In Germany appx. 4,600 women are diagnosed every year with cervical cancer, leading to 1,500 deaths. Infections with sexually transmitted human papillomaviruses (HPV) are a prerequisite for cervical cancer. Since 2007, routine HPV vaccination for girls has been recommended in Germany. However, because HPV infections are not notifiable in Germany, other means of data collection are needed to evaluate and document the impact of HPV vaccination. In 2010-12, we conducted an initial population-based study among women aged 20-25 years to assess baseline HPV prevalence and genotype-distribution in a mainly vaccine-naïve population. To estimate HPV prevalence ten years after vaccine introduction and to assess possible effects of vaccination, a follow-up study will be carried out in 2017/18. Here we present details of the study design.
Nationwide population-based cross-sectional study to examine HPV prevalence in 20-25 year-old vaccinated and unvaccinated women in Germany. Cervico-vaginal self-sampling via EvalynBrush (Rovers, Netherlands) and multiplexed genotyping HPV test Optiplex (Diamex, Germany) is used.
We will recruit at least 1,173 women aged 20-25 years. Recruitment will be based on a random sample from the residents’ registration offices of all communities in Germany, using a two-step sampling design stratified by geographical location (former Eastern/Western Germany) and population density (rural/urban). Using a self-sampling device participants will take vaginal cell samples that will be tested for HPV infections with 18 high-risk (e.g. 16, 18, 31, 45) and 8 low-risk types (e.g. 6, 11). In addition, participants will be asked to answer a questionnaire comprising questions on socio-demographics, sexual behavior, immunosuppressive diseases/medication, and HPV vaccination status; furthermore, they will be asked to provide proof of their vaccination status by uploading a photo of their vaccination card. The study was designed by considering major aspects of the baseline study to allow for comparison of results. First results of the study are expected in 2018.
The study will help to answer the following questions:
For women aged 20-25 years in Germany,
What is the prevalence of a) vaccine-preventable and non-vaccine-preventable and b) high-risk HPV types in 2017/18 and in comparison to the baseline study?
What is the difference in HPV prevalence in vaccinated vs non-vaccinated young women?
What is the effectiveness (at population level) of HPV vaccination?
What are risk factors for being unvaccinated or HPV positive?
The study will contribute to the evaluation of the existing HPV vaccination recommendation in Germany.