Feasibility and Acceptability of Offering Self-sampling to Non-attendees in Primary Care (DEPIST)
|ClinicalTrials.gov Identifier: NCT02698423|
Recruitment Status : Completed
First Posted : March 3, 2016
Results First Posted : July 2, 2017
Last Update Posted : June 6, 2018
University Hospital, Geneva
Information provided by (Responsible Party):
Prof. Patrick Petignat, University Hospital, Geneva
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.
|Condition or disease||Intervention/treatment||Phase|
|Cancer of the Uterine Cervix||Device: Cobas HPV DNA Test Other: Papanicolau test||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||667 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Human Papillomavirus Testing Versus Liquid-based Cytology for Non-attendees of Cervical Cancer Screening: Results of a Randomised Controlled Trial|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||January 2016|
Experimental: Cobas HPV DNA test
Women will be invited to perform HPV self-testing with the Cobas HPV DNA test at home.
Device: Cobas HPV DNA Test
Women will receive a home-sent sample for HPV self-testing
Active Comparator: 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.
Other: Papanicolau test
Women will be invited to come in for a physician-performed Pap test
Primary Outcome Measures :
- 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 [ Time Frame: 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 :
- Proportion of Women With a Positive HPV Self-test Who Underwent All the Recommended Follow-up Clinical Investigations. [ Time Frame: 1 year ]Assess the compliance with further follow-up among women having tested positive for the presence of HPV at baseline screening.
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