HIV Infection Clinical Trial
Official title:
Improving Antiretroviral Medication Adherence Among HIV-infected Youth: Phase I
HIV is increasing among adolescents and young adults in the US. Antiretroviral medications,
when taken correctly (≥90% of prescribed doses taken), can vastly improve life expectancy.
However, adherence among HIV-infected young people is suboptimal, and few interventions are
available to help adolescents adhere to treatment.
The first phase of the study is an intervention development phase, which includes conducting
interviews with 40 HIV-infected youth for input on the adaptation of the approach. The
information obtained from the qualitative interviews is used to adapt the Life-Steps
intervention (designed by our group for HIV-infected adults) to be responsive to the needs
of HIV-infected adolescents, with acceptability of topics and content, and feasibility of
intervention delivery to be tested in an open pilot trial.
This phase of the protocol focuses on setting up the infrastructure necessary for conducting
the study, including hiring and training activities with study staff. This time will be
spent conducting interviews and using these data to inform the development of the
intervention protocol and adaptation of all Life-Steps intervention materials, including
study assessment instruments, for HIV-infected youth.
The interview is a one-time event and will last for 1.5-2 hours. It has two components: a
quantitative assessment and a qualitative discussion. After all participants have completed
the informed consent and assent (if under the age of 18) processes, the research staff will
administer a brief quantitative assessment that will ask questions related to demographics,
medication adherence, sexual risk, substance use, and psychosocial condition. The second
part of the interview will be an open discussion. The interviews will be conducted by a
trained member of the research staff. The interviews will be informed by a pre-determined
qualitative topic guide.
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