Prevalence of HPV Infection Using Self-sampling

NCT ID: NCT03474211

Last Updated: 2018-03-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2017-09-30

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.

Conditions

HPV - Anogenital Human Papilloma Virus Infection

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

vaccinated

No interventions assigned to this group

non vaccinated

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 31 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Geneva

OTHER

Sponsor Role: lead

Responsible Party

Jeannot Emilien

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: DERIVED

PMID: 31236272 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

CER: 15-257

Identifier Type: -

Identifier Source: org_study_id