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

President and Fellows of Harvard College

Status

Completed

Conditions

HIV/AIDS

Study type

Observational

Funder types

Other

NIH

Identifiers

NCT02119702

1P01HD103133 (U.S. NIH Grant/Contract)

1P01HD103133 - PH300

PH300 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

818 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Exclusion Criteria: