A Proximity-incentive Strategy for Cervical Cancer Screening
A Proximity-incentive Strategy for Cervical Cancer Screening
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 300 for each site. The total estimated duration of the
 project is 48 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.
Scientific context :

 In France, cervical cancer screening is based on a cervical smear every three years for women
 aged 25 to 30 years, and on a High-Risk HPV (HR-HPV) detection test every five years for
 women aged 30 to 65 years. One of the main concerns in France is poor attendance to this
 screening program. Among non-attendee women, older women (> 50 years old) and women of
 unfavourable socio-economic conditions are the most represented groups. This observation led
 French Health Authorities to implement population-based organized cervical cancer screening
 (DO CCU) starting in 2019. The Departments of Hérault and Aude are among those in Occitanie
 region (south of France) with the lowest participation to cervical cancer screening. In 2017,
 a group composed of academics, health professionals, the Regional Center for Cancer Screening
 in Occitanie and the Association for Breast Cancer Screening in Montpellier-Hérault organized
 a preliminary study based on a self-questionnaire showing high acceptability of vaginal
 self-sampling by women aged 25 to 65 years, particularly for women older than 50 years.

 The aim of this interventional research is to increase women's participation to cervical
 cancer screening and to identify psycho-social determinants associated with screening
 observance. For this purpose, the integrative model of change (Attitude Social Influence
 Self-efficacy Mode - ASE model) from Vries et al. (2013) seems an interesting model to better
 understand behavioural changes regarding participation to cervical cancer screening using the
 proposed strategy.

 Research hypothesis:

 The project is a proximity-incentive strategy complementary to DO CCU based on direct
 proposal by a trained mid-wife 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
 along with information on cervical cancer, will increase their participation to cervical
 cancer screening. Secondary hypotheses are that 1) motivational determinants of ASE and
 contextual opportunities are associated with the realization of vaginal self-sampling 2) and
 that vaginal self-sampling is an efficient strategy for cervical cancer screening (i.e.
 number of self-sampling performed and sent to the laboratory, and number of follow-up for
 women with a positive HR-HPV DNA test among women who accepted the self-sample device).

 Intervention description:

 Women aged 50 to 65 years with no cervical smear or no 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). Non attendee-women will be proposed a
 vaginal self-sample device (Evalyn® brush) to perform at home and send back by mail to the
 laboratory of the Hospital of Montpellier, which will perform HR-HPV testing using the Cobas
 4800 HPV DNA detection test. Women with positive HR-HPV DNA test will be asked to perfom a
 cervical smear and completion of follow-up will be monitored.

 During recruitment, women will complete a questionnaire with the help of a midwife on their
 socio-economic environment, motivational determinants and on their willingness to perform the
 vaginal self-sample. These data will be analyzed according to their participation to the
 proposed screening strategy. In addition, semi-directive interviews will be conducted in a
 sub-group of women (45 women for each site) to identify the barriers and levers of screening
 participation.

 The number of women to be recruited (i.e. non-attendee women aged 50 to 65 years, who
 accepted the vaginal self-sample device among those to whom it has been proposed) is 300 for
 each site.

 The total estimated duration of the project is 48 months, based on 12 months for preparation
 of the questionnaires, study subject approvals package and staff recruitment and training, 24
 months for women's recruitment, 12 months for follow-up of women with positive HR-HPV DNA
 test, for data analysis and final report.

 Expected Health public impact are (a) an increase in participation to cervical cancer
 screening of women aged 50 to 65 years in the Departments of Hérault and Aude (b) the
 development of a proximity-incentive strategy to increase cervical cancer screening within
 vulnerable populations and populations with limited access to health care in those
 Departments (c) the identification of psycho social determinants involved in cervical cancer
 screening attendance (i.e. motivational factors, self-efficacy) (d) the construction of a
 regional network of professionals involved in cervical cancer screening, including health
 professionals, field teams, committee-based associations and researchers (e) the development
 of hypotheses and models for future transferability of this intervention to other Departments
 of the Occitanie Region as a complement of the national DO CCU program.
Inclusion Criteria:

 -  Asymptomatic women 50 to 65 years old (50 and 65 years included)

 -  With no cervical smear (or gynecologic examination) for at least 3 years (≥ 3 years)

 -  Able to understand the study and provide voluntarily a written consent to participate

 -  Able to understand and answer the questions of the study questionnaire by themselves
 or with the help of a self-chosen third party

 -  Beneficiary of social security insurance

 Exclusion Criteria:

 -  Women deprived of their liberty, protected adults or vulnerable persons

 -  Known cervical lesion or known HPV status

 -  History of hysterectomy

 -  History of cervix pathology (conization, laser treatment of the cervix)

 -  History of cervical cancer

 -  Known immune-depression