HPV - Anogenital Human Papilloma Virus Infection Clinical Trial
Official title:
Prevalence of HPV Infection Using Self-sampling Screening and Monitoring the Earlier Impact of HPV-Vaccination Program in Switzerland
Background: Currently prevalence of HPV infections for high risk strains among young women in
Switzerland is unknown. In addition, since 2008 a vaccination program to prevent these
infections has been implemented in a number of cantons, but its actual population impact is
currently unknown. For now, HPV screening in Switzerland is mainly performed by gynecologists
or during gynecological consultation at hospital. This method is certainly effective, but
expensive; population coverage of screening is still insufficient. A whole segment of the
target population does not participate in this screening especially young people of foreign
origin, for various reasons: economic cost, no gynecological, and for other reasons.
Several studies raise the effectiveness and efficiency of self-sampling to increase coverage
of screening, and the rate of participation of non-participants. Through this study, the
investigators evaluate effectiveness of this vaccination on the prevalence of HPV infections
using HPV prevalence kit and assess evolution of infection and clearance of HPV virus during
5 years in a population of young unvaccinated and vaccinated women.
Method: During the study, each participants will perform a vaginal swab sampling by auto to
research HPV. These samples will be sent to a laboratory where HPV typing is done by PCR
using the Anyplex ™ II technology.
The study will focus on a sample of 400 young women. Participants must complete a
questionnaire containing demographic questions and their HPV immunization status. Vaccination
coverage expected in this population is about 50%. Depending on the state of vaccination, two
different groups will be vaccinated vs unvaccinated (200 women per group). The cases of HPV
infection are then calculated for each group and compared as a function of the status of
vaccination. Statistical tests will be applied McNemar's test for comparison between the HPV
prevalence rates between the 2 groups.
Expected Results: This study will allow us to confirm the possibility of using self-sampling
as a method of screening and monitoring of HPV infections in the general population, it will
also enable us to document the effectiveness of HPV vaccination by comparing prevalence rate
of HPV infections among a group of young girls vaccinated and not vaccine and assess
evolution of infection and clearance of HPV virus.
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