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Completed

NCT Number: NCT03873376

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

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.

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Key information

Conditions

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

Age range

35 year–69 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cancer Registry of Norway

Oslo, Pb 5313 Majorstuen, 0304, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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-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.

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

Primary outcomes

  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 outcomes

  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: 6 months

    Attendance to follow-up among women with a positive screening test will be surveyed 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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

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

Registry information

Official study title

A Pragmatic Randomized Controlled Trial of Self-sampling Among Long-term Non-attenders to Cervical Cancer Screening

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 13, 2019
Registry last updated
Apr 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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