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

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University of Aarhus

Status

Completed

Conditions

Cervical Cancer

Treatments

Behavioral: HPV self-sampling kit mailed directly
Behavioral: HPV self-sampling kit on demand
Behavioral: Second reminder

Study type

Interventional

Funder types

Other

Identifiers

NCT02680262
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Details and patient eligibility

About

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.

Full 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).

Enrollment

9,327 estimated patients

Sex

Female

Ages

30 to 64 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

9,327 participants in 3 patient groups

Intervention group 1
Experimental group
Description:
HPV self-sampling kit mailed directly
Treatment:
Behavioral: HPV self-sampling kit mailed directly
Intervention group 2
Experimental group
Description:
HPV self-sampling kit on demand
Treatment:
Behavioral: HPV self-sampling kit on demand
Intervention group 3
Experimental group
Description:
second reminder
Treatment:
Behavioral: Second reminder

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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