Pediatric Impact: Promoting Adherence to Medications Among HIV-infected Children
NCT ID: NCT00134602
Last Updated: 2012-09-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
180 participants
INTERVENTIONAL
2003-04-30
2008-10-31
Brief Summary
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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.
Detailed Description
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The enhanced intervention will be coordinated by an onsite Adherence Coordinator (AC) and implemented primarily by the AC or another member of the study staff. Participants assigned to the comparison group will receive a minimal intervention that will consist of an educational video and health education pamphlets about general health. All participants will continue to receive the standard-of-care at their respective sites during the study period. Assessments of all participants will be done at baseline (Assessment A), 1 month (Assessment B), and 4 months (Assessment C) following the intervention. Each assessment will include an interview to collect the following information from families:
* socio-demographic data;
* parental/child report of child's medication taking or adherence (self-reported adherence);
* mental health functioning (of parents and child, using standardized measures);
* HIV (of parents) and medication knowledge (of parents and child);
* medical review of child's hospital chart.
The baseline assessment of adherence to medications will include electronic recording of medication taking via a MEMS® cap done over a four-week period. Ongoing electronic assessment of adherence will occur for the duration of the study. Pharmacy refill data will also be obtained for a portion of the study participants for whom data are available.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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Needs assessment followed by tailored intervention
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
5 Years
12 Years
ALL
No
Sponsors
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Jacobi Medical Center
OTHER
Children's National Research Institute
OTHER
Howard University
OTHER
Centers for Disease Control and Prevention
FED
Responsible Party
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Principal Investigators
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Andrew Wiznia, MD
Role: PRINCIPAL_INVESTIGATOR
Jacobi Medical Center, Bronx, NY
Tamara Rakusan, MD
Role: PRINCIPAL_INVESTIGATOR
Children's National Research Institute
Sohail Rana, MD
Role: PRINCIPAL_INVESTIGATOR
Howard University Hospital, Pediatrics Department
Locations
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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
Countries
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Other Identifiers
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U64/CCU219540
Identifier Type: -
Identifier Source: secondary_id
U64/CCU319449
Identifier Type: -
Identifier Source: secondary_id
CDC-NCHSTP-3660
Identifier Type: -
Identifier Source: org_study_id