NCT02698423

Feasibility and Acceptability of Offering Self-sampling to Non-attendees in Primary Care

Human Papillomavirus Testing Versus Liquid-based Cytology for Non-attendees of Cervical Cancer Screening: Results of a Randomised Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 667 (actual)
• Sponsor: University Hospital, Geneva · Academic / Other
• Sex: Female
• Age: 25 Years – 69 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine whether human-papillomavirus (HPV) self-sampling can be used as a primary screening test for unscreened women.

Detailed description

Women residing in the canton of Geneva, aged between 25 and 69 years, who haven't had a Pap test in the last three years, will be invited to participate. Participation to the study will be encouraged through public displays, social networks, and medical consultations. Women meeting the eligibility criteria will be enrolled in the study. They will be randomized into two groups and will receive a home-sent letter, inviting them to either come in for a Pap test or to perform and send back the HPV self-sample that they'll receive at their domicile. Both groups will also receive a questionnaire, in order to better understand the reasons for their previous non-attendance to cervical cancer screening.

Conditions

• Cancer of the Uterine Cervix

Interventions

Type	Name	Description
DEVICE	Cobas HPV DNA Test	Women will receive a home-sent sample for HPV self-testing
OTHER	Papanicolau test	Women will be invited to come in for a physician-performed Pap test

Timeline

• Start date: 2011-09-01
• Primary completion: 2016-01-01
• Completion: 2016-01-01
• First posted: 2016-03-03
• Last updated: 2018-06-06
• Results posted: 2017-07-02