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

Not Applicable

Completed

• Conditions: Cancer of the Uterine Cervix
• Interventions: Device: Cobas HPV DNA Test; Other: Papanicolau test

• Registration Number: NCT02698423
• Lead Sponsor: University Hospital, Geneva

Brief 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.

Study Timeline

• Study Start: 2011-09
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Study First Submitted: 2016-02-23
• Study First Submitted QC: 2016-02-26
• Study First Posted: 2016-03-03
• Results First Submitted: 2017-05-02
• Results First Submitted QC: 2017-06-02
• Results First Posted: 2017-07-02
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-10
• Last Update Posted: 2018-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 667

Inclusion Criteria

• No previous cervical cancer screening test in the last three years

Exclusion Criteria

• pregnancy
• previous hysterectomy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cobas HPV DNA test	Cobas HPV DNA Test	Women will be invited to perform HPV self-testing with the Cobas HPV DNA test at home.
Papanicolau test	Papanicolau test	Women will be invited to come to the hospital to undergo a Papanicolau test (Pap test), which will be performed by the clinician.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Performed HPV Self-testing Compared to the Number of Participants Who Responded to the Invitation to Come to the Hospital for Pap Testing	1 year	Compare the participation rate to cervical cancer screening for home-based human papillomavirus testing based on self-sampling versus clinic-based, physician-performed Pap testing.

Secondary Outcome Measures

Name	Time	Method
Proportion of Women With a Positive HPV Self-test Who Underwent All the Recommended Follow-up Clinical Investigations.	1 year	Assess the compliance with further follow-up among women having tested positive for the presence of HPV at baseline screening.