Psychiatric interviews
BehavioralMeasures and questionnaires regarding mental health, pain, and adherence to treatment. No actual treatment or intervention is given as part of this study.
NCT Number: NCT00100542
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.
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Notify Me6 year–17 year
All sexes
Observational
San Juan City Hospital, San Juan, Puerto Rico
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for HIV Infected Participants:
Inclusion criteria
for HIV Uninfected Participants:
Inclusion criteria
for All Participants:
Exclusion criteria
for HIV Infected Participants:
Exclusion criteria
for All Participants:
Measures and questionnaires regarding mental health, pain, and adherence to treatment. No actual treatment or intervention is given as part of this study.
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Network
Psychiatric Co-Morbidity in Perinatally HIV-Infected Children and Adolescents
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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