Psychiatric Problems in Children and Adolescents Infected With HIV at Birth
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Purpose
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.
| Condition | Intervention |
|---|---|
|
HIV Infections Mental Disorders |
Behavioral: Psychiatric interviews |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Psychiatric Co-Morbidity in Perinatally HIV-Infected Children and Adolescents |
| Estimated Enrollment: | 800 |
| Study Start Date: | April 2005 |
| Study Completion Date: | September 2006 |
| Primary Completion Date: | September 2006 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
1
All HIV infected and uninfected participants and their caregivers.
|
Behavioral: 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.
|
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.
Eligibility| Ages Eligible for Study: | 6 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Children and their caregivers from specific clinics.
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.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00100542
Show 32 Study Locations
| Study Chair: | Sharon Nachman, MD | Department of Pediatrics, Stony Brook University |
More Information
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Wende Levy, IMPAACT |
| ClinicalTrials.gov Identifier: | NCT00100542 History of Changes |
| Other Study ID Numbers: | PACTG P1055, U01AI068632 |
| Study First Received: | January 3, 2005 |
| Last Updated: | January 20, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by International Maternal Pediatric Adolescent AIDS Clinical Trials Group:
|
Treatment Experienced Treatment Naive Psychopathology |
Anti-Retroviral Agents Child Adolescent |
ClinicalTrials.gov processed this record on March 03, 2015