Feasibility and Acceptability of Offering Self-sampling to Non-attendees in Primary Care
DEPIST
Human Papillomavirus Testing Versus Liquid-based Cytology for Non-attendees of Cervical Cancer Screening: Results of a Randomised Controlled Trial
1 other identifier
interventional
667
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2011
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
February 23, 2016
CompletedFirst Posted
Study publicly available on registry
March 3, 2016
CompletedResults Posted
Study results publicly available
July 2, 2017
CompletedJune 6, 2018
May 1, 2018
4.3 years
February 23, 2016
May 2, 2017
May 10, 2018
Conditions
Outcome Measures
Primary Outcomes (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
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.
1 year
Secondary Outcomes (1)
Proportion of Women With a Positive HPV Self-test Who Underwent All the Recommended Follow-up Clinical Investigations.
1 year
Study Arms (2)
Cobas HPV DNA test
EXPERIMENTALWomen will be invited to perform HPV self-testing with the Cobas HPV DNA test at home.
Papanicolau test
ACTIVE COMPARATORWomen will be invited to come to the hospital to undergo a Papanicolau test (Pap test), which will be performed by the clinician.
Interventions
Women will receive a home-sent sample for HPV self-testing
Women will be invited to come in for a physician-performed Pap test
Eligibility Criteria
You may qualify if:
- No previous cervical cancer screening test in the last three years
You may not qualify if:
- pregnancy
- previous hysterectomy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr Manuela Viviano
- Organization
- Geneva University Hospitals
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 23, 2016
First Posted
March 3, 2016
Study Start
September 1, 2011
Primary Completion
January 1, 2016
Study Completion
January 1, 2016
Last Updated
June 6, 2018
Results First Posted
July 2, 2017
Record last verified: 2018-05
Data Sharing
- IPD Sharing
- Will share
Data will be used for scientific publications.