Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Self-sampling for Non-participants in an Organised Cervical Cancer Screening Programme (CHOiCE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02680262
Recruitment Status : Completed
First Posted : February 11, 2016
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

Brief Summary:
The trial will evaluate the effect on participation in organised screening programme of a human papilloma virus (HPV) self-sampling kit directly mailed home or mailed on demand compared with the standard second reminder for regular screening.

Condition or disease Intervention/treatment Phase
Cervical Cancer Behavioral: HPV self-sampling kit mailed directly Behavioral: HPV self-sampling kit on demand Behavioral: Second reminder Not Applicable

Detailed Description:
The CHOice trial is a parallel randomised controlled, open label trial. Participants will be equally randomised into three arms: 1) Directly mailed a second reminder including a HPV self-sampling kit; 2) Mailed a second reminder offering a HPV self-sampling kit, to be ordered by e-mail, by text message, by phone, or by website; and 3) Mailed a second reminder for a conventional practitioner-collected sample (control group).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 9327 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Three-armed Randomised Controlled Trial of Non-participants in an Organised Cervical Cancer Screening Programme
Actual Study Start Date : March 2016
Actual Primary Completion Date : October 2017
Actual Study Completion Date : February 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Arm Intervention/treatment
Experimental: Intervention group 1
HPV self-sampling kit mailed directly
Behavioral: HPV self-sampling kit mailed directly
Women in intervention group 1 will be mailed a modified second reminder, a leaflet entitled Information about HPV self-sampling, and a self-sampling kit. The leaflet provides information about HPV and cervical cancer including benefits and harms about HPV self-sampling compared to regular screening. The kit includes a brush device (Evelyn Brush, Rovers Medical Devices B.V, Oss, Netherlands) to collect a cervico-vaginal sample for subsequent hrHPV testing, written and drawn instructions on how to obtain and mail the sample, and a pre-stamped return envelope addressed to the Department of Pathology, Randers Regional Hospital performing the hrHPV testing.

Experimental: Intervention group 2
HPV self-sampling kit on demand
Behavioral: HPV self-sampling kit on demand

Women in intervention group 2 receive the same material as arm 1, except for the kit, which will only be mailed to the women on demand. Additionally, the leaflet for this group contains information on how to order the kit.

The modified second reminder in both intervention groups informs of the opportunity to collect a self-sample if wanted, but also about the opportunity to have a conventional specimen taken at a general practitioner (usual procedure).


Experimental: Intervention group 3
second reminder
Behavioral: Second reminder
The standard second reminder informs women about the ongoing opportunity to have a conventional cervical sample taken by a general practitioner. (control group)




Primary Outcome Measures :
  1. Women who participate by returning a HPV self-sampling kit or having a practitioner-collected sample in the intervention groups compared to the proportion of women who have a practitioner-collected sample in the control group at 90 days after mail out. [ Time Frame: 90 days ]
    Primary outcome will be the proportion of women who participate by returning a HPV self-sampling kit or having a practitioner-collected sample in the intervention groups compared to the proportion of women who have a practitioner-collected sample in the control group at 90 days after mail out.


Secondary Outcome Measures :
  1. Women with a positive HPV self-collected sample who attend follow-up testing at 30, 60 or 90 days after mail out. [ Time Frame: 30,60 or 90 days ]
    Secondary outcome will be the proportion of women with a positive HPV self-collected sample who attend follow-up testing at 30, 60 or 90 days after mail out of results



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   30 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women resident in the Central Denmark Region who have not participate in cervical cancer screening after an invitation and one reminder

Exclusion Criteria:

  • Women younger than 30 years are not included due to the lower specificity of HPV DNA tests in younger women

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): NCT02680262


Locations
Layout table for location information
Denmark
Mette Tranberg Nielsen
Randers, Randers NØ, Denmark, 8930
Sponsors and Collaborators
University of Aarhus
Investigators
Layout table for investigator information
Principal Investigator: Mette Tranberg Nielsen, Phd Student Department of Public Health Programmes
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT02680262    
Other Study ID Numbers: af_randers
First Posted: February 11, 2016    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The study is approved by the Danish Data Protection Agency, (j.no.:1-16-02-495-15)
Keywords provided by University of Aarhus:
HPV self-sampling, cervical cancer screening
Additional relevant MeSH terms:
Layout table for MeSH terms
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases