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Due to Chief Investigator relocating out of the United Kingdom.
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| Name | Class |
|---|---|
| Abbott | INDUSTRY |
| Copan Italia SPA , Via F. Perotti, 10, 25125 Brescia, Italy | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Self-sampling | Experimental | (Self-collecting a vaginal sample with a swab for HPV testing) Women in the experimental arm will have the option of vaginal self-sampling for HPV testing, in addition to the routine screening test. They can choose one of them. |
|
| Routine smear | Active Comparator | (Collection of cervical sample for routine cervical screening) Women in the control arm will only receive the routine cervical screening invitation letter. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self-collecting a vaginal sample with a swab for HPV testing | Procedure | The vaginal sample self-collected with the Floq swab will be tested for Human Papillomavirus (HPV) using Abbott RealTime PCR assay. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 months since the recruitment |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of HPV positive women who have subsequently had a smear test | 2 months since the HPV test result | |
| Proportion of smear positive women referred to colposcopy | 1 month since the smear result |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ceri Jones | Head of Research, Development & Innovation, UHCW, Coventry | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Coventry & Warwickshire | Coventry | Warwickshire | CV2 2DX | United Kingdom |
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| Collection of cervical sample for routine cervical screening | Procedure | 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) |
|
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| Proportion of women referred to colposcopy had attended colposcopy | 3 months since the smear result |
| Proportion of women attended colposcopy had a CIN2+ | 4 months since the smear result |
| Assess the women's attitude towards self-sampling and its feasibility | Analysing data of user questionnaires | 2 months since the recruitment |
| Assess the women's attitude towards the feasibility of self-sampling | Analysing data of user questionnaires | 2 months since the recruitment |
| ID | Term |
|---|---|
| D002577 | Uterine Cervical Diseases |
| ID | Term |
|---|---|
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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