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

Not Applicable

Completed

• Conditions: Cervical Cancer
• Interventions: Behavioral: HPV self-sampling kit mailed directly; Behavioral: HPV self-sampling kit on demand; Behavioral: Second reminder

• Registration Number: NCT02680262
• Lead Sponsor: 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.

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).

Study Timeline

• Study First Submitted: 2016-01-27
• Study First Submitted QC: 2016-02-08
• Study First Posted: 2016-02-11
• Study Start: 2016-03
• Primary Completion: 2017-10
• Study Completion: 2018-02-01
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-12
• Last Update Posted: 2018-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 9327

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group 1	HPV self-sampling kit mailed directly	HPV self-sampling kit mailed directly
Intervention group 2	HPV self-sampling kit on demand	HPV self-sampling kit on demand
Intervention group 3	Second reminder	second reminder

Primary Outcome Measures

Name	Time	Method
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	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

Name	Time	Method
Women with a positive HPV self-collected sample who attend follow-up testing at 30, 60 or 90 days after mail out.	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

Trial Locations

Locations (1)

Mette Tranberg Nielsen; 🇩🇰 Randers, Randers NØ, Denmark