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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Human Papilloma Virus, Cervical Intraepithelial Neoplasia, Cervical Cancer

Intervention / Treatment
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* Diagnostic Test: HPV testing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women ages 23-29 invited to screening. Exclusion Criteria: Women who do not show up for screening or do not consent.

Ages Eligible for Study
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Minimum Age: 23 Years
Maximum Age: 29 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HPV-based screening<br>Women 23-29 invited to cervical screening will have their samples analyzed for HPV. | Diagnostic Test: HPV testing<br>* 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.<br>|

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Organized screening, HPV vaccination, Human papilloma virus, Prevention