Cervical Cancer ScreeningNCT06995157
Characteristics of Human Papillomavirus (HPV) Infections and HPV Vaccine Attitudes Among Slovenian Women After the Introduction of HPV Vaccination
A study testing Offering HPV vaccine in people with Cervical Cancer Screening and Vaccination Uptake, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial summary
Cervical cancer (CC), primarily caused by persistent infection with high-risk human papillomavirus (HPV) types, remains a significant public health issue. Despite the availability of prophylactic HPV vaccines and improved screening methods, vaccination coverage and uptake remain suboptimal in many countries, including… Read more about this study
- Who is it for?
- Ages Up to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer Screening, Vaccination Uptake
- What is being tested?
- Offering HPV vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Sep 2023to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 35 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- regular cervical smear (CS) every 3 years after a previously normal CS result, first CS at entry into the ZORA screening program, second CS one year after entering the ZORA screening program following a previously normal first CS, control CS after a pathological cytological result or after a non-neoplastic cytological result or after conization or laser vaporization of the cervix, and curative CS due to signs or pathological clinical findings
Who cannot join
- pregnancy at the time of the gynecological examination, menstrual bleeding at the time of the gynecological examination, inflammation of the vagina and/or cervix at the time of the gynecological examination, other medical and clinical conditions that prevent the taking of a CS, condition after hysterectomy, already taken CS for the purpose of the present study, and hypersensitivity to the active substances or any excipient of the HPV vaccine
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Slovenia1 site, 1 recruiting
- Recruiting
UMC Ljubljana
Ljubljana, Municipality of Domžale, 1000
Ana Pflaum, MD, 38651302582, ana.pflaum@kclj.si
ana.pflaum@gmail.com
About this study
Cervical cancer (CC), primarily caused by persistent infection with high-risk human papillomavirus (HPV) types, remains a significant public health issue. Despite the availability of prophylactic HPV vaccines and improved screening methods, vaccination coverage and uptake remain suboptimal in many countries, including Slovenia. In 2020, the WHO launched a global strategy to eliminate CC, emphasizing 90% HPV vaccination coverage among girls, 70% screening of women at key ages, and 90% treatment of identified cases by 2030.
The EVEN FASTER concept proposes that targeting a specific age group of women-those bridging unvaccinated and vaccinated cohorts-with simultaneous HPV screening and vaccination may significantly reduce HPV transmission. Swedish data support this, showing a 62-64% reduction in high-risk HPV infections following combined interventions in women aged 23-30.
Read more
In Slovenia, HPV vaccination has been available since 2006 for girls, and since 2021 for boys, with average uptake around 50%. However, no comparable model has been implemented or studied locally. This proposed clinical study will assess HPV vaccine acceptability among women in Slovenia, identify barriers to uptake, define an optimal target age group for intervention, and evaluate the effectiveness of offering concurrent screening and vaccination to accelerate CC prevention in this region.
Women will be invited to participate during their preventive gynecological examination within Slovenia's national cervical cancer screening program (ZORA). Inclusion criteria include regular cervical smears (CS) every 3 years following a previously normal result, first or second CS after entering the ZORA program, follow-up CS after abnormal cytology, non-neoplastic findings, or cervical procedures, and CS due to clinical indications. Exclusion criteria include pregnancy, menstruation, cervical or vaginal inflammation, other medical conditions preventing CS collection, prior hysterectomy, prior CS taken for this study, or known hypersensitivity to HPV vaccine components.
Eligible women will be invited by the attending gynecologist and nurse. After the exam, participants will complete an anonymous questionnaire covering demographics, screening history, vaccination status, and vaccine attitudes. Assistance will be provided if needed.
Women aged ≤35 who are unvaccinated will receive counseling on HPV vaccination, including benefits and risks. Those consenting will receive free vaccination with the nonavalent Gardasil®9 vaccine, following a three-dose schedule (0, 1-2, 6 months).
Around 500 women aged ≤35 are expected in this sub-group, with fewer than half anticipated to accept vaccination. Data will be anonymized and analyzed using SPSS (p < 0.05).
- Conditions
- Cervical Cancer Screening, Vaccination Uptake
- Being tested
- Offering HPV vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Offering HPV vaccineBiological
During regular cervical cancer prevention visit with the gynecologist, HPV vaccine will be offered to participants 35 years or younger.
| Study group | Role | What they receive |
|---|---|---|
| Taking HPV sample and offering HPV vaccination | Other | Not described Receives: Biological: Offering HPV vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
HPV vaccine uptake
We expect 50% of participants to opt for vaccination.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start1 Sep 2023
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Cancer ScreeningStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Collaborators
- MSD Pharmaceuticals LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06995157
- Sponsor's protocol ID
- 0120-240/2023/3
- Status last verified
- May 2025
- First submitted
- 20 May 2025
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics of Human Papillomavirus (HPV) Infections and HPV Vaccine Attitudes Among Slovenian Women After the Introduction of HPV Vaccination
- ClinicalTrials.gov ID
- NCT06995157
- Acronym / sponsor ID
- 0120-240/2023/3
- Conditions
- Cervical Cancer Screening, Vaccination Uptake
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Collaborators
- MSD Pharmaceuticals LLC
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 29 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cervical cancer (CC), primarily caused by persistent infection with high-risk human papillomavirus (HPV) types, remains a significant public health issue. Despite the availability of prophylactic HPV vaccines and improved screening methods, vaccination coverage and uptake remain suboptimal in many countries, including Slovenia. In 2020, the WHO launched a global strategy to eliminate CC, emphasizing 90% HPV vaccination coverage among girls, 70% screening of women at key ages, and 90% treatment of identified cases by 2030.
The EVEN FASTER concept proposes that targeting a specific age group of women-those bridging unvaccinated and vaccinated cohorts-with simultaneous HPV screening and vaccination may significantly reduce HPV transmission. Swedish data support this, showing a 62-64% reduction in high-risk HPV infections following combined interventions in women aged 23-30.
In Slovenia, HPV vaccination has been available since 2006 for girls, and since 2021 for boys, with average uptake around 50%. However, no comparable model has been implemented or studied locally. This proposed clinical study will assess HPV vaccine acceptability among women in Slovenia, identify barriers to uptake, define an optimal target age group for intervention, and evaluate the effectiveness of offering concurrent screening and vaccination to accelerate CC prevention in this region.
Women will be invited to participate during their preventive gynecological examination within Slovenia's national cervical cancer screening program (ZORA). Inclusion criteria include regular cervical smears (CS) every 3 years following a previously normal result, first or second CS after entering the ZORA program, follow-up CS after abnormal cytology, non-neoplastic findings, or cervical procedures, and CS due to clinical indications. Exclusion criteria include pregnancy, menstruation, cervical or vaginal inflammation, other medical conditions preventing CS collection, prior hysterectomy, prior CS taken for this study, or known hypersensitivity to HPV vaccine components.
Eligible women will be invited by the attending gynecologist and nurse. After the exam, participants will complete an anonymous questionnaire covering demographics, screening history, vaccination status, and vaccine attitudes. Assistance will be provided if needed.
Women aged ≤35 who are unvaccinated will receive counseling on HPV vaccination, including benefits and risks. Those consenting will receive free vaccination with the nonavalent Gardasil®9 vaccine, following a three-dose schedule (0, 1-2, 6 months).
Around 500 women aged ≤35 are expected in this sub-group, with fewer than half anticipated to accept vaccination. Data will be anonymized and analyzed using SPSS (p < 0.05).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Taking HPV sample and offering HPV vaccination | Other | Biological: Offering HPV vaccine |
Who may qualify
- Ages
- Up to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- regular cervical smear (CS) every 3 years after a previously normal CS result, first CS at entry into the ZORA screening program, second CS one year after entering the ZORA screening program following a previously normal first CS, control CS after a pathological cytological result or after a non-neoplastic cytological result or after conization or laser vaporization of the cervix, and curative CS due to signs or pathological clinical findings
Key exclusion criteria (1 listed)
- pregnancy at the time of the gynecological examination, menstrual bleeding at the time of the gynecological examination, inflammation of the vagina and/or cervix at the time of the gynecological examination, other medical and clinical conditions that prevent the taking of a CS, condition after hysterectomy, already taken CS for the purpose of the present study, and hypersensitivity to the active substances or any excipient of the HPV vaccine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Offering HPV vaccineDuring regular cervical cancer prevention visit with the gynecologist, HPV vaccine will be offered to participants 35 years or younger. | Biological | Taking HPV sample and offering HPV vaccination |
Primary outcome
HPV vaccine uptake
Time frame: 2 years
We expect 50% of participants to opt for vaccination.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Offering HPV vaccine in people with Cervical Cancer Screening and Vaccination Uptake, run by University Medical Centre Ljubljana at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HPV vaccine uptake (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2025.