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Background Isolation of hospitalized persons under investigation (PUIs) for coronavirus disease 2019 (COVID-19) reduces nosocomial transmission risk. Efficient evaluation of PUIs is needed to preserve scarce healthcare resources. We describe the development, implementation, and outcomes of an inpatient diagnostic algorithm and clinical decision support system (CDSS) to evaluate PUIs. Methods We conducted a pre-post study of CORAL (COvid Risk cALculator), a CDSS that guides frontline clinicians through a risk-stratified COVID-19 diagnostic workup, removes transmission-based precautions when workup is complete and negative, and triages complex cases to infectious diseases (ID) physician review. Before CORAL, ID physicians reviewed all PUI records to guide workup and precautions. After CORAL, frontline clinicians evaluated PUIs directly using CORAL. We compared pre- and post-CORAL frequency of repeated severe acute respiratory syndrome coronavirus 2 nucleic acid amplification tests (NAATs), time from NAAT result to PUI status discontinuation, total duration of PUI status, and ID physician work hours, using linear and logistic regression, adjusted for COVID-19 incidence. Results Fewer PUIs underwent repeated testing after an initial negative NAAT after CORAL than before CORAL (54% vs 67%, respectively; adjusted odd ratio, 0.53 [95% confidence interval, .44–.63]; P Conclusions CORAL is an efficient and effective CDSS to guide frontline clinicians through the diagnostic evaluation of PUIs and safe discontinuation of precautions.

The Adolescent Medicine Trials Network for HIV/AIDS Interventions is evaluating treatment adherence interventions (AI) to improve virologic suppression (VS) among youth with HIV (YWH). Using a microsimulation model, we compared two strategies: standard-of-care (SOC) and a hypothetical 12-month AI that increased cohort-level VS in YWH in care by an absolute ten percentage points and cost $100/month/person. Projected outcomes included primary HIV transmissions, deaths and life-expectancy, lifetime HIV-related costs, and incremental cost-effectiveness ratios (ICERs, $/quality-adjusted life-year [QALY]). Compared to SOC, AI would reduce HIV transmissions by 15% and deaths by 12% at 12 months. AI would improve discounted life expectancy/person by 8 months at an added lifetime cost/person of $5,300, resulting in an ICER of $7,900/QALY. AI would be cost-effective at $2,000/month/person or with efficacies as low as a 1 percentage point increase in VS. YWH-targeted adherence interventions with even modest efficacy could improve life expectancy, prevent onward HIV transmissions, and be cost-effective.La Red de Ensayos Médicos sobre Adolescentes para Realizar Intervenciones sobre el VIH/SIDA está evaluando intervenciones de adherencia (IAs) al tratamiento para mejorar la supresión virológica (SV) entre los jóvenes con VIH (JCV). Usando un modelo de microsimulación, comparamos dos estrategias: cuidado convencional (CC) y una intervención de adherencia hipotética durando 12 meses que aumentaría la SV a nivel de cohorte entre JCV en tratamiento por 10 puntos de porcentuales y que costaría US$ 100/mes/persona. Resultados proyectados incluyeron transmisiones de VIH primarias, muertes y esperanza de vida, costos de por vida asociados con el VIH, y razones incrementales de costo-efectividad (RICEs, $/año de vida ajustado por la calidad [AVAC]). Comparado al CC, la IA reduciría transmisiones de VIH por 15% y muertes por 12% a los 12 meses. La IA mejoraría esperanza de vida descontada/persona por 8 meses a un costo de por vida adicional/persona de US$ 5.300, resultando en una RICE de US$ 7.900/AVAC. La IA sería costo-efectiva a un costo de US$ 2.000/mes/persona o si mejorara SV por al menos un punto porcentual. Intervenciones de adherencia dirigidas a jóvenes con una eficacia incluso modesta podrían mejorar esperanza de vida, prevenir transmisiones de VIH, y ser costo-efectivas.

Background While studies from large cities affected by coronavirus disease 2019 (COVID-19) have reported on the prevalence of SARS-CoV-2 in the context of universal testing during admission for delivery, the patient demographic, social and clinical factors associated with SARS-CoV-2 infection in pregnant women are not fully understood. Objective To evaluate the epidemiological factors associated with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in women admitted for labour and delivery, in the context of universal screening at four Boston-area hospitals. Methods In this prospective cohort study, we reviewed the health records of all women admitted for labour and delivery at four hospitals from the largest health system in Massachusetts between 19 April 2020 and 27 June 2020. We calculated the risk of SARS-CoV-2 infection, including asymptomatic infection. We calculated associations between SARS-CoV-2 infection and demographic and clinical characteristics. Results A total of 93 patients (3.2%, 95% confidence interval 2.5, 3.8) tested positive for SARS-CoV-2 infection on admission for labour and delivery out of 2945 patients included in the analysis; 80 (86.0%) of the patients who tested positive were asymptomatic at the time of testing. Factors associated with SARS-CoV-2 infection included the following: younger age, obesity, African American or Hispanic race/ethnicity, residence in heavily affected communities (as measured in cases reported per capita), presence of a household member with known SARS-CoV-2 infection, non-health care essential worker occupation and MassHealth or Medicaid insurance compared to commercial insurance. 93.8% of patients testing positive for SARS-CoV-2 on admission had one or more identifiable factors associated with disease acquisition. Conclusions In this large sample of deliveries during the height of the surge in infections during the spring of 2020, SARS-CoV-2 infection was largely concentrated in patients with distinct demographic characteristics, those largely from disadvantaged communities. Racial disparities seen in pregnancy persist with respect to SARS-CoV-2 infection.

To compare the unit and total costs of three models of ART care for mother-infant pairs during the postpartum phase from provider and patient's perspectives: (i) local standard of care with women in general ART services and infants at well-baby clinics; (ii) women and infants continue to receive care through an integrated maternal and child care approach during the postpartum breastfeeding period; and (iii) referral of women directly to community adherence clubs with their infants receiving care at well-baby clinics.Capital and recurrent cost data (relating to buildings, furniture, equipment, personnel, overheads, maintenance, medication, diagnostic tests and immunisations) were collected from a provider's perspective at six sites in Cape Town, South Africa. Patient time, collected via time-and-motion observation and questionnaires, was used to estimate patient perspective costs and is comprised of lost productivity time, time spent travelling and the direct cost of travelling.The cost of postpartum ART visits under models I, II and III was US $13, US $10 and US $7 per visit for a mother-infant pair, respectively, in 2018 US$. The annual costs for the mother-infant pair utilising the average visit frequencies (a mean of 4.5, 6.9 and 6.7 visits postpartum for models I, II and III, respectively) including costs for infant immunisations, visits, medication and diagnostic tests for both mothers and infants were: I - US $222, II - US $335 and III - US $249. Sensitivity analysis to assess the impact of visit frequency on visit cost showed that Model I annual costs would be most costly if visit frequency was equalised.This comparative analysis of three models of care provides novel data on unit costs and insight into the costs to provide ART and care to mother-infant pairs during the delicate postpartum phase. These costs may be used to help make decisions around integrated services models and differentiated service delivery for postpartum WLH and their children.Comparer le coût et unitaire et total de trois modèles de soins ART pour les paires mère-enfant pendant la phase post-partum selon les perspectives du fournisseur et du patient: (I) - normes locales des soins avec les femmes dans les services généraux de l'ART et les nourrissons dans les cliniques de bien-être pour bébés; (II) - les femmes et les nourrissons continuent de recevoir des soins via une approche intégrée de soins maternels et infantiles pendant la période d'allaitement post-partum; et (III) - orientation des femmes directement vers les clubs d'adhésion communautaires, leurs nourrissons recevant des soins dans les cliniques de bien-être pour bébés pour bébés. MÉTHODES: Les données sur les coûts d'investissement et les coûts récurrents (relatifs aux bâtiments, au mobilier, à l'équipement, au personnel, aux frais généraux, à l'entretien, aux médicaments, aux tests de diagnostic et aux vaccinations) ont été recueillies selon le point de vue du prestataire sur six sites à Cape Town, en Afrique du Sud. Le temps du patient, recueilli via l'observation du temps et des mouvements et des questionnaires, a été utilisé pour estimer les coûts selon le point de vue du patient, et comprend le temps de productivité perdu, le temps passé en déplacement et le coût direct du déplacement. RÉSULTATS: Le coût des visites ART post-partum dans les modèles I, II et III était respectivement de 13 USD, 10 USD et 7 USD par visite pour une paire mère-enfant en USD de 2018. Les coûts annuels pour la paire mère-enfant en utilisant la fréquence moyenne des visites (une moyenne de 4,5 ; 6,9 et 6,7 visites post-partum pour les modèles I, II et III respectivement), y compris les coûts des vaccinations infantiles, des visites, des médicaments et des tests diagnostiques pour les mères et les nourrissons étaient: I - 222 USD, II - 335 USD et III - 249 USD. L'analyse de sensibilité pour évaluer l'impact de la fréquence des visites sur le coût des visites a montré que les coûts annuels du modèle I seraient les plus élevés si la fréquence des visites était égalisée.Cette analyse comparative de trois modèles de soins fournit de nouvelles données sur les coûts unitaires et un aperçu des coûts de fourniture de l’ART et de soins aux paires mère-enfant pendant la phase délicate du post-partum. Ces coûts peuvent être utilisés pour aider à la prise des décisions concernant les modèles de services intégrés et la prestation de services différenciés pour les femmes en période de post-partum et leurs enfants.

Scaling up of point-of-care testing (POCT) for early infant diagnosis of HIV (EID) could reduce the large gap in infant testing. However, suboptimal POCT EID could have limited impact and potentially high avoidable costs. This study models the cost-effectiveness of a quality assurance system to address testing performance and screening interruptions, due to, for example, supply stockouts, in Kenya, Senegal, South Africa, Uganda and Zimbabwe, with varying HIV epidemics and different health systems.We modelled a quality assurance system-raised EID quality from suboptimal levels: that is, from misdiagnosis rates of 5%, 10% and 20% and EID testing interruptions in months, to uninterrupted optimal performance (98.5% sensitivity, 99.9% specificity). For each country, we estimated the 1-year impact and cost-effectiveness (US$/DALY averted) of improved scenarios in averting missed HIV infections and unneeded HIV treatment costs for false-positive diagnoses.The modelled 1-year costs of a national POCT quality assurance system range from US$ 69 359 in South Africa to US$ 334 341 in Zimbabwe. At the country level, quality assurance systems could potentially avert between 36 and 711 missed infections (i.e. false negatives) per year and unneeded treatment costs between US$ 5808 and US$ 739 030.The model estimates adding effective quality assurance systems are cost-saving in four of the five countries within the first year. Starting EQA requires an initial investment but will provide a positive return on investment within five years by averting the costs of misdiagnoses and would be even more efficient if implemented across multiple applications of POCT.L'intensification du dépistage au point des soins (DPS) pour le diagnostic précoce du VIH chez le nourrisson (DPVN) pourrait réduire le grand écart dans le dépistage des nourrissons. Cependant, un DPVN DPS sous-optimal pourrait avoir un impact limité et des coûts évitables potentiellement élevés. Cette étude modélise la rentabilité d'un système d'assurance qualité pour traiter les performances des tests et les interruptions de dépistage, dues par exemple à des ruptures de stock, au Kenya, au Sénégal, en Afrique du Sud, en Ouganda et au Zimbabwe, avec des épidémies variables du VIH et des systèmes de santé différents. MÉTHODES: Nous avons modélisé une qualité de DPVN soulevée par le système d'assurance qualité à partir de niveaux sous-optimaux: c'est-à-dire des taux d'erreurs de diagnostic de 5%, 10% et 20% et des interruptions des tests de DPVN en mois, à des performances optimales ininterrompues (sensibilité de 98,5%, spécificité de 99,9%). Pour chaque pays, nous avons estimé l'impact sur un an et la rentabilité (en USD/DALY évitée) de scénarios améliorés pour éviter les infections à VIH manquées et les coûts inutiles de traitement du VIH pour les diagnostics faux positifs. RÉSULTATS: Les coûts modélisés sur un an d'un système national d'assurance qualité DPS vont de 69.359 USD en Afrique du Sud à 334.341 USD au Zimbabwe. Au niveau des pays, les systèmes d'assurance de la qualité pourraient potentiellement éviter entre 36 et 711 infections manquées (c'est-à-dire des faux négatifs) par an et des coûts de traitement inutiles entre 5.808 et 739.030 USD.Le modèle estime que l'ajout de systèmes d'assurance qualité efficaces permet de réaliser des économies dans quatre des cinq pays au cours de la première année. Le lancement de l'assurance qualité nécessite un investissement initial, mais fournira un retour sur investissement positif dans les cinq ans en évitant les coûts des diagnostics erronés et serait encore plus efficace s'il était mis en œuvre dans plusieurs applications de DPS.

Supplemental Digital Content is Available in the Text., Background: To improve early infant HIV diagnosis (EID) programs, options include replacing laboratory-based tests with point-of-care (POC) assays or investing in strengthened systems for sample transport and result return. Setting: We used the CEPAC-Pediatric model to examine clinical benefits and costs of 3 EID strategies in Zimbabwe for infants 6 weeks of age. Methods: We examined (1) laboratory-based EID (LAB), (2) strengthened laboratory-based EID (S-LAB), and (3) POC EID (POC). LAB/S-LAB and POC assays differed in sensitivity (LAB/S-LAB 100%, POC 96.9%) and specificity (LAB/S-LAB 99.6%, POC 99.9%). LAB/S-LAB/POC algorithms also differed in: probability of result return (79%/91%/98%), time until result return (61/53/1 days), probability of initiating antiretroviral therapy (ART) after positive result (52%/71%/86%), and total cost/test ($18.10/$30.47/$30.71). We projected life expectancy (LE) and average lifetime per-person cost for all HIV-exposed infants. We calculated incremental cost-effectiveness ratios (ICERs) from discounted (3%/year) LE and costs in $/year-of-life saved (YLS), defining cost effective as an ICER

BACKGROUND Adolescents and young adults (AYA) with HIV experience poorer health outcomes compared with adults. To improve care for AYA with HIV, information about patterns of costly health care resource utilization is needed. METHODS Among 13-30 year olds in the US HIV Research Network, we stratified outpatient visits, emergency department (ED) visits, and inpatient days/person-year (PY) by HIV acquisition model [perinatal (PHIVY) and nonperinatal (NPHIVY)], age (13-17, 18-23, and 24-30 years), CD4 strata (

Introduction The COVID‐19 pandemic has affected women and children globally, disrupting antiretroviral therapy (ART) services and exacerbating pre‐existing barriers to care for both pregnant women and paediatric populations. Methods We used the Spectrum modelling package and the CEPAC‐Pediatric model to project the impact of COVID‐19‐associated care disruptions on three key populations in the 21 Global Plan priority countries in sub‐Saharan Africa: (1) pregnant and breastfeeding women living with HIV and their children, (2) all children (aged 0–14 years) living with HIV (CLWH), regardless of their engagement in care and (3) CLWH who were engaged in care and on ART prior to the start of the pandemic. We projected clinical outcomes over the 12‐month period of 1 March 2020 to 1 March 2021. Results Compared to a scenario with no care disruption, in a 3‐month lockdown with complete service disruption, followed by 3 additional months of partial (50%) service disruption, a projected 755,400 women would have received PMTCT care (a 21% decrease), 187,800 new paediatric HIV infections would have occurred (a 77% increase) and 516,800 children would have received ART (a 35% decrease). For children on ART as of March 2020, we projected 507,200 would have experienced ART failure (an 80% increase). Additionally, a projected 88,400 AIDS‐related deaths would have occurred (a 27% increase) between March 2020 and March 2021, with 51,700 of those deaths occurring among children engaged in care as of March 2020 (a 54% increase). Conclusions While efforts will continue to curb morbidity and mortality stemming directly from COVID‐19 itself, it is critical that providers also consider the immediate and indirect harms of this pandemic, particularly among vulnerable populations. Well‐informed, timely action is critical to meet the health needs of pregnant women and children if the global community is to maintain momentum towards an AIDS‐free generation.

International audience; Introduction: Evaluating outcomes of paediatric patients with HIV provides crucial data for clinicians and policymakers. We analysed mortality and clinical events rates among children, adolescents, and youth with perinatally acquired HIV (PHIV) aged 0 to 24 years stratified by time‐varying age and CD4, before and after antiretroviral therapy (ART), in the paediatric IeDEA multiregional collaboration (East, West, Central and Southern Africa, Asia‐Pacific, and Central/South America and the Caribbean).Methods: ART‐naïve children with HIV enrolled before age 10 (proxy for perinatal infection) at IeDEA sites between 2004 and 2016, with ≥1 CD4 measurement during follow‐up were included. We estimated incidence rates (IR) and 95% confidence intervals (95% CI) of mortality and first occurrence of WHO‐4 and WHO‐3 events, excluding tuberculosis, during person‐years (PY) spent within different age (19) had increased mortality post‐ART. IRs for first occurrence of WHO‐4 and WHO‐3 events were 1.3/100 PY (95% CI: 1.2 to 1.4) and 2.1/100 PY (95% CI: 2.0 to 2.2) respectively. These were also associated with lower CD4 and younger age strata.Conclusions: Mortality and incidence of clinical events were highest in both younger (19 years) youth with PHIV. Scaling‐up services for 19 years (adolescent‐ and youth‐focused health services) is critical to improve outcomes among PHIVY.

ImportanceWith recent surges in COVID-19 incidence and vaccine authorization for children aged 5 to 11 years, elementary schools face decisions about requirements for masking and other mitigation measures. These decisions require explicit determination of community objectives (eg, acceptable risk level for in-school SARS-CoV-2 transmission) and quantitative estimates of the consequences of changing mitigation measures.ObjectiveTo estimate the association between adding or removing in-school mitigation measures (eg, masks) and COVID-19 outcomes within an elementary school community at varying student vaccination and local incidence rates.Design, Setting, and ParticipantsThis decision analytic model used an agent-based model to simulate SARS-CoV-2 transmission within a school community, with a simulated population of students, teachers and staff, and their household members (ie, immediate school community). Transmission was evaluated for a range of observed local COVID-19 incidence (0-50 cases per 100 000 residents per day, assuming 33% of all infections detected). The population used in the model reflected the mean size of a US elementary school, including 638 students and 60 educators and staff members in 6 grades with 5 classes per grade.ExposuresVariant infectiousness (representing wild-type virus, Alpha variant, and Delta variant), mitigation effectiveness (0%-100% reduction in the in-school secondary attack rate, representing increasingly intensive combinations of mitigations including masking and ventilation), and student vaccination levels were varied.Main Outcomes and MeasuresThe main outcomes were (1) probability of at least 1 in-school transmission per month and (2) mean increase in total infections per month among the immediate school community associated with a reduction in mitigation; multiple decision thresholds were estimated for objectives associated with each outcome. Sensitivity analyses on adult vaccination uptake, vaccination effectiveness, and testing approaches (for selected scenarios) were conducted.ResultsWith student vaccination coverage of 70% or less and moderate assumptions about mitigation effectiveness (eg, masking), mitigation could only be reduced when local case incidence was 14 or fewer cases per 100 000 residents per day to keep the mean additional cases associated with reducing mitigation to 5 or fewer cases per month. To keep the probability of any in-school transmission to less than 50% per month, the local case incidence would have to be 4 or fewer cases per 100 000 residents per day.Conclusions and RelevanceIn this study, in-school mitigation measures (eg, masks) and student vaccinations were associated with substantial reductions in transmissions and infections, but the level of reduction varied across local incidence. These findings underscore the potential role for responsive plans that deploy mitigation strategies based on local COVID-19 incidence, vaccine uptake, and explicit consideration of community objectives.

Summary: Although dendritic cells are among the human cell population best equipped for cell-intrinsic antiviral immune defense, they seem highly susceptible to infection with the Zika virus (ZIKV). Using highly purified myeloid dendritic cells isolated from individuals with naturally acquired acute infection, we here show that ZIKV induces profound perturbations of transcriptional signatures relative to healthy donors. Interestingly, we noted a remarkable downregulation of antiviral interferon-stimulated genes and innate immune sensors, suggesting that ZIKV can actively suppress interferon-dependent immune responses. In contrast, several host factors known to support ZIKV infection were strongly upregulated during natural ZIKV infection; these transcripts included AXL, the main entry receptor for ZIKV; SOCS3, a negative regulator of ISG expression; and IDO-1, a recognized inducer of regulatory T cell responses. Thus, during in vivo infection, ZIKV can transform the transcriptome of dendritic cells in favor of the virus to render these cells highly conducive to ZIKV infection. : Sun et al. find distinct transcriptional signatures in myeloid dendritic cells isolated from individuals with naturally acquired Zika Virus infection. These data indicate that Zika virus can reprogram dendritic cells to increase their susceptibility to further ZIKV infection. Keywords: Zika virus, flavivirus, interferon stimulated genes, dendritic cells, acute infection, RNA-seq, SOCS3, IDO-1, AXL

Polymerase chain reaction testing at birth ("birth-testing") is suggested by new World Health Organization guidelines for rapid diagnosis of infants infected with HIV in utero. However, there are few data on the implementation of this approach in sub-Saharan Africa, and whether birth testing affects uptake of subsequent routine early infant diagnosis (EID) testing at 6-10 weeks of age is unknown.We reviewed 575 consecutive infants undergoing targeted high-risk birth testing in Cape Town, South Africa, and matched those testing HIV negative at birth (n = 551) to HIV-exposed infants who did not receive birth testing (n = 551). Maternal and infant clinical and demographic data, including EID testing uptake, were abstracted from routine records.Overall, 3.8% of all birth tests conducted were positive while later EID testing positivity rates were 0.5% for those infants testing HIV negative at birth and 0.4% for those without birth testing. Infants who underwent birth testing were less likely to present for later EID compared with those without a birth test (73% vs. 85%; P0.001). This difference persisted after adjusting for maternal and infant characteristics (adjusted odds ratio, 0.60; 95% confidence interval: 0.41-0.86) and across demographic and clinical subgroups. Infants undergoing birth testing also presented for later EID at a significantly older age (mean age, 60 vs. 50 days; P0.001).While the yield of targeted high-risk birth testing in this setting appears high, neonates testing HIV negative at birth may be less likely to present for subsequent EID testing. For birth testing implementation to contribute to overall EID program goals, structured interventions are required to support follow-up EID services after negative birth test results.

Background Cardiovascular disease (CVD) is an increasing cause of morbidity among persons living with human immunodeficiency virus (HIV; PLWH). We projected cumulative CVD risk in PLWH in care compared to the US general population and persons HIV-uninfected, but at high risk for HIV. Methods We used a mathematical model to project cumulative CVD incidence. We simulated a male and female cohort for each of 3 populations: US general population; HIV-uninfected, at high risk for HIV; and PLWH. We incorporated the higher smoking prevalence and increased CVD risk due to smoking into the HIV-infected and HIV-uninfected, at high risk for HIV populations. We incorporated HIV-attributable CVD risk, independent of smoking. Results For men, life expectancy ranged from 70.2 to 77.5 years and for women from 67.0 to 81.1 years (PLWH, US general population). Without antiretroviral therapy, lifetime CVD risk for HIV-infected males and females was 12.9% and 9.0%. For males, by age 60, cumulative CVD incidence was estimated at 20.5% in PLWH in care, 14.6% in HIV-uninfected high-risk persons, and 12.8% in the US general population. For females, cumulative CVD incidence was projected to be 13.8% in PLWH in care, 9.7% for high-risk HIV-uninfected persons, and 9.4% in the US general population. Lifetime CVD risk was 64.8% for HIV-infected males compared to 54.8% for males in the US general population, but similar among females. Conclusions CVD risks should be a part of treatment evaluation among PLWH. CVD prevention strategies could offer important health benefits for PLWH and should be evaluated.

This article seeks to report on the prevalence of asymptomatic SARS-CoV-2 in women presenting to the labor and delivery units in Boston, another high-prevalence community in the United States The 4 major hospitals affiliated with Mass General Brigham Health provide maternity care to ~14,750 women per year Over 18 days of universal testing on the labor and delivery units, 763 women were admitted and 757 (99 2%) were tested Of those, 139 had symptoms possibly consistent with COVID-19 Of symptomatic women, 11 of 139 (7 9%) tested positive Among asymptomatic women, 9 of 618 (1 5%) tested positive Thus, 9 of 20 patients positive for SARS-CoV-2 at admission (45%) had no symptoms of COVID-19 at presentation The percentage of asymptomatic women who tested positive varied by hospital: 2 7% and 1 5% in the 2 academic hospitals, 1 8% and 0 6% in the 2 community hospitals Across the 4 hospitals, none of the positive asymptomatic women developed COVID-19 symptoms during the delivery hospitalization and all 9 newborns tested negative for SARS-CoV-2 In a large healthcare system in metropolitan Boston, the study identified a low prevalence of COVID-19 infection among asymptomatic pregnant women presenting for admission to the labor and delivery units The incidence of asymptomatic infection amongst women admitted to the labor and delivery units in greater Boston was substantially lower than that of New York City despite similar case counts per capita Notably, the 1%-2% incidence of asymptomatic infection in our population more closely mirrors asymptomatic infection rates in other areas Several theories may explain the lower prevalence of asymptomatic infection in Boston compared to New York City: (1) we began testing >30 days after physical distancing orders were placed by the state and hence were sampling at a time with declining community transmission, the overall population density of greater Boston is lower than New York City, perhaps leading to less community-based transmission, and some New York hospitals transiently stopped or considered stopping birth partners from attending deliveries, which could have led to some women underreporting symptoms

Background: Prevention of mother-to-child transmission of HIV implementation faces significant challenges globally particularly in the context of universal lifelong antiretroviral therapy (ART) for all HIV-infected pregnant women. Methods: We describe the rationale and methods of the Maternal and Child Health-Antiretroviral Therapy (MCH-ART) study an implementation science project examining strategies for providing HIV care and treatment to HIV-infected women who initiate ART during pregnancy and their HIV-exposed infants. Results: MCH-ART is composed of 3 interrelated study designs across the antenatal and postnatal periods. Phase 1 is a cross-sectional evaluation of consecutive HIV-infected pregnant women seeking antenatal care; phase 2 is an observational cohort of all women from phase 1 who are eligible for initiation of ART following local guidelines; and phase 3 is a randomized trial of strategies for delivering ART to breastfeeding women from phase 2 during the postpartum period. During each phase a set of study measurement visits is carried out separately from antenatal care and ART services; a maximum of 9 visits takes place from the beginning of antenatal care through 12 months postpartum. In parallel in-depth interviews are used to examine issues of ART adherence and retention qualitatively and costs and cost-effectiveness of models of care are examined. Separate substudies examine health outcomes in HIV-uninfected women and their HIV-unexposed infants and the role of the adherence club model for long-term adherence and retention. Discussion: Combining observational and experimental components the MCH-ART study presents a novel approach to understand and optimize ART delivery for MCH. Copyright © 2016 Wolters Kluwer Health Inc.. Open Access.

Background Adolescents and young adults (AYA) with HIV experience worse health outcomes than adults with HIV in the United States. Little is known about AYA patterns of utilization of costly healthcare resources. Methods We estimated utilization of outpatient, emergency department (ED), and inpatient care among 13–30 year-olds from 2006–2015. We stratified outpatient visits, ED visits and inpatient days per person-year (PY) by transmission mode (perinatal (PHIVY), non-perinatal (NPHIVY), age (13–17, 18–23, 24–30 years), CD4 strata (< 200, 200–499, ≥ 500 cells/µL) and presence or absence of viral load (VL) suppression ( Results Among 4,450 AYA (PHIVY: 15%; NPHIVY: 85%), mean (SD) follow-up was 2.8 years (2.5) [PHIVY: 4.2 years (3.1); NPHIVY: 2.5 years (2.3)]. Mean age was 21.4 years (PHIVY: 16.9 years; NPHIVY: 22.3 years) and female sex was 28% (PHIVY: 52%; NPHIVY: 23%). Among PHIVY, most person-time (PT) was spent between ages 13–23 years (13–17 years: 43%; 18–23 years: 45%), CD4 ≥ 500/µL (61%), and VL < 400 c/mL (69%). Among NPHIVY, most PT was spent between ages 24 and 30 years (56%), CD4 ≥ 500/µL (54%), and VL < 400 c/mL (66%). PT spent while prescribed ARVs and VL ≥ 400 c/mL was 30% (PHIVY) and 24% (NPHIVY). For both PHIVY and NPHIVY, outpatient visit rates were higher at younger ages (13–17 years and 18–23 years), lower CD4 (< 200, 200–499/µL), and among those prescribed ARVs (Figure 1). Rates of ED visits and inpatient days were higher during PT spent at older ages (18–23 years, 24–30 years), lower CD4 (< 200, 200–499/µL), and VL ≥ 400 c/mL (Figures 2 and 3). Overall, utilization was higher among PHIVY than NPHIVY (outpatient: 12.1 vs. 6.0/PY; ED: 0.4 vs. 0.3/PY; inpatient: 1.5 vs. 0.8/PY). The overall rate of AIDS-defining conditions was 4.5/100 PY (Figure 4). Conclusion Among AYA with HIV, more ED visits and inpatient days were observed during time spent at older ages, lower CD4 counts, and VL ≥ 400 c/mL. While AIDS-defining conditions were rare, associated resource utilization was substantial. Interventions to improve retention in care, virologic suppression, and immune response may improve outcomes, and thus decrease costly resource utilization, for AYA with HIV as they transition to adulthood. Disclosures All authors: No reported disclosures.

Few studies have reported CD4%- and age-stratified rates of World Health Organization Stage 3 (WHO3) events, World Health Organization Stage 4 (WHO4) events, tuberculosis (TB) and mortality in HIV-infected infants before initiation of antiretroviral therapy.HIV-infected children enrolled before 1 year of age in the International Epidemiologic Databases to Evaluate AIDS East Africa region (October 1, 2002, to November, 2008) were included. We estimated incidence rates of earliest clinical event (WHO3, WHO4 and TB), before antiretroviral therapy initiation per local guidelines, stratified by current age (or ≥6 months) and current CD4% (15%, 15-24%, ≥25%). CD4%-stratified mortality rates were estimated separately for children who did not experience a clinical event ("background" mortality) and for children who experienced an event, including "acute" mortality (≤30 days post event) and "later" mortality (30 days post event).Among 847 children (median enrollment age: 4.8 months; median pre-antiretroviral therapy follow up: 10.8 months; 603 (71%) with ≥1 CD4% recorded), event rates were comparable for those aged6 and ≥6 months. Current CD4% was associated with risk of WHO4 events for children6 months of age and with all evaluated events for children ≥6 months old (P0.05). "Background" mortality was 3.7-8.4/100 person-years (PY). "Acute" mortality (≤30 days post event) was 33.8/100 PY (after TB) and 41.1/100 PY (after WHO3 or WHO4). "Later" mortality (30 days post event) ranged by CD4% from 4.7 to 29.1/100 PY.In treatment-naïve, HIV-infected infants, WHO3, WHO4 and TB events were common before and after 6 months of age and led to substantial increases in mortality. Early infant HIV diagnosis and treatment are critically important, regardless of CD4%.

BACKGROUND: We describe severe morbidity and health care resource utilization (HCRU) among HIV-infected children on antiretroviral therapy (ART) in Abidjan Cote dIvoire. METHODS: All HIV-infected children enrolled in an HIV-care program (2004-2009) were eligible for ART initiation until database closeout death ART interruption or loss to follow-up. We calculated incidence rates (IRs) of density per 100 child-years (CYs) for severe morbidity HCRU (outpatient care and inpatient care) and associated factors using frailty models with a Weibull distribution. RESULTS: Of 332 children with a median age of 5.7 years and median follow-up of 2.5 years 65.4% were severely immunodeficient by World Health Organization (WHO) criteria and all received cotrimoxazole prophylaxis. We recorded 464 clinical events in 228 children; the overall IR was 57.6/100 CYs [95% confidence interval (CI): 52.1 to 62.5]. Severe morbidity was more frequent in children on protease inhibitor (PI)-based ART compared to those on other regimens [adjusted hazards ratio (aHR): 1.83; 95% CI: 1.35 to 2.47] and to those moderately/severely immunodeficient compared to those not (aHR: 1.57; 95% CI: 1.13 to 2.18 and aHR: 2.53; 95% CI: 1.81 to 3.55 respectively). Of the 464 events 371 (80%) led to outpatient care (IR: 45.6/100 CYs) and 164 (35%) to inpatient care (IR: 20.2/100 CYs). In adjusted analyses outpatient care was significantly less frequent in children older than 10 years compared with children younger than 2 years (aHR: 0.49; 95% CI: 0.31 to 0.78) and in those living furthest from clinics compared with those living closest (aHR: 0.65; 95% CI: 0.47 to 0.90). Both inpatient and outpatient HCRU were negatively associated with cotrimoxazole prophylaxis. CONCLUSIONS: Despite ART HIV-infected children still require substantial utilization of health care services.

We examined HIV-1 resistance in children failing first-line and second-line antiretroviral therapy in South Africa, all with clade C virus. Those exposed to full-dose ritonavir had multiple protease resistance mutations. Nineteen percent had wild-type virus. Appropriate antiretroviral therapy sequencing in sub-Saharan African children is essential for prolong treatment options.

BACKGROUND: We describe health care resource utilization among HIV-1-infected children who have not yet undergone antiretroviral treatment (ART) in Abidjan Cote dIvoire. METHODS: HIV-infected children enrolled prospectively in an HIV care programme in 2 health facilities in Abidjan (2004-2009) were followed up from date of inclusion until database closeout death ART initiation or loss to follow-up (no clinical contact for more than 6 months). Incidences of health care resource utilization (outpatient care inpatient day care and hospitalization) were described according to severe morbidity and mixed effect log linear models were computed to identify associated factors. RESULTS: Overall 405 children were included entering care at a median age of 4.5 years 66.9% were receiving cotrimoxazole prophylaxis and 27.7% met 2006 WHO criteria for immunodeficiency by age. The median follow-up time was 11.6 months (interquartile range: 1.4; 30.7). Overall 371 clinical events occurred in 162 children yielding to an incidence rate (IR) of 60.9/100 child-years (CY) [95% confidence interval (CI): 55.1 to 67.2]: 57% of clinical events led to outpatient care (IR: 33/100 CY) 38% to inpatient day care (IR: 22/100 CY) and 10% to hospitalization (IR: 5.9/100 CY). Further medical examinations were made allowing confirmed diagnoses in 40% of those (IR: 22.4/100 CY). Outpatient care was less common among immunodeficient children than those not (relative risk [RR] = 0.32 95% CI: 0.18 to 0.56) in those whose main caregivers are both parents compared with those who are primarily cared for by their mother only (RR = 0.34 95% CI: 0.15 to 0.77). CONCLUSION: Untreated HIV-infected children require substantial inpatient and outpatient care in a context where ART is scaling up but still not available to all.

OBJECTIVES:To access the costs of care for Ivoirian children before and after initiating LPV/r-based antiretroviral therapy (ART) before the age of two. METHODS:We assessed the direct costs of care for all HIV-infected children over the first 12 months on LPV/r-based ART initiated

Silicone, commonly used in cosmetic procedures owing to its presumed inertness, can yield serious sequelae including acute embolization and pneumonitis. Chronic pulmonary sequelae in response to silicone injection have not been previously described. We report a case of chronic progressive granulomatous pneumonitis in response to subcutaneous silicone injections in a transgender male-to-female patient infected with human immunodeficiency virus 1 (HIV-1). After receiving silicone injections to the buttock, the patient developed rapid onset dyspnea, pleuritic chest pain, fever, and chills. Chest computed tomography revealed diffuse peripheral interstitial opacities. She responded symptomatically to prednisone with subsequent intermittent symptomatic flares. Four years later, she developed marked dyspnea and cough. Chest computed tomography showed progressive diffuse ground-glass and nodular opacities. Lung biopsies demonstrated numerous spheroid silicone particles within the lung interstitium and small pulmonary vessels, surrounded by foreign body giant cells and nonnecrotizing granulomatous inflammation. We speculate that HIV-1–infected patients may be at risk for chronic, progressive granulomatous pneumonitis due to silicone injection years after their procedure owing to shifting levels of cell-mediated immunity.

As the global community evaluates the unprecedented investment in the scale-up of human immunodeficiency virus (HIV) therapy and considers future investments in HIV care, it is crucial to identify those HIV interventions that maximize the benefit realized from each dollar spent. The use of laboratory monitoring assays--CD4 cell count and HIV RNA level--in decisions about when to initiate and switch antiretroviral therapy may offer substantial clinical benefit, but their economic value remains controversial. Cost-effectiveness analysis can be used to evaluate the value for money of strategies for HIV care, including alternative approaches to laboratory monitoring. Five published cost-effectiveness analyses address the question of CD4 cell count and HIV RNA level monitoring for HIV-infected patients in Africa, with differing conclusions. We describe the use of cost-effectiveness analysis in resource-limited settings and review the cost-effectiveness literature with regard to monitoring the CD4 cell count and HIV RNA level in Africa, highlighting some of the most critical issues in this debate.

International audience; INTRODUCTION: In 2010, the WHO recommended women living with HIV breastfeed for 12 months while taking antiretroviral therapy (ART) to balance breastfeeding benefits against HIV transmission risks. To inform the 2016 WHO guidelines, we updated prior research on the impact of breastfeeding duration on HIV-free infant survival (HFS) by incorporating maternal ART duration, infant/child mortality and mother-to-child transmission data.METHODS: Using the Cost-Effectiveness of Preventing AIDS Complications (CEPAC)-Infant model, we simulated the impact of breastfeeding duration on 24-month HFS among HIV-exposed, uninfected infants. We defined "optimal" breastfeeding durations as those maximizing 24-month HFS. We varied maternal ART duration, mortality rates among breastfed infants/children, and relative risk of mortality associated with replacement feeding ("RRRF"), modelled as a multiplier on all-cause mortality for replacement-fed infants/children (range: 1 [no additional risk] to 6). The base-case simulated RRRF = 3, median infant mortality, and 24-month maternal ART duration.RESULTS: In the base-case, HFS ranged from 83.1% (no breastfeeding) to 90.2% (12-months breastfeeding). Optimal breastfeeding durations increased with higher RRRF values and longer maternal ART durations, but did not change substantially with variation in infant mortality rates. Optimal breastfeeding durations often exceeded the previous WHO recommendation of 12 months.CONCLUSIONS: In settings with high RRRF and long maternal ART durations, HFS is maximized when mothers breastfeed longer than the previously-recommended 12 months. In settings with low RRRF or short maternal ART durations, shorter breastfeeding durations optimize HFS. If mothers are supported to use ART for longer periods of time, it is possible to reduce transmission risks and gain the benefits of longer breastfeeding durations.

Author(s): Neilan, Anne M; Bulteel, Alexander JB; Freedberg, Kenneth A; Hosek, Sybil; Landovitz, Raphael J; Walensky, Rochelle P; Wilson, Craig M; Ciaranello, Andrea L

Responses to antiretroviral therapy (ART) among human immunodeficiency virus (HIV)-infected children in resource-limited settings have recently been reported, but outcomes vary. We sought to derive pooled estimates of the 12-month rate of virologic suppression (HIV RNA,400 copies/mL) and gain in CD4 cell percentage (DeltaCD4%) for children initiating ART in resource-limited settings.We conducted a systematic review and meta-analysis of published reports of HIV RNA and CD4 outcomes for treatment-naive children aged 0-17 years old by means of the Medline, EMBASE (Excerpta Medica Database), and LILACS (Latin American and Caribbean Health Sciences Literature) electronic databases and the Cochrane Clinical Trials Register. Pooled estimates of the reported proportion with HIV RNA400 copies/mL and DeltaCD4% after 12 months of ART were derived using patient-level estimates and fixed- and random-effects models. To approximate intention-to-treat analyses, in sensitivity analyses children with missing 12-month data were assumed to have HIV RNA400 copies/mL or DeltaCD4% of zero.In patient-level estimates after 12 months of ART, the pooled proportion with virologic suppression was 70% (95% confidence interval [CI], 67%-73%); the pooled DeltaCD4% was 13.7% (95% CI, 11.8%-15.7%). Results from the fixed- and random-effects models were similar. In approximated intention-to-treat analyses, the pooled estimates decreased to 53% with virologic suppression (95% CI, 50%-55%) and to a DeltaCD4% of 8.5% (95% CI, 5.5%-11.4%).Pooled estimates of reported virologic and immunologic benefits after 12 months of ART among HIV-infected children in resource-limited settings are comparable with those observed among children in developed settings. Consistency in reporting on reasons for missing data will aid in the evaluation of ART outcomes in resource-limited settings.

Objective While autogenous arteriovenous access is preferred, prosthetic arteriovenous grafts (AVG) are still required in a large number of patients. Infection of AVGs occurs frequently and may cause life-threatening bleeding or sepsis. Multiple treatment strategies have been advocated (ranging from graft preservation to excision with complex concomitant reconstructions), indicating a lack of consensus on appropriate management of infected AVGs. We undertook this study to evaluate if, in the setting of anastomotic involvement, brachial artery ligation distal to the origin of the deep brachial artery accompanied by total graft excision (BAL) is safe and effective. Methods All prosthetic arteriovenous graft infections managed by a single surgeon between 1995 and 2006 were reviewed retrospectively. Patients were identified from a computerized vascular registry, and data were obtained via patient charts and the electronic medical record. Results We identified 45 AVG infections in 43 patients. Twenty-one patients (49%) demonstrated arterial anastomotic involvement and were treated with BAL; these form the cohort for this analysis. Mean patient age was 53.2 (SD 9.5) years. The primary etiologies for end stage renal disease (ESRD) were hypertension (29%), HIV (24%), and diabetes (19%). An upper arm AVG was present in 95% of patients; one (5%) had a forearm AVG. The majority of grafts were polytetrafluoroethylene (PTFE) (90%). Follow-up was 100% at 1 month, 86% at 3 months, and 67% at 6 months. No ischemic or septic complications occurred in the 21 patients who underwent BAL. Conclusion BAL is an effective and expeditious method to deal with an infected arm AVG in frequently critically ill patients with densely scarred wounds. In the short term, BAL appears to be well tolerated without resulting ischemic complications. Further study with longer duration of follow-up is necessary to ascertain whether BAL results in definitive cure, or whether patients may ultimately manifest ischemic changes and require additional intervention.

We performed a quasi-experiment to assess the effects of a focused health care intervention delivered in transitional housing facilities in Sacramento, California. Four transitional housing facilities (THFs) receiving the intervention were compared with 2 THFs that did not receive it. A multidisciplinary team provided a diverse package of services to residents at the intervention sites. Residents at comparison sites received usual care. Survey and physical examination data were collected in repeated cross-sectional surveys at baseline (pre-intervention) and after 6 and 18 months of follow-up (post-intervention). Using analysis of covariance techniques, our statistical models showed improved odds of receiving recommended gynecologic preventive care and decreased odds of frequent Emergency Department use at 18 months among residents at the intervention sites. At 6 months, residents at the intervention sites also experienced improved blood pressure control. There was no intervention effect on residents' access to specialists or on physical functioning, mental health, or dental health.

As perinatally human immunodeficiency virus-infected youth (PHIVY) in the United States grow older and more treatment experienced, clinicians need updated information about the association of age, CD4 cell count, viral load (VL), and antiretroviral (ARV) drug use with risk of opportunistic infections, key clinical events, and mortality to understand patient risks and improve care.To examine the incidence or first occurrence during follow-up of key clinical events (including Centers for Disease Control and Prevention stage B [CDC-B] and stage C [CDC-C] events) and mortality among PHIVY stratified by age, CD4 cell count, and VL and ARV status.Combining data from the Pediatric HIV/AIDS Cohort Study (PHACS) Adolescent Master Protocol and International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) P1074 multicenter cohort studies (March 2007 through April 2015), we estimated event rates during person-time spent in key strata of age (7-12, 13-17, and 18-30 years), CD4 cell count (200, 200-499, and ≥500/μL), and a combined measure of VL and ARV status (VL400 or ≥400 copies/mL; ARV therapy or no ARV therapy). A total of 1562 participants in the PHACS Adolescent Master Protocol and IMPAACT P1074 were eligible, and 1446 PHIVY from 41 ambulatory sites in the 12 US states, including Puerto Rico were enrolled. The dates of analysis were March 2015 through January 2017.Clinical event rates stratified by person-time in age, CD4 cell count, and VL and ARV categories.A total of 1446 PHIVY participated in the study (mean [SD] age, 14.6 [4.6] years; 759 female [52.5%]; 953 black [65.9%]). During a mean (SD) follow-up of 4.9 (1.3) years, higher incidences of CDC-B events, CDC-C events, and mortality were observed as participants aged. Older PHIVY (aged 13-17 and 18-30 years) spent more time with a VL of 400 copies/mL or more and with a CD4 cell count of less than 200/µL compared with 7- to 12-year-old participants (30% and 44% vs 22% of person-time with a VL≥400 copies/mL; 5% and 18% vs 2% of person-time with CD4 cell count200/µL; P .001 for each comparison). We observed higher rates of CDC-B events, CDC-C events, bacterial infections, and mortality at lower CD4 cell counts, as expected. The mortality rate among older PHIVY was 6 to 12 times that among the general US population. Higher rates of sexually transmitted infections were also observed at lower CD4 cell counts after adjusting for age.Older PHIVY were at increased risk of viremia, immunosuppression, CDC-B events, CDC-C events, and mortality. Interventions to improve ARV therapy adherence and optimize models of care for PHIVY as they age are urgently needed to improve long-term outcomes among PHIVY.

Rochelle Walensky and colleagues use a model-based analysis to examine which of the 2010 WHO antiretroviral therapy guidelines should be implemented first in resource-limited settings by ranking them according to survival, cost-effectiveness, and equity., Background The new 2010 World Health Organization (WHO) HIV treatment guidelines recommend earlier antiretroviral therapy (ART) initiation (CD4, Editors' Summary Background Since 1981, acquired immunodeficiency syndrome (AIDS) has killed more than 25 million people, and about 33 million people (30 million of them in low- and middle-income countries) are now infected with the human immunodeficiency virus (HIV), which causes AIDS. HIV destroys immune system cells (including CD4 cells, a type of lymphocyte), leaving infected individuals susceptible to other infections (so-called opportunistic infections). Early in the AIDS epidemic, most people with HIV died within 10 years of infection. Then, in 1996, highly active antiretroviral therapy (ART)—a combination of several powerful antiretroviral drugs—was developed. Now, in resource-rich countries, clinicians care for people with HIV by prescribing ART regimens tailored to each individual's needs. They also regularly measure the amount of virus in their patients' blood, test for antiretroviral-resistant viruses, and monitor the health of their patients' immune systems through regular CD4 cell counts. As a result, the life expectancy of patients with HIV in developed countries has dramatically improved. Why Was This Study Done? Initially, resource-limited countries could not afford to provide ART for their populations, and the life expectancy of HIV-positive people remained low. Now, through the concerted efforts of governments, the World Health Organization (WHO), and other international agencies, more than a third of the people in low- and middle-income countries who need ART are receiving it. However, many without access are still in need of ART, and ART programs in developing countries follow a public-health approach rather than an individualized approach. That is, drug regimens, clinical decision-making, and disease monitoring are all standardized and follow recommendations in the 2006 WHO ART guidelines. This year (2010), these guidelines were revised. The guidelines now recommend the following: earlier ART initiation—when the CD4 count falls below 350/µl of blood, instead of below 200/µl as in the 2006 guidelines; the provision of sequential ART regimens instead of a single regimen; and the replacement of the antiretroviral drug stavudine with tenofovir, a less toxic but more expensive drug, in first-line ART regimens. However, many resource-limited countries are still struggling to implement the 2006 guidelines, so which of these new recommendations should be prioritized? Here, the researchers use a mathematical model to address this question. What Did the Researchers Do and Find? The Cost Effectiveness of AIDS Complications (CEPAC)–International model simulates the natural history and treatment of HIV disease. The researchers entered South African clinical and cost data for HIV treatment into this model and then used it to project survival and costs in a hypothetical group of South African HIV-positive patients under alternative guideline prioritization scenarios. The reference strategy for the simulations (denoted as “stavudine/WHO/one-line”) assumed that patients (with a mean CD4 count of 375/µl) began a single stavudine-based ART regimen when they developed WHO stage III/IV HIV disease (i.e., when patients develop multiple opportunistic infections such as tuberculosis and pneumonia). When the new guideline recommendations were considered separately, ART initiation at CD4

We review recent studies on the inheritance of affective disorders and schizophrenia. Both groups of diseases have substantial genetic and nongenetic components, and their inheritance does not fit simple Mendelian models. Linkage studies implicate the Xp28 and 11p15 regions as potential disease loci in affective illness, and the 5q11-q13 region in schizophrenia. These conclusions are highly controversial, however, and must be viewed as extremely tentative.

Background: Pediatric antiretroviral therapy (ART) has been shown to substantially reduce morbidity and mortality in HIV-infected infants and children. To accurately project program costs, analysts need accurate estimations of antiretroviral drug (ARV) costs for children. However, the costing of pediatric antiretroviral therapy is complicated by weight-based dosing recommendations which change as children grow. Methods: We developed a step-by-step methodology for estimating the cost of pediatric ARV regimens for children ages 0–13 years old. The costing approach incorporates weight-based dosing recommendations to provide estimated ARV doses throughout childhood development. Published unit drug costs are then used to calculate average monthly drug costs. We compared our derived monthly ARV costs to published estimates to assess the accuracy of our methodology. Results: The estimates of monthly ARV costs are provided for six commonly used first-line pediatric ARV regimens, considering three possible care scenarios. The costs derived in our analysis for children were fairly comparable to or slightly higher than available published ARV drug or regimen estimates. Conclusions: The methodology described here can be used to provide an accurate estimation of pediatric ARV regimen costs for cost-effectiveness analysts to project the optimum packages of care for HIV-infected children, as well as for program administrators and budget analysts who wish to assess the feasibility of increasing pediatric ART availability in constrained budget environments.