This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator.Antiretroviral therapy (ART) has enormous promise for reducing Human Immunodeficiency Virus (HIV)-related morbidity and mortality, but ART regimens are often complex, prone to side effects, and expensive, and ART adherence is often extremely poor. The individual and public health consequences of suboptimal ART adherence are significant and include treatment failure, viral load increase, immune compromise, development of multidrug resistant (MDR) HIV, and potential transmission of drug resistant HIV to uninfected others. Although the consequences of suboptimal ART adherence are well-recognized, ART adherence promotion efforts in clinical settings are typically intermittent and ad hoc. When adherence promotion interventions are systematically implemented in clinical care settings, they almost always involve exceedingly time-, cost-, and labor-intensive one-on-one counseling procedures that cannot be widely deployed to assist substantial numbers of HIV+ patients to adhere to ART over time. Moreover, to date, relatively few theoryART adherence promotion interventions have been conducted, rigorously evaluated, and found to be effective in increasing ART adherence. The present research employs a well-validated conceptualization of health behavior change, the Information-Motivation-Behavioral Skills (IMB) model (J. Fisher & Fisher, 1992, 2000, 2002; W. Fisher & Fisher, 1993, 1999; W. Fisher et al., in press), as a basis for the design and implementation of a cost-, time- and labor-efficient, completely individualized and engaging, computer-assisted ART adherence promotion intervention. The intervention we propose will be employed on an ongoing basis in the context of routine clinical care, to teach adherence enhancement strategies to HIV+ patients about to begin ART, and to increase adherence and maintenance of adherence among HIV+ patients currently on ART. The proposed research has four specific aims:1. We will conduct elicitation research with HIV+ patients in clinical care and with HIV care clinicians, to explore the dynamics of ART nonadherence in the HIV+ clinical population, and to identify the optimal structure and content of a theory-based, computer-assisted ART adherence intervention linked to clinical care visits. Elicitation research findings will be systematically integrated to guide the development of the intervention and to increase its ecological validity by adapting it to the dynamics of ART nonadherence among clinic patients, and to the realities of real-life clinical settings.2. Based on elicitation research findings, guided by the IMB model, and employing motivational interviewing (MI) techniques as an intervention delivery system, we will design, pilot test, refine, and fully implement a theory-based, computer-assisted ART adherence intervention that is linked to naturally occurring HIV clinical care. 3. We will conduct rigorous intervention outcome research comparing the effects of the ART adherence intervention with an appropriate standard-of-care control group with respect to multiple measures of adherence collected over 18 months. Rates of adherence, estimated by three types of indicators (self-reports of adherence to medication, pharmacy refill records, and viral load assessments) will be collected over an 18 month period and will serve as the major outcomes of interest. We hypothesize that participants in the intervention condition will demonstrate better adherence, as defined by greater gains in absolute values of the adherence indicators noted above and by a larger proportion of participants who experience success in achieving and sustaining clinically optimal levels of adherence (e.g., 95%), compared to those in the control condition. Additionally, we predict that individuals who use the intervention training arm component before beginning ART will demonstrate better initial degrees of adherence, compared to controls. Finally, we predict that changes in adherence as a result of the intervention will be mediated by intervention effects on ART adherence information, motivation, and behavioral skills.4. We will use the standard-of-care control group from the intervention outcome research as a no-cost cohort for a longitudinal natural history study of ART adherence in HIV+ patients. We will test putative proximal determinants of adherence to therapy, including levels of adherence-related information, motivation, and behavioral skills. We will also test the influence on adherence of subjective and objective health status, substance use, depressed mental health functioning, changing ART regimens, development of new drugs, and other historical events that may occur over the course of the study. We hypothesize that ART adherence will be predicted longitudinally by ART adherence related information, motivation, and behavioral skills. We also hypothesize that longitudinal trends in adherence will be influenced by factors such as substance use, mental health functioning, and historical events.
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