## Protocol Section
### Identification Module
**NCT ID:** NCT05229679

**Brief Title:** HPV-based Screening Among Women 23-29 Years of Age

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

#### Organization Study ID Info
**ID:** 2020-00053
#### Organization
**Class:** OTHER
**Full Name:** Karolinska Institutet
### Status Module
#### Completion Date
**Date:** 2038-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-10-06

**Type:** ACTUAL

**Last Update Submit Date:** 2023-10-05

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2038-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2020-11-16

**Type:** ACTUAL

**Status Verified Date:** 2023-10

#### Study First Post Date
**Date:** 2022-02-08
**Type:** ACTUAL
**Study First Submit Date:** 2021-11-30
**Study First Submit QC Date:** 2022-01-27
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Karolinska Institutet

#### Responsible Party

**Investigator Affiliation:** Karolinska Institutet

**Investigator Full Name:** Joakim Dillner

**Investigator Title:** Professor of Infectious Disease Epidemiology; Director of R&D

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Human Papilloma Virus

- Cervical Intraepithelial Neoplasia

- Cervical Cancer

**Keywords:**

- Organized screening

- HPV vaccination

- Human papilloma virus

- Prevention

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 180000

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Women 23-29 invited to cervical screening will have their samples analyzed for HPV.

**Intervention Names:**

- Diagnostic Test: HPV testing

**Label:** HPV-based screening

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- HPV-based screening

**Description:** 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.

**Name:** HPV testing

**Type:** DIAGNOSTIC_TEST

### Outcomes Module

#### Primary Outcomes

**Description:** Cervical cancer incidence in the intervention group compared to a historical control group.

**Measure:** Incidence of cervical cancer

**Time Frame:** Measured once during 1 year, year 1.

**Description:** Cervical cancer incidence in the intervention group compared to a historical control group.

**Measure:** Incidence of cervical cancer

**Time Frame:** Measured once during 1 year, year 2.

**Description:** Cervical cancer incidence in the intervention group compared to a historical control group.

**Measure:** Incidence of cervical cancer

**Time Frame:** Measured once during 1 year, year 3.

**Description:** Cervical cancer incidence in the intervention group compared to a historical control group.

**Measure:** Incidence of cervical cancer

**Time Frame:** Measured once during 1 year, year 4.

**Description:** Cervical cancer incidence in the intervention group compared to a historical control group.

**Measure:** Incidence of cervical cancer

**Time Frame:** Measured once during 1 year, year 5.

**Description:** Cervical cancer incidence in the intervention group compared to a historical control group.

**Measure:** Incidence of cervical cancer

**Time Frame:** Measured once during 1 year, year 6.

**Description:** Cervical cancer incidence in the intervention group compared to a historical control group.

**Measure:** Incidence of cervical cancer

**Time Frame:** Measured once during 1 year, year 7.

**Description:** Cervical cancer incidence in the intervention group compared to a historical control group.

**Measure:** Incidence of cervical cancer

**Time Frame:** Measured once during 1 year, year 8.

**Description:** Cervical cancer incidence in the intervention group compared to a historical control group.

**Measure:** Incidence of cervical cancer

**Time Frame:** Measured once during 1 year, year 9.

**Description:** Cervical cancer incidence in the intervention group compared to a historical control group.

**Measure:** Incidence of cervical cancer

**Time Frame:** Measured once during 1 year, year 10.

#### Secondary Outcomes

**Description:** 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.

**Measure:** Cost-effectiveness of the new screening method

**Time Frame:** Measured once during 1 year, year 1.

**Description:** 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.

**Measure:** Cost-effectiveness of the new screening method

**Time Frame:** Measured once during 1 year, year 2.

**Description:** 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.

**Measure:** Cost-effectiveness of the new screening method

**Time Frame:** Measured once during 1 year, year 3.

**Description:** 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.

**Measure:** Cost-effectiveness of the new screening method

**Time Frame:** Measured once during 1 year, year 4.

**Description:** 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.

**Measure:** Cost-effectiveness of the new screening method

**Time Frame:** Measured once during 1 year, year 5.

**Description:** 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.

**Measure:** Cost-effectiveness of the new screening method

**Time Frame:** Measured once during 1 year, year 6.

**Description:** 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.

**Measure:** Cost-effectiveness of the new screening method

**Time Frame:** Measured once during 1 year, year 7.

**Description:** 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.

**Measure:** Cost-effectiveness of the new screening method

**Time Frame:** Measured once during 1 year, year 8.

**Description:** 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.

**Measure:** Cost-effectiveness of the new screening method

**Time Frame:** Measured once during 1 year, year 9.

**Description:** 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.

**Measure:** Cost-effectiveness of the new screening method

**Time Frame:** Measured once during 1 year, year 10.

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Women ages 23-29 invited to screening.

Exclusion Criteria:

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

**Gender Based:** True

**Gender Description:** Individuals with a cervix and with a personal ID number indicating that they are a female, are eligible.

**Maximum Age:** 29 Years

**Minimum Age:** 23 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** joakim.dillner@ki.se

**Name:** Joakim Dillner, MD, PhD

**Phone:** +46 (0) 72-468 24 60

**Role:** CONTACT

**Contact 2:**

**Email:** miriam.elfstrom@ki.se

**Name:** Miriam Elfström, PhD

**Phone:** +46 (0) 70-381 62 77

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Lund

**Country:** Sweden

**Facility:** Region of Skåne

**State:** Skåne

**Status:** ACTIVE_NOT_RECRUITING

**Zip:** 221 00

**Location 2:**

**City:** Stockholm

**Contacts:**

***Contact 1:***

- **Email:** joakim.dillner@ki.se

- **Name:** Joakim Dillner, MD, PhD

- **Phone:** +46 (0) 72-468 24 60

- **Role:** CONTACT

**Country:** Sweden

**Facility:** Region Stockholm

**Status:** RECRUITING

**Zip:** 102 39

#### Overall Officials

**Official 1:**

**Affiliation:** Karolinska University Hospital/Karolinska Institutet

**Name:** Joakim Dillner, MD, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Description:** IPD has been discussed but a plan isn't finalized.

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009369

- Term: Neoplasms

- ID: D000002577

- Term: Uterine Cervical Diseases

- ID: D000014591

- Term: Uterine Diseases

- ID: D000005831

- Term: Genital Diseases, Female

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000091662

- Term: Genital Diseases

- ID: D000018307

- Term: Neoplasms, Squamous Cell

- ID: D000009375

- Term: Neoplasms, Glandular and Epithelial

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000011230

- Term: Precancerous Conditions

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

- Abbrev: BC01

- Name: Infections

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M5830

- Name: Uterine Cervical Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M17522

- Name: Virus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M13131

- Name: Papilloma

- Relevance: HIGH

- As Found: Papilloma

- ID: M5826

- Name: Uterine Cervical Dysplasia

- Relevance: HIGH

- As Found: Cervical Intraepithelial Neoplasia

- ID: M5825

- Name: Uterine Cervical Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17339

- Name: Uterine Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8943

- Name: Genital Diseases, Female

- Relevance: LOW

- As Found: Unknown

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M20451

- Name: Neoplasms, Squamous Cell

- Relevance: LOW

- As Found: Unknown

- ID: M12320

- Name: Neoplasms, Glandular and Epithelial

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M14111

- Name: Precancerous Conditions

- Relevance: LOW

- As Found: Unknown

- ID: T1074

- Name: Cervical Intraepithelial Neoplasia

- Relevance: HIGH

- As Found: Cervical Intraepithelial Neoplasia

### Condition Browse Module - Meshes

- ID: D000010212

- Term: Papilloma

- ID: D000002578

- Term: Uterine Cervical Dysplasia

### Misc Info Module

- Version Holder: 2024-05-24
