Current Environment:

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 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.

Conditions

HIV/AIDS

Recruitment Status

Recruiting

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 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.

Eligibility 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
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

Gender

All

Min Age

18 Years

Max Age

N/A

Download Date

August 26, 2021

Principal Investigator

Paige Williams

Primary Contact Information

Liz Salomon, EdM

617-432-6762

lsalomon@hsph.harvard.edu

For more information on this trial, visit clinicaltrials.gov.

Contact

For more information and to contact the study team: