This is a prospective cohort study designed to define the impact of HIV infection and antiretroviral therapy (ART) on young adults with perinatal HIV infection (YAPHIV) as they transition into adulthood. A group of of perinatally exposed but uninfected young adults from a similar sociodemographic background and age distribution will be enrolled for comparison.
AMP Up aims to define the impact of HIV infection and antiretroviral therapy (ART) on young adults with perinatal HIV infection as they transition into adulthood. A group of uninfected perinatally-exposed young adults from a similar sociodemographic background and age distribution will be enrolled for comparison. The primary objectives of this study are: * To identify infectious and non-infectious complications of HIV disease and toxicities resulting from long-term ART, including disease progression, immune dysfunction, viral resistance, end-organ disease, and mortality. * To define the impact of HIV infection and ART on the long-term clinical outcomes of young adults, including: * Metabolic abnormalities and risk factors for cardiovascular disease, including glucose and lipid metabolism, blood pressure, and body composition. * Sexually transmitted infections (Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, syphilis, human papillomavirus (HPV), genital warts and HSV) among males and females, and cervical HPV-associated pre-cancers and cancers and Mycoplasma genitalium and other vaginal microbiota among females. * Reproductive health, fertility, and pregnancy outcomes including mother-to-child transmission of HIV. * To define the impact of perinatal HIV infection, its concomitant risk factors and ART on long-term neurocognitive and behavioral health outcomes, including: * Mental health and neurocognitive functioning. * Health care behaviors, including adherence to ART, participation in health care services, and transition to adult clinical care. * Risk behaviors, including sexual behavior and substance use. * Independent living skills, and vocational and education achievement necessary for successful transition to adult functioning and quality of life.
Study Type
OBSERVATIONAL
Enrollment
818
University of California San Diego
La Jolla, California, United States
University of Colorado Denver Health Sciences Center
Aurora, Colorado, United States
HIV disease progression
Factors of interest for this outcome include virologic suppression, immune impairment, immune activation, changes in ART, cumulative exposure to specific ART, viral resistance, co-infections, and host genetic polymorphisms. Data will be collected through chart abstraction and laboratory assessments and central laboratory testing.
Time frame: Annually for 6 years
Metabolic abnormalities
Factors of interest include BMI, body composition, systolic and diastolic blood pressure, lipid levels (total cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides). Data will be collected by chart review, physical assessments, and laboratory evaluations.
Time frame: Annually for 6 years
Sexually transmitted infections (STI)
STI testing and chart review conducted annually.
Time frame: Annually for 6 years
Pregnancies
Data collected annually through online surveys and chart abstraction.
Time frame: Annually for 6 years
Mental health problems
Assessed at annually through the Patient Health Questionnaire (PHQ-9)) and General Anxiety Disorder-7 (GAD-7)
Time frame: Annually for 6 years
ART adherence
Data collected annually through an online survey.
Time frame: Annually for 6 years
Prevalence of risk behaviors including risky sexual behavior and licit and illicit substance use
Participants will complete an annual online survey.
Time frame: Annually for 6 years
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Children's Diagnostic and Treatment Center
Fort Lauderdale, Florida, United States
University of Miami
Miami, Florida, United States
Ann and Robert H. Lurie Children's Hospital
Chicago, Illinois, United States
Tulane University Health Sciences Center
New Orleans, Louisiana, United States
Children's Hospital Boston
Boston, Massachusetts, United States
Rutgers - New Jersey Medical School
Newark, New Jersey, United States
Bronx Lebanon Hospital Center
The Bronx, New York, United States
Jacobi Medical Center
The Bronx, New York, United States
...and 4 more locations
Transition to adult functioning
Every year participants will complete an online survey to collect data on educational attainment, employment, independent living and quality of life.
Time frame: Every 3 years for 6 years
Hearing dysfunction
Assessed through the NIH Toolbox and a questionnaire to be completed at Entry, Year 3 and Year 6 visits.
Time frame: Every 3 years for 6 years
Language development
The Clinical Evaluation of Language Fundamentals (CELF) IV assessment will be completed at the Entry or Year 3 visit.
Time frame: Once, at the Entry or Year 3 visit
End-organ disease
Factors of interest for this outcome include virologic suppression, immune impairment, immune activation, changes in ART, cumulative exposure to specific ART, viral resistance, co-infections, and host genetic polymorphisms. Data will be collected through chart abstraction and laboratory assessments.
Time frame: Annually for 6 years
Mortality
Factors of interest for this outcome include virologic suppression, immune impairment, immune activation, changes in ART, cumulative exposure to specific ART, viral resistance, co-infections, and host genetic polymorphisms. Data will be collected through chart abstraction and laboratory assessments.
Time frame: Annually for 6 years
Risk factors for cardiovascular disease
Factors of interest include BMI, body composition, systolic and diastolic blood pressure, lipid levels (total cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides) and cumulative cardiometabolic risk. Data will be collected by chart review, physical assessments, and laboratory evaluations.
Time frame: Annually for 6 years
Cervical HPV-associated pre-cancers and cancers (among female participants)
Data collected through annual chart review.
Time frame: Annually for 6 years
Cognitive impairment
Assessed at Entry, Years 3, 6, 9, and 12 visits through the NIH Toolbox.
Time frame: Every 3 years for 6 years
Maternal-to-child HIV transmission
Data collected through annual chart review.
Time frame: Annually for 6 years