Skip to main content
OpenTrials
Completed

NCT Number: NCT00100542

Psychiatric Problems in Children and Adolescents Infected With HIV at Birth

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

San Juan City Hospital, San Juan, Puerto Rico

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for HIV Infected Participants:

  • Acquired HIV through mother-to-child transmission

Inclusion criteria

for HIV Uninfected Participants:

  • HIV uninfected

Inclusion criteria

for All Participants:

  • 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

for HIV Infected Participants:

  • Acquired HIV through adult high-risk behavior, blood transfusion, or abuse

Exclusion criteria

for All Participants:

  • IQ of 69 or lower, for participants whose primary language is English. More information on this criterion can be found in the protocol.

Treatment and study plan

Psychiatric interviews

Behavioral

Measures and questionnaires regarding mental health, pain, and adherence to treatment. No actual treatment or intervention is given as part of this study.

Sponsors and collaborators

Lead sponsor

International Maternal Pediatric Adolescent AIDS Clinical Trials Group

Network

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Institute of Allergy and Infectious Diseases (NIAID)
  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Psychiatric Co-Morbidity in Perinatally HIV-Infected Children and Adolescents

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Jan 4, 2005
Registry last updated
Jan 21, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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.

Published trials that share one or more normalized conditions with this study.