Mass Azithromycin Distribution to Prevent Child Mortality in Burkina Faso: The CHAT Randomized Clinical Trial.

Importance: Repeated mass distribution of azithromycin has been shown to reduce childhood mortality by 14% in sub-Saharan Africa. However, the estimated effect varied by location, suggesting that the intervention may not be effective in different geographical areas, time periods, or conditions. Objective: To evaluate the efficacy of twice-yearly azithromycin to reduce mortality in children in the presence of seasonal malaria chemoprevention. Design, Setting, and Participants: This cluster randomized placebo-controlled trial evaluating the efficacy of single-dose azithromycin for prevention of all-cause childhood mortality included 341 communities in the Nouna district in rural northwestern Burkina Faso. Participants were children aged 1 to 59 months living in the study communities. Interventions: Communities were randomized in a 1:1 ratio to receive oral azithromycin or placebo distribution. Children aged 1 to 59 months were offered single-dose treatment twice yearly for 3 years (6 distributions) from August 2019 to February 2023. Main Outcomes and Measures: The primary outcome was all-cause childhood mortality, measured during a twice-yearly enumerative census. Results: A total of 34 399 children (mean [SD] age, 25.2 [18] months) in the azithromycin group and 33 847 children (mean [SD] age, 25.6 [18] months) in the placebo group were included. A mean (SD) of 90.1% (16.0%) of the censused children received the scheduled study drug in the azithromycin group and 89.8% (17.1%) received the scheduled study drug in the placebo group. In the azithromycin group, 498 deaths were recorded over 60 592 person-years (8.2 deaths/1000 person-years). In the placebo group, 588 deaths were recorded over 58 547 person-years (10.0 deaths/1000 person-years). The incidence rate ratio for mortality was 0.82 (95% CI, 0.67-1.02; P = .07) in the azithromycin group compared with the placebo group. The incidence rate ratio was 0.99 (95% CI, 0.72-1.36) in those aged 1 to 11 months, 0.92 (95% CI, 0.67-1.27) in those aged 12 to 23 months, and 0.73 (95% CI, 0.57-0.94) in those aged 24 to 59 months. Conclusions and Relevance: Mortality in children (aged 1-59 months) was lower with biannual mass azithromycin distribution in a setting in which seasonal malaria chemoprevention was also being distributed, but the difference was not statistically significant. The study may have been underpowered to detect a clinically relevant difference. Trial Registration: ClinicalTrials.gov Identifier: NCT03676764.

The effects of cool roofs on health, environmental, and economic outcomes in rural Africa: study protocol for a community-based cluster randomized controlled trial.

BACKGROUND: High ambient air temperatures in Africa pose significant health and behavioral challenges in populations with limited access to cooling adaptations. The built environment can exacerbate heat exposure, making passive home cooling adaptations a potential method for protecting occupants against indoor heat exposure. METHODS: We are conducting a 2-year community-based stratified cluster randomized controlled trial (cRCT) implementing sunlight-reflecting roof coatings, known as "cool roofs," as a climate change adaptation intervention for passive indoor home cooling. Our primary research objective is to investigate the effects of cool roofs on health, indoor climate, economic, and behavioral outcomes in rural Burkina Faso. This cRCT is nested in the Nouna Health and Demographic Surveillance System (HDSS), a population-based dynamic cohort study of all people living in a geographically contiguous area covering 59 villages, 14305 households and 28610 individuals. We recruited 1200 participants, one woman and one man, each in 600 households in 25 villages in the Nouna HDSS. We stratified our sample by (i) village and (ii) two prevalent roof types in this area of Burkina Faso: mud brick and tin. We randomized the same number of people (12) and homes (6) in each stratum 1:1 to receiving vs. not receiving the cool roof. We are collecting outcome data on one primary endpoint - heart rate, (a measure of heat stress) and 22 secondary outcomes encompassing indoor climate parameters, blood pressure, body temperature, heat-related outcomes, blood glucose, sleep, cognition, mental health, health facility utilization, economic and productivity outcomes, mosquito count, life satisfaction, gender-based violence, and food consumption. We followed all participants for 2 years, conducting monthly home visits to collect objective and subjective outcomes. Approximately 12% of participants (n = 152) used smartwatches to continuously measure endpoints including heart rate, sleep and activity. DISCUSSION: Our study demonstrates the potential of large-scale cRCTs to evaluate novel climate change adaptation interventions and provide evidence supporting investments in heat resilience in sub-Saharan Africa. By conducting this research, we will contribute to better policies and interventions to help climate-vulnerable populations ward off the detrimental effects of extreme indoor heat on health. TRIAL REGISTRATION: German Clinical Trials Register (DRKS) DRKS00023207. Registered on April 19, 2021.

Azithromycin during Routine Well-Infant Visits to Prevent Death.

BACKGROUND: Mass distribution of azithromycin to children 1 to 59 months of age has been shown to reduce childhood all-cause mortality in some sub-Saharan African regions, with the largest reduction seen among infants younger than 12 months of age. Whether the administration of azithromycin at routine health care visits for infants would be effective in preventing death is unclear. METHODS: We conducted a randomized, placebo-controlled trial of a single dose of azithromycin (20 mg per kilogram of body weight) as compared with placebo, administered during infancy (5 to 12 weeks of age). The primary end point was death before 6 months of age. Infants were recruited at routine vaccination or other well-child visits in clinics and through community outreach in three regions of Burkina Faso. Vital status was assessed at 6 months of age. RESULTS: Of the 32,877 infants enrolled from September 2019 through October 2022, a total of 16,416 infants were randomly assigned to azithromycin and 16,461 to placebo. Eighty-two infants in the azithromycin group and 75 infants in the placebo group died before 6 months of age (hazard ratio, 1.09; 95% confidence interval [CI], 0.80 to 1.49; P = 0.58); the absolute difference in mortality was 0.04 percentage points (95% CI, -0.10 to 0.21). There was no evidence of an effect of azithromycin on mortality in any of the prespecified subgroups, including subgroups defined according to age, sex, and baseline weight, and no evidence of a difference between the two trial groups in the incidence of adverse events. CONCLUSIONS: In this trial conducted in Burkina Faso, we found that administration of azithromycin to infants through the existing health care system did not prevent death. (Funded by the Bill and Melinda Gates Foundation; CHAT ClinicalTrials.gov number, NCT03676764.).

Single-dose azithromycin for infant growth in Burkina Faso: Prespecified secondary anthropometric outcomes from a randomized controlled trial.

BACKGROUND: Antibiotic use during early infancy has been linked to childhood obesity in high-income countries. We evaluated whether a single oral dose of azithromycin administered during infant-well visits led to changes in infant growth outcomes at 6 months of age in a setting with a high prevalence of undernutrition in rural Burkina Faso. METHODS AND FINDINGS: Infants were enrolled from September 25, 2019, until October 22, 2022, in a randomized controlled trial designed to evaluate the efficacy of a single oral dose of azithromycin (20 mg/kg) compared to placebo when administered during well-child visits for prevention of infant mortality. The trial found no evidence of a difference in the primary endpoint. This paper presents prespecified secondary anthropometric endpoints including weight gain (g/day), height change (mm/day), weight-for-age Z-score (WAZ), weight-for-length Z-score (WLZ), length-for-age Z-score (LAZ), and mid-upper arm circumference (MUAC). Infants were eligible for the trial if they were between 5 and 12 weeks of age, able to orally feed, and their families were planning to remain in the study area for the duration of the study. Anthropometric measurements were collected at enrollment (5 to 12 weeks of age) and 6 months of age. Among 32,877 infants enrolled in the trial, 27,298 (83%) were followed and had valid anthropometric measurements at 6 months of age. We found no evidence of a difference in weight gain (mean difference 0.03 g/day, 95% confidence interval (CI) -0.12 to 0.18), height change (mean difference 0.004 mm/day, 95% CI -0.05 to 0.06), WAZ (mean difference -0.004 SD, 95% CI -0.03 to 0.02), WLZ (mean difference 0.001 SD, 95% CI -0.03 to 0.03), LAZ (mean difference -0.005 SD, 95% CI -0.03 to 0.02), or MUAC (mean difference 0.01 cm, 95% CI -0.01 to 0.04). The primary limitation of the trial was that measurements were only collected at enrollment and 6 months of age, precluding assessment of shorter-term or long-term changes in growth. CONCLUSIONS: Single-dose azithromycin does not appear to affect weight and height outcomes when administered during early infancy. TRIAL REGISTRATION: ClinicalTrials.gov NCT03676764.

Assessing the Effect of Extreme Weather on Population Health Using Consumer-Grade Wearables in Rural Burkina Faso: Observational Panel Study.

BACKGROUND: Extreme weather, including heat and extreme rainfall, is projected to increase owing to climate change, which can have adverse impacts on human health. In particular, rural populations in sub-Saharan Africa are at risk because of a high burden of climate-sensitive diseases and low adaptive capacities. However, there is a lack of data on the regions that are anticipated to be most exposed to climate change. Improved public health surveillance is essential for better decision-making and health prioritization and to identify risk groups and suitable adaptation measures. Digital technologies such as consumer-grade wearable devices (wearables) may generate objective measurements to guide data-driven decision-making. OBJECTIVE: The main objective of this observational study was to examine the impact of weather exposure on population health in rural Burkina Faso using wearables. Specifically, this study aimed to assess the relationship between individual daily activity (steps), sleep duration, and heart rate (HR), as estimated by wearables, and exposure to heat and heavy rainfall. METHODS: Overall, 143 participants from the Nouna health and demographic surveillance system in Burkina Faso wore the Withings Pulse HR wearable 24/7 for 11 months. We collected continuous weather data using 5 weather stations throughout the study region. The heat index and wet-bulb globe temperature (WBGT) were calculated as measures of heat. We used linear mixed-effects models to quantify the relationship between exposure to heat and rainfall and the wearable parameters. Participants kept activity journals and completed a questionnaire on their perception of and adaptation to heat and other weather exposure. RESULTS: Sleep duration decreased significantly (P<.001) with higher heat exposure, with approximately 15 minutes shorter sleep duration during heat stress nights with a heat index value of ≥25 °C. Many participants (55/137, 40.1%) reported that heat affected them the most at night. During the day, most participants (133/137, 97.1%) engaged in outdoor physical work such as farming, housework, or fetching water. During the rainy season, when WBGT was highest, daily activity was highest and increased when the daily maximum WBGT surpassed 30 °C during the rainiest month. In the hottest month, daily activity decreased per degree increase in WBGT for values >30 °C. Nighttime HR showed no significant correlation with heat exposure. Daytime HR data were insufficient for analysis. We found no negative health impact associated with heavy rainfall. With increasing rainfall, sleep duration increased, average nightly HR decreased, and activity decreased. CONCLUSIONS: During the study period, participants were frequently exposed to heat and heavy rainfall. Heat was particularly associated with impaired sleep and daily activity. Essential tasks such as harvesting, fetching water, and caring for livestock expose this population to weather that likely has an adverse impact on their health. Further research is essential to guide interventions safeguarding vulnerable communities.

Anthropometric Differences in Community- Versus Clinic-Recruited Infants Participating in a Trial of Azithromycin for Prevention of Childhood Mortality in Burkina Faso.

Clinic-based recruitment for preventative interventions for child health may select for healthier populations compared with community-based outreach. Nutritional status during infancy as measured by anthropometry is predictive of mortality, growth faltering later in life, and poor cognitive development outcomes. We evaluated baseline differences in infant nutritional status among children recruited directly in their community versus clinic recruitment among infants participating in a trial of azithromycin compared with placebo for prevention of mortality in three districts of Burkina Faso. Infants between 5 and 12 weeks of age were recruited in their community of residence via vaccine outreach teams or in primary health-care clinics during vaccine clinics. Weight, height, and mid upper arm circumference were measured. We used linear and logistic regression models to compare anthropometric outcomes among community and clinic recruited infants, adjusting for age at enrollment, gender, and season. Among 32,877 infants enrolled in the trial, 21,273 (64.7%) were recruited via community outreach. Mean weight-for-age z-score (WAZ) was -0.60 ± 1.2 (SD), weight-for-length z-score (WLZ) was -0.16 ± 1.5, and length-for-age z-score was-0.53 ± 1.3. Infants enrolled in the community had lower WAZ (mean difference, -0.12; 95% CI, -0.20 to -0.04) and WLZ (mean difference, -0.21; 95% CI, -0.32 to -0.09). Community-recruited infants were more often underweight (WAZ < -2; odds ratio [OR], 1.25; 95% CI, 1.09-1.43) and wasted (WLZ < -2; OR, 1.54; 95% CI, 1.31-1.79). There was no evidence of a difference in height-based measures. Community and clinic recruitment likely reach different populations of children.

Determinants of COVID-19 vaccine readiness and hesitancy among adults in sub-Saharan Africa.

There is very limited data on the extent and determinants of COVID-19 vaccine hesitancy among adults living in sub-Saharan Africa since the global roll-out of vaccines began in 2021. This multi-country survey sought to investigate COVID-19 vaccine hesitancy and other predictors of readiness to get vaccinated. We conducted surveys among adults residing in nine urban and rural areas in Burkina Faso, Ethiopia, Ghana, Nigeria, and Tanzania in late 2021. Log binomial regression models were used to identify prevalence and factors associated with vaccine hesitancy and beliefs around COVID-19 misinformation. We completed a total of 2,833 interviews. Among all respondents, 9% had never heard of a COVID-19 vaccine, 12% had been vaccinated, and 20% knew someone else who had been vaccinated. The prevalence of vaccine hesitancy varied by country (Ethiopia 29%, Burkina Faso 33%, Nigeria 34%, Ghana 42%, Tanzania 65%), but not by rural or urban context. People who did not think the vaccine was safe or effective, or who were unsure about it, were more likely to be vaccine hesitant. Those who reported they did not have a trusted source of information about the vaccine (aPR: 1.25, 95% CI: 1.18,1.31) and those who thought the vaccine would not be made available to them within the year were more likely to be vaccine hesitant. Women were more likely to be vaccine hesitant (aPR: 1.31, 95% CI: 1.19,1.43) and believe COVID-19 falsehoods (aPR: 1.05, 95% CI: 1.02,1.08). The most commonly believed falsehoods were that the vaccine was developed too fast and that there was not enough information about whether the vaccine was effective or not. Educational campaigns targeted at misinformation and tailored to suit each country are recommended to build trust in COVID-19 vaccines and reduce hesitancy.

Widening the lens of population-based health research to climate change impacts and adaptation: the climate change and health evaluation and response system (CHEERS).

Background: Climate change significantly impacts health in low-and middle-income countries (LMICs), exacerbating vulnerabilities. Comprehensive data for evidence-based research and decision-making is crucial but scarce. Health and Demographic Surveillance Sites (HDSSs) in Africa and Asia provide a robust infrastructure with longitudinal population cohort data, yet they lack climate-health specific data. Acquiring this information is essential for understanding the burden of climate-sensitive diseases on populations and guiding targeted policies and interventions in LMICs to enhance mitigation and adaptation capacities. Objective: The objective of this research is to develop and implement the Change and Health Evaluation and Response System (CHEERS) as a methodological framework, designed to facilitate the generation and ongoing monitoring of climate change and health-related data within existing Health and Demographic Surveillance Sites (HDSSs) and comparable research infrastructures. Methods: CHEERS uses a multi-tiered approach to assess health and environmental exposures at the individual, household, and community levels, utilizing digital tools such as wearable devices, indoor temperature and humidity measurements, remotely sensed satellite data, and 3D-printed weather stations. The CHEERS framework utilizes a graph database to efficiently manage and analyze diverse data types, leveraging graph algorithms to understand the complex interplay between health and environmental exposures. Results: The Nouna CHEERS site, established in 2022, has yielded significant preliminary findings. By using remotely-sensed data, the site has been able to predict crop yield at a household level in Nouna and explore the relationships between yield, socioeconomic factors, and health outcomes. The feasibility and acceptability of wearable technology have been confirmed in rural Burkina Faso for obtaining individual-level data, despite the presence of technical challenges. The use of wearables to study the impact of extreme weather on health has shown significant effects of heat exposure on sleep and daily activity, highlighting the urgent need for interventions to mitigate adverse health consequences. Conclusion: Implementing the CHEERS in research infrastructures can advance climate change and health research, as large and longitudinal datasets have been scarce for LMICs. This data can inform health priorities, guide resource allocation to address climate change and health exposures, and protect vulnerable communities in LMICs from these exposures.

Using wearable devices to generate real-world, individual-level data in rural, low-resource contexts in Burkina Faso, Africa: A case study.

Background: Wearable devices may generate valuable data for global health research for low- and middle-income countries (LMICs). However, wearable studies in LMICs are scarce. This study aims to investigate the use of consumer-grade wearables to generate individual-level data in vulnerable populations in LMICs, focusing on the acceptability (quality of the devices being accepted or even liked) and feasibility (the state of being workable, realizable, and practical, including aspects of data completeness and plausibility). Methods: We utilized a mixed-methods approach within the health and demographic surveillance system (HDSS) to conduct a case study in Nouna, Burkina Faso (BF). All HDSS residents older than 6 years were eligible. N = 150 participants were randomly selected from the HDSS database to wear a wristband tracker (Withings Pulse HR) and n = 69 also a thermometer patch (Tucky thermometer) for 3 weeks. Every 4 days, a trained field worker conducted an acceptability questionnaire with participants, which included questions for the field workers as well. Descriptive and qualitative thematic analyses were used to analyze the responses of study participants and field workers. Results: In total, n = 148 participants were included (and n = 9 field workers). Participant's acceptability ranged from 94 to 100% throughout the questionnaire. In 95% of the cases (n = 140), participants reported no challenges with the wearable. Most participants were not affected by the wearable in their daily activities (n = 122, 83%) and even enjoyed wearing them (n = 30, 20%). Some were concerned about damage to the wearables (n = 7, 5%). Total data coverage (i.e., the proportion of the whole 3-week study duration covered by data) was 43% for accelerometer (activity), 3% for heart rate, and 4% for body shell temperature. Field workers reported technical issues like faulty synchronization (n = 6, 1%). On average, participants slept 7 h (SD 3.2 h) and walked 8,000 steps per day (SD 5573.6 steps). Acceptability and data completeness were comparable across sex, age, and study arms. Conclusion: Wearable devices were well-accepted and were able to produce continuous measurements, highlighting the potential for wearables to generate large datasets in LMICs. Challenges constituted data missingness mainly of technical nature. To our knowledge, this is the first study to use consumer-focused wearables to generate objective datasets in rural BF.

Simplified dosing of oral azithromycin for children 1-11 months old in child survival programmes: age-based and height-based dosing protocols.

BACKGROUND: To facilitate mass distribution of azithromycin, trachoma control programmes use height instead of weight to determine dose for children 6 months to 15 years old. WHO has recommended azithromycin distribution to children 1-11 months old to reduce mortality in high mortality settings under carefully monitored conditions. Weight was used to determine dose in children 1-5 months old in studies of azithromycin distribution for child survival, but a simplified approach using age or height for all aged 1-11 months old could increase programme efficiency in real-world settings. METHODS: This secondary analysis used data from two cluster randomised trials of azithromycin distribution for child mortality in Niger and Burkina Faso. An exhaustive search algorithm was developed to determine the optimal dose for different age groups, using tolerance limits of 10-20 mg/kg for children 1-2 months old and 15-30 mg/kg for children 3-11 months old. Height-based dosing was evaluated against the existing trachoma dosing pole and with a similar exhaustive search. RESULTS: The optimal two-tiered age-based approach suggested a dose of 80 mg (2 mL) for children 1-2 months old and 160 mg (4 mL) for children 3-11 months old. Under this schedule, 89%-93% of children would have received doses within tolerance limits in both study populations. Accuracy was 93%-94% with a three-tiered approach, which resulted in doses of 80 mg (2 mL), 120 mg (3 mL) and 160 mg (4 mL) for children 1-2, 3-4 and 5-11 months old, respectively. For children 1-5 months old, the existing height pole would result in 70% of doses within tolerance limits. The optimisation identified height-based dosing options with 95% accuracy, although this would require changes to the existing dosing pole as well as additional training to measure infants lying flat. CONCLUSIONS: Overall, an age-based approach with two age tiers resulted in high accuracy while considering both concerns about overdosing in this young population and simplicity of field operations.

High seroprevalence of SARS-CoV-2 in Burkina-Faso, Ghana and Madagascar in 2021: a population-based study.

BACKGROUND: The current COVID-19 pandemic affects the entire world population and has serious health, economic and social consequences. Assessing the prevalence of COVID-19 through population-based serological surveys is essential to monitor the progression of the epidemic, especially in African countries where the extent of SARS-CoV-2 spread remains unclear. METHODS: A two-stage cluster population-based SARS-CoV-2 seroprevalence survey was conducted in Bobo-Dioulasso and in Ouagadougou, Burkina Faso, Fianarantsoa, Madagascar and Kumasi, Ghana between February and June 2021. IgG seropositivity was determined in 2,163 households with a specificity improved SARS-CoV-2 Enzyme-linked Immunosorbent Assay. Population seroprevalence was evaluated using a Bayesian logistic regression model that accounted for test performance and age, sex and neighbourhood of the participants. RESULTS: Seroprevalence adjusted for test performance and population characteristics were 55.7% [95% Credible Interval (CrI) 49·0; 62·8] in Bobo-Dioulasso, 37·4% [95% CrI 31·3; 43·5] in Ouagadougou, 41·5% [95% CrI 36·5; 47·2] in Fianarantsoa, and 41·2% [95% CrI 34·5; 49·0] in Kumasi. Within the study population, less than 6% of participants performed a test for acute SARS-CoV-2 infection since the onset of the pandemic. CONCLUSIONS: High exposure to SARS-CoV-2 was found in the surveyed regions albeit below the herd immunity threshold and with a low rate of previous testing for acute infections. Despite the high seroprevalence in our study population, the duration of protection from naturally acquired immunity remains unclear and new virus variants continue to emerge. This highlights the importance of vaccine deployment and continued preventive measures to protect the population at risk.

Wearables for Measuring Health Effects of Climate Change-Induced Weather Extremes: Scoping Review.

BACKGROUND: Although climate change is one of the biggest global health threats, individual-level and short-term data on direct exposure and health impacts are still scarce. Wearable electronic devices (wearables) present a potential solution to this research gap. Wearables have become widely accepted in various areas of health research for ecological momentary assessment, and some studies have used wearables in the field of climate change and health. However, these studies vary in study design, demographics, and outcome variables, and existing research has not been mapped. OBJECTIVE: In this review, we aimed to map existing research on wearables used to detect direct health impacts and individual exposure during climate change-induced weather extremes, such as heat waves or wildfires. METHODS: We conducted a scoping review according to the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) framework and systematically searched 6 databases (PubMed [MEDLINE], IEEE Xplore, CINAHL [EBSCOhost], WoS, Scopus, Ovid [MEDLINE], and Google Scholar). The search yielded 1871 results. Abstracts and full texts were screened by 2 reviewers (MK and IM) independently using the inclusion and exclusion criteria. The inclusion criteria comprised studies published since 2010 that used off-the-shelf wearables that were neither invasive nor obtrusive to the user in the setting of climate change-related weather extremes. Data were charted using a structured form, and the study outcomes were narratively synthesized. RESULTS: The review included 55,284 study participants using wearables in 53 studies. Most studies were conducted in upper-middle-income and high-income countries (50/53, 94%) in urban environments (25/53, 47%) or in a climatic chamber (19/53, 36%) and assessed the health effects of heat exposure (52/53, 98%). The majority reported adverse health effects of heat exposure on sleep, physical activity, and heart rate. The remaining studies assessed occupational heat stress or compared individual- and area-level heat exposure. In total, 26% (14/53) of studies determined that all examined wearables were valid and reliable for measuring health parameters during heat exposure when compared with standard methods. CONCLUSIONS: Wearables have been used successfully in large-scale research to measure the health implications of climate change-related weather extremes. More research is needed in low-income countries and vulnerable populations with pre-existing conditions. In addition, further research could focus on the health impacts of other climate change-related conditions and the effectiveness of adaptation measures at the individual level to such weather extremes.

Gut Resistome after Antibiotics among Children with Uncomplicated Severe Acute Malnutrition: A Randomized Controlled Trial.

A broad-spectrum antibiotic, typically amoxicillin, is included in many country guidelines as part of the management of uncomplicated severe acute malnutrition (SAM) in children without overt clinical symptoms of infection. Alternative antibiotics may be beneficial for children with SAM without increasing selection for beta-lactam resistance. We conducted a 1:1 randomized controlled trial of single dose azithromycin versus a 7-day course of amoxicillin for SAM. Children 6-59 months of age with uncomplicated SAM (mid-upper arm circumference < 11.5 cm and/or weight-for-height Z-score < -3) were enrolled in Boromo District, Burkina Faso, from June through October 2020. Rectal swabs were collected at baseline and 8 weeks after treatment and processed using DNA-Seq. We compared the resistome at the class level in children randomized to azithromycin compared with amoxicillin. We found no evidence of a difference in the distribution of genetic antibiotic resistance determinants to any antibiotic class 8 weeks after treatment. There was no difference in genetic macrolide resistance determinants (65% azithromycin, 65% placebo, odds ratio, OR, 1.00, 95% confidence interval, CI, 0.43-2.34) or beta-lactam resistance determinants (82% azithromycin, 83% amoxicillin, OR 0.94, 95% CI, 0.33-2.68) at 8 weeks. Although presence of genetic antibiotic resistance determinants to macrolides and beta-lactams was common, we found no evidence of a difference in the gut resistome 8 weeks after treatment. If there are earlier effects of antibiotics on selection for genetic antibiotic resistance determinants, the resistome may normalize by 8 weeks.

How does baseline anthropometry affect anthropometric outcomes in children receiving treatment for severe acute malnutrition? A secondary analysis of a randomized controlled trial.

Mid-upper arm circumference (MUAC) < 11.5 cm and weight-for-height Z-score (WHZ) < -3 are used for screening for severe acute malnutrition (SAM). Underweight and concurrent wasting and stunting may better target those at the highest risk of mortality. We compared anthropometric outcomes in children enrolled in a trial of antibiotics for SAM based on categories of baseline anthropometry, including indicators for programme admission (WHZ < -3, MUAC < 11.5) and alternative indicators (weight-for-age Z-score [WAZ] < -3, concurrent wasting and stunting [WHZ < -3 and height-for-age Z-score < -3]). Participants were followed weekly until nutritional recovery and at 8 weeks. We evaluated changes in weight gain (g/kg/day), MUAC, and WHZ in children admitted by admissions criteria (MUAC only, WHZ only, or MUAC and WHZ) and by underweight or concurrent wasting and stunting. Of 301 admitted children, 100 (33%) were admitted based on MUAC only, 41 (14%) WHZ only, and 160 (53%) both MUAC and WHZ, 210 (68%) were underweight and 67 (22%) were concurrently wasted/stunted. Low MUAC and low WHZ children had the lowest probability of nutritional recovery (17% vs. 50% for MUAC-only and 34% for WHZ-only). There was no difference in weight gain velocity or WHZ by admissions criteria (WHZ and/or MUAC). Underweight and concurrently wasted/stunted children had lower MUAC and WHZ at 8 weeks compared with those who were not underweight or concurrently wasted and stunted. Children with both low MUAC and low WHZ had the worst outcomes. Relying on MUAC alone may miss children who have poor outcomes. Other indicators, such as WAZ, may be useful for identifying vulnerable children.

Comparing Azithromycin to Amoxicillin in the Management of Uncomplicated Severe Acute Malnutrition in Burkina Faso: A Pilot Randomized Trial.

Azithromycin is a promising alternative to amoxicillin in the management of uncomplicated severe acute malnutrition (SAM) as it can be administered as a single dose and has efficacy against several pathogens causing infectious disease and mortality in children under 5. In this pilot trial, we aimed to establish the feasibility of a larger randomized controlled trial and provide preliminary evidence comparing the effect of azithromycin to amoxicillin on weight gain in children with uncomplicated SAM. We enrolled children 6-59 months old with uncomplicated SAM at six healthcare centers in Burkina Faso. Participants were randomized to a single dose of azithromycin or a 7-day course of amoxicillin and followed weekly until nutritional recovery and again at 8 weeks. Apart from antibiotics, participants received standard of care, which includes ready-to-use therapeutic food. Primary feasibility outcomes included enrollment potential, refusals, and loss to follow-up. The primary clinical outcome was weight gain (g/kg/day) over 8 weeks. Outcome assessors were masked. Between June and October 2020, 312 children were screened, 301 were enrolled with zero refusals, and 282 (93.6%) completed the 8-week visit. Average weight gain was 2.5 g/kg/day (standard deviation [SD] 2.0) in the azithromycin group and 2.6 (SD 1.7) in the amoxicillin group (mean difference -0.1, 95% CI -0.5 to 0.3, P = 0.63). Fewer adverse events were reported in the azithromycin group (risk ratio 0.50, 95% CI 0.31-0.82, P = 0.006). With strong enrollment and follow-up, a fully powered trial in this setting is feasible.

The Impact of Wearable Technologies in Health Research: Scoping Review.

BACKGROUND: Wearable devices hold great promise, particularly for data generation for cutting-edge health research, and their demand has risen substantially in recent years. However, there is a shortage of aggregated insights into how wearables have been used in health research. OBJECTIVE: In this review, we aim to broadly overview and categorize the current research conducted with affordable wearable devices for health research. METHODS: We performed a scoping review to understand the use of affordable, consumer-grade wearables for health research from a population health perspective using the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) framework. A total of 7499 articles were found in 4 medical databases (PubMed, Ovid, Web of Science, and CINAHL). Studies were eligible if they used noninvasive wearables: worn on the wrist, arm, hip, and chest; measured vital signs; and analyzed the collected data quantitatively. We excluded studies that did not use wearables for outcome assessment and prototype studies, devices that cost >€500 (US $570), or obtrusive smart clothing. RESULTS: We included 179 studies using 189 wearable devices covering 10,835,733 participants. Most studies were observational (128/179, 71.5%), conducted in 2020 (56/179, 31.3%) and in North America (94/179, 52.5%), and 93% (10,104,217/10,835,733) of the participants were part of global health studies. The most popular wearables were fitness trackers (86/189, 45.5%) and accelerometer wearables, which primarily measure movement (49/189, 25.9%). Typical measurements included steps (95/179, 53.1%), heart rate (HR; 55/179, 30.7%), and sleep duration (51/179, 28.5%). Other devices measured blood pressure (3/179, 1.7%), skin temperature (3/179, 1.7%), oximetry (3/179, 1.7%), or respiratory rate (2/179, 1.1%). The wearables were mostly worn on the wrist (138/189, 73%) and cost <€200 (US $228; 120/189, 63.5%). The aims and approaches of all 179 studies revealed six prominent uses for wearables, comprising correlations-wearable and other physiological data (40/179, 22.3%), method evaluations (with subgroups; 40/179, 22.3%), population-based research (31/179, 17.3%), experimental outcome assessment (30/179, 16.8%), prognostic forecasting (28/179, 15.6%), and explorative analysis of big data sets (10/179, 5.6%). The most frequent strengths of affordable wearables were validation, accuracy, and clinical certification (104/179, 58.1%). CONCLUSIONS: Wearables showed an increasingly diverse field of application such as COVID-19 prediction, fertility tracking, heat-related illness, drug effects, and psychological interventions; they also included underrepresented populations, such as individuals with rare diseases. There is a lack of research on wearable devices in low-resource contexts. Fueled by the COVID-19 pandemic, we see a shift toward more large-sized, web-based studies where wearables increased insights into the developing pandemic, including forecasting models and the effects of the pandemic. Some studies have indicated that big data extracted from wearables may potentially transform the understanding of population health dynamics and the ability to forecast health trends.

Azithromycin versus Amoxicillin and Malarial Parasitemia among Children with Uncomplicated Severe Acute Malnutrition: A Randomized Controlled Trial.

Antibiotics are recommended by the WHO as part of the management of uncomplicated severe acute malnutrition in children. We evaluated whether azithromycin, an antibiotic with antimalarial properties, improved malarial parasitemia outcomes in children with severe acute malnutrition compared with amoxicillin, an antibiotic commonly used for severe acute malnutrition that does not have antimalarial properties. Total of 301 children were randomized (1:1) to a single oral dose of azithromycin or a 7-day course of amoxicillin and followed for 8 weeks. We found no significant evidence that children receiving azithromycin had improved parasitemia outcomes relative to amoxicillin. Although azithromycin may have advantages over amoxicillin in terms of dosing and administration for uncomplicated severe acute malnutrition, it may not yield additional benefit for malaria outcomes.

Feasibility, acceptability and validation of wearable devices for climate change and health research in the low-resource contexts of Burkina Faso and Kenya: Study protocol.

As the epidemiological transition progresses throughout sub-Saharan Africa, life lived with diseases is an increasingly important part of a population's burden of disease. The burden of disease of climate-sensitive health outcomes is projected to increase considerably within the next decades. Objectively measured, reliable population health data is still limited and is primarily based on perceived illness from recall. Technological advances like non-invasive, consumer-grade wearable devices may play a vital role in alleviating this data gap and in obtaining insights on the disease burden in vulnerable populations, such as heat stress on human cardiovascular response. The overall goal of this study is to investigate whether consumer-grade wearable devices are an acceptable, feasible and valid means to generate data on the individual level in low-resource contexts. Three hundred individuals are recruited from the two study locations in the Nouna health and demographic surveillance system (HDSS), Burkina Faso, and the Siaya HDSS, Kenya. Participants complete a structured questionnaire that comprises question items on acceptability and feasibility under the supervision of trained data collectors. Validity will be evaluated by comparing consumer-grade wearable devices to research-grade devices. Furthermore, we will collect demographic data as well as the data generated by wearable devices. This study will provide insights into the usage of consumer-grade wearable devices to measure individual vital signs in low-resource contexts, such as Burkina Faso and Kenya. Vital signs comprising activity (steps), sleep (duration, quality) and heart rate (hr) are important measures to gain insights on individual behavior and activity patterns in low-resource contexts. These vital signs may be associated with weather variables-as we gather them from weather stations that we have setup as part of this study to cover the whole Nouna and Siaya HDSSs-in order to explore changes in behavior and other variables, such as activity, sleep, hr, during extreme weather events like heat stress exposure. Furthermore, wearable data could be linked to health outcomes and weather events. As a result, consumer-grade wearables may serve as a supporting technology for generating reliable measurements in low-resource contexts and investigating key links between weather occurrences and health outcomes. Thus, wearable devices may provide insights to better inform mitigation and adaptation interventions in these low-resource settings that are direly faced by climate change-induced changes, such as extreme weather events.

Indication for Antibiotic Prescription Among Children Attending Primary Healthcare Services in Rural Burkina Faso.

Of 61 355 visits by children <5 years old to 48 government-run primary healthcare facilities in Nouna District, Burkina Faso, 30 975 had an antibiotic prescribed (58% for pneumonia diagnoses). A minority of prescriptions were for diagnoses not requiring antibiotics, including malaria, nonbloody diarrhea, and cough without pneumonia.

Azithromycin for uncomplicated severe acute malnutrition: study protocol for a pilot randomized controlled trial.

BACKGROUND: Given the high risk of infectious mortality among children with severe acute malnutrition (SAM), the World Health Organization recommends routine administration of a broad-spectrum antibiotic like amoxicillin as part of the management of uncomplicated SAM. However, evidence for the efficacy of amoxicillin to improve nutritional recovery or reduce mortality has been mixed. With a long half-life and evidence of efficacy to reduce mortality in high-risk populations, azithromycin is a potential alternative to amoxicillin in the management of SAM. In this pilot study, we aim to compare the efficacy of azithromycin to amoxicillin to improve nutritional outcomes in children with uncomplicated SAM. METHODS: This pilot randomized controlled trial will enroll 300 children with uncomplicated SAM from 6 Centre de Santé et de Promotion Sociale in the Boromo health district in Burkina Faso. Eligible children are randomized to receive a single directly observed dose of oral azithromycin or a 7-day course of oral amoxicillin in addition to the standard package of care for uncomplicated SAM. Enrolled children are followed weekly until nutritional recovery, and all children return for a final study visit at 8 weeks after enrollment. Anthropometric indicators, vital status, and clinical outcomes are monitored at each visit and compared by arm. Primary feasibility outcomes include enrollment potential, refusals, loss to follow-up, and completeness of data collection. The primary clinical outcome is weight gain (g/kg/day) over the 8-week study period. DISCUSSION: This pilot trial will establish the feasibility of conducting a full-scale randomized controlled trial to evaluate alternative antibiotics in this setting and provide preliminary evidence for the efficacy of azithromycin compared to amoxicillin to improve outcomes for children with SAM. TRIAL REGISTRATION: This trial was first registered on clinicaltrials.gov on 26 June 2018 ( NCT03568643 ).