Feasibility of Sending a Direct Send HPV Self-sampling Kit to Long-term Screening Non-attenders

NCT ID: NCT04909281

Last Updated: 2021-06-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 741 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-08-28
• Study Completion Date: 2020-04-04

Brief Summary

All women in one Swedish county who had not participated in the organized screening program for at least 10 years were sent an HPV self-sampling kit. Women who were positive for HPV were referred to a gynecological examination including colposcopy and further testing according to national guidelines.

Detailed Description

In this cohort study nested in the organized cervical screening program, all women who had not participated in the organized screening program for at least 10 years in one Swedish county were eligible. Women were identified through the screening hub register that administrates for all invitations, referrals, and monitoring of the cervical screening program. The county screening hub invites approximately 30 000 women yearly to routine screening. Those who had opted out of the screening program, undergone hysterectomy, or changed their personal identification number (PNR) were excluded. HPV self-sampling kits with instructions and invitation letters were sent from the Department of Laboratory Medicine, Falun Hospital, in batches over 4 weeks. Lists of invitees were checked against changes in the screening hub register for individuals who moved, emigrated, died, or had taken a routine screening sample before sending a kit. Samples were received and HPV-analysis was performed.

If the self-sample HPV test was negative, the woman was returned to the screening program according to routine practice. HPV-positive women were referred without triage for further investigation to a gynecologist responsible for the clinical follow-up of high-risk women. The gynecological examination included colposcopy as well as biopsies and a liquid based cytology (LBC) sample (analyzed for cytology and HPV), which are routine examinations in clinical practice according to national and international guidelines. Colposcopies were performed within 3 months of a positive self-sample. If the colposcopic examination or the cytological/histopathological results indicated high-grade squamous intraepithelial lesions (HSIL) or invasive cervical cancer, women underwent treatment by conization and/or hysterectomy according to national guidelines The Cobas® PCR Female Swab Sample Packet was used for self-sampling, as previous studies had determined that the sensitivity for HPV was high and comparable with cervical samples used in the organized screening program. The HPV analysis was performed at the Department of Laboratory Medicine, Falun Hospital using the Cobas 4800 HPV Test (Roche Molecular Systems, South Branchburg, New Jersey, USA).

Conditions

HPV; Cervical Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Long-term non-attenders in the cervical screening program

All women who had not attended tthe cervical screening program in Sweden for at least 10 years were eligeble.

Self-sampling HPV

Intervention Type: DIAGNOSTIC_TEST

In this cohort study nested in the organized cervical screening program, all women who had not participated in the organized screening program for at least 10 years in one Swedish county were eligible.

Interventions

Self-sampling HPV

In this cohort study nested in the organized cervical screening program, all women who had not participated in the organized screening program for at least 10 years in one Swedish county were eligible.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Women who had not participated in the organized screening program for at least 10 years

Exclusion Criteria

• Women who were hystrectomized, moved, died

• Minimum Eligible Age: 33 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Falu Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hanna Sahlgren

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hanna I Sahlgren, md

Role: PRINCIPAL_INVESTIGATOR

RCC

Miriam K Elfström, phd

Role: PRINCIPAL_INVESTIGATOR

RCC

Locations

Falu Lasarett

Falun, Dalarna County, Sweden

Countries

Sweden

Other Identifiers

DNR 2019-02564

Identifier Type: -

Identifier Source: org_study_id