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Investigates the pattern and predictors of weight gain during pregnancy among HIV-1-infected women in Tanzania. Association of weight loss to AIDS progression; Observation of the weekly weight gain of pregnant HIV-infected women; Factors affecting the weight gain differences among pregnant women.

Examines the timing and correlates of HIV-1 transmission through breastfeeding among HIV-infected pregnant women from Dar es Salaam, Tanzania. Mean duration of breastfeeding; Number of infections observed; Infection risk by age.

Examines the effectiveness of highly active antiretroviral therapy in improving the weight loss and survival of HIV-positive patients. Impact of wasting on the survival rate of patients receiving HAART; Accounts on the predominant features of HIV disease progression; Effects of protease inhibitors on fat-free mass.

Latent-class analysis was used to evaluate the usefulness of markers of hepatitis C virus (HCV) infection in characterizing the true, underlying infection in a community-based Japanese population. Antibodies to HCV were detected in 24%, HCV RNA in 22%, and HCV core protein in 19% of stored serum samples from 372 adults. A 2-class model suggested that positive results for any 2 virus markers defined the current HCV infection class, with an estimated prevalence of 22% (95% confidence interval, 18%–26%). The sensitivity for detection of current HCV infection was highest for anti-HCV (97%) and was more moderate for HCV RNA (91%) and HCV core protein (85%). The specificity for each marker was ≥96%. In general, the association between demographic factors and current HCV infection status was strengthened by use of latent-class analysis that combined data for markers of HCV infection, when compared with results of logistic regression analysis for each marker separately. [ABSTRACT FROM AUTHOR]

Focuses on a study which determined whether adherence with one antiretroviral medication predicts adherence with other antiretroviral medications. Methods; Results; Discussion.

Background: Worksite-based nutrition interventions can serve as access points to facilitate healthy eating and translate existing knowledge of cardiometabolic disease prevention. We explored perceptions, facilitators, and barriers for healthy eating in a cafeteria at a large worksite in Mexico City.Methods: We conducted an exploratory qualitative study in a large department store in Mexico City with ~ 1500 employees. We conducted eight focus group discussions (FGD) with 63 employees stratified by job category (sales, maintenance, shipping, restaurant, cafeteria, administrative staff, and sales managers). Employees were invited to participate in the FGD if they were at the store at the day and time of the FGD for their job type. FGDs were audio-recorded, transcribed verbatim and analyzed using the thematic method. This process involved the researches´ familiarizing themselves with the data, generating initial codes, searching for themes, reviewing the themes, defining and naming themes, and then interpreting the data.Results: Employees defined healthy eating as eating foods that are fresh, diverse, and prepared hygienically. The most commonly reported facilitators of healthy eating at the worksite were availability of affordable healthy food options and employees' high health awareness. Major barriers to healthy eating included unavailability of healthy foods, unpleasant taste of food, and preference for fatty foods and meat. For lower-wage workers, affordability was a major concern. Other barriers included lack of time to eat work and long working hours.Conclusion: A broad range of factors affect healthy eating at the cafeteria, some related to nutrition and some related to the employees type of job. Availability of healthy, hygienic, and tasty food at an affordable price could lead to healthier food choices in the worksite cafeteria. These strategies, along with work schedules that allow sufficient time for healthy eating, may help improve dietary behaviors and health of employees. [ABSTRACT FROM AUTHOR]

Considers evidence which suggests that homocysteine is a risk factor for cardiovascular disease in adults, though little information exists on homocysteine levels in children. Study to describe the distribution of serum homocysteine concentrations among children and to examine the association between homocysteine levels and several characteristics, including serum levels of folic acid and vitamins B12 and B6; Design; Setting; Participants; Main outcome measure; Results; Conclusions.

Evaluates the predictors of plasma concentrations of dichlorodiphenyldichloroethylene (DDE) and polychlorinated biphenyls (PCB) in a group of women with breast cancer in the United States. Positive association of fish consumption and PCB; Primary source of exposure; Presence of organochlorines in food crops; Plasma concentrations of DDE and PCB.

Background: In HIV-1-infected women, poor micronutrient status has been associated with faster progression of HIV-1 disease and adverse birth outcomes. We assessed the effects of vitamin A and multivitamins on birth outcomes in such women.Methods: In Tanzania, 1075 HIV-1-infected pregnant women at between 12 and 27 weeks' gestation received placebo (n=267), vitamin A (n=269), multivitamins excluding vitamin A (n=269), or multivitamins including vitamin A (n=270) in a randomised, double-blind, placebo-controlled trial with a 2x2 factorial design. We measured the effects of multivitamins and vitamin A on birth outcomes and counts of T lymphocyte subsets. We did analyses by intention to treat.Results: 30 fetal deaths occurred among women assigned multivitamins compared with 49 among those not on multivitamins (relative risk 0.61 [95% CI 0.39-0.94] p=0.02). Multivitamin supplementation decreased the risk of low birthweight (<2500 g) by 44% (0.56 [0.38-0.82] p=0.003), severe preterm birth (<34 weeks of gestation) by 39% (0.61 [0.38-0.96] p=0.03), and small size for gestational age at birth by 43% (0.57 [0.39-0.82] p=0.002). Vitamin A supplementation had no significant effect on these variables. Multivitamins, but not vitamin A, resulted in a significant increase in CD4, CD8, and CD3 counts.Interpretation: Multivitamin supplementation is a low-cost way of substantially decreasing adverse pregnancy outcomes and increasing T-cell counts in HIV-1-infected women. The clinical relevance of our findings for vertical transmission and clinical progression of HIV-1 disease is yet to be ascertained. [ABSTRACT FROM AUTHOR]

Background: Training lay people to deliver mental health interventions in the community can be an effective strategy to mitigate mental health manpower shortages in low- and middle-income countries. The healthy beginning initiative (HBI) is a congregation-based platform that uses this approach to train church-based lay health advisors to conduct mental health screening in community churches and link people to care. This paper explores the potential for a clergy-delivered therapy for mental disorders on the HBI platform and identifies the treatment preferences of women diagnosed with depression. Methods: We conducted focus group discussion and free-listing exercise with 13 catholic clergy in churches that participated in HBI in Enugu, Nigeria. These exercises, guided by the positive, existential, or negative (PEN-3) cultural model, explored their role in HBI, their beliefs about mental disorders, and their willingness to be trained to deliver therapy for mental disorders. We surveyed women diagnosed with depression in the same environment to understand their health-seeking behavior and treatment preferences. The development of the survey was guided by the health belief model. Results: The clergy valued their role in HBI, expressed understanding of the bio-psycho-socio-spiritual model of mental disorders, and were willing to be trained to provide therapy for depression. Majority of the women surveyed preferred to receive therapy from trained clergy (92.9%), followed by a psychiatrist (89.3%), and psychologist (85.7%). Conclusion: These findings support a potential clergy-focused, faith-informed adaptation of therapy for common mental disorders anchored in community churches to increase access to treatment in a resource-limited setting. [ABSTRACT FROM AUTHOR]

Background: Hematological status may predict HIV disease progression and mortality among adults initiating highly active antiretroviral therapy (HAART).Objectives: We aimed to examine the relation of anemia and iron status at HAART initiation with survival and morbidity outcomes.Methods: We conducted a case-cohort study of 570 HIV-infected adults initiating HAART who were enrolled in a trial of multivitamins in Tanzania. Hemoglobin, serum ferritin, and hepcidin concentrations were assessed at HAART initiation and participants were followed up monthly. We adjusted serum ferritin for inflammation using a regression correction method to characterize hematological status. Cox proportional hazards models were used to estimate HRs for mortality and incident clinical outcomes.Results: We found an 83% prevalence of anemia, 15% prevalence of iron deficiency anemia, and 66% prevalence of anemia of chronic diseases (ACD). The prevalence of elevated iron was 33% and 19% had iron deficiency (ID). After multivariate adjustment, severe anemia (HR: 2.57; 95% CI: 1.49, 4.45) and ACD (HR: 4.71; 95% CI: 2.91, 7.62) were associated with increased risk of mortality as compared with nonanemic participants. In addition, both ID (HR: 2.65; 95% CI: 1.08, 7.78) and elevated iron (HR: 2.83; 95% CI: 2.10, 3.82) were associated with increased risk of mortality as compared with normal iron concentrations. Severe anemia and elevated iron concentrations were associated with incident wasting and >10% weight loss (P values <0.05).Conclusions: Anemia and both ID and elevated iron were associated with increased mortality among HIV-infected adults initiating HAART. Safety and efficacy studies including anemia etiology, timing of HAART initiation, and dose of iron supplementation among HIV patients appear warranted.This trial was registered at clinicaltrials.gov as NCT00383669. [ABSTRACT FROM AUTHOR]

Context: The Patient Protection and Affordable Care Act increases healthcare access and includes provisions that directly impact access to and cost of evidence-based colorectal cancer screening. The Affordable Care Act's removal of cost sharing for colorectal cancer screening as well as Medicaid expansion have been hypothesized to increase screening and improve other health outcomes. However, since its passage in 2010, there is little consensus on the Affordable Care Act's impact.Evidence Acquisition: Data from March 2010 to June 2019 were reviewed and 21 relevant studies were identified; 19 studies examined colorectal cancer screening with most finding increased screening rates.Evidence Synthesis: Eleven studies found significant increases, 5 found nonsignificant increases, 3 found nonsignificant decreases, and 1 study found a significant decrease in colorectal cancer screening. Three studies examined the impact on colorectal cancer incidence and stage of diagnosis, where a significant 2.4% increase in early diagnosis was found in one and a nonsignificant increase in incidence in another. However, survival improved after Medicaid expansion.Conclusions: Free preventive colorectal cancer screening and Medicaid expansion because of passage of the Affordable Care Act have been, in general, positively associated with modest improvements in screening rates across the country. Future studies are needed that investigate the longer-term impact of the Affordable Care Act on colorectal cancer morbidity and mortality rates, as screening is only the first step in treatment of cancerous and precancerous lesions, preventing them from progressing. Moreover, more studies examining subpopulations are needed to better assess where gaps in care remain. [ABSTRACT FROM AUTHOR]

Background: Zinc and vitamin A supplementation have both been shown to affect iron status, hemoglobin (Hb) concentration, and anemia in animal and human studies. However, evidence on their combined use in pregnancy, in the context of iron-folic acid (IFA) supplementation, remains limited.Objective: This study determined the effects of prenatal zinc, vitamin A, and iron supplementation on maternal hematologic and micronutrient status at delivery in Tanzania.Methods: We analyzed 2 large randomized controlled trials, using generalized estimating equations, and examined the effect of daily zinc (25 mg) and vitamin A (2500 IU) supplementation starting in the first trimester of pregnancy compared with placebo (n = 2500), and separately evaluated the safety and efficacy of daily iron (60 mg) supplementation among iron-replete pregnant women (n = 1500). Blood samples from baseline and delivery were tested for Hb, serum ferritin, soluble transferrin receptor, plasma zinc, and zinc protoporphyrin.Results: Zinc and vitamin A supplementation were associated with lower Hb concentrations at delivery of  -0.26 g/dL (95% CI: -0.50, -0.02 g/dL) and -0.25 g/dL (95% CI: -0.49, -0.01 g/dL), respectively. Vitamin A increased mean ferritin concentrations at delivery (14.3 μg/L, 95% CI: 1.84, 29.11 μg/L), but was associated with increased risk of severe anemia (RR: 1.41; 95% CI: 1.06, 1.88). Among women who were iron replete at baseline, iron supplementation reduced the risk of iron depletion at delivery by 47% (RR: 0.53; 95% CI: 0.43, 0.65). There was no effect of zinc or iron supplements on plasma zinc concentrations.Conclusions: Our findings support existing WHO guidelines on prenatal iron, vitamin A, and zinc supplementation among pregnant women. In this setting, scaling uptake of prenatal iron supplements is warranted, but prenatal zinc and vitamin A supplementation did not benefit maternal hematologic status at delivery. In settings where vitamin A deficiency is endemic, the efficacy and safety of the WHO recommended prenatal vitamin A supplementation require further evaluation. [ABSTRACT FROM AUTHOR]

In many public health and medical research settings, information on key covariates may not be readily available or too expensive to gather for all individuals in the study. In such settings, the two-phase design provides a way forward by first stratifying an initial (large) phase I sample on the basis of covariates readily available (including, possibly, the outcome), and sub-sampling participants at phase II to collect the expensive measure(s). When the outcome of interest is binary, several methods have been proposed for estimation and inference for the parameters of a logistic regression model, including weighted likelihood, pseudo-likelihood and maximum likelihood. Although these methods yield consistent estimation and valid inference, they do so solely on the basis of the phase I stratification and the detailed covariate information obtained at phase II. Moreover, they ignore any additional information that is readily available at phase I but was not used as part of the stratified sampling design. Motivated by the potential for efficiency gains, especially concerning parameters corresponding to the additional phase I covariates, we propose a novel augmented pseudo-likelihood estimator for two-phase studies that makes use of all available information. In contrast to recently-proposed weighted likelihood-based methods that calibrate to the influence function of the model of interest, the methods we propose do not require the development of additional models and, therefore, enjoy a degree of robustness. In addition, we expand the broader framework for pseudo-likelihood based estimation and inference to permit link functions for binary regression other than the logit link. Comprehensive simulations, based on a one-time cross sectional survey of 82,887 patients undergoing anti-retroviral therapy in Malawi between 2005 and 2007, illustrate finite sample properties of the proposed methods and compare their performance competing approaches. The proposed method yields the lowest standard errors when the model is correctly specified. Finally, the methods are applied to a large implementation science project examining the effect of an enhanced community health worker program to improve adherence to WHO guidelines for at least four antenatal visits, in Dar es Salaam, Tanzania. [ABSTRACT FROM AUTHOR]

In stepped wedge designs (SWD), clusters are randomized to the time period during which new patients will receive the intervention under study in a sequential rollout over time. By the study's end, patients at all clusters receive the intervention, eliminating ethical concerns related to withholding potentially efficacious treatments. This is a practical option in many large-scale public health implementation settings. Little statistical theory for these designs exists for binary outcomes. To address this, we utilized a maximum likelihood approach and developed numerical methods to determine the asymptotic power of the SWD for binary outcomes. We studied how the power of a SWD for detecting risk differences varies as a function of the number of clusters, cluster size, the baseline risk, the intervention effect, the intra-cluster correlation coefficient, and the time effect. We studied the robustness of power to the assumed form of the distribution of the cluster random effects, as well as how power is affected by variable cluster size. % SWD power is sensitive to neither, in contrast to the parallel cluster randomized design which is highly sensitive to variable cluster size. We also found that the approximate weighted least square approach of Hussey and Hughes (2007, Design and analysis of stepped wedge cluster randomized trials. Contemporary Clinical Trials 28, 182-191) for binary outcomes under-estimates the power in some regions of the parameter spaces, and over-estimates it in others. The new method was applied to the design of a large-scale intervention program on post-partum intra-uterine device insertion services for preventing unintended pregnancy in the first 1.5 years following childbirth in Tanzania, where it was found that the previously available method under-estimated the power. [ABSTRACT FROM AUTHOR]

To determine the glycemic index (GI) of selected cereals and association with their microstructure. The GI of whole grain pilaf (WGP), instant brown rice (IBR), whole maize ugali (MWU), and refined maize ugali (RMU) was assessed in a randomized trial. Fourteen healthy participants with mean age of 25 years were administered 50 g portions of available carbohydrates from glucose and various test foods after an overnight fast on separate occasions. Capillary blood samples of participants were used to measure blood glucose over 2 hr. The GI was calculated as per standard protocol. The microstructure of test foods, determined by scanning electron microscopy was evaluated to understand the measured GI values. The GI (mean ± standard error) of IBR was the highest (87.8 ± 6.8) followed by RMU (74.7 ± 6.5) and WMU (71.4 ± 5.1). WGP had medium GI (58.9 ± 5.1; P < 0.01 vs. IBR). Microstructure examination of IBR revealed disruption of bran layer and presence of fissures indicating loss of intactness of bran. Stereozoom images for WGP revealed intact bran and germ. For RMU and WMU, the grain was milled leading to loss of integrity. IBR, RMU, and WMU have high GI values, which is likely due to disruption of bran layer, endosperm modification (IBR), and loss of grain matrix (WMU, RMU). WGP has medium GI probably due to fairly intact bran and germ. Practical Application: Wholegrain or whole meal flour may not necessarily be low in glycemic index (GI; low GI < 55; medium 55 to 69 and high GI ≥70). "Ugali" a commonly consumed cereal staple food in Tanzania made from either refined or whole meal maize flour was found to be a high GI food. Intact whole grain foods, such as whole grain pilaf (mixed intact whole grains) is a healthier alternative to milled whole grains such as whole meal maize flour. Instant quick cooking brown rice exhibited a high GI, due to the processing method, suggesting that regular brown rice may be a healthier option. [ABSTRACT FROM AUTHOR]

Background: Growing laboratory and animal model evidence supports the potentially carcinogenic effects of some phthalates, chemicals used as plasticizers in a wide variety of consumer products, including cosmetics, medications, and vinyl flooring. However, prospective data on whether phthalates are associated with human breast cancer risk are lacking.Methods: We conducted a nested case-control study within the Women's Health Initiative (WHI) prospective cohort (n = 419 invasive case subjects and 838 control subjects). Control subjects were matched 2:1 to case subjects on age, enrollment date, follow-up time, and WHI study group. We quantified 13 phthalate metabolites and creatinine in two or three urine samples per participant over one to three years. Multivariable conditional logistic regression analysis was used to estimate odds ratios (ORs) and 95% confidence intervals (CIs) for breast cancer risk associated with each phthalate biomarker up to 19 years of follow-up.Results: Overall, we did not observe statistically significant positive associations between phthalate biomarkers and breast cancer risk in multivariable analyses (eg, 4th vs 1st quartile of diethylhexyl phthalate, OR = 1.03, 95% CI = 0.91 to 1.17). Results were generally similar in analyses restricted to disease subtypes, to nonusers of postmenopausal hormone therapy, stratified by body mass index, or to case subjects diagnosed within three, five, or ten years.Conclusions: In the first prospective analysis of phthalates and postmenopausal breast cancer, phthalate biomarker concentrations did not result in an increased risk of developing invasive breast cancer. [ABSTRACT FROM AUTHOR]

In sub-Saharan Africa, female bar workers (FBWs) often serve as informal sex workers. Little is known about the prevalence of HIV and HIV-related risk factors among FBWs in Dar es Salaam (DSM), Tanzania. Using an adapted Structural HIV Determinants Framework, we identified structural, interpersonal, psychosocial, and behavioral risk factors for HIV acquisition. We compared the prevalence of HIV and HIV-related risk factors among a random sample of 66 FBWs from DSM to an age-standardized, representative sample of female DSM-residents from the 2016 Demographic and Health and 2011–2012 AIDS Indicator Surveys. Compared to other women in DSM, FBWs had elevated prevalence of all four groups of risk factors. Key risk factors included gender and economic inequalities (structural); sexual violence and challenges negotiating condom use (interpersonal); depression, post-traumatic stress disorder, and low social support (psychosocial); and history of unprotected sex, multiple sex partners, and high alcohol consumption (behavioral). HIV prevalence did not differ between FBWs (7.1%, 95% CI 3.7-13.3%) and survey respondents (7.7%, 95% CI: 5.3-11.1%), perhaps due to FBWs' higher – though sub-optimal – engagement with HIV prevention strategies. Elevated exposure to HIV-related risk factors but low HIV prevalence suggests economic, psychosocial, and biomedical interventions may prevent HIV among FBWs in DSM. [ABSTRACT FROM AUTHOR]

We develop a new method for covariate error correction in the Cox survival regression model, given a modest sample of internal validation data. Unlike most previous methods for this setting, our method can handle covariate error of arbitrary form. Asymptotic properties of the estimator are derived. In a simulation study, the method was found to perform very well in terms of bias reduction and confidence interval coverage. The method is applied to data from the Health Professionals Follow‐Up Study (HPFS) on the effect of diet on incidence of Type II diabetes. [ABSTRACT FROM AUTHOR]

Our objective was to explore how mothers' attitudes and relationships with their daughters may impact the cervical cancer prevention behaviors of daughters with diverse sexual orientations. We examined 8,143 mother–daughter dyads from the Nurses' Health Study 2 and Growing Up Today Study. During the daughter's adolescence, each mother reported her beliefs about the importance of regular Pap testing for her daughter, the frequency of communication with her daughter about Pap testing, her beliefs about Pap testing and human papillomavirus (HPV) vaccines, and her acceptance of sexual minorities (e.g., bisexuals, lesbians). Mothers and daughters separately reported relationship satisfaction. Log-binomial models were used to examine the longitudinal association between maternal factors and daughter's receipt of a Pap test and HPV vaccination. Nearly all maternal factors predicted the daughter's likelihood to have a Pap test and HPV vaccination. Higher levels of acceptance for sexual minorities and better relationship quality were also positively associated with these cervical cancer prevention behaviors. Yet, after adjusting for the maternal factors, there was little attenuation of the existing sexual orientation-related disparities in Pap tests or HPV vaccination. Mothers can play an important role in their daughters' cervical cancer prevention behaviors through novel processes like being more accepting of sexual minorities and having a good relationship quality. However, in this study, maternal factors did not explain much of the sexual orientation-related disparities in cervical cancer prevention. Efforts to ensure a mother is accepting of sexual minorities and has a good relationship quality with her daughter may improve that daughter's reproductive health. [ABSTRACT FROM AUTHOR]

The standard two-stage approach for estimating non-linear dose-response curves based on aggregated data typically excludes those studies with less than three exposure groups. We develop the one-stage method as a linear mixed model and present the main aspects of the methodology, including model specification, estimation, testing, prediction, goodness-of-fit, model comparison, and quantification of between-studies heterogeneity. Using both fictitious and real data from a published meta-analysis, we illustrated the main features of the proposed methodology and compared it to a traditional two-stage analysis. In a one-stage approach, the pooled curve and estimates of the between-studies heterogeneity are based on the whole set of studies without any exclusion. Thus, even complex curves (splines, spike at zero exposure) defined by several parameters can be estimated. We showed how the one-stage method may facilitate several applications, in particular quantification of heterogeneity over the exposure range, prediction of marginal and conditional curves, and comparison of alternative models. The one-stage method for meta-analysis of non-linear curves is implemented in the dosresmeta R package. It is particularly suited for dose-response meta-analyses of aggregated where the complexity of the research question is better addressed by including all the studies. [ABSTRACT FROM AUTHOR]

Background: Home delivery and late and infrequent attendance at antenatal care (ANC) are responsible for substantial avoidable maternal and pediatric morbidity and mortality in sub-Saharan Africa. This cluster-randomized trial aimed to determine the impact of a community health worker (CHW) intervention on the proportion of women who (i) visit ANC fewer than 4 times during their pregnancy and (ii) deliver at home.Methods and Findings: As part of a 2-by-2 factorial design, we conducted a cluster-randomized trial of a home-based CHW intervention in 2 of 3 districts of Dar es Salaam from 18 June 2012 to 15 January 2014. Thirty-six wards (geographical areas) in the 2 districts were randomized to the CHW intervention, and 24 wards to the standard of care. In the standard-of-care arm, CHWs visited women enrolled in prevention of mother-to-child HIV transmission (PMTCT) care and provided information and counseling. The intervention arm included additional CHW supervision and the following additional CHW tasks, which were targeted at all pregnant women regardless of HIV status: (i) conducting home visits to identify pregnant women and refer them to ANC, (ii) counseling pregnant women on maternal health, and (iii) providing home visits to women who missed an ANC or PMTCT appointment. The primary endpoints of this trial were the proportion of pregnant women (i) not making at least 4 ANC visits and (ii) delivering at home. The outcomes were assessed through a population-based household survey at the end of the trial period. We did not collect data on adverse events. A random sample of 2,329 pregnant women and new mothers living in the study area were interviewed during home visits. At the time of the survey, the mean age of participants was 27.3 years, and 34.5% (804/2,329) were pregnant. The proportion of women who reported having attended fewer than 4 ANC visits did not differ significantly between the intervention and standard-of-care arms (59.1% versus 60.7%, respectively; risk ratio [RR]: 0.97; 95% CI: 0.82-1.15; p = 0.754). Similarly, the proportion reporting that they had attended ANC in the first trimester did not differ significantly between study arms. However, women in intervention wards were significantly less likely to report having delivered at home (3.9% versus 7.3%; RR: 0.54; 95% CI: 0.30-0.95; p = 0.034). Mixed-methods analyses of additional data collected as part of this trial suggest that an important reason for the lack of effect on ANC outcomes was the perceived high economic burden and inconvenience of attending ANC. The main limitations of this trial were that (i) the outcomes were ascertained through self-report, (ii) the study was stopped 4 months early due to a change in the standard of care in the other trial that was part of the 2-by-2 factorial design, and (iii) the sample size of the household survey was not prespecified.Conclusions: A home-based CHW intervention in urban Tanzania significantly reduced the proportion of women who reported having delivered at home, in an area that already has very high uptake of facility-based delivery. The intervention did not affect self-reported ANC attendance. Policy makers should consider piloting, evaluating, and scaling interventions to lessen the economic burden and inconvenience of ANC.Trial Registration: ClinicalTrials.gov NCT01932138. [ABSTRACT FROM AUTHOR]

BACKGROUND: Recent evidence suggests that higher levels of residential greenness may contribute to better mental health. Despite this, few studies have considered its impact on depression, and most are cross-sectional. OBJECTIVE: The objective of this study was to examine surrounding residential greenness and depression risk prospectively in the Nurses' Health Study. METHODS: A total of 38,947 women (mean age throughout follow-up 70 y [range 54-91 y]) without depression in 2000 were followed to 2010. Residential greenness was measured using the satellite-based Normalized Difference Vegetation Index (NDVI) and defined as the mean greenness value within [Formula: see text] and [Formula: see text] radii of the women's residences in July of each year. Incidence of depression was defined according to the first self-report of either physician-diagnosed depression or regular antidepressant use. We used Cox proportional hazards models to examine the relationship between greenness and depression incidence and assessed physical activity as a potential effect modifier and mediator. RESULTS: Over 315,548 person-years, 3,612 incident depression cases occurred. In multivariable-adjusted models, living in the highest quintile of residential greenness within [Formula: see text] was associated with a 13% reduction in depression risk ([Formula: see text] [95% confidence interval (CI): 0.78, 0.98]) compared with the lowest quintile. The association between greenness and depression did not appear to be mediated by physical activity, nor was there evidence of effect modification by physical activity. CONCLUSIONS: In this population of mostly white women, we estimated an inverse association between the highest level of surrounding summer greenness and the risk of self-reported depression. [ABSTRACT FROM AUTHOR]

Implementation trials often involve clustering via risk networks, where only some participants directly receive the intervention. The individual effect is that among directly treated persons beyond being in an intervention network; the disseminated effect is that among persons engaged with those directly treated. In this article, we employ a causal inference framework and discuss assumptions and estimators for individual and disseminated effects and apply them to the HIV Prevention Trials Network 037 Study. HIV Prevention Trials Network 037 was a phase III, network-level, randomized controlled human immunodeficiency virus (HIV) prevention trial conducted in the United States and Thailand from 2002 to 2006 that recruited injection drug users, who were assigned to either an intervention group or a control group, and their risk network members, who received no direct intervention. Combining individual and disseminated effects, we observed a 35% composite rate reduction in the adjusted model (risk ratio = 0.65, 95% confidence interval: 0.47, 0.90). Methodology is now available for estimating the full set of these effects, enhancing knowledge gained from network-randomized trials. Although the overall effect gains validity from network randomization, we show that it will generally be less than the composite effect. Additionally, if only index participants benefit from the intervention, as the network size increases, the overall effect tends toward the null—an unfortunate and misleading conclusion. [ABSTRACT FROM AUTHOR]

Background: Hypertensive disorders of pregnancy (HDP) affect 10% to 15% of women and are associated with a 2-fold increased risk of cardiovascular disease (CVD).Objectives: This study sought to determine whether inclusion of HDP in an established CVD risk score improves prediction of CVD events in women.Methods: The analysis comprised 106,230 ≤10-year observations contributed by 67,406 women, age ≥40 years, free of prior CVD, with data available on model covariates in the Nurses' Health Study II. Participants were followed up for confirmed myocardial infarction, fatal coronary heart disease, or stroke from 1989 to 2013. We fit an established CVD risk prediction model (Model A: age, total cholesterol and high-density lipoprotein cholesterol, systolic blood pressure, antihypertensive medication use, current smoking, diabetes mellitus) and compared it to the same model plus HDP and parity (Model B); Cox proportional hazards models were used to obtain predicted probabilities for 10-year CVD risk.Results: HDP and parity were associated with 10-year CVD risk independent of established CVD risk factors, overall and at ages 40 to 49 years. However, inclusion of HDP and parity in the risk prediction model did not improve discrimination (Model A: C-index = 0.691; Model B: C-index = 0.693; p value for difference = 0.31) or risk reclassification (net reclassification improvement = 0.4%; 95% confidence interval: -0.2 to 1.0%; p = 0.26).Conclusions: In this first test of the clinical utility of HDP and parity in CVD risk prediction, additional inclusion of HDP and parity in an established risk score did not improve discrimination or reclassification in this low-risk population; this might be because of the known associations between HDP and established CVD risk factors in the reference model. [ABSTRACT FROM AUTHOR]

Background: Women with a history of hypertensive disorders of pregnancy (HDP) are nearly twice as likely to develop cardiovascular disease (CVD) as those who are normotensive during pregnancy. However, the emergence of CVD risk factors after HDP is less well-understood. Objective: To identify associations between HDP and maternal CVD risk factors and chart the trajectory of risk factor development after pregnancy. Design: Observational cohort study. Setting: United States. Participants: 58 671 parous NHS II (Nurses' Health Study II) participants who did not have CVD or risk factors of interest at baseline. Measurements: Women were followed for self-reported physician diagnosis of chronic hypertension and hypercholesterolemia and confirmed type 2 diabetes mellitus (T2DM) from their first birth through 2013; mean follow-up ranged from 25 to 32 years across these end points. Multivariable Cox proportional hazards models estimated hazard ratios (HRs) and 95% CIs, with adjustment for prepregnancy confounders. Results: Compared with women who were normotensive during pregnancy, those with gestational hypertension (2.9%) or preeclampsia (6.3%) in their first pregnancy had increased rates of chronic hypertension (HRs, 2.8 [95% CI, 2.6 to 3.0] and 2.2 [CI, 2.1 to 2.3], respectively), T2DM (HRs, 1.7 [CI, 1.4 to 1.9] and 1.8 [CI, 1.6 to 1.9], respectively), and hypercholesterolemia (HRs, 1.4 [CI, 1.3 to 1.5] and 1.3 [CI, 1.3 to 1.4], respectively). Although these women were more likely to develop CVD risk factors throughout follow-up, the relative risk for chronic hypertension was strongest within 5 years after their first birth. Recurrence of HDP further elevated risks for all end points. Limitation: Participants self-reported HDP. Conclusion: Women with HDP in their first pregnancy had increased rates of chronic hypertension, T2DM, and hypercholesterolemia that persisted for several decades. These women may benefit from lifestyle intervention and early screening to reduce lifetime risk for CVD. [ABSTRACT FROM AUTHOR]

Objective: FFQ are often used to estimate food and nutrient intakes to rank individuals by their level of intake. We evaluated the relative validity of a semi-quantitative FFQ created for use in Tanzania by comparing it with two 24 h diet recalls.Design: We measured relative validity of the FFQ with deattenuated energy-adjusted rank correlations for nutrients, deattenuated rank correlations for food groups, and performed a cross-classification analysis of energy-adjusted nutrient quartiles using percentage of agreement and Bland-Altman analysis.Setting: Interviews were conducted in 2014 in participants' homes in Ukonga, Dar es Salaam, Tanzania.Subjects: We surveyed 317 adults aged 40 years or older from the general public.Results: Deattenuated energy-adjusted rank correlation coefficients of nutrients ranged from -0·03 for riboflavin to 0·41 for percentage of energy from carbohydrates, with a median correlation of 0·21. Coefficients for food groups ranged from 0·00 for root vegetables to 0·51 for alcohol, with a median of 0·35. Relative to the average of the two 24 h diet recalls, the FFQ overestimated energy intake and intakes of all nutrients and food groups, other than tea, with ratios among nutrients ranging from 1·34 for SFA to 7·08 for vitamin A; and among food groups from 0·92 for tea to 9·00 for fruit. The percentage of participants classified into the same nutrient intake quartile ranged from 23 % for SFA to 32 % for both niacin and pantothenic acid, with a median of 28 %.Conclusions: The FFQ performed moderately well in urban Tanzanian adults. [ABSTRACT FROM AUTHOR]

Some interventions are intended to benefit both individuals and the groups to which they belong. When a treatment given to one person exerts a causal effect on others, the treatment is said to exhibit spillover, dissemination, or interference. However, defining meaningful causal effects under spillover can be challenging. In this commentary, we discuss the meaning of the "individual effect," a quantity proposed to summarize the effect of treatment on the person who receives it, when spillover may be present. [ABSTRACT FROM AUTHOR]

The partial population attributable risk (pPAR) is used to quantify the population-level impact of preventive interventions in a multifactorial disease setting. In this paper, we consider the effect of nondifferential risk factor misclassification on the direction and magnitude of bias of pPAR estimands and related quantities. We found that the bias in the uncorrected pPAR depends nonlinearly and nonmonotonically on the sensitivities, specificities, relative risks, and joint prevalence of the exposure of interest and background risk factors, as well as the associations between these factors. The bias in the uncorrected pPAR is most dependent on the sensitivity of the exposure. The magnitude of bias varies over a large range, and in a small region of the parameter space determining the pPAR, the direction of bias is away from the null. In contrast, the crude PAR can only be unbiased or biased towards the null by risk factor misclassification. The semiadjusted PAR is calculated using the formula for the crude PAR but plugs in the multivariate-adjusted relative risk. Because the crude and semiadjusted PARs continue to be used in public health research, we also investigated the magnitude and direction of the bias that may arise when using these formulae instead of the pPAR. These PAR estimators and their uncorrected counterparts were calculated in a study of risk factors for colorectal cancer in the Health Professionals Follow-up Study, where it was found that because of misclassification, the pPAR for low folate intake was overestimated with a relative bias of 48%, when red meat and alcohol intake were treated as misclassified risk factors that are not modified, and when red meat was treated as the modifiable risk factor, the estimated value of the pPAR went from 14% to 60%, further illustrating the extent to which misclassification can bias estimates of the pPAR. [ABSTRACT FROM AUTHOR]

Abstract: Introduction: Retention on antiretroviral therapy (ART) is critical for the successful adoption of the test and treat policy by sub‐Saharan African countries, and for realizing the United Nations programme on HIV and AIDS target of 90‐90‐90. This qualitative study explores HIV positive clients’ reasons for discontinuing ART under the MaxART test and treat implementation study in Swaziland. Methods: Clients identified as lost to follow‐up (LTFU) in the programme database, who had initiated ART under the intervention arm of the MaxART study, were purposively selected from two facilities. LTFU was defined as stopping ART refill for three months or longer from the date of last appointment, and not being classified as transferred out or deceased. Semi‐structured face‐to‐face interviews were conducted with nine clients and one treatment supporter between July and August 2017. All interviews were conducted in the local language, audio‐recorded, summarized or transcribed and translated to English for thematic analysis. Results: Respondents described mobility as the first step in a chain of events that affected retention in care. It was entwined with precarious employment, care delivery, interactions with health workers, lack of social support, anticipated stigma and ART‐related side‐effects, including the exacerbation of hunger. The chains of events involved several intersecting reasons that occurred one after the other as a series of contiguous and linked events that led to clients’ eventual discontinuation of ART. The individual accounts of step‐by‐step decision‐making revealed the influence of multi‐layered contexts and the importance of critical life‐events. Conclusions: Clients’ reasons for abandoning ART are a complex, inextricably interwoven chain of events rather than a single occurrence. Mobility is often the first step in the process and commonly results from precarious economic and social circumstances. Currently the health system poorly caters to the reality of people's mobile lives. Interventions should seek to increase healthcare workers’ understanding of the chain of events leading up to discontinuation on ART and the social dilemmas that clients face. [ABSTRACT FROM AUTHOR]

OBJECTIVES: Young women who are sexual minorities (eg, bisexual and lesbian) are approximately twice as likely as those who are heterosexual to have a teen pregnancy. Therefore, we hypothesized that risk factors for teen pregnancy would vary across sexual orientation groups and that other potential risk factors exist that are unique to sexual minorities. METHODS: We used multivariable log-binomial models gathered from 7120 young women in the longitudinal cohort known as the Growing Up Today Study to examine the following potential teen pregnancy risk factors: childhood maltreatment, bullying victimization and perpetration, and gender nonconformity. Among sexual minorities, we also examined the following: sexual minority developmental milestones, sexual orientation-related stress, sexual minority outness, and lesbian, gay, and bisexual social activity involvement. RESULTS: Childhood maltreatment and bullying were significant teen pregnancy risk factors among all participants. After adjusting for childhood maltreatment and bullying, the sexual orientation-related teen pregnancy disparities were attenuated; these risk factors explained 45% of the disparity. Among sexual minorities, reaching sexual minority developmental milestones earlier was also associated with an increased teen pregnancy risk. CONCLUSIONS: The higher teen pregnancy prevalence among sexual minorities compared with heterosexuals in this cohort was partially explained by childhood maltreatment and bullying, which may, in part, stem from sexual orientation-related discrimination. Teen pregnancy prevention efforts that are focused on risk factors more common among young women who are sexual minorities (eg, childhood maltreatment, bullying) can help to reduce the existing sexual orientation-related teen pregnancy disparity. [ABSTRACT FROM AUTHOR]

Much evidence suggests a role for inflammation in the pathogenesis of endometriosis. Although investigators in numerous case-control studies have found elevation of inflammatory markers in patients with endometriosis, results were not consistent, and no prior prospective study is known to exist.We conducted a case-control study nested within the Nurses' Health Study II in which we examined associations between levels of plasma inflammatory markers (interleukin-1 beta, interleukin-6, soluble tumor necrosis factor α receptors 1 and 2, and high-sensitivity C-reactive protein) and the risk of laparoscopically confirmed endometriosis. From blood collections in 1996-1999 and 2007, we ascertained 350 cases patients with incident endometriosis and 694 matched controls. Women with interleukin-1 beta levels in quintiles 2-4 had a higher risk of endometriosis (for the second quintile, relative risk (RR) = 3.30, 95% confidence interval (CI): 1.06, 10.3; for the third quintile, RR = 3.36, 95% CI: 1.09, 10.4; and for the fourth quintile, RR = 4.64, 95% CI: 1.58, 13.6; P for trend = 0.62), which suggested an association beginning at 0.47 pg/mL or greater. A significant nonlinear association with levels of soluble tumor necrosis factor α receptor 2 was observed, with elevated risk of endometriosis at concentrations greater than 3,400 pg/mL. Plasma interleukin-6, soluble tumor necrosis factor α receptor 1, and high-sensitivity C-reactive protein levels were not associated with endometriosis risk. Further research in larger studies with younger age at blood collection and longer time from blood to surgical diagnosis are required to confirm these associations. [ABSTRACT FROM AUTHOR]

Abstract: Introduction: Global scale up of anti‐retroviral therapy (ART) has led to expansion of HIV treatment and prevention across sub‐Saharan Africa. However, age and gender‐specific disparities persist leading to failures in fulfillment of Sustainability Development Goals, including SDG3 (achieving healthy lives and wellbeing for all, at all ages) and SDG5 (gender equality). We assessed ART initiation and adherence, loss to follow‐up, all‐cause death and early death, according to SDG3 and SDG5 indicators among a cohort of HIV‐infected children and adolescents enrolled in care in Dar‐es‐Salaam, Tanzania Methods: SDG3 indicators included young (<5 years) and older paediatric children (5 to <10 years), early adolescent (10 to <15 years) and late adolescent (15 to <20 years) age group divisions and the SDG5 indicator was gender. Associations of age group and gender with ART initiation, loss to follow‐up and all‐cause death, were analysed using Cox proportional hazards regression and with adherence, using generalized estimating equations (GEE) with the Poisson distribution. Associations of age group and gender with early death were analysed, using log‐Poisson regression with empirical variance. Results: A total of 18,315 enrollees with at least one clinic visit were included in this cohort study. Of these 7238 (40%) were young paediatric , 4169 (23%) older paediatric, 2922 (16%) early adolescent and 3986 (22%) late adolescent patients at enrolment. Just over half of paediatric and early adolescents and around four fifths of the late adolescents were female. Young paediatric patients were at greater risk of early death, being almost twice as likely to die within 90 days. Males were at greater risk of early death once initiated on ART (HR 1.35, 95% CI 1.09, 1.66)), while females in late adolescence were at greatest risk of late death (HR 2.44 [1.60, 3.74] <0.01). Late adolescents demonstrated greater non‐engagement in care (RR 1.21 (95% CI 1.16, 1.26)). Among both males and females, early paediatric and late adolescent groups experienced significantly greater loss to follow‐up. Conclusion: These findings highlight equity concerns critical to the fulfillment of SDG3 and SDG5 within services for children and adolescents living with HIV in sub‐Saharan Africa. Young paediatric and late adolescent age groups were at increased risk of late diagnosis, early death, delayed treatment initiation and loss of continuity of care. Males were more likely to die earlier. Special attention to SDG3 and SDG5 disparities for children and adolescents living with HIV will be critical for fulfillment of the 2030 SDG agenda. [ABSTRACT FROM AUTHOR]

Background: There is increasing evidence that nut consumption decreases the risk of cardiovascular disease. However, there are few data on the health effects of cashew nuts among adults with type 2 diabetes (T2DM).Objective: The study aimed to investigate the effects of cashew nut supplementation on glycemia, body weight, blood pressure, and lipid profile in Asian Indians with T2DM.Methods: In a parallel-arm, randomized controlled trial, 300 adults with T2DM [mean ± SD age: 51 ± 9.3 y; body mass index (BMI; in kg/m2): 26.0 ± 3.4; 55% male] were randomly assigned to receive advice to follow a standard diabetic diet (control) or similar advice plus 30 g cashew nuts/d (intervention) for 12 wk. The macronutrient composition of the prescribed diabetic diet was 60-65% energy from carbohydrates, 15-25% from fat, and the rest from protein. Differences between groups in changes in anthropometric and biochemical variables were analyzed using linear models with robust variance estimation under an assumed independence working correlation.Results: Participants in the intervention group had a greater decrease in systolic blood pressure from baseline to 12 wk than did controls (-4.9 ± 13.7 compared with -1.7 ± 11.6 mm Hg; P = 0.04) and a greater increase in plasma HDL cholesterol compared with controls (+1.7 ± 5.6 compared with +0.1 ± 4.6 mg/dL; P = 0.01). There were no differences between the groups with respect to changes in body weight, BMI, blood lipid, and glycemic variables. Plasma oleic acid concentrations and self-reported dietary intake of nuts, oleic acid, and monounsaturated fatty acids suggested excellent compliance with the nut consumption.Conclusion: Cashew nut supplementation in Asian Indians with T2DM reduced systolic blood pressure and increased HDL cholesterol concentrations with no deleterious effects on body weight, glycemia, or other lipid variables. This study was registered at the clinical trial registry of India as CTRI/2017/07/009022. [ABSTRACT FROM AUTHOR]

Background: There is robust clinical evidence to support offering early access to antiretroviral treatment (ART) to all HIV-positive individuals, irrespective of disease stage, to both improve patient health outcomes and reduce HIV incidence. However, as the global treatment guidelines shift to meet this evidence, it is still largely unknown if early access to ART for all (also referred to as "treatment as prevention" or "universal test and treat") is a feasible intervention in the resource-limited countries where this approach could have the biggest impact on the course of the HIV epidemics. The MaxART Early Access to ART for All (EAAA) implementation study was designed to determine the feasibility, acceptability, clinical outcomes, affordability, and scalability of offering early antiretroviral treatment to all HIV-positive individuals in Swaziland's public sector health system.Methods: This is a three-year stepped-wedge randomized design with open enrollment for all adults aged 18 years and older across 14 government-managed health facilities in Swaziland's Hhohho Region. Primary endpoints are retention and viral suppression. Secondary endpoints include ART initiation, adherence, drug resistance, tuberculosis, HIV disease progression, patient satisfaction, and cost per patient per year. Sites are grouped to transition two at a time from the control (standard of care) to intervention (EAAA) stage at each four-month step. This design will result in approximately one half of the total observation time to accrue in the intervention arm and the other half in the control arm. Our estimated enrolment number, which is supported by conservative power calculations, is 4501 patients over the course of the 36-month study period. A multidisciplinary, mixed-methods approach will be adopted to supplement the randomized controlled trial and meet the study aims. Additional study components include implementation science, social science, economic evaluation, and predictive HIV incidence modeling.Discussion: A stepped-wedge randomized design is a causally strong and robust approach to determine if providing antiretroviral treatment for all HIV-positive individuals is a feasible intervention in a resource-limited, public sector health system. We expect our study results to contribute to health policy decisions related to the HIV response in Swaziland and other countries in sub-Saharan Africa.Trial Registration: ClinicalTrials.gov, NCT02909218 . Registered on 10 July 2016. [ABSTRACT FROM AUTHOR]

There is widespread vitamin and mineral deficiency problem in Tanzania with known deficiencies of at least vitamin A, iron, folate and zinc, resulting in lasting negative consequences especially on maternal health, cognitive development and thus the nation’s economic potential. Folate deficiency is associated with significant adverse health effects among women of reproductive age, including a higher risk of neural tube defects. Several countries, including Tanzania, have implemented mandatory fortification of wheat and maize flour but evidence on the effectiveness of these programs in developing countries remains limited. We evaluated the effectiveness of Tanzania’s food fortification program by examining folate levels for women of reproductive age, 18–49 years. A prospective cohort study with 600 non-pregnant women enrolled concurrent with the initiation of food fortification and followed up for 1 year thereafter. Blood samples, dietary intake and fortified foods consumption data were collected at baseline, and at 6 and 12 months. Plasma folate levels were determined using a competitive assay with folate binding protein. Using univariate and multivariate linear regression, we compared the change in plasma folate levels at six and twelve months of the program from baseline. We also assessed the relative risk of folate deficiency during follow-up using log-binomial regression. The mean (±SE) pre–fortification plasma folate level for the women was 5.44-ng/ml (±2.30) at baseline. These levels improved significantly at six months [difference: 4.57ng/ml (±2.89)] and 12 months [difference: 4.27ng/ml (±4.18)]. Based on plasma folate cut-off level of 4 ng/ml, the prevalence of folate deficiency was 26.9% at baseline, and 5% at twelve months. One ng/ml increase in plasma folate from baseline was associated with a 25% decreased risk of folate deficiency at 12 months [(RR = 0.75; 95% CI = 0.67–0.85, P<0.001]. In a setting where folate deficiency is high, food fortification program with folic acid resulted in significant improvements in folate status among women of reproductive age. [ABSTRACT FROM AUTHOR]

Introduction: Rapid diagnostic testing has made HIV diagnosis and subsequent treatment more accessible. However, multiple factors, including improper implementation of testing strategies and clerical errors, have been reported to lead to HIV misdiagnosis. The World Health Organization has recommended HIV retesting prior to antiretroviral therapy (ART) initiation which has become pertinent with scaling up of Early Access to ART for All (EAAA). In this analysis, misdiagnosed clients are identified from a subgroup of clients enrolled in EAAA implementation study in Swaziland. Methods: The subgroup to assess misdiagnosis was identified from enrolled EAAA study clients, who had an undetectable viral load prior to ART initiation between September 1, 2014 and May 31, 2016. One hundred and five of 2533 (4%) clients had an undetectable viral load prior to initiation to ART (pre-ART). The HIV status of clients was confirmed using the Determine HIV 1/2 and Uni-Gold HIV 1/2 rapid tests performed serially as recommended by the national testing algorithm. The status of clients on ART was additionally confirmed by fourth-generation HIV Ag/Ab combo tests, Architect and Genscreen Ultra. Results: Fourteen of the 105 (13%) clients were false positive (HIV negative) on confirmation testing, of whom five (36%) were still in pre-ART care, while nine (64%) were in ART care. Overall, proportion of false positive was 0.6% (14/2533). The false-positive clients had a median CD4 of 791 cells/ml (interquartile range (IQR): 628, 967) compared to 549 cells/ml (IQR: 387, 791) for true positives (HIV positive) ( p = 0.0081) and were nearly 20 years older ( p = 0.0008). Conclusions: Overall 0.6% of all enrolled EAAA clients were misdiagnosed, and 64% of misdiagnosed clients were initiated on ART. With adoption of EAAA guidelines by national governments, ART initiation regardless of immunological criteria, strengthening of proficiency testing and adoption of retesting prior to ART initiation would allow identification of misdiagnosed clients and further reduce potential of initiating misdiagnosed clients on ART. [ABSTRACT FROM AUTHOR]

Introduction: Rapid diagnostic testing has made HIV diagnosis and subsequent treatment more accessible. However, multiple factors, including improper implementation of testing strategies and clerical errors, have been reported to lead to HIV misdiagnosis. The World Health Organization has recommended HIV retesting prior to antiretroviral therapy (ART) initiation which has become pertinent with scaling up of Early Access to ART for All (EAAA). In this analysis, misdiagnosed clients are identified from a subgroup of clients enrolled in EAAA implementation study in Swaziland. Methods: The subgroup to assess misdiagnosis was identified from enrolled EAAA study clients, who had an undetectable viral load prior to ART initiation between September 1, 2014 and May 31, 2016. One hundred and five of 2533 (4%) clients had an undetectable viral load prior to initiation to ART (pre-ART). The HIV status of clients was confirmed using the Determine HIV 1/2 and Uni-Gold HIV 1/2 rapid tests performed serially as recommended by the national testing algorithm. The status of clients on ART was additionally confirmed by fourth-generation HIV Ag/Ab combo tests, Architect and Genscreen Ultra. Results: Fourteen of the 105 (13%) clients were false positive (HIV negative) on confirmation testing, of whom five (36%) were still in pre-ART care, while nine (64%) were in ART care. Overall, proportion of false positive was 0.6% (14/2533). The false-positive clients had a median CD4 of 791 cells/ml (interquartile range (IQR): 628, 967) compared to 549 cells/ml (IQR: 387, 791) for true positives (HIV positive) (p = 0.0081) and were nearly 20 years older (p = 0.0008). Conclusions: Overall 0.6% of all enrolled EAAA clients were misdiagnosed, and 64% of misdiagnosed clients were initiated on ART. With adoption of EAAA guidelines by national governments, ART initiation regardless of immunological criteria, strengthening of proficiency testing and adoption of retesting prior to ART initiation would allow identification of misdiagnosed clients and further reduce potential of initiating misdiagnosed clients on ART. [ABSTRACT FROM AUTHOR]

Calibrating dietary self-report instruments is recommended as a way to adjust for measurement error when estimating diet-disease associations. Because biomarkers available for calibration are limited, most investigators use self-reports (e.g., 24-hour recalls (24HRs)) as the reference instrument. We evaluated the performance of 24HRs as reference instruments for calibrating food frequency questionnaires (FFQs), using data from the Validation Studies Pooling Project, comprising 5 large validation studies using recovery biomarkers. Using 24HRs as reference instruments, we estimated attenuation factors, correlations with truth, and calibration equations for FFQ-reported intakes of energy and for protein, potassium, and sodium and their densities, and we compared them with values derived using biomarkers. Based on 24HRs, FFQ attenuation factors were substantially overestimated for energy and sodium intakes, less for protein and potassium, and minimally for nutrient densities. FFQ correlations with truth, based on 24HRs, were substantially overestimated for all dietary components. Calibration equations did not capture dependencies on body mass index. We also compared predicted bias in estimated relative risks adjusted using 24HRs as reference instruments with bias when making no adjustment. In disease models with energy and 1 or more nutrient intakes, predicted bias in estimated nutrient relative risks was reduced on average, but bias in the energy risk coefficient was unchanged. [ABSTRACT FROM AUTHOR]

Objective: To examine the association between complementary feeding and risks of diarrhea and acute respiratory infection (ARI) among HIV-exposed infants aged 6–24 months. Design: We prospectively used an Infant and Child Feeding Index (ICFI) to measure complementary feeding practices (breastfeeding status, food consistency, dietary diversity, food group frequency, and meal frequency). We determined the association of ICFI and each of its components with the risk of diarrhea and ARI. Generalized estimating equations were used to estimate the relative risks for morbidity episodes. Setting: Dar es Salaam, Tanzania. Subjects: A total of 2092 HIV-exposed infants followed from 6 months of age to 24 months of age. Results: The ICFI score ranged from 0 to 9; the median score was 6 (interquartile range = 4–7). Low ICFI scores were likely associated with increased risk of dysentery [low vs. high tertile risk ratio (RR): 1.40; 95% confidence interval (CI): 0.93 to 2.10; P for trend = 0.02] and respiratory infection (low vs. high tertile RR: 1.16; 95% CI: 0.96 to 1.41; P for trend = 0.01). Low dietary diversity scores were likely associated with higher risk of dysentery (low vs. high tertile RR: 1.47; 95% CI: 0.92 to 2.35; P for trend = 0.03) and respiratory infection (low vs. high tertile RR: 1.41; 95% CI: 1.13 to 1.76; P for trend = 0.01). Low food consistency scores were associated with higher risk of respiratory infection (RR: 1.77; 95% CI: 1.40 to 2.26; P < 0.01). Conclusions: In this setting, low ICFI, dietary diversity, and food consistency scores were likely associated with increased risk of diarrhea and ARI among HIV-exposed infants. [ABSTRACT FROM AUTHOR]

Background: While food pricing is a promising strategy to improve diet, the prospective impact of food pricing on diet has not been systematically quantified. Objective: To quantify the prospective effect of changes in food prices on dietary consumption. Design: We systematically searched online databases for interventional or prospective observational studies of price change and diet; we also searched for studies evaluating adiposity as a secondary outcome. Studies were excluded if price data were collected before 1990. Data were extracted independently and in duplicate. Findings were pooled using DerSimonian-Laird's random effects model. Pre-specified sources of heterogeneity were analyzed using meta-regression; and potential for publication bias, by funnel plots, Begg's and Egger's tests. Results: From 3,163 identified abstracts, 23 interventional studies and 7 prospective cohorts with 37 intervention arms met inclusion criteria. In pooled analyses, a 10% decrease in price (i.e., subsidy) increased consumption of healthful foods by 12% (95%CI = 10–15%; N = 22 studies/intervention arms) whereas a 10% increase price (i.e. tax) decreased consumption of unhealthful foods by 6% (95%CI = 4–8%; N = 15). By food group, subsidies increased intake of fruits and vegetables by 14% (95%CI = 11–17%; N = 9); and other healthful foods, by 16% (95%CI = 10–23%; N = 10); without significant effects on more healthful beverages (-3%; 95%CI = -16-11%; N = 3). Each 10% price increase reduced sugar-sweetened beverage intake by 7% (95%CI = 3–10%; N = 5); fast foods, by 3% (95%CI = 1–5%; N = 3); and other unhealthful foods, by 9% (95%CI = 6–12%; N = 3). Changes in price of fruits and vegetables reduced body mass index (-0.04 kg/m2 per 10% price decrease, 95%CI = -0.08–0 kg/m2; N = 4); price changes for sugar-sweetened beverages or fast foods did not significantly alter body mass index, based on 4 studies. Meta-regression identified direction of price change (tax vs. subsidy), number of intervention components, intervention duration, and study quality score as significant sources of heterogeneity (P-heterogeneity<0.05 each). Evidence for publication bias was not observed. Conclusions: These prospective results, largely from interventional studies, support efficacy of subsidies to increase consumption of healthful foods; and taxation to reduce intake of unhealthful beverages and foods. Use of subsidies and combined multicomponent interventions appear most effective. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background: During the year following the birth of a child, 40% of women are estimated to have an unmet need for contraception. The copper IUD provides safe, effective, convenient, and long-term contraceptive protection that does not interfere with breastfeeding during the postpartum period. Postpartum IUD (PPIUD) insertion should be performed by a trained provider in the early postpartum period to reduce expulsion rates and complications, but these services are not widely available. The International Federation of Obstetricians and Gynecologists (FIGO) will implement an intervention that aims to institutionalize PPIUD training as a regular part of the OB/GYN training program and to integrate it as part of the standard practice at the time of delivery in intervention hospitals. Methods: This trial uses a cluster-randomized stepped wedge design to assess the causal effect of the FIGO intervention on the uptake and continued use of PPIUD and of the effect on subsequent pregnancy and birth. This trial also seeks to measure institutionalization of PPIUD services in study hospitals and diffusion of these services to other providers and health facilities. This study will also include a nested mixed-methods performance evaluation to describe intervention implementation. Discussion: This study will provide critical evidence on the causal effects of hospital-based PPIUD provision on contraceptive choices and reproductive health outcomes, as well as on the feasibility, acceptability and longer run institutional impacts in three low- and middle-income countries. [ABSTRACT FROM AUTHOR]

Objective: To investigate the association between laparoscopically confirmed endometriosis and the risk of breast cancer. Previous research on endometriosis and breast cancer has reported mixed results.Methods: Our prospective cohort study included 116,430 women from the Nurses' Health Study II cohort followed from 1989 until 2013. Our primary analysis investigated the association between self-reported laparoscopically confirmed endometriosis and the risk of breast cancer. Breast cancer diagnosis was verified through medical records. Multivariable adjusted Cox proportional hazard models were used to calculate hazard ratios (HRs) and 95% confidence intervals (CIs). Breast cancer was further classified by menopausal status at the time of diagnosis and tumor hormone receptor status verified through tissue microarrays when available and medical records.Results: At baseline, 5,389 (5%) women reported laparoscopically confirmed endometriosis. Over 24 years of follow-up, 4,979 (3%) incident breast cancer cases were diagnosed. Women with endometriosis were not at higher risk for overall (adjusted HR 0.96, 95% CI 0.88-1.06), premenopausal (adjusted HR 1.05, 95% CI 0.89-1.23), or postmenopausal breast cancer (adjusted HR 0.93, 95% CI 0.80-1.07). However, associations varied by tumor hormone receptor status (P value, test for heterogeneity: .001), although women with endometriosis were not at increased risk of estrogen- and progesterone receptor-positive (ER+/PR+) tumors (adjusted HR 1.00, 95% CI 0.87-1.14) or ER- and PR- tumors (adjusted HR 0.90, 95% CI 0.67-1.21). Women with endometriosis reported 2.87 ER+/PR- breast cancer cases per 10,000 person-years compared with women without endometriosis (1.32/10,000 person-years), which resulted in nearly a twofold increased risk of ER+/PR- breast cancers (adjusted HR 1.90, 95% CI 1.44-2.50).Conclusion: Endometriosis was not found to be associated with overall risk of breast cancer in this study; however, endometriosis was significantly associated with an increased risk of ER+/PR- breast tumors, which should be interpreted cautiously. [ABSTRACT FROM AUTHOR]

Background. Elevated blood pressure has been reported among treatment naïve HIV-infected patients. We investigated prevalence of hypertension and its associated risk factors in a HAART naïve HIV-infected population in Dar es Salaam, Tanzania. Methods. A cross-sectional analysis was conducted among HAART naïve HIV-infected patients. Hypertension was defined as systolic blood pressure (SBP) ≥ 140 mmHg and/or diastolic blood pressure (DBP) ≥ 90 mmHg. Overweight and obesity were defined as body mass index (BMI) between 25.0–29.9 kg/m2 and ≥30 kg/m2, respectively. We used relative risks to examine factors associated with hypertension. Results. Prevalence of hypertension was found to be 12.5%. After adjusting for possible confounders, risk of hypertension was 10% more in male than female patients. Patients aged ≥50 years had more than 2-fold increased risk for hypertension compared to 30–39-years-old patients. Overweight and obesity were associated with 51% and 94% increased risk for hypertension compared to normal weight patients. Low CD4+ T-cell count, advanced WHO clinical disease stage, and history of TB were associated with 10%, 42%, and 14% decreased risk for hypertension. Conclusions. Older age, male gender, and overweight/obesity were associated with hypertension. Immune suppression and history of TB were associated with lower risk for hypertension. HIV treatment programs should screen and manage hypertension even in HAART naïve individuals. [ABSTRACT FROM AUTHOR]

Assessing the magnitude of heterogeneity in a meta-analysis is important for determining the appropriateness of combining results. The most popular measure of heterogeneity, I(2) , was derived under an assumption of homogeneity of the within-study variances, which is almost never true, and the alternative estimator, R^I, uses the harmonic mean to estimate the average of the within-study variances, which may also lead to bias. This paper thus presents a new measure for quantifying the extent to which the variance of the pooled random-effects estimator is due to between-studies variation, R^b, that overcomes the limitations of the previous approach. We show that this measure estimates the expected value of the proportion of total variance due to between-studies variation and we present its point and interval estimators. The performance of all three heterogeneity measures is evaluated in an extensive simulation study. A negative bias for R^b was observed when the number of studies was very small and became negligible as the number of studies increased, while R^I and I(2) showed a tendency to overestimate the impact of heterogeneity. The coverage of confidence intervals based upon R^b was good across different simulation scenarios but was substantially lower for R^I and I(2) , especially for high values of heterogeneity and when a large number of studies were included in the meta-analysis. The proposed measure is implemented in a user-friendly function available for routine use in r and sas. R^b will be useful in quantifying the magnitude of heterogeneity in meta-analysis and should supplement the p-value for the test of heterogeneity obtained from the Q test. Copyright © 2016 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]