Psychiatric Problems in Children and Adolescents Infected With HIV at Birth
NCT ID: NCT00100542
Last Updated: 2011-01-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
800 participants
OBSERVATIONAL
2005-04-30
2006-09-30
Brief Summary
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Detailed Description
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No treatment will be given as part of this study. The study will last for 96 weeks and be divided into two parts. In Part 1, HIV infected and uninfected participants and their caregivers will complete a series of measures and questionnaires regarding mental health, pain, and adherence to treatment. In Part 2, all participants and their caregivers will complete a subset of the original measures at Weeks 48 and 96. This follow-up part of the study will assess any long-term changes in psychiatric symptoms. In addition, a subset of HIV infected and uninfected participants and their caregivers will take part in psychiatric interviews at specified study sites. A portion of these interviews will be audio-taped.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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1
All HIV infected and uninfected participants and their caregivers.
Psychiatric interviews
Measures and questionnaires regarding mental health, pain, and adherence to treatment. No actual treatment or intervention is given as part of this study.
Interventions
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Psychiatric interviews
Measures and questionnaires regarding mental health, pain, and adherence to treatment. No actual treatment or intervention is given as part of this study.
Eligibility Criteria
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Inclusion Criteria
* HIV uninfected
* Living with same parent or primary caregiver for at least 12 months prior to study screening
* Willing and able to provide consent or assent
Exclusion Criteria
* IQ of 69 or lower, for participants whose primary language is English. More information on this criterion can be found in the protocol.
6 Years
17 Years
ALL
Yes
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
National Institute of Mental Health (NIMH)
NIH
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
NETWORK
Responsible Party
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IMPAACT
Principal Investigators
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Sharon Nachman, MD
Role: STUDY_CHAIR
Department of Pediatrics, Stony Brook University
Locations
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Long Beach Memorial (Pediatric)
Long Beach, California, United States
Los Angeles County Medical Center/USC
Los Angeles, California, United States
UCLA Medical Center (Pediatric)
Los Angeles, California, United States
4601 UCSD Mother, Child & Adolescent HIV Program
San Diego, California, United States
UCSF, Moffitt Hospital (Pediatric)
San Francisco, California, United States
Harbor-UCLA Medical Center
Torrance, California, United States
Childrens Hospital (U. Colorado, Denver)
Denver, Colorado, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Howard University Hospital
Washington D.C., District of Columbia, United States
North Broward Hospital District
Fort Lauderdale, Florida, United States
University of Florida - Health Science Center
Jacksonville, Florida, United States
University of Miami (Pediatric)
Miami, Florida, United States
University of South Florida
St. Petersburg, Florida, United States
Chicago Childrens Memorial Hospital (Pediatric)
Chicago, Illinois, United States
University of Maryland (Pediatric)
Baltimore, Maryland, United States
Childrens Hospital of Boston
Boston, Massachusetts, United States
University of Massachusetts Medical School
Worcester, Massachusetts, United States
New York University School of Medicine
New York, New York, United States
Metropolitan Hospital Center
New York, New York, United States
Mt. Sinai Medical Center
New York, New York, United States
State University of New York at Stony Brook
Stony Brook, New York, United States
SUNY Upstate Medical University
Syracuse, New York, United States
Bronx Lebanon Hospital Center
The Bronx, New York, United States
Jacobi Medical Center
The Bronx, New York, United States
Duke University (Pediatric)
Durham, North Carolina, United States
Childrens Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
St. Christophers Hosp. for Children, Philadelphia
Philadelphia, Pennsylvania, United States
St. Jude Childrens Research Hospital, Memphis
Memphis, Tennessee, United States
Children's Hospital and Regional Medical Center/Seattle
Seattle, Washington, United States
Northwest Family Ctr./Harborview Medical Center
Seattle, Washington, United States
University of Washington Medical Ctr.
Seattle, Washington, United States
San Juan City Hospital
San Juan, , Puerto Rico
Countries
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References
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Bachanas PJ, Kullgren KA, Schwartz KS, Lanier B, McDaniel JS, Smith J, Nesheim S. Predictors of psychological adjustment in school-age children infected with HIV. J Pediatr Psychol. 2001 Sep;26(6):343-52. doi: 10.1093/jpepsy/26.6.343.
De Luca A, Ciancio BC, Larussa D, Murri R, Cingolani A, Rizzo MG, Giancola ML, Ammassari A, Ortona L. Correlates of independent HIV-1 replication in the CNS and of its control by antiretrovirals. Neurology. 2002 Aug 13;59(3):342-7. doi: 10.1212/wnl.59.3.342.
Gaughan DM, Hughes MD, Oleske JM, Malee K, Gore CA, Nachman S; Pediatric AIDS Clinical Trials Group 219C Team. Psychiatric hospitalizations among children and youths with human immunodeficiency virus infection. Pediatrics. 2004 Jun;113(6):e544-51. doi: 10.1542/peds.113.6.e544.
Lwin R, Melvin D. Paediatric HIV infection. J Child Psychol Psychiatry. 2001 May;42(4):427-38.
Mellins CA, Smith R, O'Driscoll P, Magder LS, Brouwers P, Chase C, Blasini I, Hittleman J, Llorente A, Matzen E; NIH NIAID/NICHD/NIDA-Sponsored Women and Infant Transmission Study Group. High rates of behavioral problems in perinatally HIV-infected children are not linked to HIV disease. Pediatrics. 2003 Feb;111(2):384-93. doi: 10.1542/peds.111.2.384.
Chernoff M, Nachman S, Williams P, Brouwers P, Heston J, Hodge J, Di Poalo V, Deygoo NS, Gadow KD; IMPAACT P1055 Study Team. Mental health treatment patterns in perinatally HIV-infected youth and controls. Pediatrics. 2009 Aug;124(2):627-36. doi: 10.1542/peds.2008-2441. Epub 2009 Jul 13.
Nachman S, Chernoff M, Williams P, Hodge J, Heston J, Gadow KD. Human immunodeficiency virus disease severity, psychiatric symptoms, and functional outcomes in perinatally infected youth. Arch Pediatr Adolesc Med. 2012 Jun 1;166(6):528-35. doi: 10.1001/archpediatrics.2011.1785.
Other Identifiers
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PACTG P1055
Identifier Type: -
Identifier Source: org_study_id
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