Human Papilloma Virus, Cervical Intraepithelial Neoplasia, Cervical Cancer
Conditions
Keywords
Organized screening, HPV vaccination, Human papilloma virus, Prevention
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.
Interventions
DIAGNOSTIC_TESTHPV 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.
Sponsors
Karolinska Institutet
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
23 Years to 29 Years
Healthy volunteers
No
Inclusion criteria
* Women ages 23-29 invited to screening.
Exclusion criteria
* Women who do not show up for screening or do not consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of cervical cancer | Measured once during 1 year, year 1. | Cervical cancer incidence in the intervention group compared to a historical control group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cost-effectiveness of the new screening method | Measured once during 1 year, year 1. | 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. |
Countries
Sweden
Contacts
Primary ContactJoakim Dillner, MD, PhD
Backup ContactMiriam Elfström, PhD
Outcome results
None listed