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

Description

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.

Study Start Date

April 2014

Estimated Completion Date

July 2020

Interventions

No interventions cited

Specialties

  • Internal Medicine: Infectious Disease
  • Infectious Disease: HIV/Immunodeficiency

MeSH Terms

  • Acquired Immunodeficiency Syndrome

Study ID

Harvard School of Public Health -- HD052102 - PH300

Status

Unknown

Trial ID

NCT02119702

Study Type

Observational

Trial Phase

N/A

Enrollment Quota

850

Sponsor

Harvard School of Public Health

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

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Study Locations and Contact Information (13)

Study Location Distance Name Phone Email
Childrens Hospital Boston - Boston, Massachusetts 2.6 miles None None None
Jacobi Medical Center - Bronx, New York 176.6 miles None None None
Bronx Lebanon Hospital Center - Bronx, New York 178.9 miles None None None
Rutgers New Jersey Medical School - Newark, New Jersey 195.5 miles None None None
St Christophers Hospital for Children - Philadelphia, Pennsylvania 265.8 miles None None None
Ann and Robert H Lurie Childrens Hospital - Chicago, Illinois 849.3 miles None None None
St Jude Childrens Research Hospital - Memphis, Tennessee 1,134.7 miles None None None
University of Miami - Miami, Florida 1,237.6 miles None None None
Childrens Diagnostic and Treatment Center - Fort Lauderdale, Florida 1,237.6 miles None None None
Tulane University Health Sciences Center - New Orleans, Louisiana 1,360.0 miles None None None
Baylor College of Medicine - Houston, Texas 1,609.9 miles None None None
University of Colorado Denver Health Sciences Center - Aurora, Colorado 1,759.8 miles None None None
University of California San Diego - la Jolla, California 2,581.5 miles None None None

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