cervical screening Cancer
Conditions
Interventions
Self-collection: Women who have failed to attend for cervical cytology screening and have reached Point 4 as detailed above (NEPCSA cervical screening invitation schedule) will be posted an invitation
Sponsors
Queen Mary University of London (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Non-responders according to the North East Primary Care Services Agency (NEPCSA) recall process. They will have received their initial screening letter, plus a first reminder letter, plus at least two non-responder cards will have been sent to their General Practitioner, identified using the NEPCSA Exeter National Health Applications and Infrastructure Services (NHAISs) System.
Exclusion criteria
Exclusion criteria: 1. Women who have written to the NEPCSA to document their refusal to take part in the NHSCSP 2. Women who contact the trial team and ask to be excluded from the trial 3. Pregnancy 4. Total abdominal hysterectomy 5. Never been sexually active 6. Women who are identified as becoming pregnant or undergoing hysterectomy following the initial test will be excluded from the analysis of data for secondary outcomes 7. HPV self-sample returned without a signed Informed Consent Form (ICF) (the Participant Information Leaflet (PIL) will state that samples returned without a signed consent form cannot be processed) 8. Informed Consent Form (ICF) returned with incomplete contact details whereby the test results cannot be sent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response to the intervention - The proportion of women responding to the intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The proportion of women responding to the intervention by returning the HPV self-sampling test within 3 months 2. The proportion of women responding to the intervention by attending for cervical cytology within 3 months 3. The proportion of women responding to the further invitation to attend for cervical cytology within 3 months 4. The proportion of women attending for a cervical cytology within 3 months having had a positive HPV test 5. The proportion of women attending for colposcopy (within 7 months of being sent their HPV self-sampling kit) having had a positive HPV test and abnormal cervical cytology of borderline or mild dyskaryosis and HPV triage positive or cytology of moderate dyskaryosis or worse. 6. The proportion of women in the comparator group attending for colposcopy within 3 months of abnormal cervical cytology of borderline or mild dyskaryosis and HPV triage positive or cytology of moderate dyskaryosis or worse 7. The proportion of women in the comparator group attending for colposcopy within 3 months of abnormal cervical cytology of borderline or mild dyskaryosis and HPV triage positive or cytology of moderate dyskaryosis or worse compared with the proportion of women attending for colposcopy (within 7 months of being sent their HPV self-sampling kit) having had a positive HPV test and abnormal cervical cytology of borderline or mild dyskaryosis and HPV triage positive or cytology of moderate dyskaryosis or worse | — |
Countries
United Kingdom
Outcome results
None listed