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
• Sponsor: University Hospital, Geneva
• 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

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Cobas HPV DNA Test	Papanicolau Test
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

Baseline Characteristics

Arm/Group Title		Cobas HPV DNA Test	Papanicolau Test	Total
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
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

Outcome Measures

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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cobas HPV DNA Test	Papanicolau Test
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.
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cobas HPV DNA Test	Papanicolau Test
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%

Adverse Events

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
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	--/--	--/--
Serious Adverse Events
	Cobas HPV DNA Test	Papanicolau Test
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/0	0/0
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

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Dr Manuela Viviano
• Organization: Geneva University Hospitals
• Phone: 07955 32 272
• EMail: manuela.viviano@hcuge.ch

• 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