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

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.

Conditions

• Cervical Cancer

Interventions

BEHAVIORAL

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

Women in the opt-in arm receive an offer to order a HPV self-sampling kit, in addition to information about the study. Women who order, receive a kit that includes a self-sampling brush (Evalyn, Rovers Medical Devices), with instructions for use and a pre-paid envelope for returning the brush for HPV testing. The women are also informed that they can attend ordinary screening, i.e. performed by a physician. Women who choose self-sampling and test positive for high-risk HPV will be 1:1 allocated to follow-up by their general practitioner or a gynecologist. Women who test negative for high-risk HPV return to the ordinary screening program

BEHAVIORAL

Opt-out; Receive self-sampling kit unsolicited

Women in the opt-out arm receive the self-sampling kit directly, without having ordered it themselves. The kit has the same contents, and the follow-up is the same, as that described for the opt-in arm.

BEHAVIORAL

Control; Receive open reminder to be screened by physician

Similar to the procedure of the national screening program, women in the control arm receive a reminder to be screened by their general practitioner, and continues in the ordinary screening program

Sponsors & Collaborators

• University Hospital, Akershus

  collaborator OTHER

• University of Oslo

  collaborator OTHER

• University of Bergen

  collaborator OTHER

• Albert Einstein College of Medicine

  collaborator OTHER

• Norwegian Institute of Public Health

  collaborator OTHER_GOV

• Oslo University Hospital

  lead OTHER

Principal Investigators

• Giske Ursin, MD, Prof · Oslo University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

35 Years

Max Age

69 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-03-11

Primary Completion

2020-02-28

Completion

2020-12-30

Countries

• Norway

Study Locations