Baptiste Leurent

Introduction: Child sexual abuse and exploitation (CSAE) are pervasive problems that significantly affect the health of children and adolescents. This paper presents the results of a cluster randomised controlled trial (cRCT) evaluating a school-based intervention designed to prevent CSAE in Brazil through education. Methods: We conducted a two-arm cRCT with parallel assignment in two Brazilian municipalities. Sixty schools were randomly allocated to intervention and control arms (30 per group) using stratified randomisation based on municipality and school type (municipal and state-run). We invited 50 randomly selected students, aged 12–17, from each school to complete surveys at baseline and endline. Teachers enrolled in GWV training completed an implementation questionnaire. Our primary analysis focused on a cross-sectional comparison of students’ CSAE risk knowledge between control and intervention schools. Results: We found no statistically significant difference in adolescents’ CSAE risk knowledge between the study arms (adjusted mean difference: 0.02, 95% CI −0.19 to 0.23, p = 0.87). There was borderline evidence of interaction by gender, with a greater difference in knowledge scores among girls (p = 0.032). No significant association was found between the number of GWV components implemented and knowledge scores. Discussion: Several factors may contribute to this result: the intervention might not have been implemented with sufficient fidelity or intensity, the true effect of GWV could be minimal and below the study's detection threshold, the intervention may have influenced outcomes that were not measured, or the intervention may simply lack effectiveness. Further rigorous evaluations and implementation studies are essential to ensure that resources are directed toward effective strategies. Trial registration: The American Economic Association’s registry for randomised controlled trials (AEA RCT Registry). RCT ID: AEARCTR-0011299, https://www.socialscienceregistry.org/trials/11299

Introduction: Child sexual abuse and exploitation (CSAE) are pervasive problems that significantly affect the health of children and adolescents. This paper presents the results of a cluster randomised controlled trial (cRCT) evaluating a school-based intervention designed to prevent CSAE in Brazil through education. Methods: We conducted a two-arm cRCT with parallel assignment in two Brazilian municipalities. Sixty schools were randomly allocated to intervention and control arms (30 per group) using stratified randomisation based on municipality and school type (municipal and state-run). We invited 50 randomly selected students, aged 12 to 17, from each school to complete surveys at baseline and endline. Teachers enrolled in GWV training completed an implementation questionnaire. Our primary analysis focused on a cross-sectional comparison of students’ CSAE risk knowledge between control and intervention schools. Results: We found no statistically significant difference in adolescents’ CSAE risk knowledge between the study arms (adjusted mean difference: 0.02, 95% CI −0.19 to 0.23, p = 0.87). There was borderline evidence of interaction by gender, with a greater difference in knowledge scores among girls (p=0.032). No significant association was found between the number of GWV components implemented and knowledge scores. Discussion: Several factors may contribute to this result: the intervention might not have been implemented with sufficient fidelity or intensity, the true effect of GWV could be minimal and below the study’s detection threshold, the intervention may have influenced outcomes that were not measured, or the intervention may simply lack effectiveness. Further rigorous evaluations and implementation studies are essential to ensure that resources are directed toward effective strategies. Trial registration: The American Economic Association’s registry for randomised controlled trials (AEA RCT Registry). RCT ID: AEARCTR-0011299, https://www.socialscienceregistry.org/trials/11299 Funding: Funding for this study was granted by the United States Department of State under the terms of Cooperative Agreement No. SSJTIP20CA0026, through the Human Trafficking Research Initiative, managed by Innovations for Poverty Action

Background: The clinical translation of positron emission tomography (PET) radiotracers for cancer management presents complex challenges. We have developed consensus-based recommendations for preclinical and clinical assessment of novel and established radiotracers, applied to image different cancer types, to improve the standardisation of translational methodologies and accelerate clinical implementation. Methods: A consensus process was developed using the RAND/UCLA Appropriateness Method (RAM) to gather insights from a multidisciplinary panel of 38 key stakeholders on the appropriateness of preclinical and clinical methodologies and stakeholder engagement for PET radiotracer translation. Panellists independently completed a consensus survey of 57 questions, rating each on a 9-point Likert scale. Subsequently, panellists attended a consensus meeting to discuss survey outcomes and readjust scores independently if desired. Survey items with median scores ≥ 7 were considered ‘required/appropriate’, ≤ 3 ‘not required/inappropriate’, and 4–6 indicated ‘uncertainty remained’. Consensus was determined as ~ 70% participant agreement on whether the item was ‘required/appropriate’ or ‘not required/not appropriate’. Results: Consensus was achieved for 38 of 57 (67%) survey questions related to preclinical and clinical methodologies, and stakeholder engagement. For evaluating established radiotracers in new cancer types, in vitro and preclinical studies were considered unnecessary, clinical pharmacokinetic studies were considered appropriate, and clinical dosimetry and biodistribution studies were considered unnecessary, if sufficient previous data existed. There was ‘agreement without consensus’ that clinical repeatability and reproducibility studies are required while ‘uncertainty remained’ regarding the need for comparison studies. For novel radiotracers, in vitro and preclinical studies, such as dosimetry and/or biodistribution studies and tumour histological assessment were considered appropriate, as well as comprehensive clinical validation. Conversely, preclinical reproducibility studies were considered unnecessary and ‘uncertainties remained’ regarding preclinical pharmacokinetic and repeatability evaluation. Other consensus areas included standardisation of clinical study protocols, streamlined regulatory frameworks and patient and public involvement. While a centralised UK clinical imaging research infrastructure and open access federated data repository were considered necessary, there was ‘agreement without consensus’ regarding the requirement for a centralised UK preclinical imaging infrastructure. Conclusions: We provide consensus-based recommendations, emphasising streamlined methodologies and regulatory frameworks, together with active stakeholder engagement, for improving PET radiotracer standardisation, reproducibility and clinical implementation in oncology.

Summary: Background: Water, sanitation and hygiene (WASH) interventions in schools may improve the health and school attendance of schoolchildren, particularly among post-menarcheal girls, but existing evidence is mixed. We examined the impact of an urban WASH in schools programme (Project WISE) on child health and attendance. Methods: The WISE cluster-randomised trial, conducted in 60 public primary schools in Addis Ababa, Ethiopia over one academic year, enrolled 2–4 randomly selected classes per school (approximately 100 pupils) from grades 2–8 (aged 7–16) in an ’open cohort’. Schools were assigned 1:1 by stratified randomisation to receive the intervention during the 2021/22 academic year or the 2022/23 academic year (waitlist control). Masking was not possible. The intervention included improvements to drinking water storage, filtration and access, alongside handwashing stations and behaviour change promotion. Planned improvements to sanitation facilities were not realised. At four unannounced classroom visits between March and June 2022 (post-intervention, approximately every four weeks), enumerators recorded primary outcomes of roll-call absence, and pupil-reported respiratory illness and diarrhoea in the past seven days among pupils present. Analysis was by intention-to-treat. This study is registered with ClinicalTrials.gov, number NCT05024890 . Findings: Of 83 eligible schools, 60 were randomly selected and assigned. In total, 6229 eligible pupils were enrolled (median per school 101·5; IQR 94–112), with 5987 enrolled at study initiation (23rd November–22nd December 2021) and the remaining 242 during follow-up. Data were available on roll-call absence for 6166 pupils (99·0%), and on pupil-reported illness for 6145 pupils (98·6%). We observed a 16% relative reduction in the odds of pupil-reported respiratory illness in the past seven days during follow-up in intervention schools vs. control schools (aOR 0·84; 95% CI 0·71– 1·00; p=0·046). No effect was observed on pupil-reported diarrhoea in the past seven days (aOR 1·15; 95% CI 0·84–1·59; p=0·39) nor roll-call absence (aOR 1·07; 95% 0·83–1·38; p=0·59). There was a small increase in menstrual care self-efficacy (aMD 3·32 on 0–100 scale; 95% CI 0·05–6·59), and no effects on the other health, wellbeing and absence secondary outcomes. Interpretation: This large-scale intervention to improve WASH conditions in schools across a large city had a borderline impact on respiratory illness among schoolchildren but no effect on diarrhoeal disease nor pupil absence. Future research should establish the relationships between WASH-related illness and absence and other downstream educational outcomes. Funding: Children’s Investment Fund Foundation. Panel: Research in context: Evidence before this study: Prior to this study, there were several systematic reviews on water, sanitation and hygiene (WASH) in schools, none of which used meta-analysis methods due to heterogeneity in intervention components and outcome measures. In the most comprehensive review in 2019, McMichael reported mixed evidence for the effectiveness of WASH in schools in low-income countries across health and educational outcomes, and randomised and non-randomised studies. Prior to starting this trial, there were two randomised trials conducted exclusively in urban schools in a low- or middle-income country: a handwashing trial in Cairo, Egypt examining absence due to influenza, and a trial of hand sanitizer and respiratory hygiene in Dhaka, Bangladesh for reducing influenza-like illness and laboratory-confirmed influenza. During this study, another randomised trial in Manila, Philippines was published, with different outcomes (malnutrition and dehydration). The effectiveness of combined water, sanitation and hygiene in urban schools on respiratory illness, diarrhoea and overall absence was not known, and some previous evaluations have used school records alone to track attendance. Previous studies evaluating WASH in schools interventions have suggested that multi-component interventions may be more effective, and that specific effects on girls’ absence might be observed with provision of a safe, private space to change menstrual materials. Added value of this study: This study provides rigorous experimental evidence on the effectiveness of an urban school-based water and hygiene intervention in reducing pupil-reported respiratory illness among schoolchildren, during the COVID-19 pandemic. There was no evidence of effects on pupil-reported diarrhoea or absence, nor gender-specific effects on absence. We highlight the value of unannounced visits for absence tracking with comparison to pupil-reported absence, and the need to distinguish seasonal and pandemic illness in future trials. Implications of all the available evidence: Our results are consistent with the mixed impacts on health and absence found in previous WASH in schools evaluations. The lack of detected effects on diarrhoea, attendance and secondary outcomes related to wellbeing and menstrual health should be considered in light of the absence of sanitation infrastructure improvements, which were not delivered until after trial completion, which may have influenced risk of diarrhoeal disease. Nonetheless, school absence is multi-factorial, and these findings temper expectations that absence can be impacted by reductions in one domain of illness and not the many other important drivers linked to poverty and gender, and few programmes are likely to be able to obtain a more ambitious infrastructure and behaviour change programme at the scale of the one included in this trial, which is currently being replicated in other cities across Ethiopia.

In this article, we introduce a new command, clan , that conducts a cluster-level analysis of cluster randomized trials. The command simplifies adjusting for individual- and cluster-level covariates and can also account for a stratified design. It can be used to analyze a continuous, binary, or rate outcome.

The spread of COVID-19 has brought challenges to health, social and economic systems around the world. With little to no prior immunity in the global population transmission has been driven primarily by human interaction. However, as with common respiratory illnesses such as the flu it's suggested that COVID-19 may become seasonal as immunity grows. Yet the effects of meteorological conditions on the spread of COVID-19 are poorly understood with previous studies producing contrasting results, due at least in part to limited and inconsistent study designs. This study investigates the effect of meteorological conditions on COVID-19 infections in England using a spatio-temporal model applied to case counts during the initial England lockdown. By modelling spatial and temporal effects to account for the nature of a human transmissible virus the model isolates meteorological effects. Inference based on 95% highest posterior density intervals shows humidity is negatively associated with COVID-19 spread. The lack of evidence for other weather factors affecting COVID-19 transmission shows care should be taken with respect to seasonality when designing COVID-19 policies and public communications.

Background: Psychosocial interventions delivered by nonspecialists can be effective at reducing common adolescent mental health problems in low-resource settings. However, there is a lack of evidence on resource-efficient methods for building capacity to deliver these interventions. Objective: The objective of this study is to evaluate the effects of a digital training (DT) course, delivered in a self-guided format or with coaching, on nonspecialists’ competency to deliver a problem-solving intervention intended for adolescents with common mental health problems in India. Methods: We will conduct a pre-post study with a nested parallel, 2-arm, individually randomized controlled trial. The study aims to recruit 262 participants, randomized 1:1 to receive either a self-guided DT course or a DT course with weekly individualized coaching provided remotely by telephone. In both arms, the DT will be accessed over 4 to 6 weeks. Participants will be nonspecialists (ie, without prior practice-based training in psychological therapies) recruited from among university students and affiliates of nongovernmental organizations in Delhi and Mumbai, India. Results: Outcomes will be assessed at baseline and 6 weeks post randomization using a knowledge-based competency measure that incorporates a multiple-choice quiz format. The primary hypothesis is that self-guided DT will lead to increased competency scores among novices with no prior experience of delivering psychotherapies. The secondary hypothesis is that digital training with coaching will have an incremental effect on competency scores compared with DT alone. The first participant was enrolled on April 4, 2022. Conclusions: The study will address an evidence gap on the effectiveness of training methods for nonspecialist providers of adolescent mental health interventions in low-resource settings. The findings from this study will be used to support wider efforts to scale up evidence-based mental health interventions for young people. Trial Registration: ClinicalTrials.gov NCT05290142; https://clinicaltrials.gov/ct2/show/NCT05290142 International Registered Report Identifier (IRRID): DERR1-10.2196/41981

BACKGROUND Psychosocial interventions delivered by nonspecialists can be effective at reducing common adolescent mental health problems in low-resource settings. However, there is a lack of evidence on resource-efficient methods for building capacity to deliver these interventions. OBJECTIVE The objective of this study is to evaluate the effects of a digital training (DT) course, delivered in a self-guided format or with coaching, on nonspecialists’ competency to deliver a problem-solving intervention intended for adolescents with common mental health problems in India. METHODS We will conduct a pre-post study with a nested parallel, 2-arm, individually randomized controlled trial. The study aims to recruit 262 participants, randomized 1:1 to receive either a self-guided DT course or a DT course with weekly individualized coaching provided remotely by telephone. In both arms, the DT will be accessed over 4 to 6 weeks. Participants will be nonspecialists (ie, without prior practice-based training in psychological therapies) recruited from among university students and affiliates of nongovernmental organizations in Delhi and Mumbai, India. RESULTS Outcomes will be assessed at baseline and 6 weeks post randomization using a knowledge-based competency measure that incorporates a multiple-choice quiz format. The primary hypothesis is that self-guided DT will lead to increased competency scores among novices with no prior experience of delivering psychotherapies. The secondary hypothesis is that digital training with coaching will have an incremental effect on competency scores compared with DT alone. The first participant was enrolled on April 4, 2022. CONCLUSIONS The study will address an evidence gap on the effectiveness of training methods for nonspecialist providers of adolescent mental health interventions in low-resource settings. The findings from this study will be used to support wider efforts to scale up evidence-based mental health interventions for young people. CLINICALTRIAL ClinicalTrials.gov NCT05290142; https://clinicaltrials.gov/ct2/show/NCT05290142 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/41981