Adolescent Master Protocol

Summary

Participation Requirements

Description

The primary objectives of AMP are: To define the impact of HIV infection and ART on growth and pubertal development (and their hormonal regulation), along with the cognitive, academic, and social development, of pre-adolescents and adolescents with perinatal HIV infection as they move through adoles...

The primary objectives of AMP are: To define the impact of HIV infection and ART on growth and pubertal development (and their hormonal regulation), along with the cognitive, academic, and social development, of pre-adolescents and adolescents with perinatal HIV infection as they move through adolescence into adulthood. To identify infectious and non-infectious complications of HIV disease, including the toxicities of antiretroviral therapy (ART). To investigate: Cognitive and behavioral changes over time, including medication adherence, family and social function, and high risk behaviors such as risky sexual behavior, licit and illicit drug use, and alcohol use; Changes in language and hearing; Changes in glucose metabolism, body composition, and bone mineralization; Changes in lipid metabolism and other risk factors for cardiovascular disease; Risk factors for secondary transmission of HIV; and The occurrence and clinical course of cervical HPV infections among females. The domain-specific aims of AMP are: Growth and sexual maturation: To longitudinally track growth and sexual maturation and the factors that influence growth and maturation in HIV-infected children when compared to HIV-exposed but uninfected children. Metabolic risk factors for cardiovascular disease: To characterize the emergence of abnormal glucose metabolism, lipid abnormalities, body composition and other risk factors for cardiovascular disease and identify the contributing influences in HIV-infected children when compared to HIV-exposed but uninfected children. Cardiac function: To estimate the prevalence of cardiac structural and functional abnormalities in HIV-infected children and youth when compared to HIV-exposed but uninfected children. Bone mineral density: To estimate the differences in bone mineral density of HIV-infected children when compared to HIV-exposed but uninfected children and to identify factors contributing to abnormal bone mineralization. Neurologic, neurodevelopment, language, and behavioral function: To examine cognitive and behavioral outcomes of HIV-infected children and adolescents, including high risk behaviors such as risky sexual behavior, licit and illicit drug use, and alcohol use, neurodevelopmental impairment, school achievement and to compare them with an HIV-exposed but uninfected control cohort. To examine non-adherence to antiretroviral therapy and predictors of non-adherence among HIV-infected children receiving ART. To examine family and psychosocial factors associated with emotional and behavioral problems. Adolescent gynecology and STI infection: To evaluate the incidence of and risk factors for acquiring STIs/vaginal infections (C. trachomatis, N. gonorrhea, T. vaginalis, syphilis, genital warts, HPV, and HSV) for males and females, and in addition bacterial vaginosis for females. To evaluate the incidence, predictors, and outcomes of pregnancy.

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