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The effect of improved rural sanitation on diarrhoea and helminth infection: design of a cluster-randomized trial in Orissa, India.

ABSTRACT: UNLABELLED: BACKGROUND:Infectious diseases associated with poor sanitation such as diarrhoea, intestinal worms, trachoma and lymphatic filariasis continue to cause a large disease burden in low income settings and contribute substantially to child mortality and morbidity. Obtaining health impact data for rural sanitation campaigns poses a number of methodological challenges. Here we describe the design of a village-level cluster-randomised trial in the state of Orissa, India to evaluate the impact of an ongoing rural sanitation campaign conducted under the umbrella of India's Total Sanitation Campaign (TSC).We randomised 50 villages to the intervention and 50 villages to control. In the intervention villages the implementing non-governmental organisations conducted community mobilisation and latrine construction with subsidies given to poor families. Control villages receive no intervention. Outcome measures include (1) diarrhoea in children under 5 and in all ages, (2) soil-transmitted helminth infections, (3) anthropometric measures, (4) water quality, (5) number of insect vectors (flies, mosquitoes), (6) exposure to faecal pathogens in the environment. In addition we are conducting process documentation (latrine construction and use, intervention reach), cost and cost-effectiveness analyses, spatial analyses and qualitative research on gender and water use for sanitation. RESULTS:Randomisation resulted in an acceptable balance between trial arms. The sample size requirements appear to be met for the main study outcomes. Delays in intervention roll-out caused logistical problems especially for the planning of health outcome follow-up surveys. Latrine coverage at the end of the construction period (55%) remained below the target of 70%, a result that may, however, be in line with many other TSC intervention areas in India. CONCLUSION:We discuss a number of methodological problems encountered thus far in this study that may be typical for sanitation trials. Nevertheless, it is expected that the trial procedures will allow measuring the effectiveness of a typical rural sanitation campaign, with sufficient accuracy and validity.

SUBMITTER: Clasen T

PROVIDER: S-EPMC3558431 | biostudies-literature | 2012 Nov

REPOSITORIES: biostudies-literature

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The effect of improved rural sanitation on diarrhoea and helminth infection: design of a cluster-randomized trial in Orissa, India.

Clasen Thomas T Boisson Sophie S Routray Parimita P Cumming Oliver O Jenkins Marion M Ensink Jeroen H J JH Bell Melissa M Freeman Matthew C MC Peppin Soosai S Schmidt Wolf-Peter WP

Emerging themes in epidemiology 20121113 1

<h4>Unlabelled</h4><h4>Background</h4>Infectious diseases associated with poor sanitation such as diarrhoea, intestinal worms, trachoma and lymphatic filariasis continue to cause a large disease burden in low income settings and contribute substantially to child mortality and morbidity. Obtaining health impact data for rural sanitation campaigns poses a number of methodological challenges. Here we describe the design of a village-level cluster-randomised trial in the state of Orissa, India to ev ...[more]

PMID: 23148587

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Project description:BackgroundThe combination of deworming and improved sanitation or hygiene may result in greater reductions in soil-transmitted helminth (STH) infection than any single intervention on its own. We measured STH prevalence in rural Bangladesh and assessed potential interactions among deworming, hygienic latrines, and household finished floors.MethodologyWe conducted a cross-sectional survey (n = 1,630) in 100 villages in rural Bangladesh to measure three exposures: self-reported deworming consumption in the past 6 months, access to a hygienic latrine, and household flooring material. We collected stool samples from children 1-4 years, 5-12 years, and women 15-49 years. We performed mini-FLOTAC on preserved stool samples to detect Ascaris lumbricoides, Enterobius vermicularis, hookworm, and Trichuris trichiura ova. Approximately one-third (32%) of all individuals and 40% of school-aged children had an STH infection. Less than 2% of the sample had moderate/heavy intensity infections. Deworming was associated with lower Ascaris prevalence (adjusted prevalence ratio (PR) = 0.53; 95% CI 0.40, 0.71), but there was no significant association with hookworm (PR = 0.93, 95% CI 0.60, 1.44) or Trichuris (PR = 0.90, 95% CI 0.74, 1.08). PRs for hygienic latrine access were 0.91 (95% CI 0.67,1.24), 0.73 (95% CI 0.43,1.24), and 1.03 (95% CI 0.84,1.27) for Ascaris, hookworm, and Trichuris, respectively. Finished floors were associated with lower Ascaris prevalence (PR = 0.56, 95% CI 0.32, 0.97) but not associated with hookworm (PR = 0.48 95% CI 0.16,1.45) or Trichuris (PR = 0.98, 95% CI 0.72,1.33). Across helminths and combinations of exposures, adjusted prevalence ratios for joint exposures were consistently more protective than those for individual exposures.ConclusionsWe found moderate STH prevalence in rural Bangladesh among children and women of childbearing age. This study is one of the first to examine independent and combined associations with deworming, sanitation, and hygiene. Our results suggest that coupling deworming with sanitation and flooring interventions may yield more sustained reductions in STH prevalence.

Project description:BackgroundDiarrhoea and growth faltering in early childhood are associated with subsequent adverse outcomes. We aimed to assess whether water quality, sanitation, and handwashing interventions alone or combined with nutrition interventions reduced diarrhoea or growth faltering.MethodsThe WASH Benefits Bangladesh cluster-randomised trial enrolled pregnant women from villages in rural Bangladesh and evaluated outcomes at 1-year and 2-years' follow-up. Pregnant women in geographically adjacent clusters were block-randomised to one of seven clusters: chlorinated drinking water (water); upgraded sanitation (sanitation); promotion of handwashing with soap (handwashing); combined water, sanitation, and handwashing; counselling on appropriate child nutrition plus lipid-based nutrient supplements (nutrition); combined water, sanitation, handwashing, and nutrition; and control (data collection only). Primary outcomes were caregiver-reported diarrhoea in the past 7 days among children who were in utero or younger than 3 years at enrolment and length-for-age Z score among children born to enrolled pregnant women. Masking was not possible for data collection, but analyses were masked. Analysis was by intention to treat. This trial is registered at ClinicalTrials.gov, number NCC01590095.FindingsBetween May 31, 2012, and July 7, 2013, 5551 pregnant women in 720 clusters were randomly allocated to one of seven groups. 1382 women were assigned to the control group; 698 to water; 696 to sanitation; 688 to handwashing; 702 to water, sanitation, and handwashing; 699 to nutrition; and 686 to water, sanitation, handwashing, and nutrition. 331 (6%) women were lost to follow-up. Data on diarrhoea at year 1 or year 2 (combined) were available for 14 425 children (7331 in year 1, 7094 in year 2) and data on length-for-age Z score in year 2 were available for 4584 children (92% of living children were measured at year 2). All interventions had high adherence. Compared with a prevalence of 5·7% (200 of 3517 child weeks) in the control group, 7-day diarrhoea prevalence was lower among index children and children under 3 years at enrolment who received sanitation (61 [3·5%] of 1760; prevalence ratio 0·61, 95% CI 0·46-0·81), handwashing (62 [3·5%] of 1795; 0·60, 0·45-0·80), combined water, sanitation, and handwashing (74 [3·9%] of 1902; 0·69, 0·53-0·90), nutrition (62 [3·5%] of 1766; 0·64, 0·49-0·85), and combined water, sanitation, handwashing, and nutrition (66 [3·5%] of 1861; 0·62, 0·47-0·81); diarrhoea prevalence was not significantly lower in children receiving water treatment (90 [4·9%] of 1824; 0·89, 0·70-1·13). Compared with control (mean length-for-age Z score -1·79), children were taller by year 2 in the nutrition group (mean difference 0·25 [95% CI 0·15-0·36]) and in the combined water, sanitation, handwashing, and nutrition group (0·13 [0·02-0·24]). The individual water, sanitation, and handwashing groups, and combined water, sanitation, and handwashing group had no effect on linear growth.InterpretationNutrient supplementation and counselling modestly improved linear growth, but there was no benefit to the integration of water, sanitation, and handwashing with nutrition. Adherence was high in all groups and diarrhoea prevalence was reduced in all intervention groups except water treatment. Combined water, sanitation, and handwashing interventions provided no additive benefit over single interventions.FundingBill & Melinda Gates Foundation.

Project description:BackgroundPoor nutrition and exposure to faecal contamination are associated with diarrhoea and growth faltering, both of which have long-term consequences for child health. We aimed to assess whether water, sanitation, handwashing, and nutrition interventions reduced diarrhoea or growth faltering.MethodsThe WASH Benefits cluster-randomised trial enrolled pregnant women from villages in rural Kenya and evaluated outcomes at 1 year and 2 years of follow-up. Geographically-adjacent clusters were block-randomised to active control (household visits to measure mid-upper-arm circumference), passive control (data collection only), or compound-level interventions including household visits to promote target behaviours: drinking chlorinated water (water); safe sanitation consisting of disposing faeces in an improved latrine (sanitation); handwashing with soap (handwashing); combined water, sanitation, and handwashing; counselling on appropriate maternal, infant, and young child feeding plus small-quantity lipid-based nutrient supplements from 6-24 months (nutrition); and combined water, sanitation, handwashing, and nutrition. Primary outcomes were caregiver-reported diarrhoea in the past 7 days and length-for-age Z score at year 2 in index children born to the enrolled pregnant women. Masking was not possible for data collection, but analyses were masked. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01704105.FindingsBetween Nov 27, 2012, and May 21, 2014, 8246 women in 702 clusters were enrolled and randomly assigned an intervention or control group. 1919 women were assigned to the active control group; 938 to passive control; 904 to water; 892 to sanitation; 917 to handwashing; 912 to combined water, sanitation, and handwashing; 843 to nutrition; and 921 to combined water, sanitation, handwashing, and nutrition. Data on diarrhoea at year 1 or year 2 were available for 6494 children and data on length-for-age Z score in year 2 were available for 6583 children (86% of living children were measured at year 2). Adherence indicators for sanitation, handwashing, and nutrition were more than 70% at year 1, handwashing fell to less than 25% at year 2, and for water was less than 45% at year 1 and less than 25% at year 2; combined groups were comparable to single groups. None of the interventions reduced diarrhoea prevalence compared with the active control. Compared with active control (length-for-age Z score -1·54) children in nutrition and combined water, sanitation, handwashing, and nutrition were taller by year 2 (mean difference 0·13 [95% CI 0·01-0·25] in the nutrition group; 0·16 [0·05-0·27] in the combined water, sanitation, handwashing, and nutrition group). The individual water, sanitation, and handwashing groups, and combined water, sanitation, and handwashing group had no effect on linear growth.InterpretationBehaviour change messaging combined with technologically simple interventions such as water treatment, household sanitation upgrades from unimproved to improved latrines, and handwashing stations did not reduce childhood diarrhoea or improve growth, even when adherence was at least as high as has been achieved by other programmes. Counselling and supplementation in the nutrition group and combined water, sanitation, handwashing, and nutrition interventions led to small growth benefits, but there was no advantage to integrating water, sanitation, and handwashing with nutrition. The interventions might have been more efficacious with higher adherence or in an environment with lower baseline sanitation coverage, especially in this context of high diarrhoea prevalence.FundingBill & Melinda Gates Foundation, United States Agency for International Development.

Project description:Improved sanitation has been hypothesized to reduce soil-transmitted helminth (STH) infections by reducing the prevalence and concentration of STH eggs/larvae in soil. We evaluated the effect of a randomized sanitation program (providing households with an improved dual-pit latrine, tools for child/animal feces management, and behavioral messaging) on reducing the prevalence and concentration of STH eggs in soil from household courtyards. We collected soil samples from 1405 households enrolled in the sanitation intervention (n = 419) and control (n = 914) groups of a cluster-randomized controlled trial (WASH Benefits) in rural Bangladesh approximately 2 years after the initiation of the interventions. We analyzed samples for Ascaris lumbricoides, Trichuris trichiura, and hookworm eggs by microscopy. We estimated prevalence ratios (PR) and egg count ratio (ECR) to compare the prevalence of STH eggs and arithmetic and geometric mean egg counts for STH eggs per gram of soil in the sanitation and control arms. Among intervention households, latrines achieved high and sustained user uptake by adults while child open defecation remained common and most households did not dispose of child feces hygienically. In courtyard soil from control households, the prevalence of any STH eggs was 75.7% and the prevalence of any larvated STH eggs was 67.3%. A. lumbricoides was detected in 63.0% of control samples and T. trichiura in 55.7% of control samples; hookworm was not detected in any sample. In the control arm, the arithmetic mean egg count for any STH was 3.96 eggs/dry gram, while the geometric mean was 1.58 eggs/dry gram. There was no difference between the intervention and control groups in the prevalence of any STH eggs (PR = 0.98 (95% CI: 0.91, 1.05)) or mean egg counts (ECR = 0.08 (95% CI: -0.10, 0.26) for geometric mean and 0.07 (95% CI: -0.22, 0.37) for arithmetic mean). Adjusted models gave similar results. A compound-level sanitation intervention that provided improved latrines and tools for disposal of child and animal feces did not have an impact on STH eggs in soil. In order to effectively reduce the prevalence and concentration of STH eggs in the environment, sustained, widespread use of sanitation strategies to isolate and hygienically dispose of child and animal feces may need to complement traditional strategies for containment of adult human feces. Trial Registration: NCT01590095.

Project description:BackgroundOral rotavirus vaccines (RVVs) are less efficacious in low-income versus high-income settings, plausibly due to more enteropathogen exposure through poor water, sanitation and hygiene (WASH). We explored associations between enteropathogens and RVV immunogenicity and evaluated the effect of improved WASH on enteropathogen carriage.MethodsWe detected stool enteropathogens using quantitative molecular methods and measured anti-rotavirus immunoglobulin A by enzyme-linked immunosorbent assay in infants enrolled to a cluster randomized 2 × 2 factorial trial of improved WASH and improved infant feeding in Zimbabwe (NCT01824940). We used multivariable regression to explore associations between enteropathogens and RVV seroconversion, seropositivity and geometric mean titer. We evaluated effects of improved WASH on enteropathogen prevalence using linear and binomial regression models with generalized estimating equations.ResultsAmong 224 infants with enteropathogen and immunogenicity data, 107 (47.8%) had ≥1 pathogen and 39 (17.4%) had ≥2 pathogens detected at median age 41 days (interquartile range: 35-54). RVV seroconversion was low (23.7%). After adjusting for Sabin-poliovirus quantity, pan-enterovirus quantity was positively associated with RVV seroconversion (relative risk 1.61 per 10-fold increase in pan-enterovirus; 95% confidence interval: 1.35-1.91); in the same model, Sabin quantity was negatively associated with RVV seroconversion (relative risk: 0.76; 95% confidence interval: 0.60-0.96). There were otherwise no meaningful associations between individual or total pathogens (bacteria, viruses, parasites or all pathogens) and any measure of RVV immunogenicity. Enteropathogen detection did not differ between randomized WASH and non-WASH groups.ConclusionsEnteropathogen infections were common around the time of rotavirus vaccination in rural Zimbabwean infants but did not explain poor RVV immunogenicity and were not reduced by a package of household-level WASH interventions.

Project description:BackgroundSoil transmitted helminths (STH) infect >1.5 billion people. Mass drug administration (MDA) effectively reduces infection; however, there is evidence for rapid reinfection and risk of potential drug resistance. We conducted a randomized controlled trial in Bangladesh (WASH Benefits, NCT01590095) to assess whether water, sanitation, hygiene and nutrition interventions, alone and combined, reduce STH in a setting with ongoing MDA.Methodology/principal findingsIn 2012-2013, we randomized 720 clusters of 5551 pregnant women into water treatment, sanitation, handwashing, combined water+sanitation+handwashing (WSH), nutrition, nutrition+WSH (N+WSH) or control arms. In 2015-2016, we enrolled 7795 children, aged 2-12 years, of 4102 available women for STH follow-up and collected stool from 7187. We enumerated STH infections with Kato-Katz. We estimated intention-to-treat intervention effects on infection prevalence and intensity. Participants and field staff were not blinded; laboratory technicians and data analysts were blinded. Prevalence among controls was 36.8% for A. lumbricoides, 9.2% for hookworm and 7.5% for T. trichiura. Most infections were low-intensity. Compared to controls, the water intervention reduced hookworm by 31% (prevalence ratio [PR] = 0.69 (0.50,0.95), prevalence difference [PD] = -2.83 (-5.16,-0.50)) but did not affect other STH. Sanitation improvements reduced T. trichiura by 29% (PR = 0.71 (0.52,0.98), PD = -2.17 (-4.03,-0.38)), had a similar borderline effect on hookworm and no effect on A. lumbricoides. Handwashing and nutrition interventions did not reduce any STH. WSH and N+WSH reduced hookworm prevalence by 29-33% (WSH: PR = 0.71 (0.52,0.99), PD = -2.63 (-4.95,-0.31); N+WSH: PR = 0.67 (0.50,0.91), PD = -3.00 (-5.14,-0.85)) and marginally reduced A. lumbricoides. Effects on infection intensity were similar.Conclusions/significanceIn a low-intensity infection setting with MDA, we found modest but sustained hookworm reduction from water treatment and combined WSH interventions. Impacts were more pronounced on STH species with short vs. long-term environmental survival. Our findings suggest possible waterborne transmission for hookworm. Water treatment and sanitation improvements can augment MDA to interrupt STH transmission.Trial registrationNCT01590095.

Project description:BACKGROUND:While women and girls face special risks from lack of access to sanitation facilities, their ability to participate and influence household-level sanitation is not well understood. This paper examines the association between women's decision-making autonomy and latrine construction in rural areas of Odisha, India. METHODS:We conducted a mixed-method study among rural households in Puri district. This included a cross sectional survey among 475 randomly selected households. These were classified as either having a functional latrine, a non-functional latrine or no latrine at all. We also conducted 17 in-depth interviews and 9 focus group discussions among household members of these three categories of households. RESULTS:Decisions on the construction of household level sanitation facilities were made exclusively by the male head in 80% of households; in 11% the decision was made by men who consulted or otherwise involved women. In only 9% of households the decision was made by women. Households where women were more involved in general decision making processes were no more likely to build a latrine, compared to households where they were excluded from decisions. Qualitative research revealed that women's non-involvement in sanitation decision making is attributed to their low socio-economic status and inability to influence the household's financial decisions. Female heads lacked confidence to take decisions independently, and were dependent on their spouse or other male family members for most decisions. The study revealed the existence of power hierarchies and dynamics within households, which constrained female's participation in decision-making processes regarding sanitation. CONCLUSIONS:Though governments and implementers emphasize women's involvement in sanitation programmes, socio-cultural factors and community and household level dynamics often prevent women from participating in sanitation-related decisions. Measures are needed for strengthening sanitation policies and effective implementation of programmes to address gender power relations and familial relationships that influence latrine adoption and use.

Dataset Information

The effect of improved rural sanitation on diarrhoea and helminth infection: design of a cluster-randomized trial in Orissa, India.

Publications

The effect of improved rural sanitation on diarrhoea and helminth infection: design of a cluster-randomized trial in Orissa, India.

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