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

Completed · Not applicable

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00134602

Run by

Centers for Disease Control and Prevention

People needed

180

Starts

2003-04-01

Expected to finish

2008-10-01

Last updated by the study team

2012-09-27

Who can join

Age: 5 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Families with a child between the ages of 5 and 12 years old who is HIV-infected and who receives care at participating hospitals
• Informed consent for and assent from the child
• Informed consent for the primary caregiver (person responsible for most of the child's medication delivery) must be obtained. The parent/legal guardian must be able to give informed consent and willing to comply with protocol requirements.
• The HIV-infected child must be currently prescribed an antiretroviral therapy regimen.

You may not qualify if…

• The child or caregiver cannot respond to self-report questions because of cognitive impairments.
• The child receives home health care in which the home health care aide dispenses all of the child's medication (essentially resulting in directly observed therapy for that child).
• The child and/or the caretaker does not speak English or Spanish.

Where it is running

• Children's National Medical Center — Washington D.C., District of Columbia, United States
• Howard University Hospital, Department of Pediatrics — Washington D.C., District of Columbia, United States
• Jacobi Medical Center — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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