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

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 perinatally
HIV-exposed, -uninfected (PHEU) 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, 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 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.

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

- Engaged in medical care and medical records are available

- At least one of the following is true:

- Previously or currently enrolled in PHACS AMP, or

- Previously enrolled in any of the studies included on the list of approved
studies for enrollment into AMP Up, or

- 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

Perinatally HIV-Exposed, -Uninfected Cohort

Inclusion Criteria:

- Perinatally HIV-exposed, perinatally-uninfected as indicated in the medical record;
the 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

- At least one of the following is true:

- Previously or currently enrolled in PHACS AMP, or

- Previously or currently enrolled in PHACS SMARTT

- Willingness to participate and provide legal written consent

Exclusion Criteria:

- Have confirmed perinatal HIV infection as documented in the medical record