Evaluation of Three Strategies Based on Vaginal Self-sampling Kit Send to Home of Unscreened Women for Cervical Cancer
APACHE-4
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
1 other identifier
interventional
10,400
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 26, 2019
CompletedFirst Posted
Study publicly available on registry
February 27, 2019
CompletedStudy Start
First participant enrolled
February 11, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 14, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 20, 2021
CompletedOctober 29, 2021
October 1, 2021
1.4 years
February 26, 2019
October 28, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (4)
Self-sampling kit sent at home
ACTIVE COMPARATORSending of a vaginal self-sampling kit at home
Self-sampling kit sent at home + SMS reminder
EXPERIMENTALSending 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
Letter offering a self-sampling kit "on request"+ SMS reminder
EXPERIMENTALSending 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
SMS offering a self-sampling kit "on request"+ SMS reminder
EXPERIMENTALSending 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
Interventions
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.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- STOP SMS
- HPV cervical pathology during treatment
- Hysterectomy including cervix
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Crcdc-Cvl
Tours, 37044, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Julie BOYARD, MSc
University Hospital of TOURS
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 26, 2019
First Posted
February 27, 2019
Study Start
February 11, 2020
Primary Completion
July 14, 2021
Study Completion
October 20, 2021
Last Updated
October 29, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will not share