Adolescent Master Protocol for Participants 18 Years of Age and Older (AMP Up)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02119702

Acronym

AMP Up

Enrollment

818

Registered

2014-04-22

Start date

2014-04-30

Completion date

2025-05-31

Last updated

2025-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV/AIDS

Keywords

HIV/AIDS, perinatal HIV infection

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

Perinatally HIV-Infected Cohort Inclusion Criteria: * 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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
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.
Mental health problems	Annually for 6 years	Assessed at annually through the Patient Health Questionnaire (PHQ-9)) and General Anxiety Disorder-7 (GAD-7)
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.
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.
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.
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.
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.
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.
Cervical HPV-associated pre-cancers and cancers (among female participants)	Annually for 6 years	Data collected through annual chart review.
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.

Countries

Puerto Rico, United States

Outcome results