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

Early Phase 1

Completed

• Conditions: Human Papillomavirus Infection; Cervical Cancer
• Interventions: Behavioral: Kit for Self-collected vaginal sample; Behavioral: Attending for cervical cytology

• Registration Number: NCT01588301
• Lead Sponsor: University Hospital, Tours

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-03-12
• Study First Submitted QC: 2012-04-27
• Study First Posted: 2012-04-30
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2014-07
• Last Update Submitted: 2014-09-11
• Last Update Posted: 2014-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 5998

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2 : Kit for Self-collected vaginal sample	Kit for Self-collected vaginal sample	Kit for Self-collected vaginal sample sent at home and then test for Human Papillomavirus (HPV)
Group 1 : Further invitation by mail	Attending for cervical cytology	Further invitation to attend for cervical cytology

Primary Outcome Measures

Name	Time	Method
Comparison of women's attitude according to the arm: participation or not to a whole screening action	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

Secondary Outcome Measures

Name	Time	Method
Analysis in sub-groups	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)	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.