Summary

for people ages 18 years and up (full criteria)
healthy people welcome
at UCLA UCSD
study started
estimated completion:
Stephen Spector (ucsd)

Description

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.

Details

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.

Keywords

HIV/AIDS HIV/AIDS, perinatal HIV infection

Eligibility

For people ages 18 years and up

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

Locations

  • University of California San Diego accepting new patients
    La Jolla California 92093 United States
  • University of Colorado Denver Health Sciences Center accepting new patients
    Aurora Colorado 80045 United States
  • Baylor College of Medicine accepting new patients
    Houston Texas 77030 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Harvard School of Public Health
Links
Pediatric HIV/AIDS Cohort Study
ID
NCT02119702
Lead Scientist
Stephen Spector
Study Type
Observational
Last Updated
September 7, 2018