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

NCT00134602 | Completed

• 3 other identifiers: CDC-NCHSTP-3660U64/CCU219540U64/CCU319449
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

HIV infection, antiretroviral therapy, adherence, pediatric

Outcome Measures

Primary Outcomes (1)

• Improved adherence to antiretroviral treatment regimen

Secondary Outcomes (2)

• Improved viral load

• Improved CD4 count

Interventions

Needs assessment followed by tailored intervention BEHAVIORAL

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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.

Sponsors & Collaborators

• Centers for Disease Control and Prevention: lead
• Jacobi Medical Center: collaborator
• Children's National Research Institute: collaborator
• Howard University: collaborator

Study Sites (3)

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

Howard University Hospital, Department of Pediatrics

Washington D.C., District of Columbia, 20060, United States

Location

Jacobi Medical Center

The Bronx, New York, 10461, United States

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Andrew Wiznia, MD

  Jacobi Medical Center, Bronx, NY

  PRINCIPAL INVESTIGATOR

• Tamara Rakusan, MD

  Children's National Research Institute

  PRINCIPAL INVESTIGATOR

• Sohail Rana, MD

  Howard University Hospital, Pediatrics Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2005
• First Posted: August 25, 2005
• Study Start: April 1, 2003
• Primary Completion: January 1, 2007
• Study Completion: October 1, 2008
• Last Updated: September 27, 2012

Record last verified: 2012-09

Locations

US (3)