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

September 11, 2014 updated by: University Hospital, Tours

Attitudes to Different Strategies Among Women Not Attending Cervical Cancer Screening: Further Invitation by Mail or Kit for Self-collected Vaginal Sample

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5998

Phase

  • Early Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)

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
9 months after the beginning of the study (sending of mails)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analysis in sub-groups
Time Frame: 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)
9 months after the beginning of the study (sending of mails)
Identification of the psychological determinants and mechanisms (checks and motivational factors)
Time Frame: 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.
9 months after the beginning of the study (sending of mails)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Tours

Investigators

  • Study Director: Ken HAGUENOER, François Rabelais University, Public Health Laboratory, Tours, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

March 12, 2012

First Submitted That Met QC Criteria

April 27, 2012

First Posted (Estimate)

April 30, 2012

Study Record Updates

Last Update Posted (Estimate)

September 12, 2014

Last Update Submitted That Met QC Criteria

September 11, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INCA08-KH / APACHE-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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