Improving Antiretroviral Medication Adherence Among HIV-infected Youth

The research will lay the groundwork for a randomized controlled trial (RCT) of a behavioral
intervention to improve medication adherence among HIV-infected youth, and will allow us to
determine whether the eventual intervention would have similar content and structure across
risk groups with varied sexual identities [lesbian, gay, or bisexual (LGB) versus
heterosexually identified]. To maximize our chances of obtaining NIH funding to conduct an
RCT, pilot data are essential. The first 2 months will be an intervention development phase,
which will include conducting interviews with 40 adolescents for input on the adaptation of
the approach. The information obtained from the qualitative interviews will be 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. The next 9 months
will be a feasibility pilot among 20 HIV-infected youth (10 LGB and 10 heterosexual). The
study will allow us to demonstrate participant acceptance, ability to recruit, feasibility
of intervention delivery with study counselors and all study procedures, and initial
clinically significant improvement in medication adherence via MEMS caps. These goals are
consistent with guidelines for a staged model of behavioral intervention development.1 For
all aspects of study implementation, Drs. Mimiaga (PI - MGH), Bogart (PI - CHB), Safren
(Co-I), and Skeer (Co-I) will be involved, contributing their complementary,
interdisciplinary skills to the project. The study team will also include as Investigators
Dr. Sandra Burchett (Clinical Director, Children's Hospital AIDS Program, Division of
Infectious Disease) and Dr. Catherine Samples (Director of the Boston HAPPENS program,
Division of Adolescent Medicine), who lead HIV clinical services at Children's Hospital
Boston.