ObjectiveContamination of weaning food leads to diarrhoea in children under 5 years. Public health interventions to improve practices in low-income and middle-income countries are rare and often not evaluated using a randomised method. We describe an intervention implementation and provide baseline data for such a trial.DesignClustered randomised controlled trial.SettingRural Gambia.Participants15 villages/clusters each with 20 randomly selected mothers with children aged 6–24 months per arm.InterventionTo develop the public health intervention, we used: (A) formative research findings to determine theoretically based critical control point corrective measures and motivational drives for behaviour change of mothers; (B) lessons from a community-based weaning food hygiene programme in Nepal and a handwashing intervention programme in India; and (C) culturally based performing arts, competitions and environmental clues. Four intensive intervention days per village involved the existing health systems and village/cultural structures that enabled per-protocol implementation and engagement of whole villager communities.ResultsBaseline village and mother’s characteristics were balanced between the arms after randomisation. Most villages were farming villages accessing health centres within 10 miles, with no schools but numerous village committees and representing all Gambia’s three main ethnic groups. Mothers were mainly illiterate (60%) and farmers (92%); 24% and 10% of children under 5 years were reported to have diarrhoea and respiratory symptoms, respectively, in the last 7 days (dry season). Intervention process engaged whole village members and provided lessons for future implementation; culturally adapted performing arts were an important element.ConclusionThis research has potential as a new low-cost and broadly available public health programme to reduce infection through weaning food. The theory-based intervention was widely consulted in the Gambia and with experts and was well accepted by the communities. Baseline analysis provides socioeconomic data and confirmation of Unicefs Multiple Indicator Cluster Survey (MICS) data on the prevalence of diarrhoea and respiratory symptoms in the dry season in the poorest region of Gambia.Trial registration numberPACTR201410000859336; Pre-results.
B y the end of October 2020, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic had spread to 6 continents and caused >45 million coronavirus disease (COVID-19) cases and 1.1 million deaths (1). Despite having 15.6% of the worldwide population (2), by October 31, 2020, Africa had only 3.9% (1.76 million) of the world's COVID-19 cases and 3.6% (42,233) of deaths during the pandemic (1). Data suggest that the pandemic is evolving differently in sub-Saharan Africa compared with the rest of the world and that the outbreak started later (3).Of note, severe COVID-19 cases seem to occur less frequently in Africa than in the rest of the world (4). Several factors have been proposed to explain this. Age is likely a major factor because older persons are at higher risk for severe disease, but Africa has an extremely young population; >60% of persons are <25 years of age (5). However, variation of CO-VID-19 severity with age alone does not fully explain the observed differences (4). Clinical cases and deaths in Africa likely are underreported because systematic surveillance is limited and no systematic death registration exists; thus, the true SARS-CoV-2 burden probably is underestimated (4). Nevertheless, local health systems in Africa, which have a lower capacity to deal with COVID-19 patients than healthcare systems in high-resource settings, were not overwhelmed, even at the peak of the epidemic (6). Although potential
Background The Gambia has high rates of under-5 mortality from diarrhoea and pneumonia, peaking during complementary-feeding age. Community-based interventions may reduce complementary-food contamination and disease rates. Methods and findings A public health intervention using critical control points and motivational drivers, delivered February–April 2015 in The Gambia, was evaluated in a cluster randomised controlled trial at 6- and 32-month follow-up in September–October 2015 and October–December 2017, respectively. After consent for trial participation and baseline data were collected, 30 villages (clusters) were randomly assigned to intervention or control, stratified by population size and geography. The intervention included a community-wide campaign on days 1, 2, 17, and 25, a reminder visit at 5 months, plus informal community-volunteer home visits. It promoted 5 key complementary-food and 1 key drinking-water safety and hygiene behaviours through performing arts, public meetings, and certifications delivered by a team from local health and village structures to all villagers who attended the activities, to which mothers of 6- to 24-month-old children were specifically invited. Control villages received a 1-day campaign on domestic-garden water use. The background characteristics of mother and clusters (villages) were balanced between the trial arms. Outcomes were measured at 6 and 32 months in a random sample of 21–26 mothers per cluster. There were no intervention or research team visits to villages between 6 and 32 months. The primary outcome was a composite outcome of the number of times key complementary-food behaviours were observed as a proportion of the number of opportunities to perform the behaviours during the observation period at 6 months. Secondary outcomes included the rate of each recommended behaviour; microbiological growth from complementary food and drinking water (6 months only); and reported acute respiratory infections, diarrhoea, and diarrhoea hospitalisation. Analysis was by intention-to-treat analysis adjusted by clustering. (Registration: PACTR201410000859336). We found that 394/571 (69%) of mothers with complementary-feeding children in the intervention villages were actively involved in the campaign. No villages withdrew, and there were no changes in the implementation of the intervention. The intervention improved behaviour adoption significantly. For the primary outcome, the rate was 662/4,351(incidence rate [IR] = 0.15) in control villages versus 2,861/4,378 (IR = 0.65) in intervention villages (adjusted incidence rate ratio [aIRR] = 4.44, 95% CI 3.62–5.44, p < 0.001), and at 32 months the aIRR was 1.17 (95% CI 1.07–1.29, p = 0.001). Secondary health outcomes also improved with the intervention: (1) mother-reported diarrhoea at 6 months, with adjusted relative risk (aRR) = 0.39 (95% CI 0.32–0.48, p < 0.001), and at 32 months, with aRR = 0.68 (95% CI 0.48–0.96, p = 0.027); (2) mother-reported diarrhoea hospitalisation at 6 months, with aRR = 0.35 (95% CI 0.19–0.66, p = 0.001), and at 32 months, with aRR = 0.38 (95% CI 0.18–0.80, p = 0.011); and (3) mother-reported acute respiratory tract infections at 6 months, with aRR = 0.67 (95% CI 0.53–0.86, p = 0.001), though at 32 months improvement was not significant (p = 0.200). No adverse events were reported. The main limitations were that only medium to small rural villages were involved. Obtaining laboratory cultures from food at 32 months was not possible, and no stool microorganisms were investigated. Conclusions We found that low-cost and culturally embedded behaviour change interventions were acceptable to communities and led to short- and long-term improvements in complementary-food safety and hygiene practices, and reported diarrhoea and acute respiratory tract infections. Trial registration The trial was registered on the 17th October 2014 with the Pan African Clinical Trial Registry in South Africa with number (PACTR201410000859336) and 32-month follow-up as an amendment to the trial.
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