A Proximity-incentive Strategy for Cervical Cancer Screening

Summary

In France, cervical cancer screening is based on a cervical smear for women aged 25 to 30 years and on High Risk- HPV (HR-HPV) testing for women aged 30 to 65 years. One of the main concerns in France is poor attendance to this screening program, up to 40% of women, which led French Health Authorities to implement population-based organized cervical cancer screening (DO CCU), based on remind letters, starting in 2019.

Our project is a complementary strategy to DO CCU based on direct proposal of a vaginal self-sample device for HR-HPV testing to non-attendee women while attending health care centers. Our hypothesis is that contacting under-screened women directly and proposing them a self-sample device to be used at home will increase their participation to cervical cancer screening.

This project will be held in the Departments of Hérault and Aude, which are among those in the region of Occitanie (south of France) with the lowest participation to cervical cancer screening.

Women aged 50 to 65 years with no cervical smear and/or gynecological examination for more than three years, will be recruited in two sites: in a mobile unit for breast cancer screening implemented in the whole Department of Hérault and in a Medical and Social Care located in a particularly deprived area of Aude (Limoux-Quillan). In each site, non attendee-women will be proposed by a trained mid-wife, a vaginal self-sample device to perform at home and send back by mail to the laboratory of the Hospital of Montpellier, which will perform HR-HPV testing. Women with positive HR-HPV DNA test will be asked to perfom a cervical smear and completion of follow-up will be monitored.

The primary objective of this study will be to evaluate attendance of under-screened women to vaginal self-sampling for cervical cancer screening, i.e. the number of women who accepted a self-sample device among women to whom it has been proposed.

A second objective will be to analyse psycho-social factors associated with cervical cancer screening in this population of non-attendee women, i.e. their socio-economic environment and the way women perceive and are implicated in cervical cancer screening. This secondary objective will be based on a specific questionnaire at recruitment and on semi-directive phone interviews in a sub-group of women. The efficacy of this screening strategy (number of women who performed vaginal self sample and sent it to the laboratory, and number of women who completed follow-up in case of a positive HR-HPV test) will also be monitored.

The number of women to be recruited is 660. The total estimated duration of the project is 60 months, including 24 months for women's recruitment.

Expected results from this project are:

* An increase in participation to cervical cancer screening of non-attendee women aged 50 to 65 years in the Departments of Hérault and Aude.
* Women's education about cervical cancer screening through discussion with the midwife during recruitment and information tools developed for the project
* Information of local health staff and community-based associations about cervical cancer screening and the place of HR-HPV testing.
* Identification of psycho-social factors and potential barriers to compliance to cervical cancer screening.
* Identification of organizational and practical difficulties that must be overcome to improve preventive actions towards deprived populations.

Conditions

• Cervical Cancer
• Uterine Cervical Disease
• Human Papilloma Virus

Interventions

BEHAVIORAL

Proximity-incentive strategy based on vaginal self-sampling for women 50 to 65 years who do not participate to cervical cancer screening

* Direct offer of a vaginal self-sampling kit with information to perform at home and send back to the laboratory for HR-HPV testing * The psychosocial determinants involved in decision-making process and compliance to cervical cancer screening will be collected from open questionnaires and by semi-directive phone interviews * Control ; Receive reminder to send the self-sample to the laboratory : After 3 and 6 months without "return", women receive a remind letter to send the vaginal self-sample to the laboratory. We call "return" the receipt of the vaginal self-sample at the laboratory. * Control ; Receive reminder to perform cervical smear in case of positive HR-HPV test : In case of a positive HR-HPV test, women are asked to perform a control cervical smear. After 3, 6 months and 12 months without "return", women and their health-care professional will receive a remind letter or a call to perform a cervical smear for control. We call "return" the performance of a pap smear.

Sponsors & Collaborators

• Paul Valérie University Montpellier

  collaborator UNKNOWN

• Regional Center for Cancer Screening (CRCDC) - Region of Occitanie - Department of Herault

  collaborator UNKNOWN

• Regional Center for Cancer Screening (CRCDC) - Region of Occitanie - Department of Aude

  collaborator UNKNOWN

• Association for Breast Cancer Screening - Department of Herault (AMHDCS)

  collaborator UNKNOWN

• University Hospital, Montpellier

  lead OTHER

Principal Investigators

• Nathalie BOULLE, MD/PhD · University Hospital, Montpellier

Study Design

Allocation

NA

Purpose

SCREENING

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

50 Years

Max Age

65 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-09-16

Primary Completion

2023-07-25

Completion

2024-07-25

Countries

• France

Study Locations