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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
9,327
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.
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).
Mette Tranberg Nielsen
Randers, Randers NØ, Denmark
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.
Time frame: 90 days
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
Time frame: 30,60 or 90 days
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The standard second reminder informs women about the ongoing opportunity to have a conventional cervical sample taken by a general practitioner. (control group)