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

University of Oslo (UIO)

Status: Completed

Conditions: Cervical Cancer

Treatments: Behavioral: Opt-out; Receive self-sampling kit unsolicited; Behavioral: Opt-in; Receive offer to order self-sampling kit; Behavioral: Control; Receive open reminder to be screened by physician

Study type: Interventional

Funder types: Other

Identifiers

NCT03873376

18/14056

182687 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5,669 patients

Sex: Female

Ages: 35 to 69 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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5,669 participants in 3 patient groups

Opt-in

Experimental group

Description:

Receive offer to order self-sampling kit

Treatment:

Behavioral: Opt-in; Receive offer to order self-sampling kit

Opt-out

Experimental group

Description:

Receive self-sampling kit unsolicited

Treatment:

Behavioral: Opt-out; Receive self-sampling kit unsolicited

Control

Experimental group

Description:

Receive open reminder to be screened by physician

Treatment:

Behavioral: Control; Receive open reminder to be screened by physician