APACHE-4: Evaluation of Three Strategies Based on Vaginal Self-sampling Kit Send to Home of Unscreened Women for Cervical Cancer

Sponsor

University Hospital, Tours (Other)

Overall Status

Completed

CT.gov ID

NCT03856684

Collaborator

Centre Régional de Coordination des Dépistages des Cancers - Centre-Val de Loire (Other), Centre d'Investigation Clinique-P1415, TOURS (Other)

10,400

Enrollment

Location

Arms

20.3

Actual Duration (Months)

513

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cervical Cancer Screening Cervical Cancer	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	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

10400 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

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

Actual Study Start Date :

Feb 11, 2020

Actual Primary Completion Date :

Jul 14, 2021

Actual Study Completion Date :

Oct 20, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Self-sampling kit sent at home Sending of a vaginal self-sampling kit at home	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.
Experimental: Self-sampling kit sent at home + SMS reminder 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 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.
Experimental: Letter offering a self-sampling kit "on request"+ SMS reminder 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 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.
Experimental: SMS offering a self-sampling kit "on request"+ SMS reminder 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 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.

Outcome Measures

Primary Outcome Measures

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 66 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Crcdc-Cvl	Tours		France	37044

Sponsors and Collaborators

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