Typology of Adherence in Adolescents: Phase II
Condition: HIV Infection
MeSH terms: HIV Infections
Study type: Observational

Summary: 
      A number of factors influence HIV-positive adolescents' acceptance of and willingness to
      continue taking anti-HIV medicines. These factors include mental health and substance abuse
      issues, barriers such as lack of medical insurance, and cognitive-behavioral barriers (such
      as a person's impression of the impact of the medicines on his/her health and a person's
      sense of his/her ability to continue taking the medications prescribed). The purpose of this
      study is to use a survey to determine how common specific barriers are that prevent HIV
      positive adolescents from taking their anti-HIV medicines and if those barriers cluster
      together. The information collected will be used to develop and validate a schema for
      classifying HIV medication adherence by barriers to adherence or clusters of barriers to
      adherence. This classification schema could then be used in the development of interventions
      that better meet the needs of HIV-infected youth.
    

Detailed description: 
      As more HIV-infected adolescents are identified and linked into care, the dyad of medication
      and medication adherence continues to be an issue for both the provider and the patients.
      Thus, developing a strategy to assess adherence and barriers to adherence in this population
      is integral so that interventions can be targeted towards adolescents' specific needs. Our
      operating premise is that the issue of drug adherence is multi-factorial and that
      interventions that combine a variety of modalities may be preferred. However, before such
      interventions can be developed, we must first develop a tool that can be used to assess
      medication adherence and to identify barriers to medication adherence in this population.

      This is a cross-sectional survey designed to assess the most prevalent combination of
      barriers to HIV medication adherence in adolescents. Specific barriers focused on in this
      study include mental health disorders, substance abuse, and cognitive-behavioral and
      structural barriers. In this Phase II study, the Adherence Staging Algorithm and the
      Participant Assessment Tool, pilot tested and modified based on findings from Phase I of the
      study, will be used to determine the prevalence of the specific barriers to adherence among
      HIV-infected youth requiring antiretroviral medication and the most common clusters of
      specific barriers. A cognitive-behavioral barriers schema for classifying HIV medication
      adherence in adolescents will be developed and validated.

      The study consists of a one-time visit with a face-to-face interview to complete two
      questionnaires: the Adherence Staging Algorithm to classify the subject's adherence to
      his/her prescribed medications, and the Participant Assessment Tool to assess the prevalence
      of barriers to adherence that the subjects may have experienced. The interview takes no more
      than 30 minutes. In addition, the patient's medical record will be reviewed for HIV-related
      clinical data such as viral load, CD4, history of medications prescribed, and barriers the
      patient may have experienced such as mental health or substance abuse problems.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The study population will consist of HIV-infected youth who are eligible for antiretroviral
        therapy (ART) based on the US Public Health Service (PHS) guidelines and have been offered
        and/or prescribed HAART by their healthcare provider. Subjects aged 12 through 24 years old
        will be recruited from youth engaged in care at the fifteen ATN clinical sites located
        across the United States and in Puerto Rico. Youth engaged in care at selected non- ATN
        clinic centers will also be offered the opportunity to participate in this study.
      
Keywords: HIV; Antiretroviral therapy (ART); HAART; Adherence; Barriers