HPVPro Study: Comparison of HPV Detection in Clinician-collected Cervical Swabs and Self-sampled Cervicovaginal Swabs

Study Overview
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Brief Summary
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Comparison of the detection of human papillomavirus DNA in paired physician-obtained cervical swabs and self-sampled cervicovaginal swabs and evaluation of HPV prevalence in Czech women screening population.

Detailed Description
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The cervical screening program in the Czech Republic is based on cytology with HPV triage. Nevertheless, cytology-based cervical screening may switch to HPV-based cervical screening in future. The implementation of primary HPV screening and insuficiency cervical screening attendance are a major challenge. The offering of self-sampling to the cervical screening non-attenders could increase women's participation as was shown in several European countries. The objective of the HPVPro study was to find out the HPV prevalence in the screening population of Czech women since there are no data for the Czech Republic. The second objective was to compare HPV DNA detection rate in paired self-sampled cervicovaginal swabs and physician-obtained cervical swabs and to determine acceptability of self-sampling HPV DNA test by Czech women. This information is important for optimisation of cervical cancer screening program in the Czech Republic.

Official Title
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HPVPro Study: Comparison of HPV Detection in Clinician-collected Cervical Swabs and Self-sampled Cervicovaginal Swabs

Conditions
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Cervical Cancer, Cervical Dysplasia, Human Papillomavirus Infection

Intervention / Treatment
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* Diagnostic Test: Self-sampling using digene HC2 DNA Collection Device
* Diagnostic Test: Self-sampling using Evalyn Brush


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women with age 30-64 years. Women attending cervical cancer screening program in Czech Republic. Women with completed informed consent. Exclusion Criteria: Pregnant women. Women with no sexual intercourse experience. Women after cervical conization or hysterectomy. Women with CIN or cervical carcinoma in anamnesis. Women at risk of increased bleeding.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Self-sampling device in media<br>Women will undergo clinician-obtained cervical swab and self-sampled cervicovaginal swab using self-sampling device in STM media. HPV will be detected by hybridization technique. | Diagnostic Test: Self-sampling using digene HC2 DNA Collection Device<br>* All women will undergo a clinician-collected cervical swab and self-collected cervicovaginal swab.<br>|
| Experimental: Dry self-sampling device<br>Women will undergo clinician-obtained cervical swab and self-sampled cervicovaginal swab using dry self-sampling device. HPV will be detected by hybridization and PCR techniques. | Diagnostic Test: Self-sampling using Evalyn Brush<br>* All women will undergo a clinician-collected cervical swab and self-collected cervicovaginal swab.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HPV prevalence | Evaluation of the prevalence of high-risk human papillomavirus infection in screening population of Czech women. | 18 months | 
| Concordance of HPV positivity in self-collected cervicovaginal swabs and clinician-collected cervical swabs | Paired cervical and cervicovaginal swabs will be collected in the same day and will be tested by the same method. Concordance of HPV positivity in both swabs will be evaluated. | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of different human papillomavirus DNA detection methods in cervical and cervicovaginal swabs. | Hybridization and PCR-based HPV detection methods will be tested in both cervical and cervicovaginal swabs and results of these two methods will be compared. | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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human papillomavirus, HPV, self-sampling, cervical swab, cervicovaginal swab, cervical cancer screening