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Sudfeld, Christopher

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Sudfeld, Christopher
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    Effect of a Center-Based Early Childhood Care and Education Program on Child Nutritional Status: A Secondary Analysis of a Stepped-Wedge Cluster Randomized Controlled Trial in Rural Sindh, Pakistan
    (Elsevier BV, 2023-12) Ali, Nazia Binte; Yousafzai, Aisha; Siyal, Saima; Bhamani, Shelina; Sudfeld, Christopher
    Background: High-quality early childhood care and education (ECCE) programs can positively impact children's development. However, as an unintended consequence, ECCE attendance may also affect children's nutritional status. Objective: We evaluated the effect of a center-based ECCE intervention on child nutritional outcomes in rural Pakistan. Methods: This study utilized data from a stepped-wedge cluster randomized controlled trial of a center-based ECCE program that trained female youth to run high-quality preschools for children aged 3.5-5.5 years (LEAPS program) in rural Sindh, Pakistan. The program did not include any school meals. A total of 99 village clusters were randomized to receive the LEAPS intervention in three steps, and repeated cross-sectional surveys were conducted to assess the impact on children (4.5-5.5 years old) at four time points. Intention-to-treat analyses with multi-level mixed-effect models were used to estimate the effect of the intervention on child anthropometric outcomes. Results: The analysis included 3,858 children with anthropometric data from four cross-sectional survey rounds. The LEAPS intervention was found to have a positive effect on child HAZ (mean difference: 0.13 z-scores; 95% confidence interval (CI): 0.02, 0.24). However, there was a negative effect on weight-based anthropometric indicators, -0.29 WHZ (95% CI: -0.42, -0.15), -0.13 BMIZ (95% CI: -0.23, -0.03), and -0.16 MUACZ (95% CI: -0.25, -0.05). An exploratory analysis suggested that the magnitude of the negative effect of LEAPS on WHZ, BMIZ, and WAZ was greater in the survey round during the COVID-19 lockdown. Discussion: The LEAPS intervention positively affected child linear growth but had negative effects on multiple weight-based anthropometric measures. ECCE programs in low- and middle-income country settings should evaluate the integration of nutrition-specific interventions (e.g., school lunch, counseling on healthy diets) and infection control strategies to promote children's healthy growth and development.
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    Efficacy of vitamin D3 supplementation in reducing incidence of pulmonary tuberculosis and mortality among HIV-infected Tanzanian adults initiating antiretroviral therapy: study protocol for a randomized controlled trial
    (BioMed Central, 2017) Sudfeld, Christopher; Mugusi, Ferdinand; Aboud, Said; Nagu, Tumaini J.; Wang, Molin; Fawzi, Wafaie
    Background: HIV-infected adults initiating antiretroviral therapy (ART) in sub-Saharan Africa continue to experience high rates of morbidity and mortality during the initial months of treatment. Observational studies in high-income and resource-limited settings indicate that HIV-infected adults with low vitamin D levels may be at increased risk of mortality, HIV disease progression, and incidence of pulmonary tuberculosis (TB). As a result, vitamin D3 supplementation may improve survival and treatment outcomes for HIV-infected adults initiating ART. Methods/Design The Trial of Vitamins-4 (ToV4) is an individually randomized, double-blind, placebo-controlled trial of vitamin D3 (cholecalciferol) supplementation conducted among 4000 HIV-infected adults with low vitamin D levels [25-hydroxyvitamin D (25(OH)D) <30 ng/mL] initiating ART in Dar es Salaam, Tanzania. The two primary aims of the trial are to determine the effect of a vitamin D3 supplementation regimen on incidence of (1) mortality and (2) pulmonary TB as compared to a matching placebo regimen. The primary safety outcome of the study is incident hypercalcemia. The investigational vitamin D3 regimen consists of oral supplements containing 50,000 IU vitamin D3 taken under direct observation at randomization and once a week for 3 weeks (four doses) followed by daily oral supplements containing 2000 IU vitamin D3 taken at home from the fourth week until trial discharge at 1 year post ART initiation. Trial participants are followed up at weekly clinic visits during the first month of ART and at monthly clinic visits thereafter until trial discharge at 1 year post ART initiation. Secondary aims of the trial are to examine the effect of the vitamin D3 regimen on CD4 T cell reconstitution, incidence of non-TB comorbidities, body mass index (BMI), depression and anxiety, physical activity, bone health, and immunologic biomarkers. Discussion The ToV4 will provide causal evidence on the effect of vitamin D3 supplementation on incidence of pulmonary TB and mortality among HIV-infected Tanzanian adults initiating ART. The trial will also give insight to whether vitamin D3 supplementation trials for the prevention of pulmonary TB should be pursued in HIV-uninfected populations. Trial registration ClinicalTrials.gov, NCT01798680. Registered on 21 February 2013. Electronic supplementary material The online version of this article (doi:10.1186/s13063-017-1819-5) contains supplementary material, which is available to authorized users.
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    Effect of maternal vitamin D3 supplementation on maternal health, birth outcomes, and infant growth among HIV-infected Tanzanian pregnant women: study protocol for a randomized controlled trial
    (BioMed Central, 2017) Sudfeld, Christopher; Manji, Karim P.; Duggan, Christopher; Aboud, Said; Muhihi, Alfa; Sando, David; Al-beity, Fadhlun M. Alwy; Wang, Molin; Fawzi, Wafaie
    Background: Vitamin D has significant immunomodulatory effects on both adaptive and innate immune responses. Observational studies indicate that adults infected with HIV with low vitamin D status may be at increased risk of mortality, pulmonary tuberculosis, and HIV disease progression. Growing observational evidence also suggests that low vitamin D status in pregnancy may increase the risk of adverse birth and infant health outcomes. As a result, antiretroviral therapy (ART) adjunct vitamin D3 supplementation may improve the health of HIV-infected pregnant women and their children. Methods/design The Trial of Vitamins-5 (ToV5) is an individually randomized, double-blind, placebo-controlled trial of maternal vitamin D3 (cholecalciferol) supplementation conducted among 2300 HIV-infected pregnant women receiving triple-drug ART under Option B+ in Dar es Salaam, Tanzania. HIV-infected pregnant women of 12–27 weeks gestation are randomized to either: 1) 3000 IU vitamin D3 taken daily from randomization in pregnancy until trial discharge at 12 months postpartum; or 2) a matching placebo regimen. Maternal participants are followed-up at monthly clinic visits during pregnancy, at delivery, and then with their children at monthly postpartum clinic visits. The primary efficacy outcomes of the trial are: 1) maternal HIV disease progression or death; 2) risk of small-for-gestational age (SGA) births; and 3) risk of infant stunting at 1 year of age. The primary safety outcome of the trial is incident maternal hypercalcemia. Secondary outcomes include a range of clinical and biological maternal and child health outcomes. Discussion The ToV5 will provide causal evidence on the effect of vitamin D3 supplementation on HIV progression and death, SGA births, and infant stunting at 1 year of age. The results of the trial are likely generalizable to HIV-infected pregnant women and their children in similar resource-limited settings utilizing the Option B+ approach. Trial registration ClinicalTrials.gov identifier: NCT02305927. Registered on 29 October 2014. Electronic supplementary material The online version of this article (doi:10.1186/s13063-017-2157-3) contains supplementary material, which is available to authorized users.
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    Scaling-Up Access to Family Planning May Improve Linear Growth and Child Development in Low and Middle Income Countries
    (Public Library of Science, 2014) Fink, Günther; Sudfeld, Christopher; Danaei, Goodarz; Ezzati, Majid; Fawzi, Wafaie
    Background: A large literature has indicated a robust association between birth spacing and child survival, but evidence on the association of birth timing with physical growth in low and middle income countries (LMICs) remains limited. Methods and Results: Data from 153 cross-sectional Demographic and Health Surveys (DHS) across 61 LMICs conducted between 1990 and 2011 were combined to assess the association of birth timing with child stunting (height-for-age z-score <−2). A total of 623,789 children of birth order 1–5 contributed to the maternal age analysis, while the birth spacing dataset consisted of 584,226 children of birth order 2 and higher. Compared to 27–34 year old mothers, maternal age under 18 years was associated with a relative stunting risk of 1.35 (95% CI: 1.29–1.40) for firstborn children, whereas the relative risk was 1.24 (95% CI: 1.19–1.29) for mothers aged 18–19 years. The association of young maternal age with stunting was significantly greater for urban residents and those in the top 50% of household wealth. Birth intervals less than 12 months and 12–23 months had relative risks for stunting of 1.09 (95% CI: 1.06–1.12) and 1.06 (95% CI: 1.05–1.06) as compared to a 24–35 month inter-pregnancy interval, respectively. The strength of both teenage pregnancy and short birth interval associations showed substantial variation across WHO region. We estimate that 8.6% (6.9–10.3%) of stunted cases in the South Asian DHS sample would have been averted by jointly eliminating teen pregnancies and birth intervals less than 24 months, while only 3.6% (1.5–5.7%) of stunting cases would have prevented in the Middle East and North Africa sample. Conclusions: Postponing the age of first birth and increasing inter-pregnancy intervals has the potential to significantly reduce the prevalence of stunting and improve child development in LMICs.
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    Tuberculosis incidence rate and risk factors among HIV-infected adults with access to antiretroviral therapy
    (Ovid Technologies (Wolters Kluwer Health), 2015) Liu, Enju; Makubi, Abel; Drain, Paul; Spiegelman, Donna; Sando, David; Li, Nan; Chalamilla, Guerino; Sudfeld, Christopher; Hertzmark, Ellen; Fawzi, Wafaie
    OBJECTIVE: The objective of this study is to determine the incidence rate and risk factors of tuberculosis (TB) among HIV-infected adults accessing antiretroviral therapy (ART) in Tanzania. DESIGN: A prospective observational study among HIV-infected adults attending HIV clinics in Dar es Salaam. METHODS: We estimated TB incidence rates among HIV-infected patients prior to and after ART initiation. We used Cox proportional hazard regressions to determine the predictors of incident TB among HIV-infected adults enrolled in the HIV care and treatment programme. RESULTS: We assessed 67 686 patients for a median follow-up period of 24 (interquartile range: 8-49) months; 7602 patients were diagnosed with active TB. The TB incidence rate was 7.9 [95% confidence interval (95% CI), 7.6-8.2] per 100 person-years prior to ART initiation, and 4.4 (95% CI, 4.2-4.4) per 100 person-years for patients receiving ART. In multivariate analyses, patients on ART in the first 3 months had a 57% higher risk of TB (hazard ratio: 1.57, 95% CI, 1.47-1.68) than those not on ART, but the risk significantly decreased with increasing duration of ART. Risk factors for incident TB included being male, having low BMI or middle upper arm circumference, lower CD4 cell count and advanced WHO disease stage. There was seasonal variation for incident TB, with higher risk observed following the rainy seasons (May, June and November). CONCLUSION: In TB endemic regions, HIV-infected patients initiating ART, particularly men and those with poor nutritional status, should be closely monitored for active TB at ART initiation. In addition to increasing the access to ART, interventions should be considered to improve nutritional status among HIV-infected patients.
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    Effect of Multivitamin Supplementation on Measles Vaccine Response among HIV-Exposed Uninfected Tanzanian Infants
    (American Society for Microbiology, 2013) Sudfeld, Christopher; Duggan, Christopher; Histed, A.; Manji, K. P.; Meydani, S. N.; Aboud, S.; Wang, Molin; Giovannucci, Edward; Fawzi, Wafaie
    Immunization and nutritional interventions are mainstays of child health programs in sub-Saharan Africa, yet few published data exist on their interactions. HIV-exposed (but uninfected) infants enrolled in a randomized placebo-controlled trial of multivitamin supplements (vitamins B complex, C, and E) conducted in Tanzania were sampled for an assessment of measles IgG quantity and avidity at 15 to 18 months. Infants were vaccinated between 8.5 and 12 months of age, and all mothers received high-dose multivitamins as the standard of care. Of 201 HIV-exposed infants who were enrolled, 138 (68.7%) were seropositive for measles. There were no effects of infant multivitamin supplementation on measles seroconversion proportions, IgG concentrations, or IgG avidity (P > 0.05). The measles seroconversion proportion was greater for HIV-exposed infants vaccinated at 10 to 11 months of age than for those vaccinated at 8.5 to 10 months (P = 0.032) and greater for infants whose mothers had a CD4 T-cell count of <200 cells/μl than for infants whose mothers had a CD4 T-cell count of >350 cells/μl (P = 0.039). Stunted infants had a significantly decreased IgG quantity compared to nonstunted infants (P = 0.012). As for measles avidity, HIV-exposed infants vaccinated at 10 to 11 months had increased antibody avidity compared to those vaccinated at 8.5 to 10 months (P = 0.031). Maternal CD4 T-cell counts of <200 cells/μl were associated with decreased avidity compared to counts of >350 cells/μl (P = 0.047), as were lower infant height-for-age z-scores (P = 0.016). Supplementation with multivitamins containing B complex, C, and E does not appear to improve measles vaccine responses for HIV-exposed infants. Studies are needed to better characterize the impact of maternal HIV disease severity on the immune system development of HIV-exposed infants and the effect of malnutrition interventions on vaccine responses. (This study has been registered at ClinicalTrials.gov under registration no. NCT00197730.)
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    Early Childhood Developmental Status in Low- and Middle-Income Countries: National, Regional, and Global Prevalence Estimates Using Predictive Modeling
    (Public Library of Science, 2016) Mccoy, Dana; Peet, Evan D.; Ezzati, Majid; Danaei, Goodarz; Black, Maureen M.; Sudfeld, Christopher; Fawzi, Wafaie; Fink, Gunther
    Background: The development of cognitive and socioemotional skills early in life influences later health and well-being. Existing estimates of unmet developmental potential in low- and middle-income countries (LMICs) are based on either measures of physical growth or proxy measures such as poverty. In this paper we aim to directly estimate the number of children in LMICs who would be reported by their caregivers to show low cognitive and/or socioemotional development. Methods and Findings: The present paper uses Early Childhood Development Index (ECDI) data collected between 2005 and 2015 from 99,222 3- and 4-y-old children living in 35 LMICs as part of the Multiple Indicator Cluster Survey (MICS) and Demographic and Health Surveys (DHS) programs. First, we estimate the prevalence of low cognitive and/or socioemotional ECDI scores within our MICS/DHS sample. Next, we test a series of ordinary least squares regression models predicting low ECDI scores across our MICS/DHS sample countries based on country-level data from the Human Development Index (HDI) and the Nutrition Impact Model Study. We use cross-validation to select the model with the best predictive validity. We then apply this model to all LMICs to generate country-level estimates of the prevalence of low ECDI scores globally, as well as confidence intervals around these estimates. In the pooled MICS and DHS sample, 14.6% of children had low ECDI scores in the cognitive domain, 26.2% had low socioemotional scores, and 36.8% performed poorly in either or both domains. Country-level prevalence of low cognitive and/or socioemotional scores on the ECDI was best represented by a model using the HDI as a predictor. Applying this model to all LMICs, we estimate that 80.8 million children ages 3 and 4 y (95% CI 48.1 million, 113.6 million) in LMICs experienced low cognitive and/or socioemotional development in 2010, with the largest number of affected children in sub-Saharan Africa (29.4.1 million; 43.8% of children ages 3 and 4 y), followed by South Asia (27.7 million; 37.7%) and the East Asia and Pacific region (15.1 million; 25.9%). Positive associations were found between low development scores and stunting, poverty, male sex, rural residence, and lack of cognitive stimulation. Additional research using more detailed developmental assessments across a larger number of LMICs is needed to address the limitations of the present study. Conclusions: The number of children globally failing to reach their developmental potential remains large. Additional research is needed to identify the specific causes of poor developmental outcomes in diverse settings, as well as potential context-specific interventions that might promote children’s early cognitive and socioemotional well-being.
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    Development and validation of an early childhood development scale for use in low-resourced settings
    (Springer Nature, 2017) Mccoy, Dana; Sudfeld, Christopher; Bellinger, David; Muhihi, Alfa; Ashery, Geofrey; Weary, Taylor Evans; Fawzi, Wafaie; Fink, Gunther
    Background:Low-cost, cross-culturally comparable measures of the motor, cognitive, and socioemotional skills of children under 3 years remain scarce. In the present paper, we aim to develop a new caregiver-reported early childhood development (ECD) scale designed to be implemented as part of household surveys in low-resourced settings. Methods: We evaluate the acceptability, test-retest reliability, internal consistency, and discriminant validity of the new ECD items, subscales, and full scale in a sample of 2481 18- to 36-month-old children from peri-urban and rural Tanzania. We also compare total and subscale scores with performance on the Bayley Scales of Infant Development (BSID-III) in a subsample of 1036 children. Qualitative interviews from 10 mothers and 10 field workers are used to inform quantitative data. Results: Adequate levels of acceptability and internal consistency were found for the new scale and its motor, cognitive, and socioemotional subscales. Correlations between the new scale and the BSID-III were high (r > .50) for the motor and cognitive subscales, but low (r < .20) for the socioemotional subscale. The new scale discriminated between children’s skills based on age, stunting status, caregiver-reported disability, and adult stimulation. Test-retest reliability scores were variable among a subset of items tested. Conclusions: Results of this study provide empirical support from a low-income country setting for the acceptability, reliability, and validity of a new caregiver-reported ECD scale. Additional research is needed to test these and other caregiver reported items in children in the full 0 to 3 year range across multiple cultural and linguistic settings.
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    Depression at antiretroviral therapy initiation and clinical outcomes among a cohort of Tanzanian women living with HIV
    (Ovid Technologies (Wolters Kluwer Health), 2017) Sudfeld, Christopher; Kaaya, Sylvia; Gunaratna, Nilupa; Mugusi, Fedinand; Fawzi, Wafaie; Aboud, Said; Smith Fawzi, Mary C.
    OBJECTIVE: The objective of the study was to assess the relationship of depression at antiretroviral therapy (ART) initiation with mortality and clinical outcomes among Tanzanian women living with HIV. DESIGN: We conducted a prospective cohort study of 1487 women who initiated ART in Dar es Salaam, Tanzania. METHODS: Symptoms of depression and anxiety were assessed using a Tanzanian-adapted and validated version of the Hopkins Symptom Checklist. Participants attended monthly clinic visits during the first 2 years of ART and CD4 T-cell counts were assessed every 4 months. Proportional hazard models were used to assess the relationship of depression with mortality and clinical outcomes. RESULTS: Symptoms consistent with depression were prevalent among 57.8% of women at ART initiation. After multivariate adjustment, including social support and stigma, depression at ART initiation was associated with increased risk of mortality [hazard ratio (HR): 1.92; 95% confidence interval (CI): 1.15-3.20; P = 0.01] and incidence of severe anemia (hemoglobin <8.5 g/dl; HR: 1.59; 95% CI: 1.07-2.37; P = 0.02). Under the assumption of causality, we estimate 36.1% (95% CI: 13.6-55.1%) of deaths among the study cohort were attributable to depression and its consequences. Depression was not significantly associated with trajectory of CD4 T-cell reconstitution or the risk of immunologic failure (P values >0.05). CONCLUSION: Elimination of depression may reduce mortality during the first 2 years of ART by one-third in our study cohort. Randomized trials and rigorous implementation studies are needed to evaluate the individual and population-level effects of integrated mental health interventions and HIV treatment approaches in resource-limited settings.
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    Effect of selenium supplementation on HIV-1 RNA detection in breast milk of Tanzanian women
    (Elsevier BV, 2014) Sudfeld, Christopher; Aboud, Said; Kupka, Roland; Mugusi, Ferdinand M.; Fawzi, Wafaie
    Objective Selenium supplementation for HIV-infected women may increase genital shedding of HIV-1, but no studies have examined the effect on viral shedding in breast milk. Research Methods and Procedures HIV-infected pregnant women enrolled at 12–27 weeks gestation in a randomized, double-blind, placebo-controlled trial of daily selenium (200 μg as selenomethionine) had cell-free HIV-1 RNA quantified in breast milk at 4–9 weeks postpartum. All participants received high dose multivitamins containing vitamin B-complex, C, and E as standard of care. Results The proportion of women with detectable (>50 copies/mL) HIV-1 RNA in breast milk appeared to be increased in the selenium group (36.4%) as compared to the placebo (27.5%) among the total cohort (n=420), but results were borderline statistically significant (RR: 1.32; 95% CI: 1.00–1.76; p=0.05). In secondary analyses, the proportion of women with detectable HIV-1 RNA in breast milk was significantly greater in the selenium group (37.8%) as compared to placebo (27.5%) among women who did not receive HAART (RR: 1.37; 95% CI: 1.03–1.82; p=0.03). This relationship was primarily due to a significant effect of selenium among primiparous women (RR: 2.24; 95% CI: 1.30–3.86; p<0.01), but not multiparous women (RR: 1.14; 95% CI: 0.81–1.59; p=0.54) (p-value for interaction=0.02). Too few women received HAART in this study (n=12) to establish the effect of selenium supplementation. Conclusions Selenium supplementation appears to increase HIV-1 RNA detection in breast milk among primiparous women not receiving HAART. Safety studies among pregnant women on HAART need to be conducted before providing selenium containing supplements.