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Quality of Life in Children With HIV Infection

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ClinicalTrials.gov Identifier: NCT00075153
Recruitment Status : Completed
First Posted : January 8, 2004
Last Update Posted : April 22, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease
HIV Infections

Detailed Description:
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.

Study Design

Study Type : Observational
Actual Enrollment : 1993 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Quality of Life in Children With HIV Infection
Study Start Date : September 2001
Primary Completion Date : July 2008
Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Quality of Life assessment [ Time Frame: 1999 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Months to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children and youth, from birth to 25 years, with perinatally acquired HIV infection enrolled in PACTG 219/219C
Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00075153


Locations
United States, New Jersey
University of Medicine and Dentistry of NJ
Newark, New Jersey, United States, 07103
Sponsors and Collaborators
University of Medicine and Dentistry of New Jersey
National Institute of Nursing Research (NINR)
Investigators
Principal Investigator: Deborah S. Storm, MSN, PhD School of Nursing, Rutgers, The State University of New Jersey
More Information

Responsible Party: University of Medicine and Dentistry of New Jersey
ClinicalTrials.gov Identifier: NCT00075153     History of Changes
Other Study ID Numbers: 1R01NR007975-01 ( U.S. NIH Grant/Contract )
R01NR007975 ( U.S. NIH Grant/Contract )
First Posted: January 8, 2004    Key Record Dates
Last Update Posted: April 22, 2014
Last Verified: April 2014

Keywords provided by Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey ):
ADOLESCENCE
HIV INFECTION
PEDIATRIC AIDS
QUALITY OF LIFE
HIV

Additional relevant MeSH terms:
Infection
Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases