Effect of hygiene interventions on acute respiratory infections in childcare, school and domestic settings in low- and middle-income countries: a systematic review.

OBJECTIVES: Acute respiratory infections (ARIs) disproportionately affect those living in low- and middle-income countries (LMICs). We aimed to determine whether hygiene interventions delivered in childcare, school or domestic settings in LMICs effectively prevent or reduce ARIs. METHODS: We registered our systematic review with PROSPERO (CRD42017058239) and searched MEDLINE, EMBASE, CENTRAL, and Scopus from inception to 17 October 2017 for randomised controlled trials (RCTs) examining the impact of hygiene interventions on ARI morbidity in adults and children in community-based settings in LMICs. We stratified data into childcare, school and domestic settings and used the Grading of Recommendations Assessment, Development and Evaluation approach to assess evidence quality. RESULTS: We identified 14 cluster RCTs evaluating hand-hygiene interventions in LMICs with considerable heterogeneity in setting, size, intervention delivery and duration. We found reduced ARI-related absenteeism and illness in childcare settings (low- to moderate-quality evidence). In school settings, we found reduced ARI-related absenteeism and laboratory-confirmed influenza (moderate- to high-quality evidence), but no reduction in ARI illness (low-quality evidence). In domestic settings, we found reduced ARI illness and pneumonia amongst children in urban settlements (high-quality evidence) but not in rural settlements (low-quality evidence), and no effect on secondary transmission of influenza in households (moderate-quality evidence). CONCLUSIONS: Evidence suggests that hand-hygiene interventions delivered in childcare, school and domestic settings can reduce ARI morbidity, but effectiveness varies according to setting, intervention target and intervention compliance. Further studies are needed to develop, deliver and evaluate targeted and sustainable hygiene interventions in LMICs.

Variability in 24 hour excretion of cyanuric acid: implications for water exposure assessment.

Cyanuric acid (CYA) excretion in urine has been used to estimate the volume of water ingested during swimming and other recreational activities in outdoor pools containing this chemical. These estimates of water ingestion are based on the assumption of 100% excretion within 24 hours, but the supporting evidence for this is scant. While adapting this methodology to investigate other water ingestion scenarios, we observed a high degree of variability in cyanuric acid excretion among experimental subjects, with over 25% of individuals excreting less than 80% of an ingested dose. Use of cyanuric acid to measure inadvertent water ingestion may be a valuable tool to generate data for health risk assessment of non-potable water sources, but our observations indicate that this technique carries an inherent degree of underestimation that should be taken into account when calculating water exposure.

Evolution of regulatory targets for drinking water quality.

The last century has been marked by major advances in the understanding of microbial disease risks from water supplies and significant changes in expectations of drinking water safety. The focus of drinking water quality regulation has moved progressively from simple prevention of detectable waterborne outbreaks towards adoption of health-based targets that aim to reduce infection and disease to a level well below detection limits at the community level. This review outlines the changes in understanding of community disease and waterborne risks that prompted development of these targets, and also describes their underlying assumptions and current context. Issues regarding the appropriateness of selected target values, and how continuing changes in knowledge and practice may influence their evolution, are also discussed.

Adoption of a microbial health-based target for Australian drinking water regulation.

The health-based targets of 1 in 10,000 for infection and 10(-6) disability adjusted life years (DALYs) per person per year are increasingly being considered, or have already been adopted, to define microbial safety targets for water. The aim of this paper is to convey information about how these two targets compare by converting each of the target values to a common metric. The metric chosen for viral (rotavirus and norovirus) and protozoan (Cryptosporidium) reference pathogens is the estimated maximum number of annual drinking water-associated cases of acute diarrhoeal disease tolerated. For the reference bacterial pathogen Campylobacter, sequelae to acute diarrhoeal illness have also been considered in estimating the tolerable number of cases for the DALY target. Also investigated is whether non-compliance with targets would be detected as a waterborne disease outbreak by the health surveillance system in an extreme hypothetical situation whereby all tolerable cases per annum occurred as a single event. The paper highlights that verification of compliance with targets cannot be demonstrated by the absence of reported drinking water-associated outbreaks alone and concludes that introduction of a quantitative health-based outcome for drinking water in Australia would help improve water quality management by providing a common goal directly linked to health outcomes.

Risk factors for community-based reports of gastrointestinal, respiratory, and dermal symptoms: findings from a cohort study in Australia.

BACKGROUND: Although gastrointestinal (GI), respiratory, and dermal symptoms are common, few studies have conducted concurrent and comparative prospective analyses of risk factors for these 3 morbidity outcomes. METHODS: We used data from a community-based randomized controlled trial among 277 South Australian families to analyze GI (diarrhea, vomiting), respiratory (sore throat, runny nose, cough) and dermal (rash, generalized itch, dermal infection) symptoms. RESULTS: Log-binomial regression analysis revealed similar risks of GI (adjusted risk ratio [RR], 1.65; 95% CI, 1.05-2.58) and respiratory (RR, 1.68; 95% CI, 1.31-2.15) symptoms among childcare/kindergarten attendees. Swimming in public pools/spas in the current or previous week was associated with all 3 symptom complexes, conferring similar risk for each (RR for GI: 1.33; 95% CI, 0.99-1.77; respiratory: 1.20; 95% CI, 1.04-1.38; dermal: 1.41; 95% CI, 1.08-1.85). Pet ownership was not associated with symptoms. Household clustering of GI and respiratory symptoms was common, and clustering of respiratory symptoms correlated with number of individuals per household. CONCLUSIONS: This simultaneous examination of risk factors for 3 health outcomes yielded new comparative data that are useful for developing prevention strategies.

Comparison of response rates and cost-effectiveness for a community-based survey: postal, internet and telephone modes with generic or personalised recruitment approaches.

BACKGROUND: Epidemiological research often requires collection of data from a representative sample of the community or recruitment of specific groups through broad community approaches. The population coverage of traditional survey methods such as mail-outs to residential addresses, and telephone contact via public directories or random-digit-dialing is declining and survey response rates are falling. There is a need to explore new sampling frames and consider multiple response modes including those offered by changes in telecommunications and internet technology. METHODS: We evaluated response rates and cost-effectiveness for three modes of survey administration (postal invitation/postal survey, postal invitation/internet survey and postal invitation/telephone survey) and two styles of contact approach (personalised and generic) in a community survey of greywater use. Potential respondents were contacted only once, with no follow up of non-responders. RESULTS: The telephone survey produced the highest adjusted response rate (30.2%), followed by the personalised postal survey (10.5%), generic postal survey (7.5%) and then the internet survey (4.7% for the personalised approach and 2.2% for the generic approach). There were some differences in household characteristics and greywater use rates between respondents to different survey modes, and between respondents to personalised and generic approaches. These may be attributable to the differing levels of motivations needed for a response, and varying levels of interest in the survey topic among greywater users and non-users. The generic postal survey had the lowest costs per valid survey received (Australian $22.93), followed by the personalised postal survey ($24.75). CONCLUSIONS: Our findings suggest that postal surveys currently remain the most economic option for population-based studies, with similar costs for personalised and generic approaches. Internet surveys may be effective for specialised groups where email lists are available for initial contact, but barriers other than household internet access still exist for community-based surveys. Given the increasing recruitment challenges facing community-based studies, there is an imperative to gather contemporary comparative data on different survey modes and recruitment approaches in order to determine their strengths, limitations and costs. Researchers also need to document and report on the potential biases in the target and respondent populations and how this may affect the data collected.

Community based study to compare the incidence and health services utilization pyramid for gastrointestinal, respiratory and dermal symptoms.

BACKGROUND: Gastrointestinal (GI), respiratory and dermal symptoms are common and cause substantial morbidity, although the information on their exact incidence and comparative burden is limited. The aim of this study was to describe the epidemiology and rate these three major symptom complexes in order to improve our understanding of the health burden imposed by these symptoms. METHODS: We used data from a community based randomised control trial conducted from June 2007 to August 2008 among 277 South Australian families consuming rainwater. Using weekly health diaries, we prospectively collected information on GI (diarrhoea or vomiting), respiratory (sore throat, runny nose or cough) and dermal (rash, generalised itch or dermal infection) symptoms, as well as on relevant GP visits, time off work and/or hospitalisation due to these symptoms. Data were analysed using generalized estimating equations approach taking into account the variable number of weeks of follow-up of each individual and within-family clustering of responses. RESULTS: Over one year, at least one episode of GI symptoms was reported by 54% of participants (95% CI 50%-58%), at least one respiratory episode by 91% (95% CI 88%-93%) and at least one episode of dermal symptoms by 27% (95% CI 24%-30%). The average number of weeks per year during which respiratory symptoms occurred was four times greater than for GI or dermal symptoms (4.9, 1.2 and 1.2 weeks, respectively, p<0.001), with an average number of GP visits per person per year being twice as frequent (0.48, 0.26, 0.19 respectively, p<0.001). However, on a per episode basis, a higher proportion of people saw a GP or were hospitalised for GI symptoms. CONCLUSIONS: This first comparative study of three different symptom complexes showed that although respiratory symptoms are most common, GI symptoms cause a greater per episode burden on healthcare resources. Measuring and comparing the community based burden of these symptom complexes will assist evidence-based allocation of resources.

Drinking rainwater: a double-blinded, randomized controlled study of water treatment filters and gastroenteritis incidence.

OBJECTIVES: We examined whether drinking untreated rainwater, a practice that is on the rise in developed countries because of water shortages, contributes to community gastroenteritis incidence. METHODS: We conducted a double-blinded, randomized controlled trial in Adelaide, Australia. Sham or active water treatment units were installed, and participants recorded incidences of illness in a health diary for 12 months. The primary outcome was highly credible gastroenteritis (HCG; characterized by a specified number of loose stools or vomiting alone or in combination with abdominal pain or nausea in a 24-hour period), and we used generalized estimating equations to account for correlations between numbers of HCG events for individuals in the same family. RESULTS: Participants reported 769 episodes during the study (0.77 episodes/person/year), with an HCG incidence rate ratio (active vs sham) of 1.05 (95% confidence interval [CI] = 0.82, 1.33). Blinding of the participants was effective (index = 0.65; 95% CI = 0.58, 0.72). CONCLUSIONS: Our results suggest that consumption of untreated rainwater does not contribute appreciably to community gastroenteritis. However, our findings may not be generalizable to susceptible and immunocompromised persons because these groups were specifically excluded from the study.

A Stepped Wedge Cluster-Randomized Trial Assessing the Impact of a Riverbank Filtration Intervention to Improve Access to Safe Water on Health in Rural India.

Sustainable and low-cost methods for delivery of safe drinking water in resource-limited settings remain suboptimal, which contributes to global diarrhea morbidity. We aimed to assess whether delivery of riverbank filtration-treated water to newly installed water storage tanks (improved quality and access, intervention condition) reduced reported diarrhea in comparison to delivery of unfiltered river water (improved access alone, control condition) in rural Indian villages. We used a stepped wedge cluster-randomized trial (SW-CRT) design involving four clusters (villages). Selection criteria included village size, proximity to a river, and lack of existing or planned community-level safe water sources. All adults and children were eligible for enrollment. All villages started in the control condition and were sequentially randomized to receive the intervention at 3-month intervals. Our primary outcome was 7-day-period prevalence of self- or caregiver-reported diarrhea, measured at 3-month intervals (five time points). Analysis was by intention to treat. Because blinding was not possible, we incorporated questions about symptoms unrelated to water consumption to check response validity (negative control symptoms). We measured outcomes in 2,222 households (9,836 participants). We did not find a measurable reduction in diarrhea post-intervention (RR: 0.98 [95% CI: 0.24-4.09]); possible explanations include low intervention uptake, availability of other safe water sources, low baseline diarrheal prevalence, and reporting fatigue. Our study highlights both the difficulties in evaluating the impact of real-world interventions and the potential for an optimized SW-CRT design to address budgetary, funding, and logistical constraints inherent in such evaluations.

Sporadic gastroenteritis and recreational swimming in a longitudinal community cohort study in Melbourne, Australia.

The relation between sporadic gastroenteritis and recreational swimming was examined in a cohort of 2,811 people in Melbourne, Australia, over a 15-month period (September 1997-February 1999). Data from a prospective community-based study of gastroenteritis were used for a Poisson analysis of temporality between reported swimming (in public or private pools/spas and in marine or freshwater settings) and a highly credible gastroenteritis (HCG) event. Overall, HCG events were more likely in participants who had swum in a public pool/spa (incidence rate ratio (IRR) = 1.25, 95% confidence interval (CI): 1.10, 1.42; P = 0.001) or river/lake/dam (IRR = 1.77, 95% CI: 1.13, 2.79; P = 0.014) during the previous week or had swum in a public pool/spa (IRR = 1.29, 95% CI: 1.13, 1.46; P < 0.001) during the previous 2 weeks. Subanalysis by age showed that HCG episodes were also more likely in adults who had swum in a private pool/spa (IRR = 1.56, 95% CI: 1.02, 2.39; P = 0.042) during the previous week or swum at an ocean/beach (IRR = 1.78, 95% CI: 1.12, 2.81; P = 0.014) during the previous 2 weeks, demonstrating significant associations between all swimming locations and gastrointestinal symptoms. This study showed that although the incremental risk of recreational swimming is significant, it is relatively small.

Transfer rates of enteric microorganisms in recycled water during machine clothes washing.

Approximately 15% of overall Australian household water usage is in the laundry; hence, a significant reduction in household drinking water demand could be achieved if potable-quality water used for clothes washing is replaced with recycled water. To investigate the microbiological safety of using recycled water in washing machines, bacteriophages MS-2 and PRD-1, Escherichia coli, and Cryptosporidium parvum oocysts were used in a series of experiments to investigate the transfer efficiency of enteric microorganisms from washing machine water to objects including hands, environmental surfaces, air, and fabric swatches. By determining the transference efficiency, it is possible to estimate the numbers of microorganisms that the user will be exposed to if recycled water with various levels of residual microorganisms is used in washing machines. Results, expressed as transfer rates to a given surface area per object, showed that the mean transfer efficiency of E. coli, bacteriophages MS-2 and PRD-1, and C. parvum oocysts from seeded water to fabric swatches ranged from 0.001% to 0.090%. Greatest exposure to microorganisms occurred through direct contact of hands with seeded water and via hand contact with contaminated fabric swatches. No microorganisms were detected in the air samples during the washing machine spin cycle, and transfer rates of bacteriophages from water to environmental surfaces were 100-fold less than from water directly to hands. Findings from this study provide relevant information that can be used to refine regulations governing recycled water and to allay public concerns about the use of recycled water.

Effectiveness and cost of recruitment strategies for a community-based randomised controlled trial among rainwater drinkers.

BACKGROUND: Community-based recruitment is challenging particularly if the sampling frame is not easily defined as in the case of people who drink rainwater. Strategies for contacting participants must be carefully considered to maximise generalisability and minimise bias of the results. This paper assesses the recruitment strategies for a 1-year double-blinded randomised trial on drinking untreated rainwater. The effectiveness of the recruitment strategies and associated costs are described. METHODS: Community recruitment of households from Adelaide, Australia occurred from February to July 2007 using four methods: electoral roll mail-out, approaches to schools and community groups, newspaper advertising, and other media involvement. Word of mouth communication was also assessed. RESULTS: A total of 810 callers were screened, with 53.5% eligible. Of those who were eligible and sent further information, 76.7% were willing to participate in the study and 75.1% were enrolled. The target for recruitment was 300 households, and this was achieved. The mail-out was the most effective method with respect to number of households randomised, while recruitment via schools had the highest yield (57.3%) and was the most cost effective when considering cost per household randomised (AUD$147.20). Yield and cost effectiveness were lowest for media advertising. CONCLUSION: The use of electoral roll mail-out and advertising via schools were effective in reaching households using untreated rainwater for drinking. Employing multiple strategies enabled success in achieving the recruitment target. In countries where electoral roll extracts are available to researchers, this method is likely to have a high yield for recruitment into community-based epidemiological studies.

Collecting household water usage data: telephone questionnaire or diary?

BACKGROUND: Quantitative Microbial Risk Assessment (QMRA), a modelling approach, is used to assess health risks. Inputs into the QMRA process include data that characterise the intensity, frequency and duration of exposure to risk(s). Data gaps for water exposure assessment include the duration and frequency of urban non-potable (non-drinking) water use. The primary objective of this study was to compare household water usage results obtained using two data collection tools, a computer assisted telephone interview (CATI) and a 7-day water activity diary, in order to assess the effect of different methodological survey approaches on derived exposure estimates. Costs and logistical aspects of each data collection tool were also examined. METHODS: A total of 232 households in an Australian dual reticulation scheme (where households are supplied with two grades of water through separate pipe networks) were surveyed about their water usage using both a CATI and a 7-day diary. Householders were questioned about their use of recycled water for toilet flushing, garden watering and other outdoor activities. Householders were also questioned about their water use in the laundry. Agreement between reported CATI and diary water usage responses was assessed. RESULTS: Results of this study showed that the level of agreement between CATI and diary responses was greater for more frequent water-related activities except toilet flushing and for those activities where standard durations or settings were employed. In addition, this study showed that the unit cost of diary administration was greater than for the CATI, excluding consideration of the initial selection and recruitment steps. CONCLUSION: This study showed that it is possible to successfully 'remotely' coordinate diary completion providing that adequate instructions are given and that diary recording forms are well designed. In addition, good diary return rates can be achieved using a monetary incentive and the diary format allows for collective recording, rather than an individual's estimation, of household water usage. Accordingly, there is merit in further exploring the use of diaries for collection of water usage information either in combination with a mail out for recruitment, or potentially in the future with Internet-based recruitment (as household Internet uptake increases).

The Australian Electoral Commission Roll has good utility for 'niche' household recruitment in population health studies.

OBJECTIVE: To investigate the recruitment of 'niche' household populations, defined by their household characteristics and/or water supply type for health studies. METHODS: The Australian Electoral Commission (AEC) database was used to recruit households for participation in two health-related studies, the first, a recycled water usage study and the second, an epidemiological study investigating household rainwater use. RESULTS: The AEC database facilitated the identification and recruitment of households using a particular water supply from among the general household population. CONCLUSIONS: The good utility of the AEC roll in household recruitment was associated with its coverage, accuracy and the ability to delimit the sampling frame according to the geographical area(s) and household characteristics of interest. Its use also allowed personalised contact to be made with potential survey participants by mail, contact that is not otherwise possible using existing telephone and on-line databases. IMPLICATIONS: The AEC database is a valuable resource for household recruitment in a diversity of health and environmental exposure surveys.

Classification of Cryptosporidium species from patients with sporadic cryptosporidiosis by use of sequence-based multilocus analysis following mutation scanning.

In the present study, we analyzed genetic variation in Cryptosporidium species from humans (n = 62) with clinical cryptosporidiosis in South Australia. Sequence variation was assessed in regions within the small subunit of nuclear rRNA (p-SSU), the 70-kDa heat shock protein (p-hsp70), and the 60-kDa glycoprotein (p-gp60) genes by employing single-strand conformation polymorphism analysis and sequencing. Based on the analyses of p-SSU and p-hsp70, Cryptosporidium hominis (n = 38) and Cryptosporidium parvum (n = 24) were identified. The analysis of p-gp60 revealed eight distinct subgenotypes, classified as C. hominis IaA17R1 (n = 3), IbA9G3R2 (n = 14), IbA10G2R2 (n = 20), and IfA12G1R1 (n = 1), as well as C. parvum IIaA18G3R1 (n = 15), IIaA20G3R1 (n = 6), IIaA22G4R1 (n = 2), and IIcA5G3R2 (n = 1). Subgenotypes IaA17R1 and IIaA22G4R1 are new. Of the six other subgenotypes, IbA10G2R2, IIaA18G3R1, IIaA20G3R1, and IIcA5G3R2 were reported previously from the state of Victoria. This is the fourth record in Australia of C. parvum subgenotype IIaA18G3R1 from humans, which, to date, has been isolated only from cattle in other countries. This subgenotype might be a significant contributor to sporadic human cryptosporidiosis and may indicate a greater zoonotic contribution to the infection of humans in the area of study. Comparative analyses revealed, for the first time, the differences in the genetic makeup of Cryptosporidium populations between two relatively close, major metropolitan cities.

Maximising response rates in household telephone surveys.

BACKGROUND: Epidemiological and other studies that require participants to respond by completing a questionnaire face the growing threat of non-response. Response rates to household telephone surveys are diminishing because of changes in telecommunications, marketing and culture. Accordingly, updated information is required about the rate of telephone listing in directories and optimal strategies to maximise survey participation. METHODS: A total of 3426 households in Sydney, Australia were approached to participate in a computer assisted telephone interview (CATI) regarding their domestic (recycled and/or drinking) water usage. Only randomly selected households in the suburb and postcode of interest with a telephone number listed in the Electronic White Pages (EWP) that matched Australian electoral records were approached. RESULTS: The CATI response rate for eligible households contacted by telephone was 39%. The rate of matching of electoral and EWP records, a measure of telephone directory coverage, was 55%. CONCLUSION: The use of a combination of approaches, such as an advance letter, interviewer training, establishment of researcher credentials, increasing call attempts and targeted call times, remains a good strategy to maximise telephone response rates. However, by way of preparation for future technological changes, reduced telephone number listings and people's increasing resistance to unwanted phone calls, alternatives to telephone surveys, such as internet-based approaches, should be investigated.

Cost of gastroenteritis in Australia: A healthcare perspective.

BACKGROUND: Acute gastroenteritis illness is a common illness that causes considerable morbidity, but current estimates of the cost to the Australian healthcare system are unknown. OBJECTIVE: To estimate the current healthcare utilisation and direct public healthcare system costs attributable to acute gastroenteritis illness in Australia. METHODS: This is an incidence-based cost-of-illness study focused on quantifying direct health care costs using a bottom-up approach. Data on general practitioner consultations, prescribed medications, diagnostic tests, specialist consultations, emergency department visits and hospital admissions were collected from national reports. RESULTS: Using 2016 prices, the estimated annual direct per capita cost of acute gastroenteritis illness was AUD$14.87 (USD$10.71), equating to AUD$20.27 (USD$14.59) per case. The estimated overall economic burden in Australia was AUD$359 million (USD$258 million; AUD$1.5 million per 100,000 people). The major contributors to this cost were hospital admissions (57.1%), emergency department visits (17.7%), and general practitioner consultations (14.0%). Children under five years of age have the highest per capita rates of acute gastroenteritis illness; however, service utilisation rates vary by age group and both young children and older adults accounted for a substantial proportion of the overall economic burden attributable to acute gastroenteritis illness. CONCLUSIONS: Although chronic diseases comprise a large cost burden on the healthcare system, acute illnesses, including acute gastroenteritis illness, also impose substantial direct healthcare system costs. Providing data on current cost estimates is useful for prioritizing public health interventions, with our findings suggesting that it would be ideal if targeted interventions to reduce hospitalisation rates among young children and older adults were available.

Recycled water and human health effects.

BACKGROUND: Recent drought conditions and diminishing drinking water storage levels in Australian capital cities have led to increasing attention being directed to water recycling and the use of alternative water sources for urban domestic use. Despite the 'in principle' acceptance by the Australian public for water recycling, support for proposed schemes is constrained by public perception of possible adverse health effects from exposure to micro-organisms and chemical contaminants. OBJECTIVE: This article describes current research investigating the health impacts of using recycled water for urban nondrinking purposes. DISCUSSION: Two complementary research approaches, quantitative microbial risk assessment and epidemiology, may be employed to assess health impacts of using recycled water for nondrinking or drinking purposes. The first of these approaches involves water quality monitoring and experimental studies. The second involves disease surveillance in which genera practitioners may play a part.

Burden of Disease Attributed to Waterborne Transmission of Selected Enteric Pathogens, Australia, 2010.

AbstractUniversal access to safe drinking water is a global priority. To estimate the annual disease burden of campylobacteriosis, nontyphoidal salmonellosis, cryptosporidiosis, giardiasis, and norovirus attributable to waterborne transmission in Australia, we multiplied regional World Health Organization (WHO) estimates of the proportion of cases attributable to waterborne transmission by estimates of all-source disease burden for each study pathogen. Norovirus was attributed as causing the most waterborne disease cases (479,632; 95% uncertainty interval [UI]: 0-1,111,874) followed by giardiasis and campylobacteriosis. The estimated waterborne disability-adjusted life year (DALY) burden for campylobacteriosis (2,004; 95% UI: 0-5,831) was 7-fold greater than other study pathogens and exceeded the WHO guidelines for drinking water quality (1 × 10-6 DALY per person per year) by 90-fold. However, these estimates include disease transmitted via either drinking or recreational water exposure. More precise country-specific and drinking water-specific attribution estimates would better define the health burden from drinking water and inform changes to treatment requirements.

Protocol for a cluster randomised stepped wedge trial assessing the impact of a community-level hygiene intervention and a water intervention using riverbank filtration technology on diarrhoeal prevalence in India.

INTRODUCTION: Diarrhoea is a leading cause of death globally, mostly occurring as a result of insufficient or unsafe water supplies, inadequate sanitation and poor hygiene. Our study aims to investigate the impact of a community-level hygiene education program and a water quality intervention using riverbank filtration (RBF) technology on diarrhoeal prevalence. METHODS AND ANALYSIS: We have designed a stepped wedge cluster randomised trial to estimate the health impacts of our intervention in 4 rural villages in Karnataka, India. At baseline, surveys will be conducted in all villages, and householders will receive hygiene education. New pipelines, water storage tanks and taps will then be installed at accessible locations in each village and untreated piped river water will be supplied. A subsequent survey will evaluate the impact of hygiene education combined with improved access to greater water volumes for hygiene and drinking purposes (improved water quantity). Villages will then be randomly ordered and RBF-treated water (improved water quality) will be sequentially introduced into the 4 villages in a stepwise manner, with administration of surveys at each time point. The primary outcome is a 7-day period prevalence of self-reported diarrhoea. Secondary outcomes include self-reported respiratory and skin infections, and reported changes in hygiene practices, household water usage and water supply preference. River, tank and tap water from each village, and stored water from a subset of households, will be sampled to assess microbial and chemical quality. ETHICS AND DISSEMINATION: Ethics approval was obtained from the Monash University Human Research Ethics Committee in Australia and The Energy and Resources Institute Institutional Ethics Committee in India. The results of the trial will be presented at conferences, published in peer-reviewed journals and disseminated to relevant stakeholders. This study is funded by an Australian National Health and Medical Research Council (NHMRC) project grant. TRIAL REGISTRATION NUMBER: ACTRN12616001286437; pre-results.