NCT01418014

Adolescent Master Protocol

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 678 (actual)
• Sponsor: Harvard School of Public Health (HSPH) · Academic / Other
• Sex: All
• Age: 7 Years
• Healthy volunteers: Accepted

Summary

The advances in treatment to prevent maternal HIV transmission to neonates have been groundbreaking. As a result, the number of new perinatally-infected children in the U.S. is now small. Subsequent improvements in the treatment of HIV-infected infants and children have been equally remarkable, ensuring that most previously infected American children have survived and are approaching adolescence. In addition, the number of HIV-infected adolescents worldwide is growing substantially in both resource-poor countries and in countries with increasing levels of health care. Therefore, there is a global cohort of children who have been living with HIV infection since birth who are aging into adolescence. Little is definitively known about the impact of HIV infection and its treatment on the maturation process in these children. AMP is a prospective cohort study designed to define the impact of HIV infection and antiretroviral therapy on pre-adolescents and adolescents with perinatal HIV infection. Domains to be investigated include growth and sexual maturation, metabolic risk factors for cardiovascular disease, cardiac function, bone health, neurologic, neurodevelopment, language, hearing and behavioral function, and sexually transmitted infections (STI).

Detailed description

The primary objectives of AMP are: 1. 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. 2. To identify infectious and non-infectious complications of HIV disease, including the toxicities of antiretroviral therapy (ART). 3. 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: 1. 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. 2. 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. 3. 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. 4. 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. 5. 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. 6. 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.

Conditions

• HIV/AIDS

Timeline

• Start date: 2007-03-01
• Primary completion: 2021-02-01
• Completion: 2021-02-01
• First posted: 2011-08-16
• Last updated: 2025-06-27

Locations

15 sites across 2 countries: United States, Puerto Rico