Anemia and Iron Supplementation in Relation to Viral Load and Mortality among 70,442 People Living with Human Immunodeficiency Virus in Tanzania.

BACKGROUND: Anemia may be associated with poor clinical outcomes among people living with human immunodeficiency virus (HIV) (PLHIV) despite highly active antiretroviral therapy (HAART). There are concerns that iron supplementation may be unsafe to prevent and treat anemia among PLHIV. OBJECTIVE: The objective of the study was to evaluate the associations of anemia and iron supplementation with mortality and viral load among PLHIV in Tanzania. METHODS: We analyzed data from a cohort of 70,442 nonpregnant adult PLHIV in Tanzania conducted between 2015 and 2019. Regression models evaluated the relationships between anemia severity and iron supplement use with mortality and unsuppressed HIV-1 viral load among all participants and stratified by whether participants were initiating or continuing HAART. RESULTS: Anemia was associated with an increased risk of mortality and unsuppressed viral load for participants who initiated or continued HAART. Iron supplement use was associated with reduced mortality risk but also had a greater risk of an unsuppressed viral load among participants continuing HAART. There was no association of iron supplement use with mortality, and unsuppressed viral load among PLHIV that were initiating HAART. There was a stronger negative association between iron supplement use and the risk of having an unsuppressed viral load among participants with stage III/IV disease compared with stage I/II disease. CONCLUSIONS: Anemia is associated with increased risk of mortality and unsuppressed viral load, but the benefits and safety of iron supplements appear to differ for those initiating compared with continuing ART as well as by HIV disease severity.

Nutrition counselling and clinical outcomes in HIV: A systematic review and meta-analysis.

BACKGROUND: People living with the HIV (PLHIV) are at an increased risk of various diseases due to a weakened immune system, particularly if they are naïve or poorly adherent to antiretroviral therapy (ART). Nutrients play a critical role in improving immune health, especially among this population. We systematically reviewed the evidence concerning the impact of nutritional counselling on the occurrence of important clinical outcomes among PLHIV. METHODS: Medical literature databases (PubMed, EMBASE and Web of Science) were searched from inception to October 2022 for relevant published studies (n = 12) of nutritional counselling and HIV-related outcomes in adults on ART. Random-effects meta-analyses were conducted when the exposure-outcome relationships were similar in three or more studies. RESULTS: Although the methodologies of nutritional intervention varied across all studies, overall, the evidence from the meta-analysis indicates a nsignificant positive association between nutrition counselling and improvements in CD4 cell count, body mass index and low-density lipoprotein concentration. However, the existing literature does not provide enough evidence to establish a significant impact of nutrition counselling on other immune, anthropometric, and metabolic outcomes including viral load, weight, and lean mass due to the differences in the study designs. CONCLUSION: Well-powered randomized controlled trials are needed that explore the effect of evidence-based, individualized nutrition counselling on HIV-related clinical outcomes.

Dietary Iron Intake and HIV-Related Outcomes Among Adults Initiating Antiretroviral Therapy in Tanzania.

OBJECTIVE: Anemia is highly prevalent among people living with HIV (PLWHIV) and is often due to iron deficiency. This study evaluated the relationship of dietary iron intake levels and sources with mortality and clinical outcomes among adults initiating HAART. DESIGN: We conducted a secondary analysis of a multivitamin supplementation trial among 2293 PLWHIV initiating HAART in Dar es Salaam, Tanzania. METHODS: Dietary iron intake was assessed with a food frequency questionnaire at HAART initiation, and participants followed until death or censoring. Total, animal-, and plant-sourced iron were categorized into quartiles. Intake of food groups was categorized into 0-1, 2-3, and ≥4 servings/wk. Cox proportional hazards models estimated hazard ratios for mortality and incident clinical outcomes. RESULTS: There were 175 deaths (8%). Red meat intake was associated with a lower risk of all-cause mortality (HR: 0.54; 95% CI: 0.35 to 0.83), AIDS-related mortality (HR: 0.49; 95% CI: 0.28 to 0.85), and severe anemia (HR: 0.57; 95% CI: 0.35 to 0.91), when intake ≥4 servings/wk, compared with 0-1 servings/wk. Legume intake was a lower risk of associated with all-cause mortality (HR: 0.49; 95% CI: 0.31 to 0.77) and AIDS-related mortality (HR: 0.37; 95% CI: 0.23 to 0.61), when intake ≥4 servings/wk, compared with 0-1 servings/wk. Although total dietary iron and overall plant-sourced iron intake were not associated with the risk of mortality or HIV-related outcomes, the highest quartile of animal-sourced iron intake was associated with a lower risk of all-cause mortality (HR: 0.56; 95% CI: 0.35 to 0.90) and a lower risk of AIDS-related mortality (HR: 0.50; 95% CI: 0.30 to 0.90), compared with the lowest quartile. CONCLUSION: Intake of iron-rich food groups may be associated with a lower risk of mortality and critical HIV-related outcomes among adults initiating HAART. TRIAL REGISTRATION: The parent trial was registered at Clinicaltrials.gov . Identifier: NCT00383669.

Dietary intake and quality for young adolescents in sub-Saharan Africa: Status and influencing factors.

Adolescents face the risk of the triple burden of malnutrition-the co-existence of micronutrient deficiencies, underweight and overweight and obesity and related noncommunicable diseases. Poor-quality diets are a modifiable risk factor for all forms of malnutrition in adolescents. However, there is limited knowledge about diet quality for African adolescents. We analyzed data from 4609 school-going adolescents aged 10-15 years in Burkina Faso, Ethiopia, Sudan and Tanzania. Dietary intake was assessed using food frequency questionnaires, and diet quality computed using the Global Diet Quality Score (GDQS). Generalized estimating equations linear regression models were used to evaluate factors associated with adolescent diet quality. Mean adolescent age was 12.4 (±1.4) years and 54% of adolescents were female. Adolescents reported physical activity on 1.5 (±1.7) days/week. The mean GDQS (±SD) was 20.6 (±4.0) (maximum 40). Adolescent consumption of vegetables, fruit, nuts and seeds, eggs, fish and poultry was low, and refined grain consumption was relatively high. Boys consumed unhealthy foods less frequently but consumed fewer cruciferous vegetables and deep orange tubers. Older adolescents had higher fish and lower red meat consumption. Having an unemployed mother versus farmer (estimate -2.60, 95% confidence interval [CI]: -4.81, -0.39), and having 3-4 days of physical activity per week versus none (estimate 0.64, 95% CI: 0.11, 1.17) were associated with GDQS. We found evidence of poor-quality adolescent diets and gender and age differences in the consumption of healthy diets. Programs to address poor-quality diets should consider tailoring interventions for adolescent girls and boys of different ages and also consider the role of physical activity in these contexts.

Adolescent health and well-being in sub-Saharan Africa: Strengthening knowledge base and research capacity through a collaborative multi-country school-based study.

In Sub-Saharan Africa (SSA), adolescents make up around one-quarter of the population who are growing up in a rapidly urbanizing environment, with its associated risks and benefits, including impacts on health, psychosocial development, nutrition, and education. However, research on adolescents' health and well-being in SSA is limited. The ARISE (African Research, Implementation Science and Education) Network's Adolescent Health and Nutrition Study is an exploratory, school-based study of 4988 urban adolescents from five countries: Burkina Faso, Ethiopia, South Africa, Sudan, and Tanzania. A multistage random sampling strategy was used to select the schools and adolescents. Adolescent boys and girls aged 10-15 years were interviewed using a standardized questionnaire by trained enumerators. The questionnaire covered multiple domains including demographic and socioeconomic characteristics, water, sanitation and hygiene practices, antimicrobial resistance, physical activity, dietary behaviours, socioemotional development, educational outcomes, media use, mental health, and menstrual hygiene (only for girls). Additionally, a desk review of health and school meal policies and programs and a qualitative investigation into health and food environments in schools were conducted with students, administrators, and food vendors. In this paper, we describe the study design and questionnaire, present profiles of young adolescents who participated in the study, and share field experiences and lessons learned for future studies. We expect that this study along with other ARISE Network projects will be a first step toward understanding young people's health risks and disease burdens, identifying opportunities for interventions and improving policies, as well as developing potential research capacities on adolescent health and well-being in the SSA region.

Stunting and thinness in school-attending adolescents in Addis Ababa.

BACKGROUND: Adolescent population Global Diet Quality Score (GDQS) is uncommon in low-income settings. Though Global Diet Quality Score is a good measure of dietary diversity, it has not been used in assessing nutritional outcomes among adolescents. Therefore, the aim of this study is to assess school-attending adolescents stunting and thinness status and associations with global diet quality scores in Addis Ababa. METHODS: A school-based cross-sectional study was conducted among school-attending adolescents in the age group of 10-14 years in urban settings in Ethiopia. A multi-stage stratified random sampling procedure was used to select schools and students. A total of 1200 adolescents were included in the study. Binary and Multinomial logistic regression analyses were used to determine the predictors of stunting and thinness respectively. RESULTS: The proportion of school-attending adolescents stunting was 8.17% (95% CI: 6.74%,9.85%) and their thinness status 12.66% (95% CI: 10.89%, 14.67%). The overall mean GDQS food groups for Seven days period consumed were 19.99 + 2.81 SD. Male adolescents were 1.95 times more likely to be stunted compared to female adolescents (1.95; 95%CI: 1.11,3.39). Frequent consumption of low-fat dairy increased the risk of thinness, while frequent consumption of citrus fruits and white root tubers decreased the risk of school-attending adolescents' thinness. CONCLUSION: The proportion of thin or stunted adolescents attending school was high still, about 1 in 10. Stunting and thinness have no association with the overall GDQS. Nutritional interventions need to consider frequent consumption of citrus fruits, low-fat dairy, and white roots and tubers in school adolescents' nutritional programs. Further studies should validate the GDQS for stunting and thinness of school adolescents.

The role of chicken management practices in children's exposure to environmental contamination: a mixed-methods analysis.

BACKGROUND: Household chicken production presents an opportunity to promote child nutrition, but the benefits might be offset by increased environmental contamination. Using household surveys, direct observations, and in-depth interviews with woman caregivers, we sought to describe the relationship between chicken management practices and household exposure to environmental contamination, and assess barriers to adopting improved husbandry practices. METHODS: First, we analyzed baseline data from 973 households raising chickens in the two interventions arms from the Agriculture-to-Nutrition (ATONU) study in Ethiopia to assess the relationship between animal management practices and environmental exposures. Second, we conducted six-hour direct observations of children's environmental exposures in 18 households. Among these households, we analyzed in-depth interviews with child caregivers. RESULTS: Quantitative analyses showed that households raised approximately 11 chickens, had animal feces visible on the property 67% of the time, and children's hands were visibly dirty 38% of the time. Households with more chickens had lower exposure to animal feces. Having a chicken coop increased the risk of observing animal feces on the property by 30%, but among those with a coop, having an enclosed coop reduced that risk by 83%. Coops that were enclosed, had fencing, and were located further from homes were associated with a reduced risk of observing animal feces and an increased likelihood of children having clean hands. Direct observations showed that chicken coops were often poorly designed or not used. On average, 3 to 5 chickens were inside homes at a time, and livestock and domestic animals were frequently inside of houses and interacting with young children. In-depth interviews revealed that protection of animals, maintenance of household cleanliness and health, type of chicken (local versus improved) and resource constraints influenced management decisions. CONCLUSIONS: Improvements in chicken management practices could mitigate the exposure of household members to environmental contamination. Our findings highlight the need for training and resources to promote safe animal husbandry practices and optimal child health in nutrition-sensitive livestock projects. TRIAL REGISTRATION: Clinical trials number: NCT03152227 ; Retrospectively registered at ClinicalTrials.gov on May 12, 2012.

The impact of integrated nutrition-sensitive interventions on nutrition and health of children and women in rural Tanzania: study protocol for a cluster-randomized controlled trial.

BACKGROUND: Nutrition-sensitive interventions such as homestead production of diverse, nutrient-rich foods, coupled with behavior change communication, may have positive effects on the nutritional status and health of rural households engaged in agriculture, particularly among women and young children. Engagement of agriculture and health extension workers in these communities may be an effective way of delivering nutrition-sensitive interventions given the dearth of trained health care providers in many developing countries. This study aims to assess the effects of integrated homestead food production, food consumption and women's empowerment interventions using a multi-sectoral approach on women's and child's health and nutrition. METHODS: This is a cluster-randomized community-based prospective study set in Rufiji district, a rural area in Eastern Tanzania. Ten randomly selected villages within the Rufiji Health and Demographic Surveillance Site (HDSS) in Eastern-Tanzania were paired and randomly assigned to the intervention or control arm. The Rufiji HDSS dataset was used to randomly sample households with women of reproductive age and children 6-36 months. The intervention includes provision of small agricultural inputs, garden training support, and nutrition and health counseling. This is delivered by community health workers and agriculture extension workers through home visits and farmer field schools. There are three time points for data collection: baseline, midline, and endline. Primary outcomes are women's and children's dietary diversity, maternal and child anemia status and growth (child stunting, child wasting, women's BMI, and women and child hemoglobin). DISCUSSION: This integrated agriculture and nutrition intervention among rural farming households is a simple and innovative solution that may contribute to the reduction of undernutrition and disease burden among women and children in developing countries. Engaging already existing workforce in the community may facilitate sustainability of the intervention package. TRIAL REGISTRATION: ClinicalTrials.gov NCT03311698, Retrospectively registered on October 17, 2017.

The effect of neonatal vitamin A supplementation on morbidity and mortality at 12 months: a randomized trial.

Background: : Neonatal vitamin A supplementation (NVAS) is an intervention hypothesized to reduce infant morbidity and mortality. The objective of this study was to assess the efficacy of neonatal vitamin A supplementation in reducing infant morbidity and mortality and assess potential sources of heterogeneity of the effect of NVAS. Methods: : We completed an individually randomized, double-blind, placebo-controlled trial in Tanzania. Infants were randomized within 3 days of birth to a single dose of vitamin A (50 000 IU) or placebo. We assessed infants at 1 and 3 days after supplementation, as well as 1, 3, 6 and 12 months after supplementation. We included all live births in the analysis and used relative risks (RR) and 95% confidence intervals (CI) to assess the risks of mortality and hospitalization by 12 months. We used general estimating equations to assess the incidence of morbidities during infancy. Results: : A total of 31 999 infants were enrolled in the study between August 2010 and March 2013. At 12 months, vitamin A did not reduce all-cause infant mortality (RR 1.04; 95% CI 0.92-1.16), nor affect hospitalization (RR 1.09; 95% CI 0.97-1.22) or all-cause morbidity (RR 1.00; 95% CI 0.96-1.05). Postpartum maternal vitamin A supplementation modified the effect of neonatal vitamin A supplementation on mortality at 12 months ( P -value, test for interaction = 0.04). Among infants born to women who received a mega-dose of vitamin A after delivery, NVAS appeared to increase the risk of death (RR 1.12; 95% CI 0.98-1.29), whereas the risk of death among infants born to women who did not receive a mega-dose was reduced (RR 0.86; 95% CI 0.70-1.06). We noted no modification of the effect of NVAS by infant gender, birthweight or maternal HIV status. Conclusion: : NVAS did not affect the risk of death or incidence of common childhood morbidities. However, this study sheds light on potential sources of heterogeneity of the effect of neonatal vitamin A supplementation which should be further examined in a pooled analysis of all NVAS trials.

Predictors of Hospitalization During the First Year of Life among 31999 Tanzanian Infants.

OBJECTIVE: This study explored the risk factors for infant hospitalization in urban and peri-urban/rural Tanzania. METHODS: We conducted a prospective cohort study examining predictors of hospitalization during the first year of life among infants enrolled at birth in a large randomized controlled trial of neonatal vitamin A supplementation conducted in urban Dar es Salaam (n = 11,895) and peri-urban/rural Morogoro region (n = 20,104) in Tanzania. Demographic, socioeconomic, environmental and birth outcome predictors of hospitalization were assessed using proportional hazard models. RESULTS: The rate of hospitalization was highest during the neonatal period in both Dar es Salaam (102/10,000 neonatal-months) and Morogoro region (78/10,000 neonatal-months). Hospitalization declined with increased age and was lowest for infants 6-12 months of age in both Dar es Salaam (11/10,000 infant-months) and Morogoro region (16/10,000 infant-months). In both Dar es Salaam and Morogoro region, older maternal age, male sex, low birth weight and being small for gestational age were significant predictors of higher risk of hospitalization (p < 0.05). Increased wealth and having a flush toilet were significantly associated with an increased risk of hospitalization in Morogoro region only (p < 0.05). CONCLUSIONS: This study determined high rates of neonatal hospitalization in Tanzania. Interventions to increase birth size may decrease risk of hospitalization. Equity in access to hospitals for poor rural families in Tanzania requires attention.

Effect of neonatal vitamin A supplementation on mortality in infants in Tanzania (Neovita): a randomised, double-blind, placebo-controlled trial.

BACKGROUND: Supplementation of vitamin A in children aged 6-59 months improves child survival and is implemented as global policy. Studies of the efficacy of supplementation of infants in the neonatal period have inconsistent results. We aimed to assess the efficacy of oral supplementation with vitamin A given to infants in the first 3 days of life to reduce mortality between supplementation and 180 days (6 months). METHODS: We did an individually randomised, double-blind, placebo-controlled trial of infants born in the Morogoro and Dar es Salaam regions of Tanzania. Women were identified during antenatal clinic visits or in the labour wards of public health facilities in Dar es Salaam. In Kilombero, Ulanga, and Kilosa districts, women were seen at home as part of the health and demographic surveillance system. Newborn infants were eligible for randomisation if they were able to feed orally and if the family intended to stay in the study area for at least 6 months. We randomly assigned infants to receive one dose of 50,000 IU of vitamin A or placebo in the first 3 days after birth. Infants were randomly assigned in blocks of 20, and investigators, participants' families, and data analysis teams were masked to treatment assignment. We assessed infants on day 1 and day 3 after dosing, as well as at 1, 3, 6, and 12 months after birth. The primary endpoint was mortality at 6 months, assessed by field interviews. The primary analysis included only children who were not lost to follow-up. This trial is registered with the Australian New Zealand Clinical Trials Registry (ANZCTR), number ACTRN12610000636055. FINDINGS: Between Aug 26, 2010, and March 3, 2013, 31,999 newborn babies were randomly assigned to receive vitamin A (n=15,995) or placebo (n=16,004; 15,428 and 15,464 included in analysis of mortality at 6 months, respectively). We did not find any evidence for a beneficial effect of vitamin A supplementation on mortality in infants at 6 months (26 deaths per 1000 livebirths in vitamin A vs 24 deaths per 1000 livebirths in placebo group; risk ratio 1·10, 95% CI 0·95-1·26; p=0·193). There was no evidence of a differential effect for vitamin A supplementation on mortality by sex; risk ratio for mortality at 6 months for boys was 1·08 (0·90-1·29) and for girls was 1·12 (0·91-1·39). There was also no evidence of adverse effects of supplementation within 3 days of dosing. INTERPRETATION: Neonatal vitamin A supplementation did not result in any immediate adverse events, but had no beneficial effect on survival in infants in Tanzania. These results strengthen the evidence against a global policy recommendation for neonatal vitamin A supplementation. FUNDING: Bill & Melinda Gates Foundation to WHO.

Health research oversight in Africa.

Increased research involving human participants in developing countries has resulted in commensurate rise in needs for functional research oversight activities. The importance of developing countries regulatory and ethical review authorities to demonstrate capability in reviewing clinical trials, quality of the products as well as clinical data obtained through well-coordinated oversight systems cannot be over-emphasized. According to the recent international changes in regulatory frameworks and evolving manufacture's strategies, African countries are now responsible to review applications and license new products without necessarily having them licensed in the north so long as they are not intended to be used there. This paper reviews the status of health research oversight in Africa and gives an overview of some mechanisms that are being put in place in an effort to strengthen oversight of health research. Practical challenges that are prevailing in the field will be highlighted.