Adherence to antiretroviral medications is critically important for persons with HIV (PWHIV). The primary aim of this 5-year study based on social cognitive and self-efficacy theory proposes to compare the effect of two intervention groups (structured [ITs] and individualized [Tl]) relative to usual care on adherence to antiretroviral therapy over time. A sample of 300 PWHIV (plus 51 for attrition), taking antiretroviral therapy and without HIV dementia will be randomly assigned to one of three study arms. Ts will receive a 12 week structured telephone delivered intervention and a 3-month maintenance program; half will then be randomized to receive 3 boosters over the next 6 months. TI will receive a 12 week individualized telephone delivered intervention based on their self identified needs and a 3-month maintenance program; half will be randomized to receive 3 boosters over the next 6 months. The usual care group will receive their regular care. Data will be collected at baseline, post-treatment (3 months), post-maintenance (6 months), post-booster (12 months), and 6 months post-booster (18 months). Adherence will be assessed using electronic event monitors (primary measure), diaries, 4-day recall, the Self reported Medication-taking Scale, and missed appointments. Secondary aims will examine the effect of adherence on clinical response and quality of life. Exploratory aims will examine: 1) the mediating effect of self-efficacy on adherence, 2) the mediating effect of adherence on the relationship between self-efficacy and outcomes: clinical response and quality of life; 3) physiologic feedback (symptoms, perceived burden of medication regimen, substance abuse) and psychologic feedback (mood, personality characteristics, interpersonal relations, perceived stigma) as possible predictors of self-efficacy. Repeated measures analyses with specified contrasts will be used to test stated hypotheses (p less than or equal too .05, two-tailed). Longitudinal data analytic techniques will be used to examine the relationship between protocol assignment and adherence over time. A similar approach will be used for the secondary aims examining intervention effect on clinical response and quality of life. Exploratory aims will be examined using structural equation modeling.

Agency
National Institute of Health (NIH)
Institute
National Institute of Nursing Research (NINR)
Type
Research Project (R01)
Project #
5R01NR004749-07
Application #
6798680
Study Section
AIDS and Related Research 8 (AARR)
Program Officer
Hare, Martha L
Project Start
1998-09-30
Project End
2008-06-30
Budget Start
2004-07-01
Budget End
2005-06-30
Support Year
7
Fiscal Year
2004
Total Cost
$553,143
Indirect Cost
Name
University of Pittsburgh
Department
Miscellaneous
Type
Schools of Nursing
DUNS #
004514360
City
Pittsburgh
State
PA
Country
United States
Zip Code
15213
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