NCT04716127: RIDECA

A Proximity-incentive Strategy for Cervical Cancer Screening

Completed NA Last updated 30 July 2024

What this trial tests

NA trial testing Proximity-incentive strategy based on vaginal self-sampling for women 50 to 65 years who do not participate to cervical cancer screening in Cervical Cancer in 656 participants. Completed in 25 July 2024.

Timeline

16 September 2021

Primary endpoint
25 July 2023

25 July 2024

Quick facts

Lead sponsor	University Hospital, Montpellier
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	screening
Enrollment	656
Start date	16 September 2021
Primary completion	25 July 2023
Estimated completion	25 July 2024
Sites	2 locations across France

Drugs / interventions tested

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

Conditions studied

• Cervical Cancer — all drugs for Cervical Cancer →
• Uterine Cervical Disease — all drugs for Uterine Cervical Disease →
• Human Papilloma Virus — all drugs for Human Papilloma Virus →

Sponsor

University Hospital, Montpellier

Who can join

Adults 50 to 65, female only, with Cervical Cancer or Uterine Cervical Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. An outreach strategy to increase uptake of vaginal self-sampling for cervical cancer screening in older French women: The RIDECA interventional research protocol.
   Lareyre O, Mollevi C, Broc G, Caspar MN, et al · · 2024 · PMID 39474856 · DOI 10.1177/17455057241292693