Breast cancer: a randomized controlled trial assessing the effect of a decision aid on mammography screening uptake: study protocol

IntroductionBreast cancer (BC) is the primary cancer among women. The World Health Organization recommends a bilateral screening mammogram every 2 years for women aged 50 to 74 years. However, it has been shown that there is an absence of information about the benefits and risks of screening. Shared medical decision-making is important to ensure patients are involved in the decision process. Decision aids can facilitative this decision-making process. This article presents a protocol to evaluate the effect of a decision aid on participation rates in the French organized BC screening program.Methods and analysisDesign and setting. The design is a 2 arm randomized controlled study, performed in the Pays de la Loire region (French West Coast). Randomization will be based on general medicine practices (Primary Care).ParticipantsWomen aged between 50 and 74 years, eligible for BC screening. In this region, there are 75000 women, and 2800 general practitioners eligible for recruitment.InterventionIn the « Decision aid for organized cancer screening » arm, the intervention will distribute invitation letters to eligible women combined with the provision of decision aid to these women and their general practitioners and an incentive to implement shared medical decision-making. In the « Standard organized cancer screening » arm, only the screening invitation will be sent to eligible women.Primary endpointBC screening participation rates will be assessed after an 18-month follow-up period.Statistical analysisIn this non-inferiority trial, the percentage of women who are up-to-date with their screening at 18 months after the intervention will be compared across arms using a generalized mixed linear model.DiscussionThe research team expect to demonstrate that providing a better explanation of the benefits and risks of BC screening is not at odds with screening participation. The study results should help policy makers thinking about implementing shared medical decision-making within the framework of organized BC screening programs in the future.Ethics and disseminationOn 6 December 2021, the protocol received a favorable opinion from the French Committee for the Protection of Persons (2021-A01583-38). This study is registered with ClinicalTrials.gov, number NCT05607849. (Version 1, November 7, 2022; https://www.clinicaltrials.gov/ct2/show/NCT05607849). The study findings will be used for publication in peer-reviewed scientific journals and presentations in scientific meetings

Cervical cancer screening uptake: A randomized controlled trial assessing the effect of sending invitation letters to non-adherent women combined with sending their general practitioners a list of their non-adherent patients (study protocol)

International audienceIntroduction Cervical cancer (CC) is the fourth most common cancer among women. It can be cured if diagnosed at an early stage and treated promptly. The World Health Organization suggests that 70% of women should be screened with a high-performance test by the age of 35. This paper reports a protocol to assess the effect of two modalities of organized CC screening programmes on CC screening uptake. Methods and analysis Design and setting: The design involves a 3-arm randomized controlled study performed in a French geographic area on the west coast. A total of 1,395 general practitioners will be randomized, depending on their general practice surgeries. Participants: The design is based on a total of 94,393 women aged 40 to 65 years who are eligible for CC screening. Intervention: In the “optimized cancer screening” group, the intervention will combine sending invitation letters to non-adherent women with sending general practitioners (GPs) a list of their non-adherent patients. In the “standard cancer screening” group, the intervention will be limited to sending invitation letters to non-adherent women. In the “usual care” group, no letter will be sent either to women or to their GPs. Primary endpoint: CC screening test uptake will be assessed after a 6-month follow-up period. Statistical analysis: The percentage of women who are up-to-date with their screening at 6 months after the intervention will be compared across arms using a generalized mixed linear model. Discussion A large-scale randomized trial of this nature is unprecedented. The study will enable us to assess a strategy relying on GPs, identified as the coordinators in this screening strategy. The study results should help policy makers to implement organized CC screening programs in the future. Ethics and dissemination The study was approved was approved by the Ethics Committee of the National College of Teaching General practitioners (IRB00010804). It was recorded in ClinicalTrials.gov on the number NCT04689178 (28 December 2020). The study findings will be used for publication in peer-reviewed scientific journals and presentations in scientific meetings

Study protocol : randomised controlled trial assessing the efficacy of strategies involving self-sampling in cervical cancer screening

Objectives: The cervical cancer screening coverage remains moderate (60%) in France. The aim of the study is to evaluate the efficacy of two experimental invitation strategies (offer of urine or vaginal self-sampling kits) to reach under-screened populations and compare them with the current invitation strategy in rural departments (low medical density and low participation rate) in France.Methods: The study is a randomised controlled trial with three arms: a control arm (conventional invitation letter) and two experimental arms (mailing of a urine or vaginal self-sampling kit). The target population includes women aged 30-65 years, who had no screening test recorded since more than 4 years and who did not respond to an invitation letter within 12 months before. The primary outcome measure is the participation rate in each arm. A team of psychologists will also investigate attitudes and experiences by semi-structured/focus-group interviews with voluntary CapU4 participants and with health professionals.Result and conclusion: CapU4 will identify effective strategies to reach women not responding to current screening invitations and will generate information about acceptance of self-sampling among women and health professionals

Optimizing Communication on HPV Vaccination to Parents of 11- to 14-Year-Old Adolescents in France: A Discrete Choice Experiment

International audienceBackground: With the aim to optimize communication during HPV vaccination campaigns in France, we elicited parental preferences around HPV vaccination.Methods: We conducted a single-profile discrete choice experiment (DCE) among parents of 11- to 14-year-old middle-school pupils, who completed an anonymous, self-administered, internet-based questionnaire during 2020-2021. The DCE comprised five attributes (vaccine-preventable disease, justification of optimal age, information on safety, indirect protection and coverage) of vaccination against an unnamed disease that were presented to respondents in ten choice tasks, or scenarios. We use fixed effect logit models to estimate attribute weights on theoretical vaccine acceptance, and random effect linear regression to estimate attribute coefficients on vaccine eagerness (decision and decision certainty). We estimated marginal effects of attributes on expected vaccine acceptance.Results: Vaccination scenarios were accepted by 55.6-89.2% of the 1291 participants. The largest marginal effects on expected vaccine acceptance in the full sample arose from prevention of cancer versus genital warts (+ 11.3 percentage points); from a "severe side effect suspicion that was not scientifically confirmed" versus a statement about "more benefits than risks" (+ 8.9 percentage points), and information on 80% vaccine coverage in neighbouring countries versus on "insufficient coverage" (+ 4.2 percentage points). Explaining the early age of vaccination by sexual debut had a strong negative impact among French monolingual parents with lower education level (vs age-independent, OR 0.48, 95% CI 0.27-0.86), but not other socio-economic groups. After removing low-quality responses (unvaried certainty and short questionnaire completion), among serial non-demanders with children not vaccinated against HPV, only disease elimination impacted vaccine eagerness positively (coefficient 0.54, 0.06-1.02).Discussion: Using DCEs to elicit parents' preferences around communication messages, notably on cancer prevention, vaccine coverage and information about vaccine safety, could help to optimize HPV vaccination promotion efforts

Optimising HPV vaccination communication to adolescents: a discrete choice experiment

International audienceBackground: Human Papillomavirus (HPV) vaccine coverage in France is below 30%, despite proven effectiveness against HPV infections and (pre-)cancerous cervical lesions. To optimise vaccine promotion among adolescents, we used a discrete choice experiment (DCE) to identify optimal statements regarding a vaccination programme, including vaccine characteristics.Methods: Girls and boys enrolled in the last two years of five middle schools in three French regions (aged 13-15 years) participated in an in-class cross-sectional self-administered internet-based study. In ten hypothetical scenarios, participants decided for or against signing up for a school-based vaccination campaign against an unnamed disease. Scenarios included different levels of four attributes: the type of vaccine-preventable disease, communication on vaccine safety, potential for indirect protection, and information on vaccine uptake among peers. One scenario was repeated with an added mention of sexual transmission.Results: The 1,458 participating adolescents (estimated response rate: 89.4%) theoretically accepted vaccination in 80.1% of scenarios. All attributes significantly impacted theoretical vaccine acceptance. Compared to a febrile respiratory disease, protection against cancer was motivating (odds ratio (OR) 1.29 [95%-CI 1.09-1.52]), but not against genital warts (OR 0.91 [0.78-1.06]). Compared to risk negation ("vaccine does not provoke serious side effects"), a reference to a positive benefit-risk balance despite a confirmed side effect was strongly dissuasive (OR 0.30 [0.24-0.36]), while reference to ongoing international pharmacovigilance without any scientifically confirmed effect was not significantly dissuasive (OR 0.86 [0.71-1.04]). The potential for indirect protection motivated acceptance among girls but not boys (potential for eliminating the disease compared to no indirect protection, OR 1.57 [1.25-1.96]). Compared to mentioning "insufficient coverage", reporting that ">80% of young people in other countries got vaccinated" motivated vaccine acceptance (OR 1.94 [1.61-2.35]). The notion of sexual transmission did not influence acceptance.Conclusion: HPV vaccine communication to adolescents can be tailored to optimise the impact of promotion efforts

Evaluation of a risk score based on dietary and lifestyle factors to target a population at risk in colorectal cancer screening

International audienc

Effectiveness of a School- and Primary Care–Based HPV Vaccination Intervention

International audienceImportance - The human papillomavirus (HPV) vaccine is safe and effective, yet vaccination coverage remains below public health objectives in many countries. Objective - To examine the effectiveness of a 3-component intervention on HPV vaccination coverage among adolescents aged 11 to 14 years 2 months after the intervention ended, each component being applied alone or in combination. Design, Setting, and Participants - A cluster randomized trial with incomplete factorial design (PrevHPV) was conducted between July 1, 2021, and April 30, 2022, in French municipalities receiving 0, 1, 2, or 3 components of the intervention. Randomization was stratified by school district and municipalities’ socioeconomic level. Analyses were carried out on 11- to 14-year-old adolescents living in all participating municipalities, regardless of what had been implemented. Intervention - The PrevHPV intervention had 3 components: (1) educating and motivating 11- to 14-year-old adolescents in middle schools, along with their parents; (2) training general practitioners (GPs) on up-to-date HPV information and motivational interviewing techniques; and (3) free HPV vaccination at school. Main Outcomes and Measures - The primary outcome was HPV vaccination coverage (≥1 dose) 2 months after the intervention ended among 11- to 14-year-old adolescents living in participating municipalities, based on the French national reimbursement database and data collected during the trial in groups randomized to implement at-school vaccination. Results - A total of 91 municipalities comprising 30 739 adolescents aged 11 to 14 years (15 876 boys and 14 863 girls) were included and analyzed. Half the municipalities were in the 2 lowest socioeconomic quintiles and access to GPs was poor in more than two-thirds of the municipalities. Thirty-eight of 61 schools (62.3%) implemented actions and 26 of 45 municipalities (57.8%) had at least 1 trained GP. The median vaccination coverage increased by 4.0 percentage points (IQR, 2.0-7.3 percentage points) to 14.2 percentage points (IQR, 9.1-17.3 percentage points) at 2 months. At-school vaccination significantly increased vaccination coverage (5.50 percentage points [95% CI, 3.13-7.88 percentage points]) while no effect was observed for adolescents’ education and motivation (−0.08 percentage points [95% CI, −2.54 to 2.39 percentage points]) and GPs’ training (−1.46 percentage points [95% CI, −3.44 to 0.53 percentage points]). Subgroup analyses found a significant interaction between at-school vaccination and access to GPs, with a higher effect when access was poor (8.62 percentage points [95% CI, 5.37-11.86 percentage points] vs 2.13 percentage points [95% CI, −1.25 to 5.50 percentage points]; P = .007 for interaction). Conclusions and Relevance - In this cluster randomized trial, within the context of the late COVID-19 pandemic period and limited school and GP participation, at-school HPV vaccination significantly increased vaccination coverage. The trial did not show a significant effect for training GPs and education and motivation, although it may be observed after more time has elapsed after the intervention

The intentions of French health university students to recommend and to receive the HPV vaccine are mainly influenced by vaccine knowledge, confidence in vaccines and personal HPV vaccination

International audienceIntroduction: Despite documented effectiveness in preventing several cancers, genital warts and safety of Human Papillomavirus (HPV) vaccine, immunization coverage among French adolescents remains far from the 80 % target. University health students (HS) in France may promote HPV vaccine through a national service (Service Sanitaire des Etudiants en Santé). We aimed to evaluate intentions to recommend the HPV vaccine to friends and relatives, to receive HPV vaccine, and to identify factors associated with these attitudes.Methods: We conducted a cross-sectional survey in five French Universities from October 2019 to February 2020, using a self-administered online questionnaire. We used bivariable and multivariable logistic regression models to identify determinants of behavior around HPV vaccine: (i) individual intention for vaccination, and (ii) vaccine recommendation to friends and relatives.Results: Among the 732 respondents (180 men, 552 women), 305 (41.7%) reported previous HPV vaccination (54.5 % among women), 504 (68.9%) would recommend the HPV vaccine to friends and relatives, 532 (72.7%) respondents would be vaccinated today if it was recommended for them. Intentions to recommend or to receive the HPV vaccine were less frequent in nursing students compared to medical and pharmacy students. After adjustment for demographical factors, HPV vaccine knowledge was associated with intention [aOR 1.30 (95%-confidence interval, 1.15-1.47)] and recommendation [1.26 (1.10-1.45)], respectively. Additionally, adjusting for knowledge about HPV infections, and confidence in vaccines in general was associated with vaccine intention [1.55, (1.30-1.84)] and recommendation [1.52 (1.24-1.86)]. HPV-vaccinated HS were more prone to recommend the HPV vaccine to friends and relatives [10.9 (6.6-17.9)].Conclusion: A majority of HS would accept and/or recommend HPV vaccines. HS with greater knowledge about the HPV vaccine were more prone to recommend it. Strengthening knowledge about HPV and its vaccination is probably necessary before their Involvement in a HPV immunization program

Barriers and facilitators to the HPV vaccine: a multicenter qualitative study of French general practitioners

International audienceBackgroundIn France, human papillomavirus (HPV) vaccination coverage is low, with only 30.7% of 17-year-old girls having received a complete HPV vaccination schedule in 2020.AimThe aim of this study is to determine the perspective and behaviors of general practitioners (GPs) regarding HPV vaccination with their patients and to identify if a reluctance is observed.Design and SettingThis qualitative study is based on semi-directed individual interviews conducted between December 2019 and December 2020. A representative sample of GPs with various profiles was included from four French regions.MethodA purposive sampling method was employed, and interviews continued until data saturation was reached. The analysis was based on grounded theory.ResultsTwenty-six GPs aged 29–66 years were interviewed. The measures taken by the French health authorities (lowering the target age, reimbursing the vaccine, extending the target population to boys) were perceived as facilitators. Reported barriers included organizational challenges due to low attendance of adolescents, and relational barriers primarily due to parental vaccine hesitancy. Physicians had to address fears regarding perceived risks and concerns about sexuality associated with HPV vaccination, which were linked to the socio-cultural characteristics of families. Physicians developed strategies including mobilizing scientific knowledge, empowering families by promoting health through prevention, repetition of vaccination proposals, personal experience, and relationship. Different practices were identified according to three GP typologies: effective, convinced but unpersuasive, and reluctant physicians.ConclusionBased on these results, specific interventions, including communication techniques, especially for hesitant or unpersuasive physicians, are needed to enable GPs to become more effective

Do boys have the same intentions to get the HPV vaccine as girls? Knowledge, attitudes, and intentions in France

International audienceBackground: The vaccine coverage against human papillomavirus (HPV) vaccination remains low in France. The objective of this study was to study adolescent perceptions by comparing boys and girls, in order to build effective school-based interventions.Methods: This paper presents a cross-sectional study in French middle school pupils. They completed online questionnaires on their knowledge and attitudes toward the HPV vaccine, HPV vaccination status, their intention, reasons to vaccinate or not to vaccinate, and psychological antecedents of vaccination. A structural equation modeling (SEM) analysis was used to test the hypothesized model.Results: The participants are 818 pupils aged from 12 to 16 years (Mage = 13.78). Most pupils were in the pre-contemplative stage (62.7 % of boys and 40.8 % of girls). SEM analysis indicated that the relationship between the level of HPV knowledge, the representations of vaccines in general, and vaccine intention was mediated by attitudes towards the HPV vaccine among both boys and girls.Conclusions: These findings reveal a high percentage of boys who do not feel concerned by the HPV vaccine and highlight the need to consider the psychological antecedents of vaccination in general in addition to the specific attitudes to the HPV vaccine