Psychiatric Problems in Children and Adolescents Infected With HIV at Birth
- Conditions
- HIV InfectionsMental Disorders
- Interventions
- Behavioral: Psychiatric interviews
- Registration Number
- NCT00100542
- Lead Sponsor
- International Maternal Pediatric Adolescent AIDS Clinical Trials Group
- Brief Summary
The purpose of this study is to determine whether HIV and anti-HIV drugs cause mental health problems or make mental health problems worse in children and adolescents who were infected with HIV at birth.
- Detailed Description
Research has shown that HIV is able to penetrate the blood-brain barrier and may significantly affect the central nervous system (CNS). Although the effects of HIV on the CNS are not fully understood, there is growing evidence that the effects are psychosocial in nature; HIV infected children experience higher rates of psychiatric symptoms and hospitalizations than their uninfected counterparts. Confounding the HIV CNS relationship is evidence suggesting that the CNS effects of HIV may also be related to antiretroviral treatment. This study will examine the rates and severity of psychiatric symptoms in both HIV infected and uninfected children and adolescents. In addition, this study will determine the relationship between duration of antiretroviral treatment and psychiatric symptoms.
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 800
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description 1 Psychiatric interviews All HIV infected and uninfected participants and their caregivers.
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (32)
UCLA Medical Center (Pediatric)
🇺🇸Los Angeles, California, United States
Chicago Childrens Memorial Hospital (Pediatric)
🇺🇸Chicago, Illinois, United States
University of Massachusetts Medical School
🇺🇸Worcester, Massachusetts, United States
North Broward Hospital District
🇺🇸Fort Lauderdale, Florida, United States
St. Christophers Hosp. for Children, Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Harbor-UCLA Medical Center
🇺🇸Torrance, California, United States
University of Florida - Health Science Center
🇺🇸Jacksonville, Florida, United States
Mt. Sinai Medical Center
🇺🇸New York, New York, United States
Los Angeles County Medical Center/USC
🇺🇸Los Angeles, California, United States
University of Maryland (Pediatric)
🇺🇸Baltimore, Maryland, United States
State University of New York at Stony Brook
🇺🇸Stony Brook, New York, United States
New York University School of Medicine
🇺🇸New York, New York, United States
Metropolitan Hospital Center
🇺🇸New York, New York, United States
Bronx Lebanon Hospital Center
🇺🇸Bronx, New York, 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
University of Miami (Pediatric)
🇺🇸Miami, Florida, United States
4601 UCSD Mother, Child & Adolescent HIV Program
🇺🇸San Diego, California, United States
Duke University (Pediatric)
🇺🇸Durham, North Carolina, United States
UCSF, Moffitt Hospital (Pediatric)
🇺🇸San Francisco, California, United States
Childrens Hospital (U. Colorado, Denver)
🇺🇸Denver, Colorado, United States
Jacobi Medical Center
🇺🇸Bronx, New York, United States
SUNY Upstate Medical University
🇺🇸Syracuse, New York, United States
Childrens Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Long Beach Memorial (Pediatric)
🇺🇸Long Beach, California, United States
University of South Florida
🇺🇸St Petersburg, Florida, United States
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States
San Juan City Hospital
🇵🇷San Juan, Puerto Rico
Childrens Hospital of Boston
🇺🇸Boston, Massachusetts, United States
Howard University Hospital
🇺🇸Washington, District of Columbia, United States
St. Jude Childrens Research Hospital, Memphis
🇺🇸Memphis, Tennessee, United States