Abstract
The efficacy of potent regimens combining antiretroviral medications has resulted in remarkable improvement in the treatment of HIV. Consequently, persons living with HIV now have the potential for many more productive years of life. Yet many persons fail to achieve maximum benefit from antiretroviral therapy because of suboptimal medication adherence. Additional research is needed to identify the most efficacious intervention components and the best methods for implementing them in real-world settings with limited resources.
The overall purpose of this study is to implement and evaluate an intervention delivered by nurses from a central site that is expected to enhance antiretroviral medication adherence among ACTG participants on first antiretroviral regimen who report less than perfect adherence. The intervention is theory based and designed to provide patients with information, skills, and affective support to enhance comprehension of the ARV medication regimen, realistically prepare them for the experience (especially side effect), and enable them to recognize, self-mange and effectively solve problems that threaten adherence over time.
A randomized design will be used with two treatment arms (enhanced telephone support and usual care). All participants will be randomized at baseline. One hundred and ninety participants will enter the study. HIV-1 infected men and women aged 18 years or older receiving their first antiretroviral therapy regimen, reporting <100% adherence and an HIV RNA-1<200 will be allowed to co-enroll (i.e. 5202 and 5231). Follow-up visits will be coordinated to coincide with the parent studies. Adherence will be measured using Medication Event Monitoring system (MEMS) caps and self reports collected at baseline and every 12 weeks post randomization. The primary endpoint will be time to virologic failure.
The duration of project is 5 years. Enrollment will be completed during the first 2 years. Subjects will be followed for an additional 2 years after the last subject is enrolled. Identifying measures to improve adherence to antiretroviral regimens constitutes an important health care priority. If successful, this study will further an understanding of adherence behavior and provide a convenient, clinically practical, cost-effective adherence intervention that is personalized and appropriate to the unique problems of diverse population of persons living with HIV.
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