Cervical Cancer
Conditions
Brief summary
The study aims to identify global and local determinants of HPV vaccine acceptability, HPV vaccine uptake and compliance as well as identify logistics and programmatic issues in each country to offer the HPV vaccine, as a potential cervical cancer prevention strategy, to mid-aged women attending screening.
Detailed description
3000 women aged within the age range of 25-45 years old will be recruited; 250-300 women per country. These women will be identified by means of screening registry lists or screening clinical visits. Eligible women will receive a study questionnaire on the HPV vaccine. Additionally, and independently of participating in the study questionnaire, those who accept will get 3 HPV vaccine doses. Depending on country preferences, either Cervarix® (Glaxosmithkline Biologicals, S.A.) at month 0, 1 and 6 or Gardasil® (Sanofi Pasteur MSD SNC) at month 0, 2 and 6, will be administered. Safety data and HPV vaccine compliance will be assessed. A sub study in Spain will also analyze acceptability of HPV vaccination in a sample of women aged 35-40 yrs identified as poor screening attenders. Two independent informed consent forms will be provided; one for the study questionnaire participation and another for HPV vaccine administration.
Interventions
Sponsors
CHU de Reims
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* women within the age range of 25-45 * attending cervical cancer screening
Exclusion criteria
* previous history of HPV vaccine administration
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| number of vaccinated patients | up to 3 years |
Countries
France
Outcome results
None listed