Self-sampling and Human Papillomavirus (HPV)-Testing for Unscreened Women in Cervical Cancer Prevention
Self-sampling and Human Papillomavirus (HPV)-Testing for Unscreened Women in Cervical Cancer Prevention
Scientific Context:

 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.
Inclusion Criteria :

 -  Women from 30 to 65 years

 -  Living in Indre-et-Loire (french territorial division 37)

 Exclusion Criteria :

 -  Women who attend organized cervical cancer screening or who answer to the invitation

 -  Cervical smear made in the three last years

 -  HPV linked cervical condition undergoing treatment

 -  Hysterectomy (including cervix)