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

NCT03873376 | Completed

• 2 other identifiers: 18/14056182687
• Study Type: interventional
• Target: 5,669
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Cancer

Keywords

mass screening; non-attendance; self-sampling; HPV

Outcome Measures

Primary Outcomes (1)

• Screening attendance rate (%)

  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

  6 months

Secondary Outcomes (3)

• Prevalence of high-risk HPV (%)

  6 months

• Prevalence of CIN2+ (proportion of cervical intraepithelial neoplasia grade 2 or worse)

  6 months

• Compliance to clinical follow-up of a high-risk HPV positive screening test (%)

  6 months

Other Outcomes (1)

• Sociodemographic characteristics (%)

  Up-to-date sociodemographic data retrieved from national registries in 2019

Study Arms (3)

Opt-in

EXPERIMENTAL

Receive offer to order self-sampling kit

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

Opt-out

EXPERIMENTAL

Receive self-sampling kit unsolicited

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

Control

EXPERIMENTAL

Receive open reminder to be screened by physician

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

Interventions

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

Opt-out; Receive self-sampling kit unsolicited 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.

Opt-out

Control; Receive open reminder to be screened by physician 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

Control

Eligibility Criteria

• Age: 35 Years - 69 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Oslo University Hospital: lead
• University Hospital, Akershus: collaborator
• University of Oslo: collaborator
• University of Bergen: collaborator
• Albert Einstein College of Medicine: collaborator
• Norwegian Institute of Public Health: collaborator

Study Sites (1)

Cancer Registry of Norway

Oslo, Pb 5313 Majorstuen, 0304, Norway

Location

Related Publications (1)

• 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.

  PMID: 35995936 DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Giske Ursin, MD, Prof

  Oslo University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 8, 2019
• First Posted: March 13, 2019
• Study Start: March 11, 2019
• Primary Completion: February 28, 2020
• Study Completion: December 30, 2020
• Last Updated: April 21, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)