Actively Recruiting
Characteristics of Human Papillomavirus (HPV) Infections and HPV Vaccine Attitudes Among Slovenian Women After the Introduction of HPV Vaccination
Led by University Medical Centre Ljubljana · Updated on 2025-05-29
500
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
Sponsors
U
University Medical Centre Ljubljana
Lead Sponsor
M
MSD Pharmaceuticals LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
Cervical cancer, mainly caused by persistent high-risk human papillomavirus (HPV) infection, remains a major public health concern. Despite available HPV vaccines and better screening, many countries, including Slovenia, have low vaccination rates. The World Health Organization aims for high vaccination and screening coverage by 2030 to eliminate cervical cancer. This study evaluates HPV vaccine acceptance among Slovenian women, identifies barriers, and explores combined HPV screening and vaccination to reduce HPV transmission and accelerate cancer prevention locally. Women attending regular gynecological exams within Slovenia's national cervical cancer screening program (ZORA) are invited to participate. Eligible women aged 35 or younger who are unvaccinated will be counseled on HPV vaccination and offered the nonavalent Gardasil®9 vaccine free of charge. The vaccine is given in three doses over six months. Participants undergo cervical smears as part of routine care, and the study includes women with normal screening results, follow-up after abnormal findings, or clinical indications. Participants complete an anonymous questionnaire about demographics, screening history, vaccination status, and vaccine attitudes, with help if needed. Researchers will monitor vaccine uptake over two years. Data will be anonymized and analyzed to understand vaccine acceptance and identify optimal target groups. The study aims to help improve HPV vaccination coverage and enhance cervical cancer prevention in Slovenia.
CONDITIONS
Brief Title
Characteristics of Human Papillomavirus (HPV) Infections and HPV Vaccine Attitudes Among Slovenian Women After the Introduction of HPV Vaccination
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Regular cervical smear every 3 years after a previously normal result
- First cervical smear at entry into the ZORA screening program
- Second cervical smear one year after entering the ZORA program following a normal first smear
- Follow-up smear after abnormal or non-neoplastic cytology, or after cervical procedures like conization or laser vaporization
- Cervical smear due to clinical signs or pathological findings
You will not qualify if you...
- Pregnancy at the time of the gynecological examination
- Menstrual bleeding at the time of the gynecological examination
- Vaginal or cervical inflammation at the time of the examination
- Other medical or clinical conditions preventing cervical smear collection
- History of hysterectomy
- Cervical smear already taken for this study
- Known hypersensitivity to HPV vaccine components
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Ongoing during regular cervical cancer prevention visits
Participants 35 years or younger are offered the HPV vaccine during their regular cervical cancer prevention visit with the gynecologist.
Visits occur every 3 years as part of routine cervical cancer prevention
Duration - 2 years
Participants are observed for HPV vaccine uptake and cervical health over 2 years.
Regular cervical smear visits every 3 years and additional visits as needed based on clinical findings
Trial Site Locations
Total: 1 location
1
UMC Ljubljana
Ljubljana, Municipality of Domžale, Slovenia, 1000
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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