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

Cancer of the Uterine Cervix Clinical Trial

— DEPIST  

Official title:

Human Papillomavirus Testing Versus Liquid-based Cytology for Non-attendees of Cervical Cancer Screening: Results of a Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02698423
• Other study ID #: CER 11-034
• Status: Completed
• Phase: N/A
• Start date: September 2011
• Est. completion date: January 2016

Study information

• Verified date: May 2018
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 667
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 69 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• pregnancy

• previous hysterectomy

Related Conditions & MeSH terms

• Cancer of the Uterine Cervix
• Uterine Cervical Neoplasms

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Proportion of Women With a Positive HPV Self-test Who Underwent All the Recommended Follow-up Clinical Investigations.	Assess the compliance with further follow-up among women having tested positive for the presence of HPV at baseline screening.	1 year