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Completed

NCT Number: NCT02680262

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

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.

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Key information

Conditions

Cervical Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

30 year–64 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mette Tranberg Nielsen

Randers, Randers NØ, 8930, Denmark

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HPV self-sampling kit mailed directly

Behavioral

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

Behavioral

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

Behavioral

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

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

Acronym: CHOiCE

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Feb 11, 2016
Registry last updated
Oct 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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