Cargando…

Study protocol of the CHOiCE trial: a three-armed, randomized, controlled trial of home-based HPV self-sampling for non-participants in an organized cervical cancer screening program

BACKGROUND: The effectiveness of cervical cancer screening programs is challenged by suboptimal participation and coverage. Offering cervico-vaginal self-sampling for human papillomavirus testing (HPV self-sampling) to non-participants can increase screening participation. However, the effect varies...

Descripción completa

Detalles Bibliográficos
Autores principales: Tranberg, Mette, Bech, Bodil Hammer, Blaakær, Jan, Jensen, Jørgen Skov, Svanholm, Hans, Andersen, Berit
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5094020/
https://www.ncbi.nlm.nih.gov/pubmed/27809810
http://dx.doi.org/10.1186/s12885-016-2859-z
_version_ 1782465043990839296
author Tranberg, Mette
Bech, Bodil Hammer
Blaakær, Jan
Jensen, Jørgen Skov
Svanholm, Hans
Andersen, Berit
author_facet Tranberg, Mette
Bech, Bodil Hammer
Blaakær, Jan
Jensen, Jørgen Skov
Svanholm, Hans
Andersen, Berit
author_sort Tranberg, Mette
collection PubMed
description BACKGROUND: The effectiveness of cervical cancer screening programs is challenged by suboptimal participation and coverage. Offering cervico-vaginal self-sampling for human papillomavirus testing (HPV self-sampling) to non-participants can increase screening participation. However, the effect varies substantially among studies, especially depending on the approach used to offer HPV self-sampling. The present trial evaluates the effect on participation in an organized screening program of a HPV self-sampling kit mailed directly to the home of the woman or mailed to the woman’s home on demand only, compared with the standard second reminder for regular screening. METHODS/DESIGN: The CHOiCE trial is a parallel, randomized, controlled, open-label trial. It will include 9327 women aged 30–64 years who are living in the Central Denmark Region and who have not participated in cervical cancer screening after an invitation and one reminder. The women will be equally randomized 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, text message, phone, or through a webpage; and 3) Mailed a second reminder for a practitioner-collected sample (control group). The primary outcome will be the proportion of women in the intervention groups who participate by returning their HPV self-sampling kit or have a practitioner-collected sample compared with the proportion of women who have a practitioner-collected sample in the control group at 90 and 180 days after mail out of the second reminders. Per-protocol and intention-to-treat analyses will be performed. The 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 the results. DISCUSSION: The CHOiCE trial will provide strong and important evidence allowing us to determine if and how HPV self-sampling can be used to increase participation in cervical cancer screening. This trial therefore has the potential to improve prevention and reduce the number of deaths caused by cervical cancer. TRIAL REGISTRATION: Current Controlled Trials NCT02680262. Registered 10 February 2016.
format Online
Article
Text
id pubmed-5094020
institution National Center for Biotechnology Information
language English
publishDate 2016
publisher BioMed Central
record_format MEDLINE/PubMed
spelling pubmed-50940202016-11-07 Study protocol of the CHOiCE trial: a three-armed, randomized, controlled trial of home-based HPV self-sampling for non-participants in an organized cervical cancer screening program Tranberg, Mette Bech, Bodil Hammer Blaakær, Jan Jensen, Jørgen Skov Svanholm, Hans Andersen, Berit BMC Cancer Study Protocol BACKGROUND: The effectiveness of cervical cancer screening programs is challenged by suboptimal participation and coverage. Offering cervico-vaginal self-sampling for human papillomavirus testing (HPV self-sampling) to non-participants can increase screening participation. However, the effect varies substantially among studies, especially depending on the approach used to offer HPV self-sampling. The present trial evaluates the effect on participation in an organized screening program of a HPV self-sampling kit mailed directly to the home of the woman or mailed to the woman’s home on demand only, compared with the standard second reminder for regular screening. METHODS/DESIGN: The CHOiCE trial is a parallel, randomized, controlled, open-label trial. It will include 9327 women aged 30–64 years who are living in the Central Denmark Region and who have not participated in cervical cancer screening after an invitation and one reminder. The women will be equally randomized 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, text message, phone, or through a webpage; and 3) Mailed a second reminder for a practitioner-collected sample (control group). The primary outcome will be the proportion of women in the intervention groups who participate by returning their HPV self-sampling kit or have a practitioner-collected sample compared with the proportion of women who have a practitioner-collected sample in the control group at 90 and 180 days after mail out of the second reminders. Per-protocol and intention-to-treat analyses will be performed. The 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 the results. DISCUSSION: The CHOiCE trial will provide strong and important evidence allowing us to determine if and how HPV self-sampling can be used to increase participation in cervical cancer screening. This trial therefore has the potential to improve prevention and reduce the number of deaths caused by cervical cancer. TRIAL REGISTRATION: Current Controlled Trials NCT02680262. Registered 10 February 2016. BioMed Central 2016-11-03 /pmc/articles/PMC5094020/ /pubmed/27809810 http://dx.doi.org/10.1186/s12885-016-2859-z Text en © The Author(s). 2016 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Study Protocol
Tranberg, Mette
Bech, Bodil Hammer
Blaakær, Jan
Jensen, Jørgen Skov
Svanholm, Hans
Andersen, Berit
Study protocol of the CHOiCE trial: a three-armed, randomized, controlled trial of home-based HPV self-sampling for non-participants in an organized cervical cancer screening program
title Study protocol of the CHOiCE trial: a three-armed, randomized, controlled trial of home-based HPV self-sampling for non-participants in an organized cervical cancer screening program
title_full Study protocol of the CHOiCE trial: a three-armed, randomized, controlled trial of home-based HPV self-sampling for non-participants in an organized cervical cancer screening program
title_fullStr Study protocol of the CHOiCE trial: a three-armed, randomized, controlled trial of home-based HPV self-sampling for non-participants in an organized cervical cancer screening program
title_full_unstemmed Study protocol of the CHOiCE trial: a three-armed, randomized, controlled trial of home-based HPV self-sampling for non-participants in an organized cervical cancer screening program
title_short Study protocol of the CHOiCE trial: a three-armed, randomized, controlled trial of home-based HPV self-sampling for non-participants in an organized cervical cancer screening program
title_sort study protocol of the choice trial: a three-armed, randomized, controlled trial of home-based hpv self-sampling for non-participants in an organized cervical cancer screening program
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5094020/
https://www.ncbi.nlm.nih.gov/pubmed/27809810
http://dx.doi.org/10.1186/s12885-016-2859-z
work_keys_str_mv AT tranbergmette studyprotocolofthechoicetrialathreearmedrandomizedcontrolledtrialofhomebasedhpvselfsamplingfornonparticipantsinanorganizedcervicalcancerscreeningprogram
AT bechbodilhammer studyprotocolofthechoicetrialathreearmedrandomizedcontrolledtrialofhomebasedhpvselfsamplingfornonparticipantsinanorganizedcervicalcancerscreeningprogram
AT blaakærjan studyprotocolofthechoicetrialathreearmedrandomizedcontrolledtrialofhomebasedhpvselfsamplingfornonparticipantsinanorganizedcervicalcancerscreeningprogram
AT jensenjørgenskov studyprotocolofthechoicetrialathreearmedrandomizedcontrolledtrialofhomebasedhpvselfsamplingfornonparticipantsinanorganizedcervicalcancerscreeningprogram
AT svanholmhans studyprotocolofthechoicetrialathreearmedrandomizedcontrolledtrialofhomebasedhpvselfsamplingfornonparticipantsinanorganizedcervicalcancerscreeningprogram
AT andersenberit studyprotocolofthechoicetrialathreearmedrandomizedcontrolledtrialofhomebasedhpvselfsamplingfornonparticipantsinanorganizedcervicalcancerscreeningprogram