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

Study Overview
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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.

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

Conditions
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Cancer of the Uterine Cervix

Intervention / Treatment
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* Device: Cobas HPV DNA Test
* Other: Papanicolau test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: No previous cervical cancer screening test in the last three years Exclusion Criteria: pregnancy previous hysterectomy

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cobas HPV DNA test<br>Women will be invited to perform HPV self-testing with the Cobas HPV DNA test at home. | Device: Cobas HPV DNA Test<br>* Women will receive a home-sent sample for HPV self-testing<br>|
| Active Comparator: Papanicolau test<br>Women will be invited to come to the hospital to undergo a Papanicolau test (Pap test), which will be performed by the clinician. | Other: Papanicolau test<br>* Women will be invited to come in for a physician-performed Pap test<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |