Self-sampling Among Long-term Non-attenders to Cervical Cancer Screening

Not Applicable

Completed

• Conditions: Cervical Cancer
• Interventions: Behavioral: Opt-out; Receive self-sampling kit unsolicited; Behavioral: Control; Receive open reminder to be screened by physician; Behavioral: Opt-in; Receive offer to order self-sampling kit

• Registration Number: NCT03873376
• Lead Sponsor: Oslo University Hospital

Brief Summary

The trial will evaluate whether human papillomavirus (HPV) self-sampling may increase cervical cancer screening attendance among under-screened women in Norway, how different ways of offering self-sampling and follow-up may affect attendance, and whether self-sampling may reduce inequities in attendance.

Detailed Description

A randomized control trial will be performed on the effect of vaginal HPV self-sampling on screening attendance, targeting women age 35-69 who have not attended screening for at least 10 years. The women will be randomly allocated to one of three interventions: (i) receive a reminder to be screened by a physician; (ii) receive a self-sampling kit; (iii) receive an offer to order a self-sampling kit. Comparisons of the screening attendance among the interventions will be made. To also address potential effects on inequities, the analyses will include comparisons by sociodemographic characteristics. The rates of cervical cancer/precancer among the interventions will also be compared. Further, to assess the feasibility of and the compliance to follow-up after a positive HPV test in this population, half of the HPV-positive women from each self-sampling arm will be referred to initial follow-up by their regular general practitioner (GP), while the other half will be referred to initial follow-up by a gynecologist. The project will be embedded in the national cervical cancer screening program, and will utilize the extensive nationwide registers describing performance and outcomes of screening collected by the Cancer Registry of Norway.

Study Timeline

• Study First Submitted: 2019-03-08
• Study Start: 2019-03-11
• Study First Submitted QC: 2019-03-12
• Study First Posted: 2019-03-13
• Primary Completion: 2020-02-28
• Study Completion: 2020-12-30
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-19
• Last Update Posted: 2022-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 5669

Inclusion Criteria

• Women living in the regions Hordaland, Vest-Agder, Rogaland or Sør-Trøndelag, who have been eligible for screening in Norway, but who have not attended screening for at least 10 years (2009-2018)

Exclusion Criteria

• Women who have not been eligible for cervical cancer screening during the entire 10 year period (2009-2018)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Opt-out	Opt-out; Receive self-sampling kit unsolicited	Receive self-sampling kit unsolicited
Control	Control; Receive open reminder to be screened by physician	Receive open reminder to be screened by physician
Opt-in	Opt-in; Receive offer to order self-sampling kit	Receive offer to order self-sampling kit

Primary Outcome Measures

Name	Time	Method
Screening attendance rate (%)	6 months	The primary outcome measure is the attendance rate to cervical cancer screening. Attendance is defined as returning a self-sampling test, or being screened by a physician during the 6 months following receipt of the invitation letter

Secondary Outcome Measures

Name	Time	Method
Prevalence of CIN2+ (proportion of cervical intraepithelial neoplasia grade 2 or worse)	6 months	Histologically confirmed CIN2+ diagnoses of all study participants who are eligible for follow-up will be retrieved from the cervical screening registry at the Cancer Registry of Norway
Compliance to clinical follow-up of a high-risk HPV positive screening test (%)	6 months	Attendance to follow-up among women with a positive screening test will be surveyed following notification of the positive test result. In addition to comparing arms, we will compare compliance of women in the self-sampling arms who are followed up by their regular GP vs. women who are followed up by a gynecologist
Prevalence of high-risk HPV (%)	6 months	Self-samples as well as physician-taken samples will be tested for high-risk HPV with the Cobas 4800 HPV-DNA test at the national HPV reference laboratory

Trial Locations

Locations (1)

Cancer Registry of Norway; 🇳🇴 Oslo, Pb 5313 Majorstuen, Norway