Co-development of a school-based and primary care-based multicomponent intervention to improve HPV vaccine coverage amongst French adolescents (the PrevHPV Study).

INTRODUCTION: Despite various efforts to improve human papillomavirus (HPV) vaccine coverage in France, it has always been lower than in most other high-income countries. The health authorities launched in 2018 the national PrevHPV research programme to (1) co-develop with stakeholders and (2) evaluate the impact of a multicomponent complex intervention aimed at improving HPV vaccine coverage amongst French adolescents. OBJECTIVE: To describe the development process of the PrevHPV intervention using the GUIDance for rEporting of intervention Development framework as a guide. METHODS: To develop the intervention, we used findings from (1) published evidence on effective strategies to improve vaccination uptake and on theoretical frameworks of health behaviour change; (2) primary data on target populations' knowledge, beliefs, attitudes, preferences, behaviours and practices as well as the facilitators and barriers to HPV vaccination collected as part of the PrevHPV Programme and (3) the advice of working groups involving stakeholders in a participatory approach. We paid attention to developing an intervention that would maximise reach, adoption, implementation and maintenance in real-world contexts. RESULTS: We co-developed three components: (1) adolescents' and parents' education and motivation using eHealth tools (web conferences, videos, and a serious video game) and participatory learning at school; (2) general practitioners' e-learning training on HPV using motivational interviewing techniques and provision of a decision aid tool and (3) easier access to vaccination through vaccination days organised on participating middle schools' premises to propose free of charge initiation of the HPV vaccination. CONCLUSION: We co-developed a multicomponent intervention that addresses a range of barriers and enablers of HPV vaccination. The next step is to build on the results of its evaluation to refine it before scaling it up if proven efficient. If so, it will add to the small number of multicomponent interventions aimed at improving HPV vaccination worldwide. PATIENT OR PUBLIC CONTRIBUTION: The public (adolescents, their parents, school staff and health professionals) participated in the needs assessment using a mixed methods approach. The public was also involved in the components' development process to generate ideas about potential activities/tools, critically revise the successive versions of the tools and provide advice about the intervention practicalities, feasibility and maintenance.

Promoting HPV vaccination at school: a mixed methods study exploring knowledge, beliefs and attitudes of French school staff.

BACKGROUND: HPV vaccine coverage in France remained lower than in most other high-income countries. Within the diagnostic phase of the national PrevHPV program, we carried out a mixed methods study among school staff to assess their knowledge, beliefs and attitudes regarding HPV, HPV vaccine and vaccination in general, and regarding schools' role in promoting HPV vaccination. METHODS: Middle school nurses, teachers and support staff from four French regions participated between January 2020 and May 2021. We combined: (i) quantitative data from self-administered online questionnaires (n = 301), analysed using descriptive statistics; and (ii) qualitative data from three focus groups (n = 14), thematically analysed. RESULTS: Less than half of respondents knew that HPV can cause genital warts or oral cancers and only 18% that no antiviral treatment exists. Almost 90% of the respondents knew the existence of the HPV vaccine but some misunderstood why it is recommended before the first sexual relationships and for boys; 56% doubted about its safety, especially because they think there is not enough information on this topic. Schools nurses had greater knowledge than other professionals and claimed that educating pupils about HPV was fully part of their job roles; however, they rarely address this topic due to a lack of knowledge/tools. Professionals (school nurses, teachers and support staff) who participated in the focus groups were unfavourable to offering vaccination at school because of parents' negative reactions, lack of resources, and perceived uselessness. CONCLUSIONS: These results highlight the need to improve school staff knowledge on HPV. Parents should be involved in intervention promoting HPV vaccination to prevent their potential negative reactions, as feared by school staff. Several barriers should also be addressed before organizing school vaccination programs in France.

Can physicians and schools mitigate social inequalities in human papillomavirus vaccine awareness, uptake and vaccination intention among adolescents? A cross-sectional study, France, 2021 to 2022.

BackgroundIn France, human papillomavirus (HPV) vaccination coverage varies across socioeconomic levels.AimWe aimed at assessing HPV vaccine awareness, uptake and vaccination intention among adolescents in France.MethodsIn a cluster-randomised study, 13-15-year-old students in 61 French middle schools completed a web-based questionnaire. We used multivariable logistic regression to evaluate determinants of HPV vaccine awareness, self-reported uptake and vaccination intention among unvaccinated students and interaction terms to explore effects of visits to family physician and remembering school lessons on vaccination. The French deprivation index of school municipalities served as proxy for socioeconomic levels.ResultsAmong 6,992 participants, awareness was significantly associated with parental education (odds ratio (OR) = 0.82; 95% confidence interval (CI): 0.71-0.95), language spoken at home (OR = 0.59; 95% CI: 0.52-0.66) and deprivation level (OR = 0.57; 95% CI: 0.44-0.71), regardless of physician visit or school lessons. Vaccine uptake was associated with parental education without a recent physician visit (OR = 0.31; 95% CI: 0.16-0.59, vs OR = 0.64; 95% CI: 0.52-0.78 with a visit, interaction p = 0.045). Vaccination intention among unvaccinated was associated with deprivation level (moderate-low vs low) among students not remembering school lessons on vaccination (OR = 0.17; 95% CI: 0.05-0.62, vs OR = 0.93; 95% CI: 0.51-1.67 remembering school lessons, interaction p = 0.022). Parental education was associated with vaccination intention among students reporting a physician visit (OR = 0.41; 95% CI: 0.26-0.64 vs OR = 1.05; 95% CI: 0.50-2.20 without a visit, interaction p = 0.034).ConclusionOur results suggest that healthcare and school could promote vaccination and mitigate social inequalities in HPV vaccination coverage.

The ABC taxonomy for medication adherence translated into French and German.

AIMS: We translated the ABC adherence taxonomy (i.e. 7 terms and their corresponding definitions) published by Vrijens et al. (2012) into French and German without changing the original meaning with the aim to promote a standardised taxonomy for medication adherence to French- and German-speaking researchers and clinicians. METHODS: A Delphi survey was performed. To generate round 1, we identified French and German synonyms for the 7 adherence terms through a literature search in PubMed. Investigators translated the original English definitions into French and German. Panellists were members of ESPACOMP-the International Society for Patient Medication Adherence; experts suggested by ESPACOMP members and first authors of medication adherence publications in French and German. Google forms were used to create online questionnaires. Delphi rounds were performed until consensus was reached. The consensus was defined according to the acceptance rate as moderate consensus (50-75%), consensus (>75-95%), and strong consensus (>95%). RESULTS: The literature search resulted in 4-6 (French) and 4-7 (German) items per English term. Delphi rounds were launched between November 2016 and April 2018. Three rounds sufficed to reach consensus on all terms and definitions from 26 French-speaking and 25 German-speaking panellists. Preferred terms for medication adherence are adhésion médicamenteuse (82%) in French and Medikamentenadhärenz (88%) in German. CONCLUSION: The use of a common terminology for medication adherence with translations in French and German will contribute to standardise the vocabulary, to harmonise research projects and ultimately ease comparison of study results among researchers and clinicians.

Do compensatory health beliefs predict behavioural intention in a multiple health behaviour change context? Evidence in individuals with cardiovascular diseases?

Multiple health behaviour change (MHBC) represents one of the best ways to prevent reoccurrence of cardiovascular events. However, few individuals with cardiovascular diseases engage in this process. The present study examined the role of compensatory health beliefs (CHB; i.e., belief that a healthy behaviour compensates an unhealthy one) as a drag to engagement in this process. Some studies have shown that CHBs predict intention to engage in healthy behaviours, but no study has investigated CHBs in individuals who actually need to change multiple health behaviours. The goal was to better understand the role of CHBs in intentions formation process among individuals with cardiac diseases in an MHBC context. One hundred and four patients completed a questionnaire at the beginning of their cardiac rehabilitation program. Results showed that: (1) CHBs negatively predicted intentions (2) but only for participants with high self-efficacy or low risk perception; (3) CHBs predictions differed depending on the nature of the compensating behaviour, and were more predictive when medication intake was the compensating one. Findings only partially confirmed previous research conducted on healthy individuals who were not in an MHBC process, and emphasized the importance of considering CHBs for individuals in this process.

How best to use and evaluate Patient Information Leaflets given during a consultation: a systematic review of literature reviews.

BACKGROUND: In the past, several authors have attempted to review randomized clinical trials (RCT) evaluating the impact of Patient Information Leaflets (PILs) used during a consultation and draw some general conclusions. However, this proved difficult because the clinical situations, size and quality of RCTs were too heterogeneous to pool relevant data. OBJECTIVE: To overcome this 30-year stalemate, we performed a review of reviews and propose general recommendations and suggestions for improving the quality of PILs, how to use them and methods for evaluating them. METHODOLOGY: We searched five databases for reviews, systematic reviews and meta-analyses describing PILs. We drew general and condition-linked conclusions concerning the impact of PILs. Checklists summarize criteria for quality PILs, and ways of using and evaluating them. RESULTS: Of 986 articles found, 24 reviews were pertinent; the five oldest considered the impact of PILs irrespective of the condition the patient consulted for; the 19 more recent ones mostly addressed precise clinical situations. DISCUSSION: Whatever the clinical situation, PILs improve patients' knowledge and satisfaction. For acute conditions, in the short-term PILs also improve adherence to treatment. For chronic diseases, invasive procedures or screening situations, their impact on adherence varies depending on the context, how the PILs are given and the invasiveness of the intervention. CONCLUSION: PILs are considered to be very useful, especially for acute conditions where the patient is the first to suffer from lack of information. We propose checklists for writing, designing, using and evaluating PILs in RCTs to enable comparisons between different studies.

Are vaccination uptake and non-uptake influenced by our emotions? An experimental study on the role of emotional processes and compassion.

OBJECTIVE: This study examined the effects of emotional arousal, emotional competence, emotion regulation (ER), and compassion on COVID-19 and flu vaccination intentions (VI) among the French population. DESIGN: Data were collected online from October to December 2020. Altogether, 451 participants (Mage = 35.8, SD = 16.4) were allocated to four groups. High positive (n = 104) or negative (n = 103) emotional arousal were induced into two groups using pictures and music, and compared against a control group (flu group; n = 116) and a reference group (COVID-19 group; n = 114). All groups completed questionnaires on emotional arousal, ER, emotional competence, compassion, and VI. RESULTS: The findings indicated a significant effect of group on VI, h2=.023, 95% CI [-.002, .09]. The Group*Gender interaction on emotional arousal was non-significant, ηp2=.015, 95%CI [.000, .041]. However, emotional arousal was observed to have a significant main effect on VI, ηp2=.09, 95% CI [.043, .238]. The ER type*Emotional arousal*Gender interaction on ER use was trend, ηp2 = .002, 95% CI [.000, .005]. The emotional competence*ER type interaction on ER use was significant, ηp2 = .028, 95% CI [.011, .049]. Only experiential avoidance mediated the relationship between emotional arousal and VI, p < .018, 95% CI [.015, .18]. CONCLUSION: Emotional arousal impacts VI. High emotional competence only reduces the use of dysfunctional ER strategies.

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

BACKGROUND: 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.

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

BACKGROUND: In France, human papillomavirus (HPV) vaccination coverage is low, with 30.7% of 17-year-old girls having received a complete HPV vaccination schedule in 2020. AIM: To determine the perspective and behaviors of general practitioners (GPs) regarding HPV vaccination with their patients and if a reluctance is observed. DESIGN AND SETTING: A qualitative study based on semi-directed individual interviews was conducted between December 2019 and December 2020. A representative sample of GPs with various profiles were included in 4 French regions. METHOD: A purposive sampling was used and interviews were continued until data saturation was reached. The analysis was based on the grounded theory. RESULTS: Twenty-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. The reported barriers were organizational, due to low attendance of adolescents, and relational, mainly due to parental vaccine hesitancy. Physicians had to deal with fears about the perceived risks and concerns about sexuality conveyed by HPV vaccination and linked to the socio-cultural characteristics of the families. Physicians developed strategies, including scientific knowledge mobilization, empowerment of families by promoting health through prevention, repetition of the vaccination proposals, personal experience and relationship. Different practices were identified according to three GP typologies: effective, convinced but unpersuasive, and reluctant physicians. CONCLUSION: Based on these results, specific interventions, including communication techniques, especially for hesitant or unpersuasive physicians, are needed to enable GPs to become more effective.

Effectiveness of a School- and Primary Care-Based HPV Vaccination Intervention: The PrevHPV Cluster Randomized Trial.

Importance: 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. Trial Registration: ClinicalTrials.gov Identifier: NCT04945655.

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.

INTRODUCTION: 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.

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

BACKGROUND: 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.

Cognitive behavioral stress management for parents: Prevention and reduction of parental burnout.

Context: Parental burnout increases the risk of deleterious consequences on parents', couples', and children's physical and mental health. Methods: The current study (N = 134) aimed to assess the effectiveness of a Cognitive Behavioural Stress Management (CBSM) group programme in terms of parental burnout reduction. In total 67 parents attended the 8-week CBSM intervention groups, and another 67 parents were assigned to the waiting-list control group. We compared the effectiveness of the CBSM intervention with a waiting-list control group directly after the end of the programme and at three-months follow-up. Results: The results showed that compared to the control group the CBSM programme contributed to the reduction of parental burnout symptoms with statistically significant and small effect size. Moreover, the contrast analyses showed that the reduction in parental burnout severity was maintained at 3 month-follow-up. The reduction in parental burnout scores was mediated by the decrease in stress and the increase in unconditional self-kindness. Conclusions: These results highlight the potential benefits of the CBSM programme for parental burnout prevention and reduction.

Psychometric validation of a 7C-model of antecedents of vaccine acceptance among healthcare workers, parents and adolescents in France.

Support for vaccine decision-making requires a tailored approach taking into account psychological antecedents of vaccine acceptance. We aimed at validating an extended 7C-model of antecedents in three different target population groups (healthcare workers [n = 3870], parents [n = 2002] and adolescents [n = 7118]) and two vaccinations (COVID-19, HPV) in France. We performed a secondary analysis of questionnaires collecting sociodemographic characteristics, attitudes and knowledge on vaccination, and vaccine status and intention. We used standard psychometric techniques to validate a first and second order latent structure, and evaluated their association with vaccine intentionality in three levels (refusal, indecision, acceptance). In all populations, the 7C-model yielded a very good model fit (CFI and TLI > 0.90) and, in comparison with non-nested and nested 5C-models, significantly improved the model performance (Ω2, p < 0.05; Wald's test, p < 0.05). The resulting vaccine readiness score was strongly associated with vaccine intentionality (acceptance vs. indecision: ßHCW = 2.93, ßParents = 2.41, ßAdolescents = 1.34; refusal vs. indecision: ßHCW = - 1.68, ßParents = - 0.16, ßAdolescents = - 0.89.). The addition of confidence in the system and social conformism among antecedents of vaccine acceptance allowed a finer understanding of the continuum moving from refusal to indecision and acceptance. To work with these antecedents in interventional research, appropriate questionnaire items should be developed for various vaccines and target populations.

How can we improve the acceptability of vaccination against Human Papillomavirus (HPV) in France? An original qualitative study with focus groups comprising parents and school staff, interviewed separately.

BACKGROUND: It has been proven that vaccination is effective against Human Papillomavirus (HPV) infections, genital warts, and pre-cancerous and cancerous cervical lesions. Nevertheless, the HPV vaccine coverage of 37.4 % in 2021 in France is one of the lowest in Europe. To explore and understand the reason why French population is so late compared to its neighbours, we carried out focus groups with mothers and with National Education school staff. We aimed to identify knowledge and perceptions of HPV in both study populations, as well as factors influencing HPV vaccination. METHODS: Between January 2020 and March 2021, we performed a qualitative study using an inductive approach with a thematic content analysis (TCA). We conducted semi-structured focus groups with 29 people including 15 mothers of adolescents in middle schools and 14 school staff from the national education system. RESULTS: Different factors influenced the decision-making process of parents and school staff: knowledge and perceptions of HPV and its vaccine, sources of information about HPV and vaccination. Mothers' discourses differed from those of school staff. They mentioned the importance of gynaecological monitoring and the negative image of pharmaceutical companies, and questioned internet as a reliable source of information. For their part, school staff mentioned cultural and/or religious affiliation, municipalities' role to inform the population, and ethical dilemma or logistical challenges regarding HPV vaccination in schools. CONCLUSION: The results of these focus groups provided information on which elements may harm or help HPV vaccination. Identified perceptions, beliefs, knowledge, barriers, and facilitators will help us to build an intervention program focus on general practitioners (GP), school staff, parents, and adolescents.

Impact of a school-based and primary care-based multicomponent intervention on HPV vaccination coverage among French adolescents: a cluster randomised controlled trial protocol (the PrevHPV study).

INTRODUCTION: Vaccination is an effective and safe strategy to prevent Human papillomavirus (HPV) infection and related harms. Despite various efforts by French authorities to improve HPV vaccine coverage (VC) these past few years, VC has remained far lower than in most other high-income countries. To improve it, we have coconstructed with stakeholders a school-based and primary care-based multicomponent intervention, and plan to evaluate its effectiveness, efficiency and implementation through a cluster randomised controlled trial (cRCT). METHODS AND ANALYSIS: This pragmatic cRCT uses an incomplete factorial design to evaluate three components applied alone or in combination: (1) adolescents and parents' education and motivation at school, using eHealth tools and participatory learning; (2) general practitioners' training on HPV using motivational interviewing techniques and provision of a decision aid tool; (3) free-of-charge access to vaccination at school. Eligible municipalities (clusters) are located in one of 14 preselected French school districts and must have only one secondary school which enrols at least 2/3 of inhabitants aged 11-14 years. A randomisation stratified by school district and deprivation index allocated 90 municipalities into 6 groups of 15. The expected overall sample size estimate is 41 940 adolescents aged 11-14 years. The primary endpoint is the HPV VC (≥1 dose) among adolescents aged 11-14 years, at 2 months, at the municipality level (data from routine databases). Secondary endpoints include: HPV VC (≥1 dose at 6 and 12 months; and 2 doses at 2, 6 and 12 months); differences in knowledge, attitudes, behaviours, and intention among adolescents, parents and general practitioners between baseline and 2 months after intervention (self-administered questionnaires); incremental cost-effectiveness ratio. Implementation measures include dose, fidelity, adaptations, reached population and satisfaction (activity reports and self-administered questionnaires). ETHICS AND DISSEMINATION: This protocol was approved by the French Ethics Committee 'CPP Sud-Est VI' on 22 December 2020 (ID-RCB: 2020-A02031-38). No individual consent was required for this type of research; all participants were informed of their rights, in particular not to participate or to oppose the collection of data concerning them. Findings will be widely disseminated (conference presentations, reports, factsheets and academic publications). TRIAL REGISTRATION NUMBER: NCT04945655.

An exploratory clinical trial on acceptance and commitment therapy as an adjunct to psychoeducational relaxation therapy for chronic pain.

Objective: The aim of this study was to compare the clinical efficacy of two differently-designed psychological interventions for chronic pain.Design: 138 patients presenting chronic pain were randomly assigned to one of two experimental conditions: (1) Psychoeducational relaxation therapy (PRT, n = 84) or (2) PRT followed by acceptance and commitment therapy (PRT + ACT, n = 54).Main outcome measures: Pain intensity, quality of life (SF-36), anxiety and depression (HADS), stress (PSS), pain catastrophizing (PCS), chronic pain acceptance (CPAQ), and psychological inflexibility (PIPS) were assessed at three time-points: before therapy (T1); at the end of the therapy (T2); and 3- months after the end of the therapy (T3).Results: In T2, the PRT intervention showed more significant improvements in the measures of mental quality of life [F (1,92) = 7.478, P < .05] and depression [F (1, 92) = 5.804, P < .05] compared to the PRT + ACT intervention. The experimental groups did not differ in their outcome measures at T3.Conclusion: PRT appears to be an effective solution in the psychological care of chronic pain. The effectiveness of this type of intervention seems to have been underestimated. The addition of ACT sessions did not significantly impact the results, indicating that both designs of interventions are effective in the short term.

Seasonal flu vaccination, a matter of emotion? An experimental study on role of compassion, socioeconomic status and perceived threat among healthcare workers.

OBJECTIVE: This study tests the impact of threat on compassion and vaccination intention among healthcare workers (HCWs) with low and high socio-economic status (SES) in France. DESIGN: A total of 309 HCWs were analyzed (Mage=39.29, SD = 11.76). Participants with high (n = 138) or low (n = 171) SES were randomly assigned to a Threat (n = 187) versus a No-Threat (n = 122) condition through filling in MacArthur's scale. During this manipulation, participants read about an interaction involving a HCW with an SES higher than that of the participant. After filling in the MacArthur scale, all participants went through a compassion manipulation. Finally, participants read a text describing a patient's distress. MAIN OUTCOME MEASURES: The primary outcome was the vaccination intention score. The secondary outcome included the compassion score. RESULTS: The interaction of the Group X SES Subjective on compassion was not significant (p = .34, ηp2 = .003, 95%CI [-.39,.07]). The interaction of the Group X Diploma on vaccination intention with high compassion was significant (p<.001, ηp2 = .173, 95%CI [.11,1.68]). Planned comparisons revealed a significant difference in vaccination intention score between HCWs with low SES between Threat (M = 3.58, SD = 2.56) and No-Threat (M = 5.27, SD = 2.27; p=.01) conditions. CONCLUSION: Ultimately, compassion inhibited the distress elicited in the threat condition in HCWs with high compassion.

Improving Mental Health and Well-Being through Informal Mindfulness Practices: An Intervention Study.

BACKGROUND: Mindfulness-based programs have been shown to be effective in reducing stress, anxiety, and depression symptoms, and enhancing well-being. However, it remains unclear whether longer formal mindfulness practices are necessary to obtain such results. We therefore aimed to assess the effectiveness of a program (FOVEA, 8 weeks, 2h/week) which was only based on brief and informal practices. METHODS: Using a switching replication design, participants (N = 139) were assigned to a FOVEA or a wait-list group, and completed the following self-report questionnaires online at three time points: perceived stress, anxiety, depression, satisfaction with life (dependent variables), and mindfulness (mediating variable). They also completed a daily practice diary. RESULTS: Relative to the wait-list group, FOVEA participants showed significantly reduced perceived stress, anxiety, and depression, and increased satisfaction with life. These changes were completely mediated by increased mindfulness, and were maintained 2.5 months after the end of the program. The effect sizes were moderate to large. CONCLUSIONS: These results underline the potential benefits of a mindfulness informal practices program for the general population. This type of program could constitute a first step towards more formal practices once the motivation to practice has been enhanced by the perceived benefits of brief practices.

Optimising HPV vaccination communication to adolescents: A discrete choice experiment.

BACKGROUND: 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.