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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

Tracking Information
First Submitted Date  ICMJE February 23, 2016
First Posted Date  ICMJE March 3, 2016
Results First Submitted Date  ICMJE May 2, 2017
Results First Posted Date  ICMJE July 2, 2017
Last Update Posted Date June 6, 2018
Study Start Date  ICMJE September 2011
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 10, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 26, 2016)
Comparison between the number of participants who performed HPV self-testing versus the number of participants who responded to the invitation to come to the hospital for Pap testing. [ Time Frame: Up to 5 years ]
Compare participation to cervical cancer screening for home-based HPV self-testing versus clinic-based Pap testing.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 10, 2018)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 26, 2016)
Proportion of Women With a Positive HPV Self-test Who Underwent All the Recommended Follow-up Clinical Investigations. [ Time Frame: Up to 5 years ]
Assess the compliance with further follow-up among HPV-positive women.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Feasibility and Acceptability of Offering Self-sampling to Non-attendees in Primary Care
Official Title  ICMJE Human Papillomavirus Testing Versus Liquid-based Cytology for Non-attendees of Cervical Cancer Screening: Results of a Randomised Controlled Trial
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE Cancer of the Uterine Cervix
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Cobas HPV DNA test
    Women will be invited to perform HPV self-testing with the Cobas HPV DNA test at home.
    Intervention: Device: Cobas HPV DNA Test
  • 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.
    Intervention: Other: Papanicolau test
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 26, 2016)
667
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2016
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • pregnancy
  • previous hysterectomy
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 25 Years to 69 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02698423
Other Study ID Numbers  ICMJE CER 11-034
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Data will be used for scientific publications.
Responsible Party Prof. Patrick Petignat, University Hospital, Geneva
Study Sponsor  ICMJE University Hospital, Geneva
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University Hospital, Geneva
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP