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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1044 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-01

Study Completion Date

2019-11-25

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.

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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.

Conditions

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Cervical Cancer Cervical Dysplasia Human Papillomavirus Infection

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Self-sampling device in media

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.

Group Type EXPERIMENTAL

Self-sampling using digene HC2 DNA Collection Device

Intervention Type DIAGNOSTIC_TEST

All women will undergo a clinician-collected cervical swab and self-collected cervicovaginal swab.

Dry self-sampling device

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.

Group Type EXPERIMENTAL

Self-sampling using Evalyn Brush

Intervention Type DIAGNOSTIC_TEST

All women will undergo a clinician-collected cervical swab and self-collected cervicovaginal swab.

Interventions

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Self-sampling using digene HC2 DNA Collection Device

All women will undergo a clinician-collected cervical swab and self-collected cervicovaginal swab.

Intervention Type DIAGNOSTIC_TEST

Self-sampling using Evalyn Brush

All women will undergo a clinician-collected cervical swab and self-collected cervicovaginal swab.

Intervention Type DIAGNOSTIC_TEST

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.

Minimum Eligible Age

30 Years

Maximum Eligible Age

64 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes