Quality of Life in Children With HIV Infection

NCT ID: NCT00075153

Last Updated: 2014-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1993 participants

Study Classification

OBSERVATIONAL

Study Start Date

2001-09-30

Study Completion Date

2008-07-31

Brief Summary

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The purpose of this study is to characterize the quality of life (QOL) and longitudinal patterns of change in QOL outcomes in children and youth with HIV infection; to identify demographic, social, disease status, treatment, and health care utilization factors that predict longitudinal changes in outcomes; to develop a conceptual model that characterizes the effects of specific factors that predict longitudinal changes in QOL; and to characterize the influence of HIV symptoms on QOL outcomes in the domains of health perceptions, physical, psychological, and social role functioning.

Detailed Description

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This is a Phase III study. This study will use national data available through a prospective, observational, longitudinal study of children and youth (n=1,993) from birth to 25 with HIV infection (Pediatric AIDS Clinical Trials Group Protocol 219/219C) to develop knowledge about the quality of life (QOL) and the factors that affect it in order to be able to implement effective nursing interventions and clinical programs to support and improve QOL in this vulnerable population of children.

Conditions

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HIV Infections

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Children and youth with perinatally acquired HIV infection
* Enrolled in PACTG 219/219C
* Completed quality of life assessment

Exclusion Criteria

--HIV exposed, not infected
Minimum Eligible Age

10 Months

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Nursing Research (NINR)

NIH

Sponsor Role collaborator

University of Medicine and Dentistry of New Jersey

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Deborah S. Storm, MSN, PhD

Role: PRINCIPAL_INVESTIGATOR

School of Nursing, Rutgers, The State University of New Jersey

Locations

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University of Medicine and Dentistry of NJ

Newark, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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R01NR007975

Identifier Type: NIH

Identifier Source: secondary_id

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1R01NR007975-01

Identifier Type: NIH

Identifier Source: org_study_id

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