Vaginal Self-sampling and Human Papillomavirus Testing in Unscreened Women

Study Overview
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Brief Summary
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Despite the existence of an effective screening test (pap smear), cervical cancer is, every year in France, the cause of more than 3,000 new cases and 1,100 deaths. But, in France, 4 in 10 women are not screened or not often enough (nearly 7 millions women). It is therefore necessary to develop new strategies to reach these women. The etiological factor of this cancer is persistent infection with High-Risk Human PapillomaVirus oncogene (HR-HPV). Thereby, HPV-based tests could be alternative screening tests. Vaginal self-sampling with HR-HPV test is simpler and less intrusive than the pap smear. It has been shown that vaginal self-sampling with HPV test is a powerful means to increase the participation rate in cervical cancer screening.

Official Title
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Attitude of Unscreened Women Face to Different Strategies to Participate in Cervical Cancer Screening by Vaginal Self-sampling : Home-mailed or Invitation to Remove to Their General Practitioner

Conditions
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Cancer Cervix

Intervention / Treatment
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* Behavioral: Group 1 remove self sample kit at gp consulting room or perform pap smear
* Behavioral: Group 2 perform self sample at home or pap smear


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: women from 30 to 65 years old women living in french territorial division 37 (Indre-et-Loire) women having a reported general practitioner in french territorial division 37 (Indre-et-Loire) Exclusion Criteria: pap smear made in the three last years

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

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: Group 1<br>Group 1 remove self sample kit at gp consulting room or perform pap smear : Study coordinators send mail inviting women to remove a kit for vaginal self-sampling at their general practitioner s consulting room. Either a pap smear is perform or, at home, women perform vaginal self sampling. Then women send it to a central laboratory for HPV test (Human papillomaVirus). | Behavioral: Group 1 remove self sample kit at gp consulting room or perform pap smear<br>* Selected general practitioners are briefly informed about the study and they receive a package of kits for vaginal self-sampling. Selected women receive a mail inviting them either to remove a kit for vaginal self-sampling at their general practitioner's consulting room or to perform a pap smear. When women choose the vaginal self-sampling, a HPV test is performed on the sample in a virology laboratory.<br>|
| Experimental: Group 2<br>Group 2 perform self sample at home or pap smear : Kit for vaginal self-sampling sent at women home. Women perform vaginal self sampling. Then women send it to a central laboratory for HPV test (Human papillomaVirus). | Behavioral: Group 2 perform self sample at home or pap smear<br>* Selected general practitioners are briefly informed about the study. Selected women receive a mail inviting them either to perform a vaginal self sampling at their home (with the kit provided) or to perform a pap smear. When women choose the vaginal self-sampling, a HPV test is performed on the sample in a virology laboratory.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participation / no participation to complete cervical cancer screening | Uncompleted cervical cancer screening is defined as one of the followings : no pap smear no vaginal self-sampling noninterpretable HPV test result and no pap smear positive HPV test result and no control pap smear | 9 months after postal mail | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vaginal self-sampling, general practitioner, Cervical cancer screening, High Risk Human papillomavirus Infection, pap smear