A Proximity-incentive Strategy for Cervical Cancer Screening

NCT04716127CompletedNAINTERVENTIONAL

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.

Key Facts

Lead Sponsor

University Hospital, Montpellier

Enrollment

656

Start Date

2021-09-16

Completion Date

2023-07-25

Study Type

INTERVENTIONAL

Official Title

Benefit From a Proximity-incentive Strategy Based on Vaginal Self-sampling for Women Who do Not Participate to Cervical Cancer Screening in Aude and Hérault [French Departments]: an Interventional Research to Reduce Social and Territorial Inequalities.

Interventions

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

Conditions

Cervical CancerUterine Cervical DiseaseHuman Papilloma Virus

Eligibility

Age Range

50 Years – 65 Years

Sex

FEMALE

Inclusion Criteria:

* Asymptomatic women 50 to 65 years old (50 and 65 years included)
* With no cervical smear (or gynecologic examination) or HPV test 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

Outcome Measures

Primary Outcomes

Attendance of under-screened women to vaginal self-sampling when the self-device is proposed directly

Number of women who accepted a self-sample device among women to whom it has been proposed

Time frame: During recruitment

Secondary Outcomes

Psychosocial determinants involved in attendance to cervical cancer screening using this screening strategy

The psychosocial determinants (motivation, self-efficacy) involved in decision-making process and compliance to cervical cancer screening will be collected from open questionnaires conducted during women recruitment and later by semi-directive phone interviews for a sub-group of women participating to the study. These data will be organized through a logical model of change. The role of socio-economic factors on cervical cancer screening adherence and self-sampling attendance will be evaluated using a validated index of social deprivation (European Deprivation Index - EDI).

Time frame: During recruitment for the questionnaire and 4 months after recruitment for the semi-directive phone interviews

Efficacy of the proposed screening strategy

Number of vaginal self-samples performed and sent to the laboratory for HPV testing by women who accepted the self-sample device

Time frame: After the last recall letter, sent 6 months after recruitment, if the vaginal self-sample has not been sent to the laboratory

Efficacy of vaginal self-sampling with HPV testing for cervical cancer screening

Number of complete follow-up (cervical smear) obtained among women who had a positive HPV test by vaginal self-sampling

Time frame: After the last recall letter, sent 12 months after informing the woman by mail of a positive HR-HPV test, if no cervical smear has been performed

Locations

Arnaud de Villeneuve Hospital, clinical trials Department, Montpellier, France

Mammobile Hérault, Montpellier, France

Linked Papers

An outreach strategy to increase uptake of vaginal self-sampling for cervical cancer screening in older French women: The RIDECA interventional research protocol

Background: In France, approximately 40% of women, including menopausal women, do not participate in cervical cancer screening. Many studies and meta-analyses have shown that self-sampling devices for high-risk human papillomavirus (HR-HPV) testing are valuable tools to increase participation. The success of self-sampling screening strategies depends on several factors, including the manner and circumstances in which the women are invited to participate. The acceptability and effectiveness of these strategies should be evaluated before further implementation. Objectives: The primary objective is to evaluate the uptake of cervical cancer screening in under-screened women, based on a direct offer of a vaginal self-sampling device by a midwife. Design: RIDECA is an interventional research project located in the South of France. Methods and Analysis: Six hundred women aged 50–65 with no cervical smear or HR-HPV test for 3 years or more will be recruited at two sites. The device will be offered to enrolled women to utilize at home and return to the Montpellier Hospital laboratory for HR-HPV testing. Completion of self-sampling by women who have accepted the device and follow-up of those with positive HR-HPV DNA tests will be monitored. During recruitment, participants will complete questionnaires on their socio-economic environment and motivational factors based on the psychosocial I-Change model. Semi-structured interviews will be conducted with a sub-group to identify barriers and levers to participation. Statistical analyses will be conducted for the full research sample and for each recruitment site. Ethics: The project was approved by the Ethical Research Committee Ile de France VI and by the French Data Protection Authority. Discussion: The results will provide useful information on the effectiveness (acceptability, efficiency) of this outreach strategy and identify barriers and levers that facilitate its implementation. Registration: ClinicalTrials.gov (NCT04716127), January 20, 2021.

Linked Investigators

Guillaume Broc

Olivier Lareyre