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

Cervical Cancer Clinical Trial

— APACHE-4  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03856684
• Other study ID #: DR170135-APACHE-4
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Cervical Cancer
• Cervical Cancer Screening
• Uterine Cervical Neoplasms

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