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

NCT ID: NCT03873376

Last Updated: 2022-04-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5669 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-11
• Study Completion Date: 2020-12-30

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.

Conditions

Cervical Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Opt-in

Receive offer to order self-sampling kit

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

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

Opt-out

Receive self-sampling kit unsolicited

Group Type: EXPERIMENTAL

Opt-out; Receive self-sampling kit unsolicited

Intervention Type: BEHAVIORAL

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.

Control

Receive open reminder to be screened by physician

Group Type: EXPERIMENTAL

Control; Receive open reminder to be screened by physician

Intervention Type: BEHAVIORAL

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

Interventions

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

Intervention Type: 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.

Intervention Type: 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

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Akershus

OTHER

Sponsor Role: collaborator

University of Oslo

OTHER

Sponsor Role: collaborator

University of Bergen

OTHER

Sponsor Role: collaborator

Albert Einstein College of Medicine

OTHER

Sponsor Role: collaborator

Norwegian Institute of Public Health

OTHER_GOV

Sponsor Role: collaborator

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Bo Terning Hansen

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Giske Ursin, MD, Prof

Role: STUDY_DIRECTOR

Oslo University Hospital

Locations

Cancer Registry of Norway

Oslo, Pb 5313 Majorstuen, Norway

Countries

Norway

References

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.

Reference Type: DERIVED

PMID: 35995936 (View on PubMed)

Other Identifiers

182687

Identifier Type: OTHER

Identifier Source: secondary_id

18/14056

Identifier Type: -

Identifier Source: org_study_id