Dynamics of Human PApilloma Virus Interactions; Internet-based Students HeAlth Research Enterprise (DyPAVIR)
Primary Purpose
Infection by Human Papilloma Virus
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Various biological sampling
Sponsored by
About this trial
This is an interventional basic science trial for Infection by Human Papilloma Virus focused on measuring Human papilloma virus, Young women, I-Share
Eligibility Criteria
Women
Inclusion Criteria:
- voluntary student consulting the health service of university
- age 18-20 y.o.
- informed consent signed
- affiliated to national health insurance
Exclusion Criteria:
- pregnancy
- end of the pregnancy within the last 3 months
- Student participating in another clinical trial
Men
Inclusion Criteria:
- being the sexual partner of a woman included in this study
- at least 18 y.o
- informed consent signed
- affiliated to national health insurance
Exclusion Criteria:
none
Sites / Locations
- Service Universitaire de Médecine Préventive et de Promotion de la Santé (SUMPPS)
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
student cohort
Arm Description
Various biological sampling blood sampling, oral, vulvar, vaginal and anal sampling for women, oral and genital sampling for men
Outcomes
Primary Outcome Measures
Proportion of HPV detection at inclusion (all HPV genotypes)
Secondary Outcome Measures
Incidence of oncogenic HPV genotypes, co-infection with different HPV genotypes
Full Information
NCT ID
NCT01988948
First Posted
November 14, 2013
Last Updated
August 30, 2016
Sponsor
Institut Pasteur
Collaborators
Versailles Saint-Quentin-en-Yvelines University, centre national de référence pour les Papillomavirus Humains, German Cancer Research Center
1. Study Identification
Unique Protocol Identification Number
NCT01988948
Brief Title
Dynamics of Human PApilloma Virus Interactions; Internet-based Students HeAlth Research Enterprise
Acronym
DyPAVIR
Official Title
Impact de la Vaccination Sur la Distribution Des génotypes de Papillomavirus (HPV) et Suivi de la Dynamique Intra-individuelle de l'Infection et Des Co-infections Dans Une Population d'étudiantes âgées de 18 à 20 Ans
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Pasteur
Collaborators
Versailles Saint-Quentin-en-Yvelines University, centre national de référence pour les Papillomavirus Humains, German Cancer Research Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Human papillomavirus (HPV) infection is the most common sexually transmitted infection. The high risk oncogenic types, HPV-16 and -18 are responsible for 70% of cervical cancers. The introduction of vaccination against two major oncogenic genotypes of HPV raises questions about genotype replacement because of the existence of other oncogenic types not targeted by the vaccine. A better understanding of natural history of HPV infection and interaction (competition, synergy) between genotypes are required in order to anticipate this phenomenon.
The aims of this study are to characterize HPV infection in young female students and to follow up HPV infection and co-infection dynamics with different genotypes, taking into account both vaccination status and immunity to HPV 16 and 18. The study also focuses on the determination of factors influencing the development of persistent cervical HPV infections.
The DyPAVIR-ISHARE study is based on the participation of 5000 young female students, from 18 to 20 years-old, all registered at the Universities of Bordeaux or Versailles Saint-Quentin (UVSQ). The 3-years follow-up includes completion of a self-administrated questionnaire regarding sexual behaviour, socio-demographic characteristics, access to health-care services and, for a sub-group of 1000 students, the taking of genital and oral self-taken samples for the detection and genotyping of HPV (every 3 months). Previously, a pilot phase study (2 visits in 3 months of interval) is set up on 50 young female students from UVSQ in order to test feasibility.
This study will provide data to gain insight into the possibility of type replacement. Moreover, this study would provide an overview of HPV vaccine coverage and effectiveness HPV incidence and factors associated with HPV infection and co-infection ; Partners recruitment would allow us to follow HPV transmission dynamics among couples, and in particular, HPV exposure in young adult women. The HPV research won't be limited to virus detection in samples but will indicate the presence or absence of HPV infection.
Finally, additional genetic studies could be conducted in order to study genetic susceptibility to HPV infection, to chronic HPV infection and to co-infection.
This research project is part of the i-Share program funded by the "Investissement d'Avenir" cohort call.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection by Human Papilloma Virus
Keywords
Human papilloma virus, Young women, I-Share
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
student cohort
Arm Type
Other
Arm Description
Various biological sampling
blood sampling,
oral, vulvar, vaginal and anal sampling for women,
oral and genital sampling for men
Intervention Type
Other
Intervention Name(s)
Various biological sampling
Primary Outcome Measure Information:
Title
Proportion of HPV detection at inclusion (all HPV genotypes)
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Incidence of oncogenic HPV genotypes, co-infection with different HPV genotypes
Time Frame
5 years
Other Pre-specified Outcome Measures:
Title
Factors associated with HPV infection and co-infection
Time Frame
5 years
Title
HPV clearance (all genotypes and genotype-specific HPV)
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Women
Inclusion Criteria:
voluntary student consulting the health service of university
age 18-20 y.o.
informed consent signed
affiliated to national health insurance
Exclusion Criteria:
pregnancy
end of the pregnancy within the last 3 months
Student participating in another clinical trial
Men
Inclusion Criteria:
being the sexual partner of a woman included in this study
at least 18 y.o
informed consent signed
affiliated to national health insurance
Exclusion Criteria:
none
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Didier Guillemot, Pr, MD
Organizational Affiliation
Unité Pharmacoépidémiologie et maladies infectieuses (PhEMI), Institut Pasteur / Université Versailles Saint-Quentin-en-Yvelines / INSERM
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Elisabeth Delarocque-Astagneau, MD
Organizational Affiliation
Unité Pharmacoépidémiologie et maladies infectieuses (PhEMI), Institut Pasteur / UVSQ / Inserm
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Emmanuelle Mathiot-Vicaigne, MD
Organizational Affiliation
Versailles Saint-Quentin-en-Yvelines University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service Universitaire de Médecine Préventive et de Promotion de la Santé (SUMPPS)
City
Versailles
ZIP/Postal Code
78000
Country
France
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Dynamics of Human PApilloma Virus Interactions; Internet-based Students HeAlth Research Enterprise
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