SummaryBackgroundChild 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 r...
Child stunting is a global problem and is only modestly responsive to dietary interventions. Numerous observational studies have shown that water quality, sanitation, and handwashing (WASH) in a household are strongly associated with linear growth of children living in the same household. We have completed three randomised efficacy trials testing improved household-level WASH with and without improved infant and young child feeding (IYCF) on stunting and diarrhoea in Bangladesh, Kenya, and Zimbabwe. In all trials, improved IYCF had a statistically significant benefit, but WASH had no effect on linear growth. In observational analyses of data from the control groups of the three trials, baseline sanitation was a strong risk factor for stunting in the study populations, suggesting this frequently reported association might be confounded by unmeasured factors of household wellbeing. WASH interventions reduced diarrhoea in Bangladesh, but not in Kenya or Zimbabwe. Intervention promoters visited participants six times per month in Bangladesh compared with monthly in Kenya and Zimbabwe; a review of the literature shows that virtually all published studies that have reported an effect on diarrhoea through home-based water treatment and handwashing promotion achieved high adherence by visiting participants at daily to fortnightly intervals. Despite achieving substantial behavioural change and significant reduction in infection prevalence for some enteric pathogens, detection of enteropathogens among children in the WASH groups of the trials was typically at ten times higher prevalence compared with high-income countries. Considering these results, we recommend that future research in the WASH sector focus on developing and evaluating interventions that are radically more effective in reducing faecal contamination in the domestic environment than the interventions implemented in these trials.
SummaryBackgroundAs mobile phone access continues to expand globally, opportunities exist to leverage these technologies to support demand for immunisation services and improve vaccine coverage. We aimed to assess whether short message service (SMS) reminders and monetary incentives can improve immunisation uptake in Kenya.MethodsIn this cluster-randomised controlled trial, villages were randomly and evenly allocated to four groups: control, SMS only, SMS plus a 75 Kenya Shilling (KES) incentive, and SMS plus 200 KES (85 KES = USD$1). Caregivers were eligible if they had a child younger than 5 weeks who had not yet received a first dose of pentavalent vaccine. Participants in the intervention groups received SMS reminders before scheduled pentavalent and measles immunisation visits. Participants in incentive groups, additionally, received money if their child was timely immunised (immunisation within 2 weeks of the due date). Caregivers and interviewers were not masked. The proportion of fully immunised children (receiving BCG, three doses of polio vaccine, three doses of pentavalent vaccine, and measles vaccine) by 12 months of age constituted the primary outcome and was analysed with log-binomial regression and General Estimating Equations to account for correlation within clusters. This trial is registered with ClinicalTrials.gov, number NCT01878435.FindingsBetween Oct 14, 2013, and Oct 17, 2014, we enrolled 2018 caregivers and their infants from 152 villages into the following four groups: control (n=489), SMS only (n=476), SMS plus 75 KES (n=562), and SMS plus 200 KES (n=491). Overall, 1375 (86%) of 1600 children who were successfully followed up achieved the primary outcome, full immunisation by 12 months of age (296 [82%] of 360 control participants, 332 [86%] of 388 SMS only participants, 383 [86%] of 446 SMS plus 75 KES participants, and 364 [90%] of 406 SMS plus 200 KES participants). Children in the SMS plus 200 KES group were significantly more likely to achieve full immunisation at 12 months of age (relative risk 1·09, 95% CI 1·02–1·16, p=0·014) than children in the control group.InterpretationIn a setting with high baseline immunisation coverage levels, SMS reminders coupled with incentives significantly improved immunisation coverage and timeliness. Given that global immunisation coverage levels have stagnated around 85%, the use of incentives might be one option to reach the remaining 15%.FundingBill & Melinda Gates Foundation.
Abstract. The prevalence and characteristics of human taeniasis/cysticercosis and porcine cysticercosis were assessed in an endemic area of the Peruvian highlands. Individuals from 10 communities had stool examinations (N ס 2,951) and serologic testing for Taenia solium antibodies (N ס 2,583). The total porcine population present (N ס 703) was also examined by serology. Cysticercosis is hyperendemic in this area and is associated with an important number of seizure cases. Human seroprevalence by village ranged from 7.1-26.9% (mean, 13.9%). Seroprevalence was higher among individuals with a history of seizures but not in those reporting a history of headache or intestinal taeniasis. Prevalence of taeniasis ranged from 0-6.7% (median, 2.5%). Coproantigen detection found 2.4 times more taeniasis cases than did microscopy (direct and after concentration). Age distribution for taeniasis showed a peak at younger ages than for seroprevalence. Porcine seroprevalence ranged from 42-75%. Random effects logistic regression models for human seropositivity demonstrated both in-house clustering of cases and a large increase in risk associated with a tapeworm carrier in the house. Besides confirming the close relationship between taeniasis and cysticercosis cases, this large-scale field study demonstrated early age of tapeworm and cysticercosis infections in humans, and short duration of taeniasis infections.
Background Coronavirus-like particles (CoVLP) that are produced in plants and display the prefusion spike glycoprotein of the original strain of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are combined with an adjuvant (Adjuvant System 03 [AS03]) to form the candidate vaccine. Methods In this phase 3, multinational, randomized, placebo-controlled trial conducted at 85 centers, we assigned adults (≥18 years of age) in a 1:1 ratio to receive two intramuscular injections of the CoVLP+AS03 vaccine or placebo 21 days apart. The primary objective of the trial was to determine the efficacy of the CoVLP+AS03 vaccine in preventing symptomatic coronavirus disease 2019 (Covid-19) beginning at least 7 days after the second injection, with the analysis performed after the detection of at least 160 cases. Results A total of 24,141 volunteers participated in the trial; the median age of the participants was 29 years. Covid-19 was confirmed by polymerase-chain-reaction assay in 165 participants in the intention-to-treat population; all viral samples that could be sequenced contained variants of the original strain. Vaccine efficacy was 69.5% (95% confidence interval [CI], 56.7 to 78.8) against any symptomatic Covid-19 caused by five variants that were identified by sequencing. In a post hoc analysis, vaccine efficacy was 78.8% (95% CI, 55.8 to 90.8) against moderate-to-severe disease and 74.0% (95% CI, 62.1 to 82.5) among the participants who were seronegative at baseline. No severe cases of Covid-19 occurred in the vaccine group, in which the median viral load for breakthrough cases was lower than that in the placebo group by a factor of more than 100. Solicited adverse events were mostly mild or moderate and transient and were more frequent in the vaccine group than in the placebo group; local adverse events occurred in 92.3% and 45.5% of participants, respectively, and systemic adverse events in 87.3% and 65.0%. The incidence of unsolicited adverse events was similar in the two groups up to 21 days after each dose (22.7% and 20.4%) and from day 43 through day 201 (4.2% and 4.0%). Conclusions The CoVLP+AS03 vaccine was effective in preventing Covid-19 caused by a spectrum of variants, with efficacy ranging from 69.5% against symptomatic infection to 78.8% against moderate-to-severe disease. (Funded by Medicago; ClinicalTrials.gov number, NCT04636697 .)
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