Prevalence of HPV Infection Using Self-sampling

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03474211
• Other study ID #: CER: 15-257
• Status: Completed
• First received: February 21, 2018
• Last updated: March 21, 2018
• Start date: September 2016
• Est. completion date: September 2017

Study information

• Verified date: March 2018
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: September 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 31 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• HPV - Anogenital Human Papilloma Virus Infection
• Infection
• Papilloma
• Papillomavirus Infections
• Virus Diseases

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of unvaccinated and vaccinated women infected by an HPV virus as assessed by using self sampling HPV kit.	1.5 years