Marc Bardou

Combined incentive actions, focusing on primary care professionals, to improve cervical cancer screening in women living in socioeconomically disadvantaged geographical areas: a study protocol of a hybrid cluster randomised effectiveness and implementation trial- RESISTE

IntroductionCervical cancer (CC) causes thousands of deaths each year. Nearly 100% of cases are caused by oncogenic strains of human papillomavirus (HPV). In most industrialised countries, CC screening (CCS) is based on the detection of HPV infections. For many reasons including lower adherence to CCS, underserved women are more likely to develop CC, and die from it. We aim to demonstrate that the use of incentives could improve screening rates among this population.Methods and analysisOur cluster randomised, controlled trial will include 10 000 women aged 30–65 years eligible for CCS, living in deprived areas in four French departments, two mainlands and two overseas, and who did not perform physician-based HPV testing within the framework of the nationally organised screening programme. HPV self-sampling kit (HPVss) will be mailed to them. Two interventions are combined in a factorial analysis design ending in four arms: the possibility to receive or not a financial incentive of €20 and to send back the self-sampling by mail or to give it to a health professional, family doctor, gynaecologist, midwife or pharmacist. The main outcome is the proportion of women returning the HPVss, or doing a physician-based HPV or pap-smear test the year after receiving the HPVss. 12-month follow-up data will be collected through the French National Health Insurance database. We expect to increase the return rate of HPV self-samples by at least 10% (from 20% to 30%) compared with the postal return without economic incentive.Ethics and disseminationEthics approval was first obtained on 2 April 2020, then on July 29 2022. The ethics committee classified the study as interventional with low risk, thus no formal consent is required for inclusion. The use of health insurance data was approved by the Commission Nationale Informatique et Libertés on 14 September 2021 (ref No 920276). An independent data security and monitoring committee was established. The main trial results will be submitted for publication in a peer-reviewed journal.Trial registration numberNCT04312178.

How can cervical screening meet the needs of vulnerable women? A qualitative comparative study with stakeholder perspectives from seven European countries

Objective This study explored and compared stakeholder perspectives on enhancements to cervical cancer screening for vulnerable women across seven European countries. Design In a series of Collaborative User Boards, stakeholders were invited to collaborate on identifying facilitators to improve cervical cancer screening. Setting This study was part of the CBIG-SCREEN project which is funded by the European Union and targets disparities in cervical cancer screening for vulnerable women ( www.cbig-screen.eu ). Data collection took place in Bulgaria, Denmark, Estonia, France, Italy, Portugal and Romania. Participants Represented stakeholders at various levels, including user representatives (vulnerable women), healthcare professionals, social workers, programme managers and decision makers. Methods 14 meetings lasting 2 hours each were held in these seven countries between October 2021 and June 2022. The meetings were audio or video recorded, transcribed and translated into English for qualitative framework analysis. Results We engaged 120 participants in the Collaborative User Boards. Proposed solutions targeted both provider and system levels. In all countries, fostering trusting relationships between vulnerable women and social or healthcare professionals, coupled with community outreach for awareness and access to testing was a consistent recommendation. Participants in Estonia, Denmark, France, Italy, Portugal and Romania advocated for tailoring healthcare services to meet the unique needs of vulnerable populations through a holistic approach. In Bulgaria and Romania, participants advocated for the need to secure free access, from screening to follow-up, and emphasised the need for organised screening with target population screening registries. Conclusion The study offers insights into stakeholders' recommendations for enhancing cervical cancer screening services for vulnerable women across seven European countries. Despite variations in the implementation level of population-based screening programmes, the imperative to optimise outreach and proximity work to improve cervical cancer screening resonated across all countries.

What are the barriers towards cervical cancer screening for vulnerable women? A qualitative comparative analysis of stakeholder perspectives in seven European countries

Objectives The aim of this study was to map and compare stakeholders’ perceptions of barriers towards cervical cancer screening for vulnerable women in seven European countries. Design In Collaborative User Boards, stakeholders were invited to participate to identify barriers towards participation in cervical cancer screening. Setting The study is nested in the European Union-funded project CBIG-SCREEN which aims to tackle inequity in cervical cancer screening for vulnerable women ( www.cbig-screen.eu ). Data collection took place in Bulgaria, Denmark, Estonia, France, Italy, Portugal and Romania. Participants Participants represented micro-level stakeholders covering representatives of users, that is, vulnerable women, meso-level stakeholders covering healthcare professionals and social workers, and macro-level stakeholders covering programme managers and decision-makers. Methods Across the seven countries, 25 meetings in Collaborative User Boards with a duration of 2 hours took place between October 2021 and June 2022. The meetings were video recorded or audio recorded, transcribed and translated into English for a qualitative framework analysis. Results 120 participants took part in the Collaborative User Boards. Context-specific barriers were related to different healthcare systems and characteristics of vulnerable populations. In Romania and Bulgaria, the lack of a continuous screening effort and lack of ways to identify eligible women were identified as barriers for all women rather than being specific for women in vulnerable situations. The participants in Denmark, Estonia, France, Italy and Portugal identified providers’ lack of cultural and social sensitivity towards vulnerable women as barriers. In all countries, vulnerable women’s fear, shame and lack of priority to preventive healthcare were identified as psychological barriers. Conclusion The study provides an overview of stakeholders’ perceived barriers towards vulnerable women’s cervical cancer screening participation in seven European countries. The organisation of healthcare systems and the maturity of screening programmes differ between countries, while vulnerable women’s psychological barriers had several similarities.

Risk of cervical cancer and high-grade lesions in vulnerable women a systematic review and meta-analysis.

Cervical cancer is largely preventable, yet causes around 300,000 deaths annually, disproportionately affecting vulnerable women. In here, we aim to estimate the risk of high-grade cervical lesions and cervical cancer among vulnerable populations in high- and upper-middle-income countries. We conduct a systematic review and meta-analysis of studies published up to February 2024 (from 2004 for HIV) across four databases. Risk of bias is assessed using the Newcastle-Ottawa Scale. We include women with low socioeconomic status, migrants, prisoners, sex workers, women with substance use disorders, mental illness, and living with HIV. The primary outcome is the pooled risk of cervical cancer and high-grade lesions; the secondary outcome is subgroup-specific risk. The analysis focuses on biologically defined females, with sex determined by author reporting. In this work, based on 127 studies, we show that vulnerable women face higher risks of cervical cancer (RR2.78; 95%CI 2.32-3.32) and high-grade lesions (RR 2.5; 95%CI 2.05-3.04), with high heterogeneity supporting equity-focused prevention strategies.

Combined Incentive Actions, Focusing on Primary Care, to Improve Cervical Cancer Screening in Women Residing in Socio-economically Disadvantaged and Untracked Geographical Areas: a Hybrid Efficacy and Implementation Trial

Though potentially eradicable, cervical cancer is the 3rd most prevalent gynecological cancer, and the 2nd most prevalent before the age of 45. In France, approximately 1100 women die from cervical cancer each year, with 5-year survival strongly linked to the stage at diagnosis (93%, 63%, 35% and 16% for stages IA, IIA, IIIA and IVA). The prevention of cervical cancer is currently based on the combination of the vaccination of adolescent girls against the most common high-risk oncogenic human papilloma virus types and routine Papanicolaou cytology (Pap smears) every three years in women aged 25 to 65 years. The Health and Social Protection Survey conducted by the Institute for Research and Documentation in Health Economics in 2012 showed that young women who are not vaccinated have a socio-economic profile similar to that of women who do not attend cervical cancer screening, mainly: (i) the least screened women and least vaccinated young women live in low-income families; (ii) a low level of education is associated with fewer Pap smears; (iii) an absence of pap smears in mothers in the last three years is associated with less human papillomavirus vaccination in their daughters. Cervical cancer is the female cancer which, in France, has the highest proportion attributable to precariousness (21.1%), and for which there are strong territorial disparities in incidence. Several factors may explain the difficulties in obtaining satisfactory rates of screening, such as geographical remoteness, the disengagement of general practitioners, economic constraints, or the geographical origin of women. Several countries such as the Netherlands have started routinely screening for cervical cancer by testing for human papillomavirus. This approach appears to be as beneficial as a screening campaign based on the Pap smear. This approach has also just been validated by the French Health Authority which, in its public health recommendation dated 11 July 2019, states that "From the age of 30, the High Authority for Health recommends that the human papillomavirus test replace the cytological examination in primary screening for cervical cancer." In addition, this recommendation states that "Vaginal self-sampling is an alternative to cervical sampling by a health professional to detect the human papillomavirus test for undetected or under-detected women. This makes it easier to screen women who never get tested or who do not get tested as recommended." Moreover, the French Authority for Health specifies "In addition, complementary studies should be carried out to evaluate the feasibility and effectiveness of the different modalities for making these vaginal self-samples available, depending on the specific populations concerned (French Guyana, Mayotte, women living on the street, in shantytowns, migrant women, with limited access to health services, etc.)". Two French trials show that when women ignored a letter sent to the home to invite them to receive a Pap smear, only 16 to 18% of women performed vaginal self-sampling when a kit was subsequently sent to their home. The delivery of a vaginal swab by a health professional does not increase adherence to screening compared to a reminder letter for a Pap smear (12% vs. 11.9%). Economic incentives may increase adherence to prevention policies, including those against human papillomavirus infections. They are often used to combat "present bias", i.e. the tendency to seek immediate, even limited, satisfaction rather than greater future satisfaction. A factorial design will be used to analyze the respective contribution of the delivery of the vaginal swab to a healthcare professional and an economic incentive of 20€. The hypothesis is that the the fact of returning the vaginal self-sampling to a health professional or an economic incentive will increase the participation of socially disadvantaged women in cervical cancer screening compared to simply returning it by mail without an incentive. It also postulate that health professionals will encourage women to perform a vaginal swab and adhere to the recommendations of the French Health Authority in case of a positive human papillomavirus test and that socially disadvantaged women will accept vaginal swabbing as a method of cervical cancer screening. Factors such as precariousness, life and migration paths, the socio-sanitary context, and the provision of primary care all play a role in prevention behaviors and may explain the heterogeneity of the observed effects.