Pediatric Impact: Promoting Adherence to Medications Among HIV-infected Children
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00134602|
Recruitment Status : Completed
First Posted : August 25, 2005
Last Update Posted : September 27, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Behavioral: Needs assessment followed by tailored intervention||Not Applicable|
The objective of this research is to develop and evaluate an intervention to promote adherence to HIV-medications among children aged 5-12 years. The research will be conducted at Jacobi Medical Center in the Bronx, NY; Children's National Medical Center in Washington, DC; and at Howard University Hospital in Washington, DC. The research will employ a randomized case control study design. Participants (dyads composed of an HIV-infected child and his/her primary caregiver) will be recruited from eligible families within each site's HIV clinic. After the study is explained and informed consent and assent (where applicable) are obtained, participants will be randomly assigned to either the enhanced intervention group (cases) or the minimal intervention group (controls). Participants assigned to the enhanced intervention group will receive a multi-component intervention, specifically tailored to their family's needs, which includes a maximum of 24 hours of contact conducted over a period of up to 12-weeks, and a 1-3 hour booster session approximately six weeks after the intervention phase is completed.
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Intervention to Promote Adherence to Antiretroviral Medications Among HIV-infected Children 5-12 Years of Age|
|Study Start Date :||April 2003|
|Actual Primary Completion Date :||January 2007|
|Actual Study Completion Date :||October 2008|
- Improved adherence to antiretroviral treatment regimen
- Improved viral load
- Improved CD4 count
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00134602
|United States, District of Columbia|
|Children's National Medical Center|
|Washington, District of Columbia, United States, 20010|
|Howard University Hospital, Department of Pediatrics|
|Washington, District of Columbia, United States, 20060|
|United States, New York|
|Jacobi Medical Center|
|Bronx, New York, United States, 10461|
|Principal Investigator:||Andrew Wiznia, MD||Jacobi Medical Center, Bronx, NY|
|Principal Investigator:||Tamara Rakusan, MD||Children's Research Institute|
|Principal Investigator:||Sohail Rana, MD||Howard University Hospital, Pediatrics Department|