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

University Hospitals (UH)

Status: Completed

Conditions: Cancer of the Uterine Cervix

Treatments: Device: Cobas HPV DNA Test; Other: Papanicolau test

Study type: Interventional

Funder types: Other

Identifiers

NCT02698423

CER 11-034

Details and patient eligibility

About

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.

Full 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.

Enrollment: 667 patients

Sex: Female

Ages: 25 to 69 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• pregnancy
• previous hysterectomy

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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667 participants in 2 patient groups

Cobas HPV DNA test

Experimental group

Description:

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

Treatment:

Device: Cobas HPV DNA Test

Papanicolau test

Active Comparator group

Description:

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

Treatment:

Other: Papanicolau test