Measurement of Adherence to ART in HIV-Infected Children in Uganda (The CHARTA Study)
Condition: HIV; HIV Infections
MeSH terms: HIV Infections
Study type: Observational

Summary: 
      This study will compare methods of determining whether HIV-infected children take their
      medications.
    

Detailed description: 
      HIV is a virus that weakens people's immune systems and can cause AIDS. Antiretroviral
      therapy (ART) is a treatment for HIV that combines different types of antiretroviral
      medications, but it must be taken throughout a person's life without missing doses to be
      effective. When people do miss doses, the HIV virus has an opportunity to develop resistance
      to the medications, making them less effective in the future. Reports indicate that as many
      as 50% of children infected with HIV who are living in resource-limited countries regularly
      miss doses of their ART. This study will test different methods for determining children's
      rates of adherence to ART medications. This will both define the exact magnitude of the
      problem and direct future efforts in increasing ART adherence in children.

      Participation in this study will last 12 months. All children enrolled will undergo a series
      of assessments of medication adherence. At baseline and every month over the course of the
      study, researchers will make unannounced home visits to measure the amount of medicine that
      remains untaken by participants and to record how many times the electronic cap on
      participants' medication bottles have been removed. Participants with cell phones will also
      receive monthly phone calls during which they will be asked to measure the amount of their
      medicine that remains untaken. At study entry and after 6 and 12 months, researchers will
      also examine child participants' medical records and the results of their regularly scheduled
      blood tests. At these blood tests, an additional half teaspoon of blood, which may be used in
      future testing, will be collected and stored by the researchers. After 3, 6, 9, and 12
      months, researchers will request to collect hair samples from child participants to test
      levels of HIV medications in the hair, but participation in this part of the study is
      optional.

      Assessments of reasons for medication adherence will also be performed. At study entry and
      after 3, 6, 9, and 12 months, children and their parents will complete questionnaires about
      their understanding of HIV medicines and HIV infection, motivation for the child to take
      medications, behaviors related to taking medications, and basic personal information. One and
      7 months after study entry, some parent participants will also complete interviews with study
      staff about giving HIV medicines to their children.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children recruited from the outpatient Children's HIV/AIDS Care Clinic at the Mbarara
        University Teaching Hospital in rural, southwestern Uganda
      
Biospecimen description: 
      Plasma samples to repeat HIV viral load testing, in the case of processing errors. If these
      samples are not needed, they may be used for immunologic or viral resistance testing at a
      future date.
    
Keywords: AIDS; Adherence to Antiretroviral Therapy; Pediatric; Resource Limited Setting; Treatment experienced