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
  Purpose

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
HIV Infections

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Quality of Life in Children With HIV Infection

Resource links provided by NLM:


Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • Quality of Life assessment [ Time Frame: 1999 ] [ Designated as safety issue: No ]

Enrollment: 1993
Study Start Date: September 2001
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   10 Months to 25 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
Principal Investigator: Deborah S. Storm, MSN, PhD School of Nursing, Rutgers, The State University of New Jersey
  More Information

No publications provided

Responsible Party: Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
ClinicalTrials.gov Identifier: NCT00075153     History of Changes
Other Study ID Numbers: 1-R01-NR007975-01, R01NR007975
Study First Received: January 2, 2004
Last Updated: April 21, 2014
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on August 21, 2014