Effectiveness of Cervical Screening in Unvaccinated, Herd Effect Protected Women (HPV400)
HPV400
1 other identifier
interventional
14,000
1 country
18
Brief Summary
To identify: 1) Whether being informed infrequently results about screening is at least as a) safe and b) accurate as frequently obtaining all information from (the present combination of opportunistic/organized) cervical screening by comparing regimen results of two screening visits at the ages of 25 and 28 years (Arm A1) vs. results of one screening visit at the age of 28 years (Arm A2) in unvaccinated herd effect protected women. Unvaccinated, frequently screened women, who are not under herd effect protection will be controls (C).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2020
Longer than P75 for not_applicable
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 9, 2020
CompletedFirst Submitted
Initial submission to the registry
February 4, 2021
CompletedFirst Posted
Study publicly available on registry
February 16, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedJanuary 13, 2025
January 1, 2025
5.2 years
February 4, 2021
January 9, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
The difference between arm A1 vs. arm C
No significant difference in the incidence ratios of CIN2/3 between arms A1 (participants under herd protection and frequently informed of the cytological results) vs. C (participants not under herd protection and frequently informed of the cytological findings) at the age of 28
Three years of follow up within 2020 - 2025
The difference between arm A2 vs. arm C
No significant difference in the incidence ratios of CIN2/3 between arms A2 (participants under herd protection and frequently informed of the cytological results) vs. C (participants not under herd protection and frequently informed of the cytological findings) at the age of 28.
Three years of follow up within 2020 - 2025
Secondary Outcomes (3)
Quality of life in infrequently vs. frequently screened unvaccinated women (RAND 36)
Three years of follow up within 2021 - 2025
Quality of life in infrequently vs. frequently screened unvaccinated women (EQ-VAS)
Three years of follow up within 2021 - 2025
Quality of life in infrequently vs. frequently screened unvaccinated women (CECA 10)
Three years of follow up within 2021 - 2025
Study Arms (3)
A1
ACTIVE COMPARATORFrequent information of screening results for cytology and/or HPV DNA at the ages of 25 (cytology only) and 28 (cytology only) vs A2
A2
NO INTERVENTIONinfrequent information of cytological screening/ HPV DNA results, only at the age 28 years.
C
ACTIVE COMPARATORThe third arm with at 8000 participants devoid of herd effect protection and frequent screening at ages 25 and 28 is enrolled for comparative analyses between A1 vs. C and A2 vs. C.
Interventions
All participants will be referred to pertinent diagnosis and treatment according to local standard of care (Käypä hoito 2010) should the cytological screening results (HSIL, ASC-H, AGC-FN) or three consecutive LSIL findings at repeated control visits within 3 years indicate it. The most common screening results (ASCUS, LSIL) are, however, not convened to arm A2 participants before age 28. All cytology and HPV DNA results results are being revealed to all trial participants at age 28 at the study end.
Eligibility Criteria
You may qualify if:
- Born 1995-1997. 25 years of age residence in one of the eight community-randomized trial A communities with documented herd effect from gender-neutral vaccination or C communities devoid of the herd effect.
You may not qualify if:
- Immune compromising disease status (e.g. transplant recipients). HPV vaccination
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tampere University Hospitallead
- Tampere Universitycollaborator
- European Unioncollaborator
- Karolinska Institutetcollaborator
Study Sites (18)
HPV-tutkimukset
Hämeenlinna, 40100, Finland
HUS
Helsinki, Finland
HPV-tutkimukset
Iisalmi, 74100, Finland
HPV-tutkimukset
Joensuu, 80100, Finland
HPV-tutkimukset
Jyväskylä, 40100, Finland
Nuorisotutkimusasema, PSHP/ Tampereen yliopisto
Kemi, 94100, Finland
Nuorisotutkimusasema, PSHP/Tampereen yliopisto
Kotka, 48100, Finland
HPV-tutkimukset
Kouvola, 45100, Finland
Nuorisotutkimusasema, PSHP; Tampereen yliopisto
Kuopio, 70100, Finland
Nuorisotutkimusasema, PSHP/ Tampereen yliopisto
Lahti, 15110, Finland
HPV-tutkimukset
Oulu, 90100, Finland
HPV-tutkimukset
Pori, 28100, Finland
HPV-tutkimukset
Porvoo, 06100, Finland
Nuorisotutkimusasema, PSHP; Tampereen yliopisto
Rauma, 26100, Finland
HPV-tutkimukset
Sastamala, 38200, Finland
HPV-tutkimukset
Seinäjoki, 60100, Finland
Nuorisotutkimusasema; PSHP/ Tamereen yliopisto
Tampere, 33100, Finland
HPV-tutkimukset
Varkaus, 78300, Finland
Related Publications (5)
Lehtinen M, Elfstrom M, Vanska S, Dillner J. Elimination of cervical cancer by refined vaccination and screening. Int J Cancer. 2025 Feb 15;156(4):886-888. doi: 10.1002/ijc.35228. Epub 2024 Oct 25. No abstract available.
PMID: 39450703BACKGROUNDLehtinen M, Bruni L, Elfstrom M, Gray P, Logel M, Mariz FC, Baussano I, Vanska S, Franco EL, Dillner J. Scientific approaches toward improving cervical cancer elimination strategies. Int J Cancer. 2024 May 1;154(9):1537-1548. doi: 10.1002/ijc.34839. Epub 2024 Jan 9.
PMID: 38196123BACKGROUNDLehtinen M, Gray P, Louvanto K, Vanska S. In 30 years, gender-neutral vaccination eradicates oncogenic human papillomavirus (HPV) types while screening eliminates HPV-associated cancers. Expert Rev Vaccines. 2022 Jun;21(6):735-738. doi: 10.1080/14760584.2022.2064279. Epub 2022 Apr 15. No abstract available.
PMID: 35404177BACKGROUNDGray P, Kann H, Pimenoff VN, Eriksson T, Luostarinen T, Vanska S, Surcel HM, Faust H, Dillner J, Lehtinen M. Human papillomavirus seroprevalence in pregnant women following gender-neutral and girls-only vaccination programs in Finland: A cross-sectional cohort analysis following a cluster randomized trial. PLoS Med. 2021 Jun 7;18(6):e1003588. doi: 10.1371/journal.pmed.1003588. eCollection 2021 Jun.
PMID: 34097688BACKGROUNDVanska S, Luostarinen T, Baussano I, Apter D, Eriksson T, Natunen K, Nieminen P, Paavonen J, Pimenoff VN, Pukkala E, Soderlund-Strand A, Dubin G, Garnett G, Dillner J, Lehtinen M. Vaccination With Moderate Coverage Eradicates Oncogenic Human Papillomaviruses If a Gender-Neutral Strategy Is Applied. J Infect Dis. 2020 Aug 17;222(6):948-956. doi: 10.1093/infdis/jiaa099.
PMID: 32161969BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Matti Lehtinen, MD, PhD
Tampere University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Frequent / Infrequent information of cytological screening results
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research coordinator
Study Record Dates
First Submitted
February 4, 2021
First Posted
February 16, 2021
Study Start
June 9, 2020
Primary Completion
August 31, 2025
Study Completion
December 31, 2025
Last Updated
January 13, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share