MORBIDITY/MORTALITY AND DISABILITY IN CHILDREN STUDY
Heena Pushkar Brahmbhatt, Assistant Professor
Johns Hopkins University, W400 Wyman Park Building, Baltimore, Md 21218
Grant 5K01TW007403-04 from Fogarty International Center
Abstract: 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 on1) 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
Keywords: 0-11 years old; 6H-Dipyrido(3, 2-b[{..}]2`, 3`-e)(1, 4)diazepin-6-one, 11-cyclopropyl-5, 11-dihydro-4-methyl-; AIDS; AIDS Seroconversion; AIDS Seropositivity; AIDS Virus; AIDS/HIV; AIDS/HIV problem; Acquired Immune Deficiency; Acquired Immune Deficiency Syndrome; Acquired Immune Deficiency Syndrome Virus; Acquired Immuno-Deficiency Syndrome; Acquired Immunodeficiency Syndrome; Acquired Immunodeficiency Syndrome Virus; Affect; Africa; Africa South of the Sahara; African; Age; Anemia; Anthropometry; Anti-HIV Positivity; Anti-Retroviral Agents; Antiretroviral Agents; Award; Behavior; Behavior Disorders; Biological; Birth; Birth Rate; Birth Weight; Breast Feeding; Breastfeeding; Caring; Cessation of life; Characteristics; Child; Child Mortality; Child Youth; Child health care; Childhood; Children (0-21); Clinical; Clinical Research; Clinical Study; Cognition; Cognitive; Communities; Cost Savings; Coupled; Data; Death; Developed Countries; Developed Nations; Development; Disease regression; Enrollment; Epidemic; Epidemiology; Evaluation; Event; Female; Fetal Age; Fetal Maturity, Chronologic; Future; Generalized Growth; Gestational Age; Growth; Growth and Development; Growth and Development function; HIV; HIV Antibody Positivity; HIV Infections; HIV Positive; HIV Positivity; HIV Seroconversion; HIV Seropositivity; HIV/AIDS; HIV/AIDS problem; HTLV-III; HTLV-III Infections; HTLV-III Seroconversion; HTLV-III Seropositivity; HTLV-III-LAV Infections; Health; Health, Child; Hearing; History; Household; Human Immunodeficiency Viruses; Human T-Cell Leukemia Virus Type III; Human T-Cell Lymphotropic Virus Type III; Human T-Lymphotropic Virus Type III; Human, Child; Immunologic Deficiency Syndrome, Acquired; Individual; Industrialized Countries; Industrialized Nations; Infant; Infection; Infrastructure; Injection of therapeutic agent; Injections; Interdisciplinary Research; Interdisciplinary Study; Intervention; Intervention Strategies; LAV-HTLV-III; Laboratories; Life; Longitudinal Studies; Lymphadenopathy-Associated Virus; Malaria; Masks; Measurement; Measures; Medical; Methods; Modeling; Morbidity; Morbidity - disease rate; Mortality; Mortality Vital Statistics; Mothers; Motor; Multidisciplinary Collaboration; Multidisciplinary Research; Neurodevelopmental Disability; Nevirapine; Numbers; Outcome; Paludism; Parturition; Plasmodium Infections; Population; Prevalence; Prevention; Prevention Measures; Preventive; Programs (PT); Programs [Publication Type]; Prophylactic treatment; Prophylaxis; Proportional Hazards Models; Purpose; QOL; Quality of life; Rate; Recording of previous events; Recurrence; Recurrent; Regression; Relative; Relative (related person); Research; Research Infrastructure; Research Resources; Research Training; Resources; Risk Behaviors; Risk Factors; Risky Behavior; Rural; Sampling; Saving, Cost; Services; Sight; Social Conditions; Social Problems; Societal Conditions; Source; Southern Africa; Statistical Methods; Stigmatization; Study, Interdisciplinary; Sub-Saharan Africa; Subsaharan Africa; T-Lymphotropic Virus Type III Infections, Human; TRNSF; Testing; Time; Tissue Growth; Transfusion; Transmission; Uganda; Vascular blood supply; Viramune; Virus-HIV; Vision; Week; Woman; anti-retroviral; antibody positive AIDS test; antigen positive AIDS test; antiretroviral; antiretroviral therapy; at risk behavior; base; behavioral disorder; behavioral health; blood supply; child physical development; children; cohort; data management; disability; enroll; experience; hazard; hearing perception; improved; interventional strategy; long-term study; ontogeny; pediatric; prevent; preventing; programs; reproductive; rural area; seropositive (AIDS test); social; social disturbance; sound perception; transmission process; vascular supply; youngster
Project start date: 2005-09-16
Project end date: 2010-08-31
Budget start date: 1-SEP-2008
Budget end date: 31-AUG-2010
PFA/PA: PAR-04-058
5K01TW007403-04 (2008): $0
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