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

NCT ID: NCT02698423

Last Updated: 2018-06-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

667 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2016-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cancer of the Uterine Cervix

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Cobas HPV DNA test

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

Group Type EXPERIMENTAL

Cobas HPV DNA Test

Intervention Type DEVICE

Women will receive a home-sent sample for HPV self-testing

Papanicolau test

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

Group Type ACTIVE_COMPARATOR

Papanicolau test

Intervention Type OTHER

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

Interventions

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Cobas HPV DNA Test

Women will receive a home-sent sample for HPV self-testing

Intervention Type DEVICE

Papanicolau test

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* pregnancy
* previous hysterectomy
Minimum Eligible Age

25 Years

Maximum Eligible Age

69 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Geneva

OTHER

Sponsor Role lead

Responsible Party

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Prof. Patrick Petignat

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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CER 11-034

Identifier Type: -

Identifier Source: org_study_id

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