Pilot Study of SystemCHANGE-HIV

Sample: The study sample will include 40 HIV+ men and women. Inclusion criteria include: a
documented HIV diagnosis; adult (18 years old or greater); and English speaking.

Design: The SystemCHANGE-HIV study will be a 15-week, randomized, two-group experimental
design including a 10-week behavioral intervention. In the experimental group, one half of
the participants (n=20) will receive the intervention; and in the control group, the other
half of the participants will undergo usual care. Both the experimental and control group
will complete the same psychometric instrument packet, three times, to give a comparison of
self-management before and after intervention and at a four-week follow up visit. This
packet includes information on medical history, demographics, HIV self-management,physical
activity, social support, social capital, mental wellness, and quality of life.Additionally,
all participants will wear an actigraph for seven consecutive days, at each data collection
point, to assess sleep.

Analysis:Preliminary data analysis will include descriptive statistics and scatter plots to
examine the distribution of each outcome at each time point, as well as each covariate of
interest. Although our randomization scheme will ensure balance of baseline variables
between the two arms (other than that due to chance alone), we will estimate the
standardized magnitude of each baseline difference as well as the correlation between each
baseline variable and each outcome of interest at 10 weeks or at 15 weeks to objectively
determine baseline variables that will be needed to estimate the unbiased effect of the
intervention on each outcome. The primary analysis will be based on intent to treat approach
and will investigate the effect of the intervention on continuous outcomes at 10 weeks or 15
weeks. In particular, an ANCOVA model will be used that adjusts for treatment arm and the
baseline level of the outcome variable. Such a model will allow us to estimate the effect of
the intervention on each outcome, adjusting for the baseline outcome.In addition, linear
mixed models will be used to determine if the effect of the intervention on the outcome at
10 weeks differs from the effect of the intervention on the outcome at 15 weeks. If needed,
all analyses will be repeated using an as-treated approach. All analyses will be performed
using a two-sided significance of 0.05.