Self-sampling and Human Papillomavirus (HPV)-Testing for Unscreened Women in Cervical Cancer Prevention (APACHE-2)

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Tours
ClinicalTrials.gov Identifier:
NCT01588301
First received: March 12, 2012
Last updated: July 29, 2014
Last verified: July 2014
  Purpose

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.

Condition Intervention Phase
Cervical Cancer
Human Papillomavirus Infection
Behavioral: Attending for cervical cytology
Behavioral: Kit for Self-collected vaginal sample
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Screening
Official Title: Attitudes to Different Strategies Among Women Not Attending Cervical Cancer Screening: Further Invitation by Mail or Kit for Self-collected Vaginal Sample

Resource links provided by NLM:


Further study details as provided by University Hospital, Tours:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

    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:
  • Analysis in sub-groups [ Time Frame: 9 months after the beginning of the study (sending of mails) ] [ Designated as safety issue: No ]

    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) ] [ Designated as safety issue: No ]

    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.



Enrollment: 5998
Study Start Date: February 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01588301

Sponsors and Collaborators
University Hospital, Tours
Investigators
Study Director: Ken HAGUENOER François Rabelais University, Public Health Laboratory, Tours, France
  More Information

No publications provided

Responsible Party: University Hospital, Tours
ClinicalTrials.gov Identifier: NCT01588301     History of Changes
Other Study ID Numbers: INCA08-KH / APACHE-2
Study First Received: March 12, 2012
Last Updated: July 29, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Tours:
Cervical Cancer Screening
Human Papillomavirus (HPV)
Self-collected vaginal sample
Cervical Smear

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Papillomavirus Infections
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
DNA Virus Infections
Virus Diseases
Tumor Virus Infections

ClinicalTrials.gov processed this record on August 28, 2014