Clinical trial NCT03474211: Prevalence of HPV Infection Using Self-sampling
Official title: Prevalence of HPV Infection Using Self-sampling Screening and Monitoring the Earlier Impact of HPV-Vaccination Program in Switzerland
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HPV - Anogenital Human Papilloma Virus Infection
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2018-03-22
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 31
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: It will take place in the health school of health and Faculty of Medicine at the University of Geneva. Trial information on the University website will be available; it will also contain a phone number for helpline. Cards to check eligibility, registration and scheduling will be available. The HPV self-collection kit will be directly distributed to participants at the end of their courses to School of Health and University of Geneva School of Medicine

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* • Eligible women aged between 18-31 years attending of Haute Ecole de Santé - Genève and Faculty of Medicine at the University of Geneva.

  * Understands study procedures and accepts voluntarily to participate by signing the informed consent form (ICF)

Exclusion Criteria:

* • History of hysterectomy or treatment on the cervix during the last 12 months

Primary outcomes:
measure: To determine the HPV prevalence of vaccine-type: 19 high-risk HPV types and 9 low-risk HPV types in a population of young unvaccinated and vaccinated women
timeFrame: 1.5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Amadane M, de Pree C, Viviano M, Vassilakos P, Jeannot E, Petignat P. Characteristics of HPV-unvaccinated undergraduate health students in Switzerland, a cross sectional study. Arch Public Health. 2019 Jun 18;77:29. doi: 10.1186/s13690-019-0348-y. eCollection 2019.