Pediatric Impact: Promoting Adherence to Medications Among HIV-infected Children
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional

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.
    

Detailed description: 
      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.
    

Intervention name(s): Needs assessment followed by tailored intervention
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV infection, antiretroviral therapy, adherence, pediatric