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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02698423
Recruitment Status : Completed
First Posted : March 3, 2016
Results First Posted : July 2, 2017
Last Update Posted : June 6, 2018
Sponsor:
Information provided by (Responsible Party):
Prof. Patrick Petignat, University Hospital, Geneva

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cancer of the Uterine Cervix Device: Cobas HPV DNA Test Other: Papanicolau test Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 667 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   25 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • pregnancy
  • previous hysterectomy
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Responsible Party: Prof. Patrick Petignat, Professor, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT02698423    
Other Study ID Numbers: CER 11-034
First Posted: March 3, 2016    Key Record Dates
Results First Posted: July 2, 2017
Last Update Posted: June 6, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be used for scientific publications.
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases