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Independent and combined effects of improved water, sanitation, and hygiene, and improved complementary feeding, on stunting and anaemia among HIV-exposed children in rural Zimbabwe: a cluster-randomised controlled trial.

ABSTRACT: BACKGROUND:Children exposed to HIV have a high prevalence of stunting and anaemia. We aimed to test the effect of improved infant and young child feeding (IYCF) and improved water, sanitation, and hygiene (WASH) on child linear growth and haemoglobin concentrations. METHODS:We did a cluster randomised 2 × 2 factorial trial in two districts in rural Zimbabwe. Women were eligible for inclusion if they permanently lived in the trial clusters (ie, the catchment area of between one and four village health workers employed by the Zimbabwean Ministry of Health and Child Care) and were confirmed pregnant. Clusters were randomly allocated to standard of care (52 clusters); IYCF (20 g small-quantity lipid-based nutrient supplement daily for infants from 6 months to 18 months, complementary feeding counselling with context-specific messages, longitudinal delivery, and reinforcement; 53 clusters); WASH (ventilated, improved pit latrine, two hand-washing stations, liquid soap, chlorine, play space, and hygiene counselling; 53 clusters); or IYCF plus WASH (53 clusters). Participants and fieldworkers were not masked. Our co-primary outcomes were length for age Z score and haemoglobin in infants at 18 months of age. Here, we report these outcomes in the HIV-exposed children, analysed by intention to treat. We estimated the effects of the interventions by comparing the two IYCF groups with the two non-IYCF groups and the two WASH groups with the two non-WASH groups, except for outcomes with an important statistical interaction between the interventions. The trial is registered at ClinicalTrials.gov (NCT01824940) and is now complete. FINDINGS:Between Nov 22, 2012, and March 27, 2015, 726 HIV-positive pregnant women were included in the trial. 668 children were evaluated at 18 months (147 from 46 standard of care clusters; 147 from 48 IYCF clusters; 184 from 44 WASH clusters; 190 from 47 IYCF plus WASH clusters). Of the 668 children, 22 (3%) were HIV-positive, 594 (89%) HIV-exposed uninfected, and 52 (8%) HIV-unknown. The IYCF intervention increased mean length for age Z score by 0·26 (95% CI 0·09-0·43; p=0·003) and haemoglobin concentration by 2·9 g/L (95% CI 0·90-4·90; p=0·005). 165 (50%) of 329 children in the non-IYCF groups were stunted, compared with 136 (40%) of 336 in the IYCF groups (absolute difference 10%, 95% CI 2-17); and the prevalence of anaemia was also lower in the IYCF groups (45 [14%] of 319) than in the non-IYCF groups (24 [7%] of 329; absolute difference 7%, 95% CI 2-12). The WASH intervention had no effect on length or haemoglobin concentration. There were no trial-related adverse or serious adverse events. INTERPRETATION:Since HIV-exposed children are particularly vulnerable to undernutrition and responded well to improved complementary feeding, IYCF interventions could have considerable benefits in areas of high antenatal HIV prevalence. However, elementary WASH interventions did not lead to improvements in growth. FUNDING:Bill & Melinda Gates Foundation, UK Aid, Wellcome Trust, Swiss Development Cooperation, US National Institutes of Health, and UNICEF.

SUBMITTER: Prendergast AJ

PROVIDER: S-EPMC6472652 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundChild stunting reduces survival and impairs neurodevelopment. We tested the independent and combined effects of improved water, sanitation, and hygiene (WASH), and improved infant and young child feeding (IYCF) on stunting and anaemia in in Zimbabwe.MethodsWe did a cluster-randomised, community-based, 2 × 2 factorial trial in two rural districts in Zimbabwe. Clusters were defined as the catchment area of between one and four village health workers employed by the Zimbabwe Ministry of Health and Child Care. Women were eligible for inclusion if they permanently lived in clusters and were confirmed pregnant. Clusters were randomly assigned (1:1:1:1) to standard of care (52 clusters), IYCF (20 g of a small-quantity lipid-based nutrient supplement per day from age 6 to 18 months plus complementary feeding counselling; 53 clusters), WASH (construction of a ventilated improved pit latrine, provision of two handwashing stations, liquid soap, chlorine, and play space plus hygiene counselling; 53 clusters), or IYCF plus WASH (53 clusters). A constrained randomisation technique was used to achieve balance across the groups for 14 variables related to geography, demography, water access, and community-level sanitation coverage. Masking of participants and fieldworkers was not possible. The primary outcomes were infant length-for-age Z score and haemoglobin concentrations at 18 months of age among children born to mothers who were HIV negative during pregnancy. These outcomes were analysed in the intention-to-treat population. We estimated the effects of the interventions by comparing the two IYCF groups with the two non-IYCF groups and the two WASH groups with the two non-WASH groups, except for outcomes that had an important statistical interaction between the interventions. This trial is registered with ClinicalTrials.gov, number NCT01824940.FindingsBetween Nov 22, 2012, and March 27, 2015, 5280 pregnant women were enrolled from 211 clusters. 3686 children born to HIV-negative mothers were assessed at age 18 months (884 in the standard of care group from 52 clusters, 893 in the IYCF group from 53 clusters, 918 in the WASH group from 53 clusters, and 991 in the IYCF plus WASH group from 51 clusters). In the IYCF intervention groups, the mean length-for-age Z score was 0·16 (95% CI 0·08-0·23) higher and the mean haemoglobin concentration was 2·03 g/L (1·28-2·79) higher than those in the non-IYCF intervention groups. The IYCF intervention reduced the number of stunted children from 620 (35%) of 1792 to 514 (27%) of 1879, and the number of children with anaemia from 245 (13·9%) of 1759 to 193 (10·5%) of 1845. The WASH intervention had no effect on either primary outcome. Neither intervention reduced the prevalence of diarrhoea at 12 or 18 months. No trial-related serious adverse events, and only three trial-related adverse events, were reported.InterpretationHousehold-level elementary WASH interventions implemented in rural areas in low-income countries are unlikely to reduce stunting or anaemia and might not reduce diarrhoea. Implementation of these WASH interventions in combination with IYCF interventions is unlikely to reduce stunting or anaemia more than implementation of IYCF alone.FundingBill & Melinda Gates Foundation, UK Department for International Development, Wellcome Trust, Swiss Development Cooperation, UNICEF, and US National Institutes of Health.

Project description:BackgroundGlobally, nearly 250 million children (43% of all children under 5 years of age) are at risk of compromised neurodevelopment due to poverty, stunting, and lack of stimulation. We tested the independent and combined effects of improved water, sanitation, and hygiene (WASH) and improved infant and young child feeding (IYCF) on early child development (ECD) among children enrolled in the Sanitation Hygiene Infant Nutrition Efficacy (SHINE) trial in rural Zimbabwe.Methods and findingsSHINE was a cluster-randomized community-based 2×2 factorial trial. A total of 5,280 pregnant women were enrolled from 211 clusters (defined as the catchment area of 1-4 village health workers [VHWs] employed by the Zimbabwean Ministry of Health and Child Care). Clusters were randomly allocated to standard of care, IYCF (20 g of small-quantity lipid-based nutrient supplement per day from age 6 to 18 months plus complementary feeding counseling), WASH (ventilated improved pit latrine, handwashing stations, chlorine, liquid soap, and play yard), and WASH + IYCF. Primary outcomes were child length-for-age Z-score and hemoglobin concentration at 18 months of age. Children who completed the 18-month visit and turned 2 years (102-112 weeks) between March 1, 2016, and April 30, 2017, were eligible for the ECD substudy. We prespecified that primary inferences would be drawn from findings of children born to HIV-negative mothers; these results are presented in this paper. A total of 1,655 HIV-unexposed children (64% of those eligible) were recruited into the ECD substudy from 206 clusters and evaluated for ECD at 2 years of age using the Malawi Developmental Assessment Tool (MDAT) to assess gross motor, fine motor, language, and social skills; the MacArthur-Bates Communicative Development Inventories (CDI) to assess vocabulary and grammar; the A-not-B test to assess object permanence; and a self-control task. Outcomes were analyzed in the intention-to-treat population. For all ECD outcomes, there was not a statistical interaction between the IYCF and WASH interventions, so we estimated the effects of the interventions by comparing the 2 IYCF groups with the 2 non-IYCF groups and the 2 WASH groups with the 2 non-WASH groups. The mean (95% CI) total MDAT score was modestly higher in the IYCF groups compared to the non-IYCF groups in unadjusted analysis: 1.35 (0.24, 2.46; p = 0.017); this difference did not persist in adjusted analysis: 0.79 (-0.22, 1.68; p = 0.057). There was no evidence of impact of the IYCF intervention on the CDI, A-not-B, or self-control tests. Among children in the WASH groups compared to those in the non-WASH groups, mean scores were not different for the MDAT, A-not-B, or self-control tests; mean CDI score was not different in unadjusted analysis (0.99 [95% CI -1.18, 3.17]) but was higher in children in the WASH groups in adjusted analysis (1.81 [0.01, 3.61]). The main limitation of the study was the specific time window for substudy recruitment, meaning not all children from the main trial were enrolled.ConclusionsWe found little evidence that the IYCF and WASH interventions implemented in SHINE caused clinically important improvements in child development at 2 years of age. Interventions that directly target neurodevelopment (e.g., early stimulation) or that more comprehensively address the multifactorial nature of neurodevelopment may be required to support healthy development of vulnerable children.Trial registrationClinicalTrials.gov NCT01824940.

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:WHO and UNICEF have proposed an action plan to achieve universal water, sanitation and hygiene (WASH) coverage in healthcare facilities (HCFs) by 2030. The WASH targets and indicators for HCFs include: an improved water source on the premises accessible to all users, basic sanitation facilities, a hand washing facility with soap and water at all sanitation facilities and patient care areas. To establish viable targets for WASH in HCFs, investigation beyond 'access' is needed to address the state of WASH infrastructure and service provision. Patient and caregiver use of WASH services is largely unaddressed in previous studies despite being critical for infection control.The state of WASH services used by staff, patients and caregivers was assessed in 17 rural HCFs in Rwanda. Site selection was non-random and predicated upon piped water and power supply. Direct observation and semi-structured interviews assessed drinking water treatment, presence and condition of sanitation facilities, provision of soap and water, and WASH-related maintenance and record keeping. Samples were collected from water sources and treated drinking water containers and analyzed for total coliforms, E. coli, and chlorine residual.Drinking water treatment was reported at 15 of 17 sites. Three of 18 drinking water samples collected met the WHO guideline for free chlorine residual of >0.2 mg/l, 6 of 16 drinking water samples analyzed for total coliforms met the WHO guideline of <1 coliform/100 mL and 15 of 16 drinking water samples analyzed for E. coli met the WHO guideline of <1 E. coli/100 mL. HCF staff reported treating up to 20 L of drinking water per day. At all sites, 60% of water access points (160 of 267) were observed to be functional, 32% of hand washing locations (46 of 142) had water and soap and 44% of sanitary facilities (48 of 109) were in hygienic condition and accessible to patients. Regular maintenance of WASH infrastructure consisted of cleaning; no HCF had on-site capacity for performing repairs. Quarterly evaluations of HCFs for Rwanda's Performance Based Financing system included WASH indicators.All HCFs met national policies for water access, but WHO guidelines for environmental standards including water quality were not fully satisfied. Access to WASH services at the HCFs differed between staff and patients and caregivers.

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Independent and combined effects of improved water, sanitation, and hygiene, and improved complementary feeding, on stunting and anaemia among HIV-exposed children in rural Zimbabwe: a cluster-randomised controlled trial.

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