Self-sampling and Human Papillomavirus (HPV)-Testing for Unscreened Women in Cervical Cancer Prevention (APACHE-2)
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|ClinicalTrials.gov Identifier: NCT01588301|
Recruitment Status : Completed
First Posted : April 30, 2012
Last Update Posted : September 12, 2014
High-risk types of human papillomavirus (HPV) are the causative agents for cervical cancer. Cervical cancer screening strategies rely on periodic Papanicolaou (Pap) testing. It's well-known that this test has significantly contributed to the reduction of mortality and morbidity due to cervical cancer. In France, it now seems that the screening strategy could be optimized. The two main ways are to reach the 7 million underscreened women (organized screening, self-sampling for HPV DNA testing) and to improve the screening test (HPV DNA testing, computer-assisted cytology). Self-collected vaginal samples (SCVS) for HPV DNA testing could be a relevant screening option: this technique appears reliable and it could allow to reach women who are never or seldom screened. The performance of the SCVS to detect cervical HPV infection has been assessed by the first part of the whole study: APACHE-1.
The goal of this study is to compare the attitudes of women not attending organized cervical cancer screening face to different strategies: further invitation to make a cervical smear or kit for self-collected vaginal sample sent at home.
Description of the project :
Nine months after a primary invitation to make a cervical smear, a random sample of 6000 women not attending organized cervical cancer screening will be randomly assigned to one of the following arms:
- Intervention arm 1:
Women will receive a further invitation to make a cervical smear
- Intervention arm 2:
Women will be directly sent the kit for self-collected vaginal sample at home. The women who will send the self-sample to the laboratory for analyse will receive their results at home as well as their general practitioner if the HPV DNA test is positive (infection by a high-risk HPV).
For them who will have a HPV DNA test positive, it will be necessary to complete the screening action with a cervical smear. That's why those women will receive an invitation to make a cervical smear if they won't do it during the 9 months following the first mail.
- Control arm: Those women will receive complete information about the study, the main results and the screening recommendations at the end of the study.
|Condition or disease||Intervention/treatment||Phase|
|Cervical Cancer Human Papillomavirus Infection||Behavioral: Attending for cervical cytology Behavioral: Kit for Self-collected vaginal sample||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5998 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Attitudes to Different Strategies Among Women Not Attending Cervical Cancer Screening: Further Invitation by Mail or Kit for Self-collected Vaginal Sample|
|Study Start Date :||February 2012|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2012|
Experimental: Group 1 : Further invitation by mail
Further invitation to attend for cervical cytology
Behavioral: Attending for cervical cytology
A further invitation to attend for cervical cytology are going to be sent by mail to women
Experimental: Group 2 : Kit for Self-collected vaginal sample
Kit for Self-collected vaginal sample sent at home and then test for Human Papillomavirus (HPV)
Behavioral: Kit for Self-collected vaginal sample
Kit for self-collected vaginal sample are going to be directly sent at women's home
|No Intervention: Group 3: Control|
- Comparison of women's attitude according to the arm: participation or not to a whole screening action [ Time Frame: 9 months after the beginning of the study (sending of mails) ]
Comparison of attitudes among women not attending organized cervical cancer according to the type of intervention or the lack of intervention: participation or not to a whole screening action.
Are considered as whole screening action:
- cervical smear
- HPV DNA testing on self-collected vaginal sample negative (no infection by a high-risk HPV)
- HPV DNA testing on self-collected vaginal sample positive (infection by a high-risk HPV) followed by a cervical smear
- Analysis in sub-groups [ Time Frame: 9 months after the beginning of the study (sending of mails) ]
Analysis in sub-groups in order to compare the efficacy of interventions according to :
- The age
- Health insurance system
- Distribution map (urban area, peri-urban area, rural area)
- Identification of the psychological determinants and mechanisms (checks and motivational factors) [ Time Frame: 9 months after the beginning of the study (sending of mails) ]
Identify the psychological determinants and mechanisms (checks and motivational factors) that can affect enrollment to the screening procedure for self-collection vaginal sample or cervical smear.
Nine months after the beginning of the study, a questionnaire will be send to the 6000 women.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01588301
|Study Director:||Ken HAGUENOER||François Rabelais University, Public Health Laboratory, Tours, France|