Self-sampling and Human Papillomavirus (HPV)-Testing for Unscreened Women in Cervical Cancer Prevention
Condition: Cervical Cancer; Human Papillomavirus Infection
MeSH terms: Papillomavirus Infections; Uterine Cervical Neoplasms
Study type: Interventional
Phase: Early Phase 1

Summary: 
      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.
    


Intervention name(s): Attending for cervical cytology; Kit for Self-collected vaginal sample
Intervention type(s): Behavioral; Behavioral
Intervention description(s): A further invitation to attend for cervical cytology are going to be sent by mail to women; Kit for self-collected vaginal sample are going to be directly sent at women's home
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Screening
Keywords: Cervical Cancer Screening; Human Papillomavirus (HPV); Self-collected vaginal sample; Cervical Smear