Quality of Life in Children With HIV Infection

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
ClinicalTrials.gov Identifier:
NCT00075153
First received: January 2, 2004
Last updated: April 21, 2014
Last verified: April 2014

January 2, 2004
April 21, 2014
September 2001
July 2008   (final data collection date for primary outcome measure)
Quality of Life assessment [ Time Frame: 1999 ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00075153 on ClinicalTrials.gov Archive Site
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Quality of Life in Children With HIV Infection
Quality of Life in Children With HIV Infection

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Retrospective
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Non-Probability Sample

Children and youth, from birth to 25 years, with perinatally acquired HIV infection enrolled in PACTG 219/219C

HIV Infections
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1993
July 2008
July 2008   (final data collection date for primary outcome measure)

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

Both
10 Months to 25 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00075153
1-R01-NR007975-01, R01NR007975
No
Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
University of Medicine and Dentistry of New Jersey
National Institute of Nursing Research (NINR)
Principal Investigator: Deborah S. Storm, MSN, PhD School of Nursing, Rutgers, The State University of New Jersey
Rutgers, The State University of New Jersey
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP