NCT03856684

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10,400 (actual)
• Sponsor: University Hospital, Tours · Academic / Other
• Sex: Female
• Age: 30 Years – 66 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cervical Cancer Screening
• Cervical Cancer

Interventions

Type	Name	Description
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.
BEHAVIORAL	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.
BEHAVIORAL	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.
BEHAVIORAL	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.

Timeline

• Start date: 2020-02-11
• Primary completion: 2021-07-14
• Completion: 2021-10-20
• First posted: 2019-02-27
• Last updated: 2021-10-29

Locations

1 site across 1 country: France