A Proximity-incentive Strategy for Cervical Cancer Screening

NCT04716127 | Completed

• 2 other identifiers: 2020-A01534-35RECHMPL20_0133
• Study Type: interventional
• Target: 656
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Direct-To-Consumer Screening and Testing; Vaginal self-sampling; HPV

Outcome Measures

Primary Outcomes (1)

• 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

  During recruitment

Secondary Outcomes (3)

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

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

• Efficacy of the proposed screening strategy

  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

  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

Study Arms (1)

Women 50 to 65 years with no regular cervical cancer screening

EXPERIMENTAL

Women aged 50 to 65 years with no cervical smear or no gynecological examination for more than three years, attending the mobile unit for breast cancer screening in the Department of Hérault, or the Medical and Social Care Center in the Department of Aude.

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

Interventions

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

* 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.

Women 50 to 65 years with no regular cervical cancer screening

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• Paul Valérie University Montpellier: collaborator
• Regional Center for Cancer Screening (CRCDC) - Region of Occitanie - Department of Herault: collaborator
• Regional Center for Cancer Screening (CRCDC) - Region of Occitanie - Department of Aude: collaborator
• Association for Breast Cancer Screening - Department of Herault (AMHDCS): collaborator

Study Sites (2)

Arnaud de Villeneuve Hospital, clinical trials Department

Montpellier, Herault, 34295, France

Location

Mammobile Hérault

Montpellier, France

Location

Related Publications (1)

• Lareyre O, Mollevi C, Broc G, Caspar MN, Pehlivanska G, Boyer H, Groc S, Corradi G, Loy-Morel S, Guy M, Tricheux N, Cousson-Gelie F, Boulle N. An outreach strategy to increase uptake of vaginal self-sampling for cervical cancer screening in older French women: The RIDECA interventional research protocol. Womens Health (Lond). 2024 Jan-Dec;20:17455057241292693. doi: 10.1177/17455057241292693.

  PMID: 39474856 BACKGROUND

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Uterine Cervical Diseases

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Nathalie BOULLE, MD/PhD

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2021
• First Posted: January 20, 2021
• Study Start: September 16, 2021
• Primary Completion: July 25, 2023
• Study Completion: July 25, 2024
• Last Updated: April 24, 2026

Record last verified: 2026-04

Locations

FR (2)