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

Cervical Cancer Clinical Trial

— CHOiCE  

Official title:

A Three-armed Randomised Controlled Trial of Non-participants in an Organised Cervical Cancer Screening Programme

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02680262
• Other study ID #: af_randers
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: February 1, 2018

Study information

• Verified date: October 2018
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9327
• Est. completion date: February 1, 2018
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

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.
• 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).
• 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)

Locations

Country	Name	City	State
Denmark	Mette Tranberg Nielsen	Randers	Randers NØ

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	90 days
Secondary	Women with a positive HPV self-collected sample who attend follow-up testing at 30, 60 or 90 days after mail out.	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	30,60 or 90 days