Clinical trial NCT03873376: Self-sampling Among Long-term Non-attenders to Cervical Cancer Screening
Official title: A Pragmatic Randomized Controlled Trial of Self-sampling Among Long-term Non-attenders to Cervical Cancer Screening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Cancer
Keywords: mass screening
non-attendance
self-sampling
HPV
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: University Hospital, Akershus
name: University of Oslo
name: University of Bergen
name: Albert Einstein College of Medicine
name: Norwegian Institute of Public Health
First posted: 2019-03-13
Enrollment: 5669
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Screening attendance rate (%)
timeFrame: 6 months
Secondary outcomes:
measure: Prevalence of high-risk HPV (%)
timeFrame: 6 months
measure: Prevalence of CIN2+ (proportion of cervical intraepithelial neoplasia grade 2 or worse)
timeFrame: 6 months
measure: Compliance to clinical follow-up of a high-risk HPV positive screening test (%)
timeFrame: 6 months
Other outcomes:
measure: Sociodemographic characteristics (%)
timeFrame: Up-to-date sociodemographic data retrieved from national registries in 2019
Locations:
city: Oslo
country: Norway
facility: Cancer Registry of Norway
state: Pb 5313 Majorstuen
Study officials:
affiliation: Oslo University Hospital
name: Giske Ursin, MD, Prof
role: STUDY_DIRECTOR
References:
citation: Aasbo G, Trope A, Nygard M, Christiansen IK, Baasland I, Iversen GA, Munk AC, Christiansen MH, Presthus GK, Undem K, Bjorge T, Castle PE, Hansen BT. HPV self-sampling among long-term non-attenders to cervical cancer screening in Norway: a pragmatic randomised controlled trial. Br J Cancer. 2022 Nov;127(10):1816-1826. doi: 10.1038/s41416-022-01954-9. Epub 2022 Aug 23.