Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Screening
Condition Cancer of the Uterine Cervix
Interventions Device: Cobas HPV DNA Test
Other: Papanicolau test
Enrollment 667
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cobas HPV DNA Test Papanicolau Test
Hide Arm/Group Description

Women will be invited to perform HPV self-testing with the Cobas HPV DNA test at home.

Cobas HPV DNA Test: Women will receive a home-sent sample for HPV self-testing.

Women will be invited to come to the hospital to undergo a Papanicolau test (Pap test), which will be performed by the clinician.

Papanicolau test: Women will be invited to come in for a physician-performed Pap test.

Period Title: Overall Study
Started 336 331
Completed 317 307
Not Completed 19 24
Reason Not Completed
Lost to Follow-up             19             24
Arm/Group Title Cobas HPV DNA Test Papanicolau Test Total
Hide Arm/Group Description

Women will be invited to perform HPV self-testing with the Cobas HPV DNA test at home.

Cobas HPV DNA Test: Women will receive a home-sent sample for HPV self-testing

Women will be invited to come to the hospital to undergo a Papanicolau test (Pap test), which will be performed by the clinician.

Papanicolau test: Women will be invited to come in for a physician-performed Pap test

Total of all reporting groups
Overall Number of Baseline Participants 336 331 667
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 336 participants 331 participants 667 participants
42.3  (10.9) 42.1  (10.8) 42.2  (10.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 336 participants 331 participants 667 participants
Female 336 331 667
Male 0 0 0
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 336 participants 331 participants 667 participants
Hispanic or Latino 105 106 211
Not Hispanic or Latino 231 225 456
Unknown or Not Reported 0 0 0
Relationship Status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 336 participants 331 participants 667 participants
With a partner 161 154 315
Single 175 177 352
1.Primary Outcome
Title 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
Hide Description 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.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cobas HPV DNA Test Papanicolau Test
Hide Arm/Group Description:

Women will be invited to perform HPV self-testing with the Cobas HPV DNA test at home.

Cobas HPV DNA Test: Women will receive a home-sent sample for HPV self-testing. N=336

Women will be invited to come to the hospital to undergo a Papanicolau test (Pap test), which will be performed by the clinician.

Papanicolau test: Women will be invited to come in for a physician-performed Pap test.

N=331

Overall Number of Participants Analyzed 336 331
Measure Type: Count of Participants
Unit of Measure: Participants
317
  94.3%
307
  92.7%
2.Secondary Outcome
Title Proportion of Women With a Positive HPV Self-test Who Underwent All the Recommended Follow-up Clinical Investigations.
Hide Description Assess the compliance with further follow-up among women having tested positive for the presence of HPV at baseline screening.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cobas HPV DNA Test Papanicolau Test
Hide Arm/Group Description:

Women will be invited to perform HPV self-testing with the Cobas HPV DNA test at home.

Cobas HPV DNA Test: Women will receive a home-sent sample for HPV self-testing.

Women will be invited to come to the hospital to undergo a Papanicolau test (Pap test), which will be performed by the clinician.

Papanicolau test: Women will be invited to come in for a physician-performed Pap test.

Overall Number of Participants Analyzed 336 331
Measure Type: Count of Participants
Unit of Measure: Participants
317
  94.3%
307
  92.7%
Time Frame [Not Specified]
Adverse Event Reporting Description Serious, and Other [Not Including Serious] Adverse Events were not monitored/assessed
 
Arm/Group Title Cobas HPV DNA Test Papanicolau Test
Hide Arm/Group Description

Women will be invited to perform HPV self-testing with the Cobas HPV DNA test at home.

Cobas HPV DNA Test: Women will receive a home-sent sample for HPV self-testing. N=336

Women will be invited to come to the hospital to undergo a Papanicolau test (Pap test), which will be performed by the clinician.

Papanicolau test: Women will be invited to come in for a physician-performed Pap test.

N=331

All-Cause Mortality
Cobas HPV DNA Test Papanicolau Test
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Cobas HPV DNA Test Papanicolau Test
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cobas HPV DNA Test Papanicolau Test
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Manuela Viviano
Organization: Geneva University Hospitals
Phone: 07955 32 272
EMail: manuela.viviano@hcuge.ch
Layout table for additonal information
Responsible Party: Prof. Patrick Petignat, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT02698423    
Other Study ID Numbers: CER 11-034
First Submitted: February 23, 2016
First Posted: March 3, 2016
Results First Submitted: May 2, 2017
Results First Posted: July 2, 2017
Last Update Posted: June 6, 2018