2.2. Procedure
All interested participants called a screening line to ensure that
they met the inclusion criteria between November 2010 and January
2011. Those meeting inclusion criteria were scheduled to attend an initial appointment with a research assistant. At this initial appointment,
participants completed an informed consent document and
received instructions on how to use an actigraph and sleep diary for
the next 7 days. An actigraph device is worn on the wrist and contains
an accelerometer that detects movement from which sleep/wake
state can be determined using an algorithm that has been validated
against EEG measures of sleep and wake time (Blackwell, 2005). Upon
correct demonstration of each tool the participants were sent home
the actigraph device to wear and the diary to complete. At the end of
1 week, the participants returned with the actigraphs, completed
sleep diaries, and completed a pen and paper survey (described
below). Following these baseline assessments, participants were
randomized to either a behavior intervention or a standard treatment
control group using block randomization with randomly chosen block
sizes of 2 and 4. A flow chart of study procedures is provided in Fig. 1.
Participants were paid $50 for completion of their assessments (per
assessment). Those randomized to the intervention group immediately
began the first intervention session and those randomized to the
control group received a copy of the HIV Symptom Management
Strategies: A Manual for People Living with HIV/AIDS. The participants
in the control group were orientated on how to use the manual by a
research assistant, and then were instructed to return in 10 weeks
(Wantland et al., 2008). The intervention group was reminded to
come to each session by a weekly phone call from the study staff. After
10 weeks both groups were called and reminded to come to the
follow up assessment. All study visits occurred at a convenient
community-based setting and all study procedures occurred between
February and June 2011. This study was registered at clinicaltrials.gov
with the trial registration number NCT01256814.