HIV Infections Clinical Trial
Official title:
Compliance Enhancement In HIV/AIDS Patients
While anti-HIV drugs can significantly reduce viral loads, the medication regimens can be complex, and patients must take them correctly for the best effect. Nonadherent patients risk developing drug resistant HIV strains. The purpose of this study is to evaluate the effectiveness of a handheld computerized system designed to help patients take their drugs correctly.
As the use of protease inhibitors and other antiretroviral medications has increased,
multiple drug resistant HIV strains have emerged, demonstrating the need for improved
patient adherence to complex drug regimens. Individual computerized adherence systems have
been proposed as a mechanism for improving patient adherence. This study will utilize
advanced computer and communication technologies to produce a handheld (PDA) product for
HIV/AIDS patients. The system serves as a patient reminder system, addresses problems of
missed medications, and monitors severity of side effects. This study will evaluate the
efficacy of the system as an adherence intervention.
Participants in the study will be randomized to either the intervention or a control group.
Participants will use the PDA daily for medication reminders, alarms, adherence tracking,
and as a source of information on HIV/AIDS. The study will last 15 weeks. Each participant
will have 6 study interviews and 2 quality control interviews. Study interviews will include
adherence questionnaires, blood tests for viral load and CD4 data, and quality of life
assessments.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Primary Purpose: Treatment
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