HIV Infections Clinical Trial
Official title:
Psychiatric Co-Morbidity in Perinatally HIV-Infected Children and Adolescents
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.
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.
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Observational Model: Case Control, Time Perspective: Prospective
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