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Pediatric Impact: Promoting Adherence to Medications Among HIV-infected Children

NCT00134602 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2012-09-27

No results posted yet for this study

Summary

The purpose of the study is to develop and evaluate an intervention to promote adherence to HIV medications among children 5-12 years of age. It compares changes in antiretroviral (ARV) adherence between the EIG (enhanced intervention group) and an MIG (minimal intervention group) from baseline to 4 months post-intervention.

Secondary outcomes include examining whether improvement in adherence to a medication regimen is associated with improved health outcomes (i.e., viral load, CD4 counts, etc.); identifying and evaluating predictors and/or mediators of adherence; studying the feasibility of electronic recording in measuring adherence in an HIV-infected pediatric population; and evaluating the relationship between the amount of intervention received (i.e., number of hours/number of sessions) and changes in adherence.

Conditions

  • HIV Infections

Interventions

BEHAVIORAL

Needs assessment followed by tailored intervention

Sponsors & Collaborators

Principal Investigators

  • Andrew Wiznia, MD · Jacobi Medical Center, Bronx, NY

  • Tamara Rakusan, MD · Children's National Research Institute

  • Sohail Rana, MD · Howard University Hospital, Pediatrics Department

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-04-30
Primary Completion
2007-01-31
Completion
2008-10-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00134602 on ClinicalTrials.gov