Cervical Cancer, Cervical Cancer Screening
Conditions
Keywords
vaginal, self-sampling, cervical cancer screening, Papillomavirus, HPV, High Risk Human papillomavirus Infection, pap smear
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.
Interventions
BEHAVIORALSelf-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.
BEHAVIORALSelf-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.
BEHAVIORALLetter 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.
BEHAVIORALSMS 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.
Sponsors
Centre Régional de Coordination des Dépistages des Cancers - Centre-Val de Loire
Centre d'Investigation Clinique-P1415, TOURS
University Hospital, Tours
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 66 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
France
Outcome results
None listed