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

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ClinicalTrials.gov Identifier: NCT03873376
Recruitment Status : Recruiting
First Posted : March 13, 2019
Last Update Posted : September 6, 2019
Sponsor:
Collaborators:
University Hospital, Akershus
University of Oslo
University of Bergen
Albert Einstein College of Medicine
Cancer Registry of Norway
Information provided by (Responsible Party):
Bo Terning Hansen, Oslo University Hospital

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.

Condition or disease Intervention/treatment Phase
Cervical Cancer Behavioral: Opt-in; Receive offer to order self-sampling kit Behavioral: Opt-out; Receive self-sampling kit unsolicited Behavioral: Control; Receive open reminder to be screened by physician Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: A Pragmatic Randomized Controlled Trial of Self-sampling Among Long-term Non-attenders to Cervical Cancer Screening
Actual Study Start Date : March 11, 2019
Estimated Primary Completion Date : February 28, 2020
Estimated Study Completion Date : December 30, 2029

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Arm Intervention/treatment
Experimental: Opt-in
Receive offer to order self-sampling kit
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

Experimental: Opt-out
Receive self-sampling kit unsolicited
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.

Experimental: Control
Receive open reminder to be screened by physician
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




Primary Outcome Measures :
  1. Screening attendance rate (%) [ Time Frame: 6 months ]
    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


Secondary Outcome Measures :
  1. Prevalence of high-risk HPV (%) [ Time Frame: 6 months ]
    Self-samples as well as physician-taken samples will be tested for high-risk HPV with the Cobas 4800 HPV-DNA test at the national HPV reference laboratory

  2. Prevalence of CIN2+ (proportion of cervical intraepithelial neoplasia grade 2 or worse) [ Time Frame: 6 months ]
    Histologically confirmed CIN2+ diagnoses of all study participants who are eligible for follow-up will be retrieved from the cervical screening registry at the Cancer Registry of Norway

  3. Compliance to clinical follow-up of a high-risk HPV positive screening test (%) [ Time Frame: 3 months ]
    Attendance to follow-up among women with a positive screening test will be surveyed during three months following notification of the positive test result. In addition to comparing arms, we will compare compliance of women in the self-sampling arms who are followed up by their regular GP vs. women who are followed up by a gynecologist


Other Outcome Measures:
  1. Sociodemographic characteristics (%) [ Time Frame: Up-to-date sociodemographic data retrieved from national registries in 2019 ]
    We will compare the distribution of sociodemographic characteristics (income, education, immigration status, age etc.) by intervention and attendance status



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Ages Eligible for Study:   35 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03873376


Contacts
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Contact: Bo Terning Hansen, Dr.scient 22 92 87 39 bo.terning.hansen@kreftregisteret.no
Contact: Gunvor Aasbø, PhD 22 92 89 19 gunvor.aasbo@kreftregisteret.no

Locations
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Norway
Cancer Registry of Norway Recruiting
Oslo, Pb 5313 Majorstuen, Norway, 0304
Contact: Karina Undem    +47 48287071    karina.undem@kreftregisteret.no   
Contact: Gunvor Aasbø, PhD    +47 48257136    gunvor.aasbo@kreftregisteret.no   
Principal Investigator: Bo Terning Hansen, Dr.Scient         
Sponsors and Collaborators
Oslo University Hospital
University Hospital, Akershus
University of Oslo
University of Bergen
Albert Einstein College of Medicine
Cancer Registry of Norway
Investigators
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Study Director: Giske Ursin, MD, Prof Oslo University Hospital

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Responsible Party: Bo Terning Hansen, Principal Investigator, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT03873376     History of Changes
Other Study ID Numbers: 18/14056
182687 ( Other Identifier: Cancer Society of Norway (Funder) )
First Posted: March 13, 2019    Key Record Dates
Last Update Posted: September 6, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bo Terning Hansen, Oslo University Hospital:
mass screening
non-attendance
self-sampling
HPV
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female