Adolescent Master Protocol for Participants 18 Years of Age and Older (AMP Up)
- Conditions
- HIV/AIDS
- Registration Number
- NCT02119702
- Lead Sponsor
- Harvard School of Public Health (HSPH)
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 820
-
Perinatal HIV infection as documented in the medical record
-
At or beyond their 18th birthday at the time of informed consent with no upper age limit
-
Willing to provide access to existing medical records
-
Available medical record documentation since early childhood of:
- ART exposure history
- Opportunistic infection prophylaxis exposure history
- Viral load and CD4+ cell count history
- Major medical events history
-
-
Willingness to participate and provide legal written consent
- HIV acquired by other than maternal-child transmission (e.g., blood products, sexual contact, and IV drug use) as documented in the medical record
Uninfected Cohort
Inclusion Criteria:
- Absence of perinatal HIV infection as indicated in the medical record; the Perinatally HIV-Exposed Uninfected (PHEU) participant may have horizontally-acquired HIV infection
- At or beyond their 18th birthday at the time of informed consent with no upper age limit
- Willingness to participate and provide legal written consent
Exclusion Criteria:
- Have confirmed perinatal HIV infection as documented in the medical record
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mental health problems Annually for 6 years Assessed at annually through the Patient Health Questionnaire (PHQ-9)) and General Anxiety Disorder-7 (GAD-7)
HIV disease progression Annually for 6 years 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.
Metabolic abnormalities Annually for 6 years 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.
Sexually transmitted infections (STI) Annually for 6 years STI testing and chart review conducted annually.
Pregnancies Annually for 6 years Data collected annually through online surveys and chart abstraction.
Transition to adult functioning Every 3 years for 6 years Every year participants will complete an online survey to collect data on educational attainment, employment, independent living and quality of life.
Mortality Annually for 6 years 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.
Cognitive impairment Every 3 years for 6 years Assessed at Entry, Years 3, 6, 9, and 12 visits through the NIH Toolbox.
Maternal-to-child HIV transmission Annually for 6 years Data collected through annual chart review.
ART adherence Annually for 6 years Data collected annually through an online survey.
Prevalence of risk behaviors including risky sexual behavior and licit and illicit substance use Annually for 6 years Participants will complete an annual online survey.
Hearing dysfunction Every 3 years for 6 years Assessed through the NIH Toolbox and a questionnaire to be completed at Entry, Year 3 and Year 6 visits.
Risk factors for cardiovascular disease Annually for 6 years 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.
Language development Once, at the Entry or Year 3 visit The Clinical Evaluation of Language Fundamentals (CELF) IV assessment will be completed at the Entry or Year 3 visit.
End-organ disease Annually for 6 years 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.
Cervical HPV-associated pre-cancers and cancers (among female participants) Annually for 6 years Data collected through annual chart review.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (14)
University of California San Diego
🇺🇸La Jolla, California, United States
University of Colorado Denver Health Sciences Center
🇺🇸Aurora, Colorado, United States
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
🇺🇸Bronx, New York, United States
Jacobi Medical Center
🇺🇸Bronx, New York, United States
St. Christopher's Hospital for Children
🇺🇸Philadelphia, Pennsylvania, United States
St. Jude Children's Research Hospital
🇺🇸Memphis, Tennessee, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
San Juan Research Hospital
🇵🇷San Juan, Puerto Rico