Surveillance Monitoring for ART Toxicities Study in HIV Uninfected Children Born to HIV Infected Women

Description

SMARTT will estimate the incidence of conditions and diagnoses potentially related to in utero exposure to antiretroviral therapy and/or exposure in the first two months of life among children born of HIV-infected mothers.

Study Start Date

March 2007

Estimated Completion Date

July 2020

Interventions

No interventions cited

Specialties

  • Nursing: Immuno/Infectious Dz
  • Infectious Disease: HIV/Immunodeficiency
  • Physician Assistant: Infectious Disease

MeSH Terms

  • HIV

Study ID

Harvard School of Public Health -- HD052102 - PH100

Status

Unknown

Trial ID

NCT01310023

Study Type

Observational

Trial Phase

N/A

Enrollment Quota

3400

Sponsor

Harvard School of Public Health

Inclusion Criteria

    Static Surveillance Cohort:
  • HIV-exposed but -uninfected infants and children
  • lack of infection must be documented by medical or research record review. Children exposed and unexposed to ART while in utero and/or in the first two months of life will be enrolled.
  • Previously enrolled in any of the studies included on the list of approved studies for enrollment into SMARTT or another study with SMARTT Protocol Chair approval if the study has data on ART exposure by pregnancy trimester, ART exposure during the first 2 months of life, and pregnancy complication data or availability of ART exposure by pregnancy trimester (including start and stop dates), ART exposure during the first 2 months of life, and pregnancy complication data in the mother and/or child's medical record.
  • Age birth to < 12 years at entry.
  • Willingness of parent/legal guardian to provide written permission for child to participate in study. Dynamic Surveillance Cohort:
  • HIV-exposed living fetus greater than or equal to 23 weeks gestation or a live infant born after 22 weeks gestation. Infants exposed and unexposed to ART will be enrolled.
  • Any infant born of an HIV-infected mother may be enrolled pending determination of the infant's HIV infection status. However, infants found to be HIV-positive will be discontinued from the study and will be referred for care outside this study. HIV infection status will be determined using the Diagnosis of Lack of Infection in HIV-Exposed Children.
  • ART exposure data by trimester of pregnancy must be available if ART exposed.
  • Entry prior to birth through < 72 hours of age.
  • Willingness of parent/legal guardian to provide written permission for child to participate in study.
  • Willingness of biological mother to enroll at initial enrollment of her child. Reference Cohort:
  • Participants from clinical settings that are similar to participants enrolled in the PHACS SMARTT Static Cohort.
  • Antiretroviral therapy unexposed children born to a mother HIV uninfected at the time of the child's birth.
  • Ages 1, 3, 5, or 9 years (± 3 months) at the time of the study visit.
  • Willingness of parent/legal guardian to provide written permission for child to participate in study.

Exclusion Criteria

    Static and Dynamic Cohorts: None Reference Cohort:
  • Monolingual Spanish-speaking child or parent/caregiver.

Gender

Both

Ages

N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Study Locations and Contact Information (25)

Study Location Distance Name Phone Email
SUNY Stony Brook - Stony Brook, New York 22.8 miles None None None
SUNY Stony Brook - Stony Brook, New York 22.8 miles None None None
Jacobi Medical Center - Bronx, New York 40.3 miles None None None
Jacobi Medical Center - Bronx, New York 40.3 miles None None None
Bronx Lebanon Hospital Center - Bronx, New York 42.6 miles None None None
Bronx Lebanon Hospital Center - Bronx, New York 42.6 miles None None None
New York University School of Medicine - New York, New York 50.2 miles None None None
New York University School of Medicine - New York, New York 50.2 miles None None None
University of Maryland - Baltimore, Maryland 222.5 miles None None None
Ann and Robert H Lurie Childrens Hospital - Chicago, Illinois 747.2 miles None None None
University of Illinois Chicago - Chicago, Illinois 748.9 miles None None None
University of Florida Health Science Center - Jacksonville, Florida 888.5 miles None None None
University of Florida Health Science Center - Jacksonville, Florida 888.5 miles None None None
University of Alabama - Birmingham, Alabama 916.1 miles None None None
University of Alabama - Birmingham, Alabama 916.1 miles None None None
Childrens Diagnostic Treatment Center - Fort Lauderdale, Florida 1,118.6 miles None None None
University of Miami - Miami, Florida 1,141.0 miles None None None
University of Miami - Miami, Florida 1,141.0 miles None None None
Tulane University Health Sciences Center - New Orleans, Louisiana 1,223.7 miles None None None
Tulane University Health Sciences Center - New Orleans, Louisiana 1,223.7 miles None None None
University of Colorado Denver Health Sciences Center - Aurora, Colorado 1,658.2 miles None None None
University of Colorado Denver Health Sciences Center - Aurora, Colorado 1,658.2 miles None None None
University of California San Diego - La Jolla, California 2,471.8 miles None None None
University of California San Diego - La Jolla, California 2,471.8 miles None None None
University of Southern California - Los Angeles, California 2,487.5 miles None None None

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