Clinical trial NCT02680262: Self-sampling for Non-participants in an Organised Cervical Cancer Screening Programme
Official title: A Three-armed Randomised Controlled Trial of Non-participants in an Organised Cervical Cancer Screening Programme
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Cancer
Keywords: HPV self-sampling, cervical cancer screening
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2016-02-11
Enrollment: 9327
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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: 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).

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 90 days
Secondary outcomes:
measure: Women with a positive HPV self-collected sample who attend follow-up testing at 30, 60 or 90 days after mail out.
timeFrame: 30,60 or 90 days
Other outcomes:
Locations:
city: Randers
country: Denmark
facility: Mette Tranberg Nielsen
state: Randers NØ
Study officials:
affiliation: Department of Public Health Programmes
name: Mette Tranberg Nielsen, Phd Student
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tranberg M, Bech BH, Blaakaer J, Jensen JS, Svanholm H, Andersen B. HPV self-sampling in cervical cancer screening: the effect of different invitation strategies in various socioeconomic groups - a randomized controlled trial. Clin Epidemiol. 2018 Aug 23;10:1027-1036. doi: 10.2147/CLEP.S164826. eCollection 2018.
citation: Tranberg M, Bech BH, Blaakaer J, Jensen JS, Svanholm H, Andersen B. Preventing cervical cancer using HPV self-sampling: direct mailing of test-kits increases screening participation more than timely opt-in procedures - a randomized controlled trial. BMC Cancer. 2018 Mar 9;18(1):273. doi: 10.1186/s12885-018-4165-4.
citation: Tranberg M, Bech BH, Blaakaer J, Jensen JS, Svanholm H, Andersen B. 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. BMC Cancer. 2016 Nov 3;16(1):835. doi: 10.1186/s12885-016-2859-z.