Morbidity/Mortality and Disability in Children Study

描述（由申请人提供）：超过300万非洲儿童感染艾滋病毒，但关于艾滋病毒感染母亲所生艾滋病毒阳性（艾滋病毒+）和艾滋病毒阴性（艾滋病毒-）儿童的发育、健康和社会状况的信息有限。这项研究将评估艾滋病毒感染对儿童健康和生存的影响，在一个队列中，72名艾滋病毒阳性和228名艾滋病毒阴性但受影响的儿童出生的艾滋病毒感染的母亲超过3。研究期间出生的儿童及其母亲/看护人将在出生时、4-6周、6个月和12个月时以及此后每年进行一次访视。具体目标是：评估儿童和/或母亲HIV感染对以下方面的影响：1）出生结局（出生体重、胎龄），2）儿童健康（发病率），3）生长发育（人体测量学），4）神经发育障碍（认知、运动和行为障碍），5）死亡率。还将评估抗逆转录病毒治疗对这些结果的影响。统计方法将包括Kaplan-Meier生存方法和对数秩检验，用于至事件发生时间分析;比例风险模型，用于估计儿童结局的校正相对风险和时间独立/依赖协变量;回归方法，用于重复测量，使用人群平均（边际）和生长（条件）模型。这些模型将把个人的基线信息、时间依赖性风险因素和复发性事件历史整合成协变量，以预测未来事件，并提供一种轨迹分析形式。这项研究是在乌干达Rakai农村地区长达十年的社区队列中进行的，该队列提供了有关孕产妇艾滋病毒状况，社会人口，行为和健康特征的广泛信息;以及有关家庭的详细数据。Rakai计划拥有广泛的现场，临床，实验室和数据管理基础设施。多学科研究小组在流行病学、临床研究、发病率和残疾评估以及统计分析方面拥有必要的专门知识。2004年，Rakai方案获得了总统艾滋病紧急救援计划提供抗逆转录病毒药物的支助，并于2005年获得了评估抗逆转录病毒药物对艾滋病毒流行病学和行为的影响的一级评估报告（1 R 01 HD 050180 -01）。然而，RO 1不提供详细的儿科评估资源，特别是神经发育障碍，这将是本培训和研究应用的主要和原始重点。在Rakai队列中嵌入拟议的研究利用了独特的资源，并节省了大量成本。这项研究将提供重要的信息，以指导干预措施，改善艾滋病毒感染和艾滋病毒影响的儿童在乌干达农村地区的护理。

DESCRIPTION (provided by applicant): Over 3 million African children are HIV-infected, but there is limited information on the development, health and social conditions of HIV-positive (HIV+) and HIV-negative (HIV-) children born to HIV-infected mothers. This study will assess the effects of HIV infection on child health and survival, in a cohort of 72 HIV+ and 228 HIV- but affected children born to HIV-infected mothers followed over 3. Children born during the study and their mothers/caretakers will be seen at birth, 4-6 weeks, 6 and 12 months, and annually thereafter. The specific aims are: To assess the effects of HIV infection in the child and/or the mother on:1) birth outcomes (birth weight, gestational age), 2) child health (morbidity), 3) growth and development (anthropometry), 4) neurodevelopmental disability (cognitive, motor, and behavioral disorders), and 5) mortality. The effects of antiretroviral therapy on each of these outcomes will also be assessed. Statistical methods will include Kaplan-Meier survival methods with log-rank tests for time to event analyses; proportional hazards models to estimate adjusted relative hazards for child outcomes with time-independent/dependent covariates; and regression methods for repeated measurements using population-average (marginal) and growth (conditional) models. The models will integrate the individual's baseline information, time-dependent risk factors, and recurrent event history into covariates for predicting future events, and provide a form of trajectory analyses. The study is nested within a decade-long community cohort in rural Rakai District, Uganda, which provides extensive information on maternal HIV status, sociodemographic, behavioral and health characteristics; and detailed data on households. The Rakai Program has an extensive field, clinical, laboratory and data management infrastructure. The multidisciplinary research team has the requisite expertise in epidemiology, clinical research, assessment of morbidity and disabilities, and in statistical analyses. In 2004, the Rakai Program received PEPFAR support for ARV provision and in 2005 was awarded a RO1 to assess ARV effects on HIV epidemiology and behaviors (1 R01 HD050180-01). However, the RO1 does not provide resources for detailed pediatric evaluations, particularly of neurodevelopmental disabilities, which will be a primary and original focus of this training and research application. Embedding the proposed study within the Rakai cohort draws upon unique resources and allows substantial cost savings. This study will provide critical information to guide interventions for improved care of HIV infected and HIV affected children in rural Uganda.