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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
The vaginal sample self-collected with the Floq swab will be tested for Human Papillomavirus (HPV) using Abbott RealTime PCR assay.
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)
University Hospital of Coventry & Warwickshire
Coventry, Warwickshire, United Kingdom
The total screening uptake rate in each arm
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.
Time frame: 2 months since the recruitment
Proportion of HPV positive women who have subsequently had a smear test
Time frame: 2 months since the HPV test result
Proportion of smear positive women referred to colposcopy
Time frame: 1 month since the smear result
Proportion of women referred to colposcopy had attended colposcopy
Time frame: 3 months since the smear result
Proportion of women attended colposcopy had a CIN2+
Time frame: 4 months since the smear result
Assess the women's attitude towards self-sampling and its feasibility
Analysing data of user questionnaires
Time frame: 2 months since the recruitment
Assess the women's attitude towards the feasibility of self-sampling
Analysing data of user questionnaires
Time frame: 2 months since the recruitment
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