Typology of Adherence in Adolescents: Phase II

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.

Inclusion Criteria:

- Between the ages of 12 years and 24 years

- Eligible for ART (antiretroviral therapy) based on US Public Health Service
guidelines

- Have been offered and/or prescribed HAART (highly active antiretroviral therapy)

- Ability to give informed consent or assent with parental permission, where required

Exclusion Criteria:

- Infected with HIV but do not require ART

- Started HAART but stopped due to medical reasons, (e.g., change in medication
guidelines, toxicity, resistance, etc.)

- Females prescribed/receiving HAART for the purpose of preventing mother-to-child
transmission