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.
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.



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.



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.



Current Controlled Trials NCT02680262 . Registered 10 February 2016.
Department of Public Health Programmes, Randers Regional Hospital, Skovlyvej 15, 8930, Randers, NØ, Denmark. mettrani@rm.dk.
Mette
0000-0002-6285-6694
M
Tranberg
Department of Public Health, Section for Epidemiology, Aarhus University, Bartholins Allé 2, 8000, Aarhus C, Denmark.
Bodil Hammer
BH
Bech
Department of Obstetrics and Gynecology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N, Denmark.
Jan
J
Blaakær
Statens Serum Institut, Artillerivej 5, 2300, Copenhagen S, Denmark.
Jørgen Skov
JS
Jensen
Department of Public Health Programmes, Randers Regional Hospital, Skovlyvej 15, 8930, Randers, NØ, Denmark.|Department of Pathology, Randers Regional Hospital, Østervangsvej 48, 8930, Randers, NØ, Denmark.
Hans
H
Svanholm
Department of Public Health Programmes, Randers Regional Hospital, Skovlyvej 15, 8930, Randers, NØ, Denmark.|Department of Clinical Medicine, Aarhus University, Palle Juul-Jensens Boulevard 82, 8200, Aarhus N, Denmark.
Berit
B
Andersen
D000328:Adult; D003718:Denmark / Q000453:epidemiology; D055088:Early Detection of Cancer; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008875:Middle Aged; D027383:Papillomaviridae / Q000302:isolation & purification; D030361:Papillomavirus Infections / Q000150:complications* / Q000821:virology; D015995:Prevalence; D011379:Prognosis; D012107:Research Design; D012648:Self Care; D013048:Specimen Handling; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis* / Q000453:epidemiology / Q000821:virology; D014626:Vaginal Smears; D055815:Young Adult; D002578:Uterine Cervical Dysplasia / Q000175:diagnosis* / Q000453:epidemiology / Q000821:virology
Cervical cancer screening; Human papillomavirus testing; Screening participation; Self-sampling