Potential impact of climatic factors on malaria in Rwanda between 2012 and 2021: a time-series analysis.

BACKGROUND: Malaria remains an important public health problem, particularly in sub-Saharan Africa. In Rwanda, where malaria ranks among the leading causes of mortality and morbidity, disease transmission is influenced by climatic factors. However, there is a paucity of studies investigating the link between climate change and malaria dynamics, which hinders the development of effective national malaria response strategies. Addressing this critical gap, this study analyses how climatic factors influence malaria transmission across Rwanda, thereby informing tailored interventions and enhancing disease management frameworks. METHODS: The study analysed the potential impact of temperature and cumulative rainfall on malaria incidence in Rwanda from 2012 to 2021 using meteorological data from the Rwanda Meteorological Agency and malaria case records from the Rwanda Health Management and Information System. The analysis was performed in two stages. First, district-specific generalized linear models with a quasi-Poisson distribution were applied, which were enhanced by distributed lag non-linear models to explore non-linear and lagged effects. Second, random effects multivariate meta-analysis was employed to pool the estimates and to refine them through best linear unbiased predictions. RESULTS: A 1-month lag with specific temperature and rainfall thresholds influenced malaria incidence across Rwanda. Average temperature of 18.5 °C was associated with higher malaria risk, while temperature above 23.9 °C reduced the risk. Rainfall demonstrated a dual effect on malaria risk: conditions of low (below 73 mm per month) and high (above 223 mm per month) precipitation correlated with lower risk, while moderate rainfall (87 to 223 mm per month) correlated with higher risk. Seasonal patterns showed increased malaria risk during the major rainy season, while the short dry season presented lower risk. CONCLUSION: The study underscores the influence of temperature and rainfall on malaria transmission in Rwanda and calls for tailored interventions that are specific to location and season. The findings are crucial for informing policy that enhance preparedness and contribute to malaria elimination efforts. Future research should explore additional ecological and socioeconomic factors and their differential contribution to malaria transmission.

Spatio-temporal dynamics of malaria in Rwanda between 2012 and 2022: a demography-specific analysis.

BACKGROUND: Despite global efforts to reduce and eventually interrupt malaria transmission, the disease remains a pressing public health problem, especially in sub-Saharan Africa. This study presents a detailed spatio-temporal analysis of malaria transmission in Rwanda from 2012 to 2022. The main objective was to gain insights into the evolving patterns of malaria and to inform and tailor effective public health strategies. METHODS: The study used yearly aggregated data of malaria cases from the Rwanda health management information system. We employed a multifaceted analytical approach, including descriptive statistics and spatio-temporal analysis across three demographic groups: children under the age of 5 years, and males and females above 5 years. Bayesian spatially explicit models and spatio scan statistics were utilised to examine geographic and temporal patterns of relative risks and to identify clusters of malaria transmission. RESULTS: We observed a significant increase in malaria cases from 2014 to 2018, peaking in 2016 for males and females aged above 5 years with counts of 98,645 and 116,627, respectively and in 2018 for under 5-year-old children with 84,440 cases with notable geographic disparities. Districts like Kamonyi (Southern Province), Ngoma, Kayonza and Bugesera (Eastern Province) exhibited high burdens, possibly influenced by factors such as climate, vector control practices, and cross-border dynamics. Bayesian spatially explicit modeling revealed elevated relative risks in numerous districts, underscoring the heterogeneity of malaria transmission in these districts, and thus contributing to an overall rising trend in malaria cases until 2018, followed by a subsequent decline. Our findings emphasize that the heterogeneity of malaria transmission is potentially driven by ecologic, socioeconomic, and behavioural factors. CONCLUSIONS: The study underscores the complexity of malaria transmission in Rwanda and calls for climate adaptive, gender-, age- and district-specific strategies in the national malaria control program. The emergence of both artemisinin and pyrethoids resistance and persistent high transmission in some districts necessitates continuous monitoring and innovative, data-driven approaches for effective and sustainable malaria control.

One Health as a potential platform to rescue the neglected fruit trees in Yucatan, Mexico.

Neglected and underutilized species of plants (NUS) have been identified by the Food and Agriculture Organization as valuable resources for fighting poverty, hunger and malnutrition as they can help make agricultural production systems more sustainable and resilient. Adaptation of NUS to changing environments over several millennia has rendered most of these plants resistant to pests and climate change. In this paper, we explore the potential values of some of the Mayan fruit trees justifying conservation efforts in their native habitats. Our research was primarily based on a scoping review using Google Scholar. We considered articles published in English, Spanish and Portuguese. Our review rendered two sets of articles including those focusing on the nutritional and medicinal properties of NUS and their products, and those focusing on their uses in traditional medicine. Both sets of papers strongly support arguments for conservation of NUS. Additionally, our scoping review expands and includes a case study on the conservation of NUS, highlighting the critical role of civil society on how it can spearhead rescue efforts of botanical resources through the creation of what is possibly the first arboretum of its kind in the Americas. Among the project's key selling points was not only the rescue of an important component of Yucatan's cultural heritage but its nutritional value as well as its potential medicinal properties. Our paper is not prescriptive on how to preserve or even commercially exploit NUS. It is intended as a thought-provoking piece on the potential of a One Health approach as a multisectoral platform to support conservation efforts, while stimulating greater interest in the subject and encouraging more action from the academic and pharmaceutical sectors as well as civil society.

A review of climate change and cardiovascular diseases in the Indian policy context.

There is growing evidence that climate change adversely affects human health. Multiple diseases are sensitive to climate change, including cardiovascular diseases (CVDs), which are also the leading cause of death globally. Countries such as India face a compounded challenge, with a growing burden of CVDs and a high vulnerability to climate change, requiring a co-ordinated, multi-sectoral response. In this framework synthesis, we analysed whether and how CVDs are addressed with respect to climate change in the Indian policy space. We identified 10 relevant national-level policies, which were analysed using the framework method. Our analytical framework consisted of four themes: (i) political commitment; (ii) health information systems; (iii) capacity building; and (iv) cross-sectoral actions. Additionally, we analysed a subset of these policies and 29 state-level climate change and health action plans using content analysis to identify health priorities. Our analyses revealed a political commitment in addressing the health impacts of climate change; however, CVDs were poorly contextualized with most of the efforts focusing on vector-borne and other communicable diseases, despite their recognized burden. Heat-related illnesses and cardiopulmonary diseases were also focused on but failed to encompass the most climate-sensitive aspects. CVDs are insufficiently addressed in the existing surveillance systems, despite being mentioned in several policies and interventions, including emergency preparedness in hospitals and cross-sectoral actions. CVDs are mentioned as a separate section in only a small number of state-level plans, several of which need an impetus to complete and include CVD-specific sections. We also found several climate-health policies for specific diseases, albeit not for CVDs. This study identified important gaps in India's disease-specific climate change response and might aid policy makers in strengthening future versions of these policies and boost research and context-specific interventions on climate change and CVDs.

Public and Patient Involvement in Migration Health Research: Eritrean and Syrian Refugees' and Asylum Seekers' Views in Switzerland.

Prior research has highlighted important healthcare access and utilization issues among new forced immigrants. We aimed to explore the role that public and patient involvement (PPI) might play in enhancing accessibility and specific contributions to migration health studies. We conducted open and in-depth interactive virtual discussions with asylum seekers and refugees from Eritrea and Syria in Switzerland. The PPI establishment consisted of three phases: inception, training and contribution. Prior to training, the concept of PPI was not straightforward to grasp, as it was a new approach-however, after training and consecutive discussions, participants were ardent to engage actively. We conclude that PPI holds promise in regard to raising awareness, improving healthcare system accessibilities and utilization, and enhancing and strengthening migration health research. Indeed, PPI volunteers were keen to raise their community's awareness through their networks and bridge an important gap between researchers and the public.

Effectiveness of Three Sampling Approaches for Optimizing Mapping and Preventive Chemotherapy against Schistosoma mansoni in the Western Part of Côte d'Ivoire.

The elimination of schistosomiasis as a public health problem by 2030 is one of the main goals put forth in the World Health Organization's roadmap for neglected tropical diseases. This study aimed to compare different sampling approaches to guide mapping and preventive chemotherapy. A cross-sectional parasitological survey was conducted from August to September 2022 in the health districts of Biankouma, Ouaninou, and Touba in the western part of Côte d'Ivoire. The prevalence and intensity of Schistosoma mansoni infection were assessed in children aged 5-14 years using three sampling approaches. The first approach involved a random selection of 50% of the villages in the health districts. The second approach involved a random selection of half of the villages selected in approach 1, thus constituting 25% of the villages in the health district. The third approach consisted of randomly selecting 15 villages from villages selected by approach 2 in each health district. The overall prevalence of S. mansoni was 23.5% (95% confidence interval (CI): 19.9-27.6%), 21.6% (95% CI: 17.1-26.8%), and 18.3% (95% CI: 11.9-27.1%) with the first, second, and third approach, respectively. The respective geometric mean S. mansoni infection intensity was 117.9 eggs per gram of stool (EPG) (95% CI: 109.3-127.3 EPG), 104.6 EPG (95% CI: 93.8-116.6 EPG), and 94.6 EPG (95% CI 79.5-112.7 EPG). We conclude that, although randomly sampling up to 50% of villages in a health district provides more precise population-based prevalence and intensity measures of S. mansoni, randomly selecting only 15 villages in a district characterized by low heterogeneity provides reasonable estimates and is less costly.

Capacities and needs of health care facilities for schistosomiasis diagnosis and management in elimination settings.

BACKGROUND: Schistosomiasis is a debilitating neglected tropical disease endemic in sub-Saharan Africa. The role of health facilities in the prevention, diagnosis, control, and elimination of schistosomiasis is poorly documented. In a setting targeted for schistosomiasis elimination in Zanzibar, we assessed the prevalence of Schistosoma haematobium among patients seeking care in a health facility and investigated schistosomiasis-related knowledge of staff, and health facilities' capacities and needs for schistosomiasis diagnosis and management. METHODS: We conducted a health facility-based mixed-method study on Pemba Island from June to August 2023. Patients aged ≥ 4 years seeking care in four health facilities were screened for S. haematobium infection using urine filtration and reagent strips. Those patients aged ≥ 10 years were additionally interviewed about signs and symptoms. Staff from 23 health facilities responded to a questionnaire assessing knowledge and practices. Ten staff participated in a focus group discussion (FGD) about capacities and needs for schistosomiasis diagnosis and management. RESULTS: The prevalence of S. haematobium infection in patients attending the health facilities, as determined by the presence of eggs in urine, was 1.1% (8/712). Microhaematuria was detected in 13.3% (95/712) of the patients using reagent strips. Among patients responding to the questionnaire, pelvic pain, pain during sex, and painful urination were reported by 38.0% (237/623), 6.3% (39/623), and 3.2% (20/623), respectively. Among the health facility staff, 90.0% (44/49) and 87.8% (43/49) identified blood in urine and pelvic pain, respectively, as symptoms of urogenital schistosomiasis, 81.6% (40/49) and 93.9% (46/49) reported collecting a urine sample and pursuing a reagent strip test, respectively, for diagnosis, and 87.8% (43/49) administered praziquantel for treatment. The most reoccurring themes in the FGD were the need for more staff training about schistosomiasis, requests for diagnostic equipment, and the need to improve community response to schistosomiasis services in health facilities. CONCLUSIONS: The prevalence of S. haematobium infection in patients seeking care in health facilities in Pemba is very low and similar to what has been reported from recent community-based cross-sectional surveys. The health facility staff had good schistosomiasis-related knowledge and practices. However, to integrate schistosomiasis patient management more durably into routine health facility activities, scalable screening pathways need to be identified and capacities need to be improved by regular staff training, and an unbroken supply of accurate point-of-care diagnostics and praziquantel for the treatment of cases.

Rapid appraisal of liver diseases using transient elastography, abdominal ultrasound, and microbiology in Côte d'Ivoire: A single-center study.

BACKGROUND: Liver diseases of infectious and non-infectious etiology cause considerable morbidity and mortality, particularly in low- and middle-income countries (LMICs). However, data on the prevalence of liver diseases and underlying risk factors in LMICs are scarce. The objective of this study was to elucidate the occurrence of infectious diseases among individuals with chronic liver damage in a rural setting of Côte d'Ivoire. METHODOLOGY: In 2021, we screened 696 individuals from four villages in the southern part of Côte d'Ivoire for hepatic fibrosis and steatosis, employing transient elastography (TE) and controlled attenuation parameter (CAP). We classified CAP ≥248 dB/m as steatosis, TE ≥7.2 kPa as fibrosis, and did subgroup analysis for participants with TE ranging from 7.2 kPa to 9.1 kPa. Clinical and microbiologic characteristics were compared to an age- and sex-matched control group (TE <6.0 kPa; n = 109). Stool samples were subjected to duplicate Kato-Katz thick smears for diagnosis of Schistosoma mansoni. Venous blood samples were examined for hepatitis B and hepatitis C virus. Additionally, an abdominal ultrasound examination was performed. PRINCIPAL FINDINGS: Among 684 individuals with valid TE measurements, TE screening identified hepatic pathologies in 149 participants (17% with fibrosis and 6% with steatosis). 419 participants were included for further analyses, of which 261 had complete microbiologic analyses available. The prevalence of S. mansoni, hepatitis B, and hepatitis C were 30%, 14%, and 7%, respectively. Logistic regression analysis revealed higher odds for having TE results between 7.2 kPa and 9.1 kPa in individuals with S. mansoni infection (odds ratio [OR] = 3.02, 95% confidence interval [CI] = 1.58-5.76, P = 0.001), while HCV infection (OR = 5.02, 95% CI = 1.72-14.69, P = 0.003) and steatosis (OR = 4.62, 95% CI = 1.60-13.35, P = 0.005) were found to be risk factors for TE ≥9.2 kPa. CONCLUSIONS/SIGNIFICANCE: Besides viral hepatitis, S. mansoni also warrants consideration as a pathogen causing liver fibrosis in Côte d'Ivoire. In-depth diagnostic work-up among individuals with abnormal TE findings might be a cost-effective public health strategy.

Prevalence and Determinants of Undernutrition in Schoolchildren in the Kilombero District, South-Eastern Tanzania.

Childhood undernutrition is a major issue in low- and middle-income countries, affecting the health, well-being, and educational outcomes of schoolchildren. This study aimed to assess the prevalence and associated factors of stunting, wasting, and underweight among schoolchildren in peri-urban areas in the south-eastern part of Tanzania. A cross-sectional study was conducted involving 930 children aged 6-12 years from four primary schools from July to August 2019. The WHO Anthro Survey Analyzer was employed to estimate the prevalence of stunting, wasting, and underweight, while logistic regression analyses examined sociodemographic background, malaria infection, anaemia, anthropometric measures, and dietary diversity score as potential factors. The prevalence of stunting, wasting, underweight, overweight, and obesity was 11.8%, 4.3%, 3.9%, 11.1%, and 2.0%, respectively. Overall, 1.5% of the children had malaria, as determined by rapid diagnostic tests, and 0.4% had severe anaemia. Univariate analysis indicated higher odds of undernutrition among children aged 9-12 compared to their younger peers. Stunting was more common among children with low and medium dietary diversity. Anaemia was found in 11.2% of schoolchildren, and severe anaemia was associated with wasting. Multivariate analysis revealed that age and low dietary diversity were significantly associated with undernutrition. These findings emphasise the need for school-based health and nutrition programmes targeting children beyond the age of 5 to improve their nutritional status and mitigate potential adverse effects on health, cognition, and academic achievement. Regular assessment of the nutritional status of schoolchildren is warranted.

Prospects and Perspectives of Health Impact Assessment: A Systematic Review of the Peer-Reviewed Literature From June 2007 to January 2023.

Objectives: In 2008, an analysis investigating health impact assessment (HIA) practice found that only 6% of HIA-related peer-reviewed publications had a focus on low- and medium-developed countries, whereas 94% were conducted in countries with a high or very high development state. We aimed to update and deepen these observations. Methods: We conducted a systematic review, searching PubMed and Web of Science for HIA-related papers published in the scientific literature from June 2007 to January 2023. Only applied HIA and papers with HIA as a subject were included. Results: The search yielded 3,036 publications and the final selection consisted of 1,019 publications. The annual number of total publications increased considerably over the past 15 years. Whereas research-driven HIA (n = 460) showed a steep increase, step-by-step HIA (n = 71) did not show a clear trend. Conclusion: The gap between the number of HIA-related peer-reviewed publications focusing on low/medium and high/very high developed countries has diminished from 6/94 to 11/89. There is a growing tendency to apply the terminology HIA for health impact modelling studies and quantitative health risk assessments.

Multiplex PCR for bacterial, viral and protozoal pathogens in persistent diarrhoea or persistent abdominal pain in Côte d'Ivoire, Mali and Nepal.

In contrast to acute diarrhoea, the aetiology of persistent digestive disorders (≥ 14 days) is poorly understood in low-resource settings and conventional diagnostic approaches lack accuracy. In this multi-country study, we compared multiplex real-time PCR for enteric bacterial, parasitic and viral pathogens in stool samples from symptomatic patients and matched asymptomatic controls in Côte d'Ivoire, Mali and Nepal. Among 1826 stool samples, the prevalence of most pathogens was highest in Mali, being up to threefold higher than in Côte d'Ivoire and up to tenfold higher than in Nepal. In all settings, the most prevalent bacteria were EAEC (13.0-39.9%) and Campylobacter spp. (3.9-35.3%). Giardia intestinalis was the predominant intestinal protozoon (2.9-20.5%), and adenovirus 40/41 was the most frequently observed viral pathogen (6.3-25.1%). Significantly different prevalences between symptomatic and asymptomatic individuals were observed for Campylobacter, EIEC and ETEC in the two African sites, and for norovirus in Nepal. Multiple species pathogen infection was common in Côte d'Ivoire and Mali, but rarely found in Nepal. We observed that molecular testing detected multiple enteric pathogens and showed low discriminatory accuracy to distinguish between symptomatic and asymptomatic individuals. Yet, multiplex PCR allowed for direct comparison between different countries and revealed considerable setting-specificity.

Acceptability and perceived feasibility of the KaziKidz health promotion intervention among educators and caregivers in schools from South Africa: a qualitative descriptive study.

BACKGROUND: Despite the uncontested benefits of physical activity, its promotion lags behind in the public health agenda of low- and middle-income countries (LMICs). School-based interventions are promising strategies to foster health during childhood, but evidence of their effectiveness is limited and inconclusive for LMICs. Thus, further investigation is needed on contextual factors associated with intervention implementation in low-resource settings. We studied the acceptability and feasibility of the KaziKidz health promotion intervention and its implementation and make recommendations to improve future adoption and sustainability. METHODS: KaziKidz was implemented in four primary schools from low-income communities in South Africa in 2019. Semi-structured interviews with four school principals, three focus group interviews with 16 educators, and another three with 16 caregivers were conducted between October and November 2021. Participants were purposively recruited. Interview transcripts were analyzed via thematic analysis using a deductive and reflexive approach. RESULTS: Three main themes influencing intervention implementation and adoption were identified: (1) prioritizing teachers' needs (2), integrating the program into the school structure, and (3) creating opportunities in the community. Supporting recommendations included: (theme 1) adopting intervention approaches that are inclusive of educators' health and providing them with capacity development and external support; (theme 2) fostering a feeling of ownership and belonging among school stakeholders to adapt interventions to specific resources and needs; and (theme 3) raising community awareness to encourage individuals to claim power over and actively engage with the program. CONCLUSIONS: Comprehensive interventions comprising health support, adequate training, and ongoing assistance for educators combined with school-wide and community outreach actions seeking to strengthen program ownership, accountability, and engagement can enhance uptake of school-based interventions and long-term maintenance. TRIAL REGISTRATION: ISRCTN15648510, registered on 17/04/2020.

Diagnostic tests for human Schistosoma mansoni and Schistosoma haematobium infection: a systematic review and meta-analysis.

BACKGROUND: Accurate diagnosis is pivotal for implementing strategies for surveillance, control, and elimination of schistosomiasis. Despite their low sensitivity in low-endemicity areas, microscopy-based urine filtration and the Kato-Katz technique are considered as reference diagnostic tests for Schistosoma haematobium and Schistosoma mansoni infections, respectively. We aimed to collate all available evidence on the accuracy of other proposed diagnostic techniques. METHODS: In this systematic review and meta-analysis, we searched PubMed, Embase, the Cochrane Library, and LILACS for studies published from database inception to Dec 31, 2022, investigating the sensitivity and specificity of diagnostic tests for S haematobium and S mansoni infections against Kato-Katz thick smears or urine microscopy (reference tests) involving adults (aged ≥18 years), school-aged children (aged 7 to 18 years), or preschool-aged children (aged 1 month to 7 years). We extracted raw data on true positives, true negatives, false positives, and false negatives for the diagnostic tests and data on the number of participants, study authors, publication year, journal, study design, participants' age and sex, prevalence of Schistosoma infection, and treatment status. To account for imperfect reference tests, we used a hierarchical Bayesian latent class meta-analysis to model test accuracy. FINDINGS: Overall, we included 121 studies, assessing 28 different diagnostic techniques. Most studies (103 [85%] of 121) were done in Africa, 14 (12%) in South America, one (1%) in Asia, and one (1%) in an unknown country. Compared with the reference test, Kato-Katz thick smears, circulating cathodic antigen urine cassette assay version 1 (CCA1, 36 test comparisons) had excellent sensitivity (95% [95% credible interval 88-99]) and reasonable specificity (74% [63-83]) for S mansoni. ELISA-based tests had a performance comparable to circulating cathodic antigen, but there were few available test comparisons. For S haematobium, proteinuria (42 test comparisons, sensitivity 73% [62-82]; specificity 94% [89-98]) and haematuria (75 test comparisons, sensitivity 85% [80-90]; specificity 96% [92-99]) reagent strips showed high specificity, with haematuria reagent strips having better sensitivity. Despite limited data, nucleic acid amplification tests (NAATs; eg, PCR or loop-mediated isothermal amplification [LAMP]) showed promising results with sensitivity estimates above 90%. We found an unclear risk of bias of about 70% in the use of the reference or index tests and of 50% in patient selection. All analyses showed substantial heterogeneity (I2>80%). INTERPRETATION: Although NAATs and immunological diagnostics show promise, the limited information available precludes drawing definitive conclusions. Additional research on diagnostic accuracy and cost-effectiveness is needed before the replacement of conventional tests can be considered. FUNDING: WHO and Luxembourg Institute of Health.

Genetic characterization of schistosome species from cattle in Côte d'Ivoire.

BACKGROUND: Schistosomiasis is a water-based parasitic disease that affects humans, livestock and wild animals. While considerable resources are dedicated to the surveillance, disease mapping, control and elimination of human schistosomiasis, this is not the case for livestock schistosomiasis. Indeed, there are important data and knowledge gaps concerning the species present, population genetic diversity, infection prevalence, morbidity and economic impact. This study aimed to identify circulating schistosome species in cattle across Côte d'Ivoire and to investigate their population diversity and structuring. METHODS: Overall, 400 adult schistosomes were collected from slaughtered cattle at six sites across Côte d'Ivoire. Additionally, 114 miracidia were collected from live cattle at one site: Ferkessédougou, in the northern part of Côte d'Ivoire. DNA from all specimens was extracted and the cox1 and ITS1/2 regions amplified and analysed to confirm species. The genetic diversity and structuring of the schistosome populations were investigated using 12 microsatellite markers. RESULTS: All adult schistosomes and miracidia presented Schistosoma bovis mitochondrial cox1 profile. Nuclear ITS1/2 data were obtained from 101 adult schistosomes and four miracidia, all of which presented an S. bovis profile. Genetic diversity indices revealed a deficiency of heterozygotes and signals of inbreeding across all sites, while structure analyses displayed little geographic structuring and differentiation. Cattle in Côte d'Ivoire thus appear to be mono-species infected with S. bovis. Hybrids of Schistosoma haematobium × S. bovis have not been identified in this study. Cattle schistosomes appear to be panmictic across the country. CONCLUSIONS: Our results contribute to a deeper understanding of schistosome populations in Ivorian cattle and emphasize a One Health approach of joint human and animal surveillance and prevention and control programmes for schistosomiasis.

Operational Differences between Product Development Partnership, Pharmaceutical Industry, and Investigator Initiated Clinical Trials.

Medicine development is a lengthy endeavour. Increasing regulatory stringency and trial complexity might lead to reduced efficiency, dwindled output, and elevated costs. However, alternative models are possible. We compared the operational differences between pharmaceutical industry sponsored trials, product development partnership trials, and investigator-initiated trials to identify key drivers of inefficiency in clinical research. We conducted an exploratory mixed-methods study with stakeholders, including clinical trial sponsors, contract research organisations, and investigators. The qualitative component included 40 semi-structured interviews, document reviews of 12 studies and observations through work shadowing in research institutions in Burkina Faso, Mali, and Switzerland. The findings were triangulated with an online survey polling clinical research professionals. The operational differences were grouped under five categories: (i) trial start-up differences including governance and management structure; (ii) study complexity; (iii) site structural and organisational differences; (iv) study conduct, quality approaches, and standard operating procedures; and (v) site capacity strengthening and collaboration. Early involvement of sites in the planning and tailored quality approaches were considered critical for clinical operations performance. Differences between the types of trials reviewed pertained to planning, operational complexities, quality approaches, and support to the sites. Integration of quality-by-design components has the potential to alleviate unnecessary process burden.

Randomized Trial to Improve Body Composition and Micronutrient Status Among South African Children.

INTRODUCTION: Physical activity (PA) promotion combined with multimicronutrient supplementation (MMNS) among school-age children may reduce fat mass accrual and increase muscle mass through different mechanisms and so benefit child health. This study determined the efficacy of combined interventions on body composition among South African schoolchildren and determined if micronutrients mediate these effects. STUDY DESIGN: Longitudinal cluster randomized controlled trial of children followed from 2019 to 2021. Statistical analyses carried from 2022 to 2023. SETTING/PARTICIPANTS: A total of 1,304 children 6-12 years of age recruited from public schools in Gqeberha, South Africa. INTERVENTION: Children were randomized by classes to either: (a) a physical activity group (PA); (b) a MMNS group; (c) a physical activity + multimicronutrient supplementation group (PA + MMNS); and (d) a placebo control group. MAIN OUTCOME MEASURES: Trajectories of overall and truncal fat free mass (FFM) and fat mass (FM) estimates in modeled at 9 and 21 months using latent growth curve models (LGCM). Changes in micronutrient concentrations at 9 months from baseline. RESULTS: An increased FFM trajectory was found among children in the MMNS arm at 9 months (Beta 0.16, 95% CI = 0.12, 0.31). The PA and MMNS arms both had positive indirect effects on this trajectory at 9 months (Beta 0.66, 95% CI = 0.44, 0.88 and Beta 0.32 95% CI = 0.1 0.5, respectively) and similarly at 21 months when mediated by zinc concentration changes. A reduced FM trajectory was found among children in the PA promotion arm at 9 months when using this collection point as the referent intercept. This arm was inversely associated with the FM trajectory at 9 months when mediated by zinc changes. CONCLUSIONS: PA and MMNS promotion in school-based interventions directly contributed to reductions in FM and increased FFM among South African children and indirectly through changes in micronutrient status. TRIAL REGISTRATION: ISRCTN, ISRCTN29534081. Registered on August 9, 2018 Institutional review board: Ethikkommission Nordwest- und Zentralschweiz" (EKNZ, project number: Req-2018-00608). Date of approval: 2018.

Relative effects of climate factors and malaria control interventions on changes of parasitaemia risk in Burkina Faso from 2014 to 2017/2018.

BACKGROUND: In Burkina Faso, the prevalence of malaria has decreased over the past two decades, following the scale-up of control interventions. The successful development of malaria parasites depends on several climatic factors. Intervention gains may be reversed by changes in climatic factors. In this study, we investigated the role of malaria control interventions and climatic factors in influencing changes in the risk of malaria parasitaemia. METHODS: Bayesian logistic geostatistical models were fitted on Malaria Indicator Survey data from Burkina Faso obtained in 2014 and 2017/2018 to estimate the effects of malaria control interventions and climatic factors on the temporal changes of malaria parasite prevalence. Additionally, intervention effects were assessed at regional level, using a spatially varying coefficients model. RESULTS: Temperature showed a statistically important negative association with the geographic distribution of parasitaemia prevalence in both surveys; however, the effects of insecticide-treated nets (ITNs) use was negative and statistically important only in 2017/2018. Overall, the estimated number of infected children under the age of 5 years decreased from 704,202 in 2014 to 290,189 in 2017/2018. The use of ITNs was related to the decline at national and regional level, but coverage with artemisinin-based combination therapy only at regional level. CONCLUSION: Interventions contributed more than climatic factors to the observed change of parasitaemia risk in Burkina Faso during the period of 2014 to 2017/2018. Intervention effects varied in space. Longer time series analyses are warranted to determine the differential effect of a changing climate on malaria parasitaemia risk.

Design of a targeted blood transcriptional panel for monitoring immunological changes accompanying pregnancy.

Background: Immunomodulatory processes exert steering functions throughout pregnancy. Detecting diversions from this physiologic immune clock may help identify pregnant women at risk for pregnancy-associated complications. We present results from a data-driven selection process to develop a targeted panel of mRNAs that may prove effective in detecting pregnancies diverting from the norm. Methods: Based on a de novo dataset from a resource-constrained setting and a dataset from a resource-rich area readily available in the public domain, whole blood gene expression profiles of uneventful pregnancies were captured at multiple time points during pregnancy. BloodGen3, a fixed blood transcriptional module repertoire, was employed to analyze and visualize gene expression patterns in the two datasets. Differentially expressed genes were identified by comparing their abundance to non-pregnant postpartum controls. The selection process for a targeted gene panel considered (i) transcript abundance in whole blood; (ii) degree of correlation with the BloodGen3 module; and (iii) pregnancy biology. Results: We identified 176 transcripts that were complemented with eight housekeeping genes. Changes in transcript abundance were seen in the early stages of pregnancy and similar patterns were observed in both datasets. Functional gene annotation suggested significant changes in the lymphoid, prostaglandin and inflammation-associated compartments, when compared to the postpartum controls. Conclusion: The gene panel presented here holds promise for the development of predictive, targeted, transcriptional profiling assays. Such assays might become useful for monitoring of pregnant women, specifically to detect potential adverse events early. Prospective validation of this targeted assay, in-depth investigation of functional annotations of differentially expressed genes, and assessment of common pregnancy-associated complications with the aim to identify these early in pregnancy to improve pregnancy outcomes are the next steps.

Strongyloidiasis.

Strongyloidiasis is a neglected tropical disease caused primarily by the roundworm Strongyloides stercoralis. Strongyloidiasis is most prevalent in Southeast Asia and the Western Pacific. Although cases have been documented worldwide, global prevalence is largely unknown due to limited surveillance. Infection of the definitive human host occurs via direct skin penetration of the infective filariform larvae. Parasitic females reside in the small intestine and reproduce via parthenogenesis, where eggs hatch inside the host before rhabditiform larvae are excreted in faeces to begin the single generation free-living life cycle. Rhabditiform larvae can also develop directly into infectious filariform larvae in the gut and cause autoinfection. Although many are asymptomatic, infected individuals may report a range of non-specific gastrointestinal, respiratory or skin symptoms. Autoinfection may cause hyperinfection and disseminated strongyloidiasis in immunocompromised individuals, which is often fatal. Diagnosis requires direct examination of larvae in clinical specimens, positive serology or nucleic acid detection. However, there is a lack of standardization of techniques for all diagnostic types. Ivermectin is the treatment of choice. Control and elimination of strongyloidiasis will require a multifaceted, integrated approach, including highly sensitive and standardized diagnostics, active surveillance, health information, education and communication strategies, improved water, sanitation and hygiene, access to efficacious treatment, vaccine development and better integration and acknowledgement in current helminth control programmes.

Randomised controlled trial on the effect of social support on disease control, mental health and health-related quality of life in people with diabetes from Côte d'Ivoire: the SoDDiCo study protocol.

INTRODUCTION: Diabetes mellitus (DM) and its severe complications contribute significantly to disability and, hence, burden of disease. Poor mental health, a frequent DM consequence, may hinder successful diabetes control in low-income and middle-income countries (LMICs). Evidence suggests social support as a cost-effective tool to improve diabetes self-management, behaviour and mental health. However, its real-world application in LMICs has rarely been tested. We aim to investigate the effect of a social support intervention on disease control, mental health and health-related quality of life in people with diabetes from Côte d'Ivoire (SoDDiCo) through a randomised controlled trial. METHODS AND ANALYSIS: The trial will take place in the Centre Antidiabétique d'Abidjan, Institut National de Santé Publique, Abidjan, Côte d'Ivoire. We will prospectively randomise up to 1500 people with newly diagnosed diabetes into two parallel arms: intervention (routine care+family supporter accompanying clinical management) and control (routine care), using gender-stratified blocked randomisation with random block sizes of 10, 16, 20 and 24. Participants will undergo baseline, 3-month and 12-month postrandomisation assessments. The primary study outcome will be glycated haemoglobin (HbA1c). Secondary outcomes will include glycaemic control (HbA1c<7.0%), presence at follow-up visits, mental health and quality of life scores. Using intention-to-treat framework, we will assess the impact of the family support intervention on these endpoints over the course of the 1-year follow-up. Effect modification by baseline social capital will be assessed. ETHICS AND DISSEMINATION: The SoDDiCo trial was approved by the Ethikkommission Nordwest- und Zentralschweiz (ref: AO_2021-00041; approved: 12 July 2021) and by Comité National d'Éthique des Sciences de la Vie et de la Santé (ref: 049-22/MSHPCMU/CNESVS-kp; approved: 20 April 2022). The randomised intervention trial will follow good clinical practice guidelines. All results will be made available to the public through abstracts at conferences as well as through peer-reviewed articles. International guidelines for authorship will be respected. TRIAL REGISTRATION NUMBER: ISRCTN10901121, ISRCTN registry.