Cervix Diseases
Conditions
Brief summary
To explore the potential for vaginal self-sampling to increase participation in cervical screening, we offer the option of self-sampling to a group of non-participants in cervical screening (intervention), in addition to the routine screening (smear) test. Women in the control group will only receive the routine screening invitation letter. The total screening uptake rate, 2 months since the recruitment in each group will be compared.
Detailed description
The aim of this research is to assess the feasibility of making vaginal self sampling available to women who have declined smear testing (defaulters), through the NHS to prevent cervical cancer. We plan to identify all defaulters living in Coventry between 30 and 40 years (n≈6000) from the cervical screening call-recall system. They will be randomized 1:1 to intervention and control arms. Women in the control arm will be sent a routine screening letter reminding them to have a smear test. Women in the intervention arm will be given the option of self-sampling for HPV testing, if they do not wish to have a smear test. They could order a self-HPV test by returning a slip in the pre-paid envelope. We then send the woman a vaginal self-collection kit. Self-collected sample will be returned to the laboratory for HPV testing. Whilst HPV positives (10-15%) will be advised to have a smear test, HPV negatives will be advised to accept their next smear test invitation.
Interventions
PROCEDURESelf-collecting a vaginal sample with a swab for HPV testing
The vaginal sample self-collected with the Floq swab will be tested for Human Papillomavirus (HPV) using Abbott RealTime PCR assay.
PROCEDURECollection of cervical sample for routine cervical screening
This is the routine cervical screening test available to the public through the NHS. This sample is collected by a clinician (usually a Practice Nurse)
Sponsors
Abbott
Copan Italia SPA , Via F. Perotti, 10, 25125 Brescia, Italy
University Hospitals Coventry and Warwickshire NHS Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* All cervical screening programme defaulters living in Coventry
Exclusion criteria
1. Pregnancy 2. Total hysterectomy (abdominal/laparoscopic/vaginal) 3. Never been sexually active/ intimate 4. Women who cannot give valid, informed, written consent 5. HPV self-sample returned without a signed consent form 6. Women who request the research team to be excluded from the trial 7. Women who have written to the Screening Services to record their refusal to take part in the NHSCSP 8. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The total screening uptake rate in each arm | 2 months since the recruitment | In the experimental arm, the numerator will be the total number of smear tests + HPV self-tests. In the active control arm, it will be total number of smear tests. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of smear positive women referred to colposcopy | 1 month since the smear result | — |
| Proportion of women referred to colposcopy had attended colposcopy | 3 months since the smear result | — |
| Proportion of HPV positive women who have subsequently had a smear test | 2 months since the HPV test result | — |
| Assess the women's attitude towards self-sampling and its feasibility | 2 months since the recruitment | Analysing data of user questionnaires |
| Assess the women's attitude towards the feasibility of self-sampling | 2 months since the recruitment | Analysing data of user questionnaires |
| Proportion of women attended colposcopy had a CIN2+ | 4 months since the smear result | — |
Countries
United Kingdom
Outcome results
None listed