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CompletedNCT00075153Updated Apr 22, 2014

Quality of Life in Children With HIV Infection

An observational study in HIV Infections, sponsored by University of Medicine and Dentistry of New Jersey. Completed at 1 site in United States. Open to participants aged 10 Months to 25 Years. Per ClinicalTrials.gov, last updated 2014-04-22.

Sponsored by University of Medicine and Dentistry of New Jersey · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
1,993
Ages
10 Months to 25 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • HIV Infections

Keywords

  • ADOLESCENCE
  • HIV INFECTION
  • PEDIATRIC AIDS
  • QUALITY OF LIFE
  • HIV
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In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 1,993 is above the median of 240 across 2,136 observational studies indexed under Infections.

Browse Infections studies →

Lead sponsor

University of Medicine and Dentistry of New Jersey is the lead sponsor of 103 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
10 Months to 25 Years
Sexes eligible
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

Inclusion criteria

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

Exclusion criteria

Exclusion criteria

--HIV exposed, not infected

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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
1,993 participants (actual)
06

What researchers measure

Primary outcomes

  1. Quality of Life assessment

    Time frame: 1999

07

Study locations

1 site
  • University of Medicine and Dentistry of NJ
    Newark, New Jersey 07103, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 22, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00075153
Lead sponsor
University of Medicine and Dentistry of New Jersey
Collaborators
National Institute of Nursing Research (NINR)
Responsible party
Sponsor
First posted
Jan 8, 2004
Start date
Sep 2001
Primary completion
Jul 2008
Completion
Jul 2008
Last update
Apr 22, 2014

Study contacts

Deborah S. Storm, MSN, PhD
principal investigator · School of Nursing, Rutgers, The State University of New Jersey

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.

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