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IntroductionExcess salt intake is a major modifiable risk factor for cardiovascular disease. Promoting salt reduction as part of routine school-health programming may be a pragmatic way to address this risk factor early in the life course but has not been tested in sub-Saharan Africa (SSA). Here we describe the formative work with stakeholders and process evaluation of pilot work to develop a school-based salt reduction programme for children aged 11-14 years, in preparation for a cluster-randomised trial in rural/urban Malawi.Materials and methodsCollection of observational data and documentary evidence (meeting minutes/field notes) from the earliest key stakeholder engagement with Malawi Ministries of Health, Education, Local Government and Rural Development and Malawi Institute of Education, and non-governmental stakeholders; and a series of semi-structured interviews and focus groups (with head teachers (n=2); teachers (n=4); parents (n=30); and learners (n=40)). Data analysed thematically and conceptualised through a Normalization Process Theory lens.ResultsFormative work illustrated a range of administrative, technical, and practical issues faced during development of the programme; including allocation of stakeholder roles and responsibilities, harmonisation with pre-existing strategies and competing priorities, resources required for programme development, and design of effective teaching materials. While participants were positive about the programme, the process evaluation identified features to be refined including perceived challenges to participation, recommended adaptations to the content and delivery of lessons, and concerns related to quantity/quality of learning resources provided.ConclusionThis study demonstrates the importance of comprehensive, sustained, and participatory stakeholder engagement in the development of a novel school health programme in SSA; and highlights the factors that were critical to successfully achieving this. We also demonstrate the value of detailed process evaluation in informing development of the programme to ensure that it was feasible and relevant to the context prior to evaluation through a cluster-randomised trial.

Summary Background Few studies have been done of patterns of treatment during mass drug administration (MDA) to control neglected tropical diseases. We used routinely collected individual-level treatment records that had been collated for the Tuangamize Minyoo Kenya Imarisha Afya (Swahili for Eradicate Worms in Kenya for Better Health [TUMIKIA]) trial, done in coastal Kenya from 2015 to 2017. In this analysis we estimate the extent of and factors associated with the same individuals not being treated over multiple rounds of MDA, which we term systematic non-treatment. Methods We linked the baseline population of the TUMIKIA trial randomly assigned to receive biannual community-wide MDA for soil-transmitted helminthiasis to longitudinal records on receipt of treatment in any of the four treatment rounds of the study. We fitted logistic regression models to estimate the association of non-treatment in a given round with non-treatment in the previous round, controlling for identified predictors of non-treatment. We also used multinomial logistic regression to identify factors associated with part or no treatment versus complete treatment. Findings 36 327 participants were included in our analysis: 16 236 children aged 2–14 years and 20 091 adults aged 15 years or older. The odds of having no treatment recorded was higher if a participant was not treated during the previous round of MDA (adjusted odds ratio [OR] 3·60, 95% CI 3·08–4·20 for children and 5·58, 5·01–6·21 for adults). For children, school attendance and rural residence reduced the odds of receiving part or no treatment, whereas odds were increased by least poor socioeconomic status and living in an urban or periurban household. Women had higher odds than men of receiving part or no treatment. However, when those with pregnancy or childbirth in the previous 2 weeks were excluded, women became more likely to receive complete treatment. Adults aged 20–25 years were the age group with the highest odds of receiving part (OR 1·41, 95% CI 1·22–1·63) or no treatment (OR 1·81, 95% CI 1·53–2·14). Interpretation Non-treatment was associated with specific sociodemographic groups and characteristics and did not occcur at random. This finding has important implications for MDA programme effectiveness, the relevance of which will intensify as disease prevalence decreases and infections become increasingly clustered. Funding Bill & Melinda Gates Foundation, Joint Global Health Trials Scheme of the Medical Research Council, UK Department for International Development, Wellcome Trust, Children's Investment Fund Foundation, and London Centre for Neglected Tropical Diseases.

Many sanitation interventions suffer from poor sustainability. Failure to maintain or replace toilet facilities risks exposing communities to environmental pathogens, yet little is known about the factors that drive sustained access beyond project life spans. Using data from a cohort of 1666 households in Kwale County, Kenya, we investigated the factors associated with changes in sanitation access between 2015 and 2017. Sanitation access is defined as access to an improved or unimproved facility within the household compound that is functional and in use. A range of contextual, psychosocial, and technological covariates were included in logistic regression models to estimate their associations with (1) the odds of sustaining sanitation access and (2) the odds of gaining sanitation access. Over two years, 28.3% households sustained sanitation access, 4.7% lost access, 17.7% gained access, and 49.2% remained without access. Factors associated with increased odds of households sustaining sanitation access included not sharing the facility and presence of a solid washable slab. Factors associated with increased odds of households gaining sanitation access included a head with at least secondary school education, level of coarse soil fragments, and higher local sanitation coverage. Results from this study can be used by sanitation programs to improve the rates of initial and sustained adoption of sanitation.

Background The DeWorm3 project is an ongoing cluster-randomised trial assessing the feasibility of interrupting the transmission of soil-transmitted helminths (STH) through mass drug administration (MDA) using study sites in India, Malawi and Benin. In this article, we describe an approach which uses a combination of statistical and mathematical methods to forecast the outcome of the trial with respect to its stated goal of reducing the prevalence of infection to below 2%. Methods Our approach is first to define the local patterns of transmission within each study site, which is achieved by statistical inference of key epidemiological parameters using the baseline epidemiological measures of age-related prevalence and intensity of STH infection which have been collected by the DeWorm3 trials team. We use these inferred parameters to calibrate an individual-based stochastic simulation of the trial at the cluster and study site level, which is subsequently run to forecast the future prevalence of STH infections. The simulator takes into account both the uncertainties in parameter estimation and the variability inherent in epidemiological and demographic processes in the simulator. We interpret the forecast results from our simulation with reference to the stated goal of the DeWorm3 trial, to achieve a target of $$\le 2\%$$ ≤ 2 % prevalence at a point 24 months post-cessation of MDA. Results Simulated output predicts that the two arms will be distinguishable from each other in all three country sites at the study end point. In India and Malawi, measured prevalence in the intervention arm is below the threshold with a high probability (90% and 95%, respectively), but in Benin the heterogeneity between clusters prevents the arm prevalence from being reduced below the threshold value. At the level of individual study arms within each site, heterogeneity among clusters leads to a very low probability of achieving complete elimination in an intervention arm, yielding a post-study scenario with widespread elimination but a few ‘hot spot’ areas of persisting STH transmission. Conclusions Our results suggest that geographical heterogeneities in transmission intensity and worm aggregation have a large impact on the effect of MDA. It is important to accurately assess cluster-level, or even smaller scale, heterogeneities in factors which influence transmission and aggregation for a clearer perspective on projecting the outcomes of MDA control of STH and other neglected tropical diseases. Graphical Abstract

We developed an electronic treatment register for the DeWorm3 Project, a cluster-randomised, controlled trial in Benin, India, and Malawi testing the feasibility of interrupting transmission of soil-transmitted helminths through community-wide mass drug administration. The electronic treatment register was designed in xlsform, deployed via the SurveyCTO mobile data collection platform, and implemented on smartphones running the Android operating system. The versatile system enables collection of census and treatment status information, facilitates data aggregation and visualisation, and permits real-time feedback loops during implementation of mass drug administration. Here we describe the system’s design and use within the DeWorm3 Project and key features, and by sharing the register here, we hope our readers will further explore its use within their research and disease-control activities.

IntroductionEvidence indicates children who suffer from ill-health are less likely to attend or complete schooling. Malaria is an important cause of morbidity and mortality in school-age children. However, they are less likely to receive malaria treatment at health facilities and evidence for how to improve schoolchildren’s access to care is limited. This study aimed to evaluate the impact of a programme of school-based malaria case management on schoolchildren’s attendance, health and education.MethodsA cluster randomised controlled trial was conducted in 58 primary schools in Zomba District, Malawi, 2011–2015. The intervention, implemented in 29 randomly selected schools, provided malaria rapid diagnostic tests and artemisinin-based combination therapy to diagnose and treat uncomplicated malaria as part of basic first aid kits known as ‘Learner Treatment Kits’ (LTK). The primary outcome was school attendance, assessed through teacher-recorded daily attendance registers and independent periodic attendance spot checks. Secondary outcomes included prevalence of Plasmodium spp infection, anaemia, educational performance, self-reported child well-being and health-seeking behaviour. A total of 9571 children from standards 1–7 were randomly selected for assessment of school attendance, with subsamples assessed for the secondary outcomes.ResultsBetween November 2013 and March 2015, 97 trained teachers in 29 schools provided 32 685 unique consultations. Female schoolchildren were significantly more likely than male to seek a consultation (unadjusted OR=1.78 (95% CI 1.58 to 2.00). No significant intervention effect was observed on the proportion of child-days recorded as absent in teacher registers (n=9017 OR=0.90 (95% CI 0.77 to 1.05), p=0.173) or of children absent during random school visits—spot checks (n=5791 OR=1.09 (95% CI 0.87 to 1.36), p=0.474). There was no significant impact on child-reported well-being, prevalence of Plasmodium spp, anaemia or education scores.ConclusionDespite high community demand, the LTK programme did not reduce schoolchildren’s absenteeism or improve health or education outcomes in this study setting.Trial registration numberClinicalTrials.gov NCT02213211.

Background: Success of mass drug administration (MDA) for control of neglected tropical diseases depends on treatment coverage and patterns across rounds. There has been limited opportunity to explore these features within programmes at scale. Here we use routinely-collected individual-level treatment records collated for the TUMIKIA trial, conducted in coastal Kenya from 2015-2017, to estimate the extent of -- and factors associated with -- systematic non-treatment in the targeted population. Methods: The trial baseline population (N=36327) was linked with treatment records from four rounds of biannual community-wide MDA for soil-transmitted helminthiasis. We fit logistic regression models to estimate the association of non-treatment with treatment status during the previous round, controlling for identified predictors of non-treatment, and used multinomial logistic regression to identify factors associated with partial or no treatment versus complete treatment. Findings: Children aged 2-14 years and individuals aged 15+ years were more likely to remain untreated if they were not treated during the previous MDA. For children, school attendance and rural residence were protective against receiving partial and no treatment. Women were more likely than men to receive partial and no treatment, unless periods of pregnancy and recent childbirth were excluded; then, women more likely received complete treatment. Adults aged 20-25 years were most likely to receive partial or no treatment. Interpretation: We identified eligible populations who received incomplete treatment across multiple MDA rounds and found that this non-treatment did not occur at random. This finding has important implications for MDA programme effectiveness and will be increasingly important as prevalence reaches low levels. Funding Statement: Funding for TUMIKIA was received from the Bill & Melinda Gates Foundation, the Joint Global Health Trials Scheme of the Medical Research Council, the UK Department for International Development, the Wellcome Trust, and the Children’s Investment Fund Foundation. This analysis was supported by the London Centre for Neglected Tropical Diseases. SK is supported by THRiVE-2, a DELTAS Africa grant # DEL-15-011 from Wellcome Trust grant # 107742/Z/15/Z and the UK government. Declaration of Interests: RMA was a non-executive director of GlaxoSmithKline during the TUMIKIA trial. GlaxoSmithKline had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. SJB is currently employed by the Bill & Melinda Gates Foundation (BMGF) but was employed by the London School of Hygiene & Tropical Medicine when TUMIKIA was designed and commenced. GlaxoSmithKline and BMGF played no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. All other authors declare no competing interests. Ethics Approval Statement: The TUMIKIA trial protocol, including measurement of treatment coverage and adherence using routine and household survey data, was approved by the Kenya Medical Research Institute and National Ethics Review Committee (SSC Number 2826) and the London School of Hygiene & Tropical Medicine (LSHTM) Ethics Committee (7177). Written informed consent was sought from the household head or adult answering the household-level questionnaire. All information and consent procedures were conducted in Kiswahili.

Introduction Few studies have simultaneously examined the role of sanitation conditions at the home, school, and community on soil-transmitted helminth (STH) infection. We examined the contribution of each domain that children inhabit (home, village, and school) to STH infection and estimated the association of STH infection with sanitation in each domain. Methods Using data from 4,104 children from Kwale County, Kenya, who reported attending school, we used logistic regression models with cross-classified random effects to calculate measures of general contextual effects and estimate associations of village sanitation coverage (percentage of households with reported access to sanitation), school sanitation coverage (number of usable toilets per enrolled pupil), and sanitation access at home with STH infection. Findings We found reported use of a sanitation facility by households was associated with reduced prevalence of hookworm infection but not with reduced prevalence of T. trichiura infection. School sanitation coverage > 3 toilets per 100 pupils was associated with lower prevalence of hookworm infection. School sanitation was not associated with T. trichiura infection. Village sanitation coverage > 81% was associated with reduced prevalence of T. trichiura infection, but no protective association was detected for hookworm infection. General contextual effects represented by residual heterogeneity between village and school domains had comparable impact upon likelihood of hookworm and T. trichiura infection as sanitation coverage in either of these domains. Conclusion Findings support the importance of providing good sanitation facilities to support mass drug administration in reducing the burden of STH infection in children., Author summary Infection by the soil-transmitted helminths (STH) whipworm and hookworm results from either ingestion of eggs or larvae or through skin exposure to larvae. These eggs and larvae develop in suitable soils contaminated with openly-deposited human faeces. Safe disposal of faeces should reduce transmission of STH, yet evidence of the impact of sanitation on STH transmission remains limited. A large, community-wide survey was conducted in 2015 to measure prevalence of STH infections in Kwale County, Kenya. Here, we used this data and observations made in schools to examine the relationship between sanitation conditions at home, school, and village and the presence of STH infection among 4,104 children who attend school. We found that sanitation access at home and school sanitation coverage (number of usable toilets per enrolled pupil), but not the overall level of village sanitation coverage (percentage of households with reported access to sanitation), was protective against hookworm infection. In contrast, only high village sanitation coverage, but not home or school sanitation, was protective against whipworm infection. Current STH control strategies emphasise periodic deworming of at-risk populations, including school-age children. Our findings highlight the need for continued efforts, alongside deworming, to extend access to good sanitation facilities at homes, schools, and across communities.

Most epidemiological studies of soil-transmitted helminth (STH) infections focus on school-going children. The majority of large-scale cross-sectional and longitudinal community-based studies have been conducted prior to the implementation of wide-scale mass drug administration (MDA). This study investigates age-related patterns in prevalence and intensity of STH infection, and associated risk factors, in a region of south coastal Kenya that had previously received three consecutive years of school-based deworming (2012–14) and four rounds of community-based MDA for lymphatic filariasis between 2003 and 2014. Between March and May 2015, a cross-sectional survey was conducted in 120 community clusters as a baseline for a cluster randomised trial. Individuals aged two years and above were randomly selected during household surveys and requested to provide stool samples, which were assessed for presence and intensity of STH using the duplicate Kato-Katz thick smear method. Species-specific predictors of presence and intensity were investigated through multilevel logistic regression and zero-inflated negative binomial regression models. Of the 19,684 individuals who provided a stool sample, 21.5% were infected with at least one STH. Hookworm was the predominant species, with an overall prevalence of 19.1%; Trichuris trichiura prevalence was 3.6% and Ascaris lumbricoides was negligible (0.4% prevalence). The vast majority were light intensity infections. Prevalence and intensity of hookworm infection were significantly higher in adults and males, and were associated with environmental conditions, low socio-economic status, household flooring, individual and household water, sanitation and hygiene (WASH) characteristics and behaviours, previous treatment, lack of shoe-wearing and not attending school. In contrast, T. trichiura was more commonly found in school-aged boys and those living in communities close to the coast, with reduced infection in the least poor individuals with private latrine access. Overall, results show that despite several years of school-based deworming, hookworm infection remains common among untreated adults in this population, suggesting that this strategy alone is insufficient to reduce community-wide hookworm infection and in the longer term to eliminate transmission. Trial registration ClinicalTrials.gov NCT02397772, Author summary Soil-transmitted helminth (STH) infections, including Trichuris trichiura, Ascaris lumbricoides and the hookworms Ancylostoma duodenale and Necator americanus, remain endemic in many regions of sub-Saharan Africa (SSA), including parts of Kenya. The current WHO-recommended treatment strategy focuses on morbidity control, and comprises periodic deworming of population groups at particular risk, including pre-school and school–age children. Consequently, the majority of epidemiological descriptions of STH have focused on infection in this age group, and are conducted using a school platform. There is therefore a notable lack of age-stratified data (that includes adults) from communities. We present data from a community-wide, cross-sectional survey of STH infection across 19,684 individuals and investigate associated risk factors at the household and individual level. We demonstrate highest prevalence and intensity of hookworm (the predominant species in this setting) in adults and males—a group not routinely included in deworming activities. There was marked geographic variation in infection risk across the study area, and an enduring relationship between infection risk and factors associated with poor access to sanitation and hygiene. Conducted after three years of ongoing, annual school-based deworming, the findings presented here are likely to be representative of many regions of SSA, with similar epidemiological and demographic profiles, implementing the current WHO-recommended STH control strategy.

School-based deworming programmes can reduce morbidity attributable to soil-transmitted helminths in children but do not interrupt transmission in the wider community. We assessed the effects of alternative mass treatment strategies on community soil-transmitted helminth infection.In this cluster-randomised controlled trial, 120 community units (clusters) serving 150 000 households in Kenya were randomly assigned (1:1:1) to receive albendazole through annual school-based treatment targeting 2-14 year olds or annual or biannual community-wide treatment targeting all ages. The primary outcome was community hookworm prevalence, assessed at 12 and 24 months through repeat cross-sectional surveys. Secondary outcomes were Ascaris lumbricoides and Trichuris trichiura prevalence, infection intensity of each soil-transmitted helminth species, and treatment coverage and costs. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT02397772.After 24 months, prevalence of hookworm changed from 18·6% (95% CI 13·9-23·2) to 13·8% (10·5-17·0) in the annual school-based treatment group, 17·9% (13·7-22·1) to 8·0% (6·0-10·1) in the annual community-wide treatment group, and 20·6% (15·8-25·5) to 6·2% (4·9-7·5) in the biannual community-wide treatment group. Relative to annual school-based treatment, the risk ratio for annual community-wide treatment was 0·59 (95% CI 0·42-0·83; p0·001) and for biannual community-wide treatment was 0·46 (0·33-0·63; p0·001). More modest reductions in risk were observed after 12 months. Risk ratios were similar across demographic and socioeconomic subgroups after 24 months. No adverse events related to albendazole were reported.Community-wide treatment was more effective in reducing hookworm prevalence and intensity than school-based treatment, with little additional benefit of treating every 6 months, and was shown to be remarkably equitable in coverage and effects.BillMelinda Gates Foundation, the Joint Global Health Trials Scheme of the Medical Research Council, the UK Department for International Development, the Wellcome Trust, and the Children's Investment Fund Foundation.

BACKGROUND: With increasing levels of enrolment, primary schools present a pragmatic opportunity to improve the access of school children to timely diagnosis and treatment of malaria, increasingly recognised as a major health problem within this age group. The expanded use of malaria rapid diagnostic tests (RDTs) and artemisinin combination therapy (ACT) by community health workers (CHWs) has raised the prospect of whether teachers can provide similar services for school children. We describe and evaluate the training of primary school teachers to use a first aid kit containing malaria RDTs and ACT for the diagnosis and treament of uncomplicated malaria in school children in southern Malawi. METHODS: We outline the development of the intervention as: (1) conception and design, (2) pilot training, (3) final training, and (4) 7-month follow up. The training materials were piloted at a four-day workshop in July 2013 following their design at national stakeholders meetings. The evaluation of the pilot training and materials were assessed in relation to increased knowledge and skill sets using checklist evaluations and questionnaires, the results of which informed the design of a final seven-day training programme held in December 2013. A follow up of trained teachers was carried out in July 2014 following 7 months of routine implementation. A total of 15 teachers were evaluated at four stages: pilot training, two weeks following pilot, final training and seven months following final training. RESULTS: A total of 15 and 92 teachers were trained at the pilot and final training respectively. An average of 93 % of the total steps required to use RDTs were completed correctly at the final training, declining to 87 % after 7 months. All teachers were observed correctly undertaking safe blood collection and handling, accurate RDT interpretation, and correct dispensing of ACT. The most commonly observed errors were a failure to wait 20 minutes before reading the test result, and adding an incorrect volume of buffer to the test cassette. CONCLUSION: Following training, teachers are able to competently use RDTs and ACTs test and treat children at school for uncomplicated malaria safely and accurately. Teachers demonstrate a comparable level of RDT use relative to non-health professional users of RDTs, and sustain this competency over a period of seven months during routine implementation.