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

Not Applicable

Recruiting

• Conditions: Cervical Intraepithelial Neoplasia; Human Papilloma Virus; Cervical Cancer
• Interventions: Diagnostic Test: HPV testing

• Registration Number: NCT05229679
• Lead Sponsor: Karolinska Institutet

Brief Summary

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.

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 Timeline

• Study Start: 2020-11-16
• Study First Submitted: 2021-11-30
• Study First Submitted QC: 2022-01-27
• Study First Posted: 2022-02-08
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-19
• Primary Completion: 2038-12-31
• Study Completion: 2038-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 180000

Inclusion Criteria

• Women ages 23-29 invited to screening.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HPV-based screening	HPV testing	Women 23-29 invited to cervical screening will have their samples analyzed for HPV.

Primary Outcome Measures

Name	Time	Method
Incidence of cervical cancer	Measured once during 1 year, year 10.	Cervical cancer incidence in the intervention group compared to a historical control group.

Secondary Outcome Measures

Name	Time	Method
Cost-effectiveness of the new screening method	Measured once during 1 year, year 10.	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.

Trial Locations

Locations (2)

Region of Skåne; 🇸🇪 Lund, Skåne, Sweden

Region Stockholm; 🇸🇪 Stockholm, Sweden