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

Not Applicable

Completed

• Conditions: Cervical Cancer; Cervical Cancer Screening

• Registration Number: NCT03856684
• Lead Sponsor: University Hospital, Tours

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-26
• Study First Submitted QC: 2019-02-26
• Study First Posted: 2019-02-27
• Study Start: 2020-02-11
• Primary Completion: 2021-07-14
• Status Verified: 2021-10
• Study Completion: 2021-10-20
• Last Update Submitted: 2021-10-28
• Last Update Posted: 2021-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 10400

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Participation / no participation to complete cervical cancer screening	9 months after postal mail (with or without the kit) or SMS	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)

Trial Locations

Locations (1)

Crcdc-Cvl; 🇫🇷 Tours, France