NCT02255084

Vaginal Self-sampling and Human Papillomavirus Testing in Unscreened Women

Attitude of Unscreened Women Face to Different Strategies to Participate in Cervical Cancer Screening by Vaginal Self-sampling : Home-mailed or Invitation to Remove to Their General Practitioner

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 3,612 (actual)
• Sponsor: University Hospital, Tours · Academic / Other
• Sex: Female
• Age: 30 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Despite the existence of an effective screening test (pap smear), cervical cancer is, every year in France, the cause of more than 3,000 new cases and 1,100 deaths. But, in France, 4 in 10 women are not screened or not often enough (nearly 7 millions women). It is therefore necessary to develop new strategies to reach these women. The etiological factor of this cancer is persistent infection with High-Risk Human PapillomaVirus oncogene (HR-HPV). Thereby, HPV-based tests could be alternative screening tests. Vaginal self-sampling with HR-HPV test is simpler and less intrusive than the pap smear. It has been shown that vaginal self-sampling with HPV test is a powerful means to increase the participation rate in cervical cancer screening.

Conditions

• Cancer Cervix

Interventions

Type	Name	Description
BEHAVIORAL	Group 1 remove self sample kit at gp consulting room or perform pap smear	Selected general practitioners are briefly informed about the study and they receive a package of kits for vaginal self-sampling. Selected women receive a mail inviting them either to remove a kit for vaginal self-sampling at their general practitioner's consulting room or to perform a pap smear. When women choose the vaginal self-sampling, a HPV test is performed on the sample in a virology laboratory.
BEHAVIORAL	Group 2 perform self sample at home or pap smear	Selected general practitioners are briefly informed about the study. Selected women receive a mail inviting them either to perform a vaginal self sampling at their home (with the kit provided) or to perform a pap smear. When women choose the vaginal self-sampling, a HPV test is performed on the sample in a virology laboratory.

Timeline

• Start date: 2015-02-01
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2014-10-02
• Last updated: 2025-12-22

Locations

1 site across 1 country: France