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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Cervical Cancer

Intervention / Treatment
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* Behavioral: HPV self-sampling kit mailed directly
* Behavioral: HPV self-sampling kit on demand
* Behavioral: Second reminder


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group 1<br>HPV self-sampling kit mailed directly | Behavioral: HPV self-sampling kit mailed directly<br>* 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.<br>|
| Experimental: Intervention group 2<br>HPV self-sampling kit on demand | Behavioral: HPV self-sampling kit on demand<br>* 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).<br>|
| Experimental: Intervention group 3<br>second reminder | Behavioral: Second reminder<br>* The standard second reminder informs women about the ongoing opportunity to have a conventional cervical sample taken by a general practitioner. (control group)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HPV self-sampling, cervical cancer screening