Completed

Quality of Life in Children With HIV Infection

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What is being collected

Data Collection

Collected from past medical records and data - Retrospective
Who is being recruted

HIV Infections

From 10 Months to 25 Years

See all eligibility criteria

How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: September 2001

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Summary

Principal SponsorUniversity of Medicine and Dentistry of New Jersey
Last updated: April 22, 2014
Sourced from a government-validated database.Claim as a partner
Study start date: September 1, 2001Actual date on which the first participant was enrolled.

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.

Official TitleQuality of Life in Children With HIV Infection 
Principal SponsorUniversity of Medicine and Dentistry of New Jersey
Last updated: April 22, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
1993 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Cohort
These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

How participants are selected
Participants are selected without using randomization. They may be chosen based on convenience, access, or willingness to participate. This approach is common when random selection isn’t practical.
Another way to select participants is through a probability sample, where participants are chosen randomly, so everyone has an equal chance to be included.

How information is collected
Researchers use data that has already been collected in the past, often through medical records or historical databases. This helps identify potential patterns or risk factors after outcomes have already occurred.Other Ways to Collect Data
Prospective: These studies collect new data moving forward over time.
Cross-sectional: These studies collect data at one single point in time.
Others: Some studies use a mix of approaches or less common designs depending on the research goal.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 10 Months to 25 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
HIV Infections
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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives
Study Objectives
Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
University of Medicine and Dentistry of NJNewark, United StatesSee the location
CompletedOne Study Center