Evaluation of Three Strategies Based on Vaginal Self-sampling Kit Send to Home of Unscreened Women for Cervical Cancer

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 (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 sending vaginal self-sampling kit (with HPV test) to unscreened women's home is a powerful means to increase the participation rate of cervical cancer screening. It seems interesting to explore methods to increase the efficiency of this strategy by optimizing the ratio of the number of kits used compared to the number of kits sent. Two approaches will be tested: a system available on request of the kit and / or the addition of an SMS (Short Message Service) reminder.

Official Title
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Randomized Trial Evaluating Women's Behavior Not Participating in Cervical Cancer Screening Facing Three Strategies for Optimizing Home Sending by Post of Vaginal Self-sampling Kit

Conditions
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Cervical Cancer Screening, Cervical Cancer

Intervention / Treatment
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* Behavioral: Self-sampling kit sent at home
* Behavioral: Self-sampling kit sent at home + SMS reminder
* Behavioral: Letter offering a self-sampling kit on request+ SMS reminder
* Behavioral: SMS offering a self-sampling kit on request+ SMS reminder


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: women from 30 to 66 years old women living in french territorial division 37 (Indre-et-Loire) women with a mobile phone in database women who do not perform a pap smear in the last 4 years women who do not answer to a first invitation letter to perform a pap smear Exclusion Criteria: STOP SMS HPV cervical pathology during treatment Hysterectomy including cervix

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 66 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 |
| --- | --- |
| Active Comparator: Self-sampling kit sent at home<br>Sending of a vaginal self-sampling kit at home | Behavioral: Self-sampling kit sent at home<br>* 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>|
| Experimental: Self-sampling kit sent at home + SMS reminder<br>Sending of a vaginal self-sampling kit at home + a SMS reminder is sent if the woman do not (in 2 months) : perform a pap smear or send her vaginal self-sample to the laboratory or contact the screening center to inform to an exclusion reason | Behavioral: Self-sampling kit sent at home + SMS reminder<br>* 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. After 2 months without return, a SMS reminder about the available self-sampling kit is sent to the woman. We call return : the receipt of the vaginal self-sample at the laboratory the performance of a pap smear Information about recent screening test or a cervical screening exclusion reason When women choose the vaginal self-sampling, a HPV test is performed on the sample in a virology laboratory.<br>|
| Experimental: Letter offering a self-sampling kit on request+ SMS reminder<br>Sending of letter offering a vaginal self-sampling kit. Women can ask for this kit on line, on our website or by calling us. If they do ask for the kit, one kit is sending to their home. For these women, a SMS reminder is sent if the woman do not (in 2 months) : perform a pap smear or send her vaginal self-sample to the laboratory or contact the screening center to inform to an exclusion reason | Behavioral: Letter offering a self-sampling kit on request+ SMS reminder<br>* Selected women receive a mail inviting them either to perform a vaginal self sampling at their home (kit provided on request) or to perform a pap smear. Women are invited to ask the kit online, on our website. For the women who ask the kit, after 2 months without return, a SMS reminder about the available self-sampling kit is sent to the woman. We call return : the receipt of the vaginal self-sample at the laboratory the performance of a pap smear Information about recent screening test or a cervical screening exclusion reason When women choose the vaginal self-sampling, a HPV test is performed on the sample in a virology laboratory.<br>|
| Experimental: SMS offering a self-sampling kit on request+ SMS reminder<br>Sending of SMS offering a vaginal self-sampling kit. Women can ask for this kit on line, on our website or by calling us. If they do ask for the kit, one kit is sending to their home. For these women, a SMS reminder is sent if the woman do not (in 2 months) : perform a pap smear or send her vaginal self-sample to the laboratory or contact the screening center to inform to an exclusion reason | Behavioral: SMS offering a self-sampling kit on request+ SMS reminder<br>* Selected women receive a SMS inviting them to ask a vaginal self sampling kit to perform a sample at home and send it to a laboratory (kit provided on request). Women are invited to ask the kit by answering 1 by SMS. For the women who ask the kit, after 2 months without return, a SMS reminder about the available self-sampling kit is sent to the woman. We call return : the receipt of the vaginal self-sample at the laboratory the performance of a pap smear Information about recent screening test or a cervical screening exclusion reason 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 | Complete cervical cancer screening is defined as one of the followings : perform a pap smear perform a vaginal self-sampling with negative HR-HPV test perform a vaginal self-sampling with noninterpretable HR-HPV test result followed by a control pap smear (nine-month extension to do the pap smear after the sending of the HPV result) perform a vaginal self-sampling with positive HR-HPV test result followed by a control pap smear (nine-month extension to do the pap smear after the sending of the HPV result) | 9 months after postal mail (with or without the kit) or SMS | 

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