The current antiretroviral regimens including protease inhibitors are quite efficacious in suppressing viral replication and decreasing morbidity and mortality. However, if adherence is suboptimal, it is presumed that viral titers will rebound and the risk of developing resistant virus increases. Adherence has long been a difficult issue in clinical medicine, and the understanding of adherence to therapy in HIV is limited. Furthermore, randomized clinical trials to improve adherence to therapy have been few, and none have been done in HIV. This project consists of two phases, an observational cohort study and a randomized clinical trial, designed to address the problem of adherence to therapy.
The specific aims of Phase I are: 1) to determine the magnitude of the difference in fraction of prescribed doses taken between individuals who do and do not maintain viral titers below the limit of quantification, 2) to assess the relationship between a priori defined adherence summary statistics (adherence descriptor variables) and virological outcomes, and 3) to determine the demographic and psychosocial characteristics of patients that are associated with poor adherence, as defined by the adherence descriptor variables identified in Aims l and 2 to be clinically relevant. Adherence will be monitored using state-of- the-art microelectronic monitoring of pill taking. Phase II is a 2x2 factorial design randomized clinical trial to test whether a beeper based mnemonic aide, a case management intervention or both improve adherence to antiretroviral therapy (Aim 4). The case manager approach is based on social problem solving, as refined by Nezu, Nezu and Perri for the treatment of depression. The mnemonic aide is a beeper located in the microelectronic monitoring device. A secondary aim of this phase is to reassess the results of Aim 2 using the subjects in the randomized clinical trial as a validation cohort (Aim 5). The short-term objectives of this project are to define the clinically relevant adherence summary statistics in HIV therapy and to identify the risk factors for exhibiting poor adherence. The long-term objective is to test two different strategies, one individually targeted (case manager) and the other broad based (mnemonic aide), to determine if these interventions can improve adherence, and ultimately, clinical outcome in HIV.

Agency
National Institute of Health (NIH)
Institute
National Institute of Mental Health (NIMH)
Type
Clinical Investigator Award (CIA) (K08)
Project #
5K08MH001584-02
Application #
6185615
Study Section
Special Emphasis Panel (ZRG1-AARR-8 (01))
Program Officer
Gordon, Christopher M
Project Start
1999-09-15
Project End
2004-08-31
Budget Start
2000-09-01
Budget End
2001-08-31
Support Year
2
Fiscal Year
2000
Total Cost
$140,624
Indirect Cost
Name
University of Pennsylvania
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
042250712
City
Philadelphia
State
PA
Country
United States
Zip Code
19104
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Petersen, Maya L; LeDell, Erin; Schwab, Joshua et al. (2015) Super Learner Analysis of Electronic Adherence Data Improves Viral Prediction and May Provide Strategies for Selective HIV RNA Monitoring. J Acquir Immune Defic Syndr 69:109-18
Simoni, Jane M; Huh, David; Wang, Yan et al. (2014) The validity of self-reported medication adherence as an outcome in clinical trials of adherence-promotion interventions: Findings from the MACH14 study. AIDS Behav 18:2285-90
Wilson, Ira B; Bangsberg, David R; Shen, Jie et al. (2013) Heterogeneity among studies in rates of decline of antiretroviral therapy adherence over time: results from the multisite adherence collaboration on HIV 14 study. J Acquir Immune Defic Syndr 64:448-54
Simoni, Jane M; Huh, David; Wilson, Ira B et al. (2012) Racial/Ethnic disparities in ART adherence in the United States: findings from the MACH14 study. J Acquir Immune Defic Syndr 60:466-72
Genberg, Becky L; Wilson, Ira B; Bangsberg, David R et al. (2012) Patterns of antiretroviral therapy adherence and impact on HIV RNA among patients in North America. AIDS 26:1415-23
Wagner, Glenn J; Goggin, Kathy; Remien, Robert H et al. (2011) A closer look at depression and its relationship to HIV antiretroviral adherence. Ann Behav Med 42:352-60
Acri, Trisha; TenHave, Thomas R; Chapman, Jennifer C et al. (2010) Lack of association between retrospectively collected pharmacy refill data and electronic drug monitoring of antiretroviral adherence. AIDS Behav 14:748-54
Bachhuber, Marcus; Bilker, Warren B; Wang, Hao et al. (2010) Is antiretroviral therapy adherence substantially worse on weekends than weekdays? J Acquir Immune Defic Syndr 54:109-10
Acri, Trisha L; Grossberg, Robert M; Gross, Robert (2010) How long is the right interval for assessing antiretroviral pharmacy refill adherence? J Acquir Immune Defic Syndr 54:e16-8

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