Clinical trial NCT01588301: Self-sampling and Human Papillomavirus (HPV)-Testing for Unscreened Women in Cervical Cancer Prevention
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Cervical Cancer
Human Papillomavirus Infection
Keywords: Cervical Cancer Screening
Human Papillomavirus (HPV)
Self-collected vaginal sample
Cervical Smear
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2012-04-30
Enrollment: 5998
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Comparison of women's attitude according to the arm: participation or not to a whole screening action
timeFrame: 9 months after the beginning of the study (sending of mails)
Secondary outcomes:
measure: Analysis in sub-groups
timeFrame: 9 months after the beginning of the study (sending of mails)
measure: Identification of the psychological determinants and mechanisms (checks and motivational factors)
timeFrame: 9 months after the beginning of the study (sending of mails)
Other outcomes:
Locations:
Study officials:
affiliation: François Rabelais University, Public Health Laboratory, Tours, France
name: Ken HAGUENOER
role: STUDY_DIRECTOR
References: