This study evaluates the effect and feasibility of expanding the target population in the Danish cervical cancer screening program to include women aged 65 to 69 years. The study also evaluates if HPV self-sampling constitutes an appropriate screening method among older women.
The study is a nationwide population-based prospective cohort study embedded in the routine cervical cancer screening program in the Central Denmark Region. The study includes all 65 to 69 years old Danish women with no record of a cervical cytology sample or screening invitation within the last five years. Furthermore, the women are not registered as ineligible for screening, eg due hysterectomy. Eligible women residing in the Central Denmark Region are allocated to the intervention group (n=20,000), while women residing in the other four Danish regions are allocated to the control group receiving standard care (n=71,500), which for this group is low-level opportunistic screening at the general practitioner (GP). The intervention group are invited for HPV-based screening by the GP or to request a self-sampling kit.
Study Type
OBSERVATIONAL
Enrollment
20,000
Women in the intervention group will receive an invitation for HPV-based cervical cancer screening by either 1) scheduling an appointment for a cervical cytology by the GP or 2) collect a cervico-vaginal sample themselves in their own home using a self-sampling kit.
Mette Tranberg Nielsen
Randers, Randers NØ, Denmark
RECRUITINGParticipation rate in the intervention group:
Participation rate, eg the roportion of targeted women participating by GP-based screening or self-sampling
Time frame: 1 year post invitation
HPV prevalence
Number of women tested positive for HPV
Time frame: 1 year post invitation
Compliance to follow-up among HPV-positive self-samplers
The proportion of HPV-positive self-samplers who attend appropriate follow-up by their GP for onward referral
Time frame: 90 days post test results
Screening history
Screening history of participants and non-participants in the intervention group
Time frame: Average of 10 years
Intervention versus control group:
Participation rate
Time frame: 1 year post invitation
Cytological findings
Proportion of abnormal cytological findings between the intervention and control group is compared
Time frame: 1 year post invitation
Histological findings
Proportion of abnormal histological findings between the intervention and control group is compared
Time frame: 1 year post invitation
Incidence
The incidence rate of cervical cancer developed within 5 year is compared between the intervention and control group
Time frame: 5 year post invitation
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Mortality
The mortality rate of cervical cancer developed within 5 year is compared between the intervention and control group
Time frame: 5 year post invitation