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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03856684
Other study ID # DR170135-APACHE-4
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 11, 2020
Est. completion date October 20, 2021

Study information

Verified date October 2021
Source University Hospital, Tours
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 10400
Est. completion date October 20, 2021
Est. primary completion date July 14, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 30 Years to 66 Years
Eligibility 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

Study Design


Intervention

Behavioral:
Self-sampling kit sent at home
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.
Self-sampling kit sent at home + SMS reminder
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.
Letter offering a self-sampling kit "on request"+ SMS reminder
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.
SMS offering a self-sampling kit "on request"+ SMS reminder
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.

Locations

Country Name City State
France Crcdc-Cvl Tours

Sponsors (3)

Lead Sponsor Collaborator
University Hospital, Tours Centre d'Investigation Clinique-P1415, TOURS, Centre Régional de Coordination des Dépistages des Cancers - Centre-Val de Loire

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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