HPV-based Screening Among Women 23-29 Years of Age

Evaluation of Organized Human Papilloma Virus (HPV) Screening of 23-29-year-old Women

The aim of the trial is to determine whether organized screening with primary HPV analysis provide higher cancer protection in the age group 23-29 years compared to primary cytology.

Study Overview

• Status: Recruiting
• Conditions: Cervical Cancer; Cervical Intraepithelial Neoplasia; Human Papilloma Virus
• Intervention / Treatment: Diagnostic test: HPV testing

Detailed Description

The aim is to investigate whether primary HPV analysis in the organized cell sampling program for women in the age group 23-29 provides higher cancer protection compared to the current method where cell samples are primarily analyzed with cytology. In this study, all women in the age group 23-29 in the Stockholm and Skåne Region of Sweden will participate. Age is defined by year of birth. For 2020, women born 1991-1997 are included. Sampling and collection of samples is the same as for cytology.

• Study Type: Interventional
• Enrollment (Estimated): 180000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joakim Dillner, MD, PhD; Phone Number: +46 (0) 72-468 24 60; Email: joakim.dillner@ki.se
• Study Contact Backup: Name: Miriam Elfström, PhD; Phone Number: +46 (0) 70-381 62 77; Email: miriam.elfstrom@ki.se

Study Locations

• Sweden
  • Stockholm, Sweden, 102 39
    • Recruiting
    • Region Stockholm
    • Contact: Joakim Dillner, MD, PhD; Phone Number: +46 (0) 72-468 24 60; Email: joakim.dillner@ki.se
  • Skåne
    • Lund, Skåne, Sweden, 221 00
      • Active, not recruiting
      • Region of Skåne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 23 years to 29 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Women ages 23-29 invited to screening.

Exclusion Criteria:

• Women who do not show up for screening or do not consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: HPV-based screening; Women 23-29 invited to cervical screening will have their samples analyzed for HPV.

Diagnostic test: HPV testing; All women age 23-29 resident in the pilot counties will be invited to HPV screening as of the study start date. The same invitation as currently used for women aged 30 and upwards will be used. This information clearly states that it is possible to opt out of the program and that data from the screening program will be collected to regional and national quality registers who will systematically evaluate the quality of the care. At the screening station, the samples are collected identically regardless of primary screening test used - there is no change in the procedures used neither for the woman or for the midwives taking the sample. HPV testing will be performed using the same purchased, CE-marked and accredited HPV screening platforms as currently used for women aged 30 and upwards. The cytology is according to the liquid-based cytology method.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of cervical cancer	Cervical cancer incidence in the intervention group compared to a historical control group.	Measured once during 1 year, year 1.
Incidence of cervical cancer	Cervical cancer incidence in the intervention group compared to a historical control group.	Measured once during 1 year, year 2.
Incidence of cervical cancer	Cervical cancer incidence in the intervention group compared to a historical control group.	Measured once during 1 year, year 3.
Incidence of cervical cancer	Cervical cancer incidence in the intervention group compared to a historical control group.	Measured once during 1 year, year 4.
Incidence of cervical cancer	Cervical cancer incidence in the intervention group compared to a historical control group.	Measured once during 1 year, year 5.
Incidence of cervical cancer	Cervical cancer incidence in the intervention group compared to a historical control group.	Measured once during 1 year, year 6.
Incidence of cervical cancer	Cervical cancer incidence in the intervention group compared to a historical control group.	Measured once during 1 year, year 7.
Incidence of cervical cancer	Cervical cancer incidence in the intervention group compared to a historical control group.	Measured once during 1 year, year 8.
Incidence of cervical cancer	Cervical cancer incidence in the intervention group compared to a historical control group.	Measured once during 1 year, year 9.
Incidence of cervical cancer	Cervical cancer incidence in the intervention group compared to a historical control group.	Measured once during 1 year, year 10.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost-effectiveness of the new screening method	Cost-effectiveness of HPV-based screening among women 23-29 as compared to cytology-based screening in the same age group. Cost data will be collected from the economy system used for the administration of the study, and compared to previous cost data.	Measured once during 1 year, year 1.
Cost-effectiveness of the new screening method	Cost-effectiveness of HPV-based screening among women 23-29 as compared to cytology-based screening in the same age group. Cost data will be collected from the economy system used for the administration of the study, and compared to previous cost data.	Measured once during 1 year, year 2.
Cost-effectiveness of the new screening method	Cost-effectiveness of HPV-based screening among women 23-29 as compared to cytology-based screening in the same age group. Cost data will be collected from the economy system used for the administration of the study, and compared to previous cost data.	Measured once during 1 year, year 3.
Cost-effectiveness of the new screening method	Cost-effectiveness of HPV-based screening among women 23-29 as compared to cytology-based screening in the same age group. Cost data will be collected from the economy system used for the administration of the study, and compared to previous cost data.	Measured once during 1 year, year 4.
Cost-effectiveness of the new screening method	Cost-effectiveness of HPV-based screening among women 23-29 as compared to cytology-based screening in the same age group. Cost data will be collected from the economy system used for the administration of the study, and compared to previous cost data.	Measured once during 1 year, year 5.
Cost-effectiveness of the new screening method	Cost-effectiveness of HPV-based screening among women 23-29 as compared to cytology-based screening in the same age group. Cost data will be collected from the economy system used for the administration of the study, and compared to previous cost data.	Measured once during 1 year, year 6.
Cost-effectiveness of the new screening method	Cost-effectiveness of HPV-based screening among women 23-29 as compared to cytology-based screening in the same age group. Cost data will be collected from the economy system used for the administration of the study, and compared to previous cost data.	Measured once during 1 year, year 7.
Cost-effectiveness of the new screening method	Cost-effectiveness of HPV-based screening among women 23-29 as compared to cytology-based screening in the same age group. Cost data will be collected from the economy system used for the administration of the study, and compared to previous cost data.	Measured once during 1 year, year 8.
Cost-effectiveness of the new screening method	Cost-effectiveness of HPV-based screening among women 23-29 as compared to cytology-based screening in the same age group. Cost data will be collected from the economy system used for the administration of the study, and compared to previous cost data.	Measured once during 1 year, year 9.
Cost-effectiveness of the new screening method	Cost-effectiveness of HPV-based screening among women 23-29 as compared to cytology-based screening in the same age group. Cost data will be collected from the economy system used for the administration of the study, and compared to previous cost data.	Measured once during 1 year, year 10.

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Investigators: Principal Investigator: Joakim Dillner, MD, PhD, Karolinska University Hospital/Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2020
• Primary Completion (Estimated): December 31, 2038
• Study Completion (Estimated): December 31, 2038

Study Registration Dates

• First Submitted: November 30, 2021
• First Submitted That Met QC Criteria: January 27, 2022
• First Posted (Actual): February 8, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 18, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Prevention; Organized screening; HPV vaccination; Human papilloma virus
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplasms by Histologic Type; Uterine Diseases; Genital Diseases, Female; Neoplasms, Glandular and Epithelial; Neoplasms, Squamous Cell; Precancerous Conditions; Uterine Cervical Diseases; Papilloma; Uterine Cervical Dysplasia
• Other Study ID Numbers: 2020-00053

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: IPD has been discussed but a plan isn't finalized.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No