NCT04133610

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,044 (actual)
• Sponsor: The Institute of Molecular and Translational Medicine, Czech Republic · Academic / Other
• Sex: Female
• Age: 30 Years – 64 Years
• Healthy volunteers: Accepted

Summary

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

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

• Cervical Cancer
• Cervical Dysplasia
• Human Papillomavirus Infection

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Self-sampling using digene HC2 DNA Collection Device	All women will undergo a clinician-collected cervical swab and self-collected cervicovaginal swab.
DIAGNOSTIC_TEST	Self-sampling using Evalyn Brush	All women will undergo a clinician-collected cervical swab and self-collected cervicovaginal swab.

Timeline

• Start date: 2018-09-01
• Primary completion: 2019-10-30
• Completion: 2019-11-25
• First posted: 2019-10-21
• Last updated: 2019-11-26

Locations

3 sites across 1 country: Czechia