HIV Infections Clinical Trial
Official title:
Adherence Strategies Using a Medication Manager and an Electronic Medication Reminder System for HIV-Infected Patients Receiving HAART
The purpose of this study is to look at different ways to help patients follow their
anti-HIV medication schedules.
It is very important that HIV-positive patients take their anti-HIV medications correctly so
they get the best possible benefit from them. Taking the drugs correctly, called
"adherence," may keep HIV virus levels in the blood (viral load) low for a longer time.
However, anti-HIV medication schedules are often complicated, and many patients have
difficulty remembering to take their drugs at the correct time. This study will look at 2
different ways to teach patients about the importance of taking their medications correctly
and to remind them when to take their medications.
Adherence to antiretroviral (AR) therapy has become increasingly important in the management
of HIV infection. Adherence to AR regimens is thought to be a critical factor in maintaining
therapeutic drug levels, thus helping ensure viral suppression and minimizing the risk of
drug resistance. However, AR regimens are often complex with demanding dosing schedules.
Patients often miss doses because they simply forget; other factors such as substance abuse,
depression, and low literacy levels also contribute to nonadherence. Adherence is influenced
not only by individual behavior but also by the services, the quality of the
patient-provider relationship, and the amount of social support offered the patient. There
is no currently agreed upon, widely used, and generalizable intervention for improving
adherence over the long course of HIV therapy. This study provides a long-term comparative
evaluation of two interventions.
Clinical sites, rather than individual patients, are randomized to one of four groups: a
medication manager, an electronic medication reminder system, a medication manager plus an
electronic medication reminder system, or usual care. Special training sessions are held for
the staff of participating units assigned to medication manager and/or electronic medication
reminder system interventions. The medication manager is a research staff member who works
individually with study patients, addressing the knowledge, motivation, and skills necessary
for adherence. The electronic medication reminder system is ALR (A Little Reminder). This is
a small, portable alarm that is programmed to sound and flash at the times of the patient's
scheduled AR medication doses. Patients enrolling into either the FIRST or MDR-HIV study at
clinical sites authorized to carry out this study are offered the option of participating in
the adherence intervention to which the clinical site has been randomly assigned. Data
collected through the FIRST and the MDR-HIV protocols are used to address the Adherence
study objectives. Patients on the FIRST protocol are assessed for time to first plasma
HIV-RNA level above 2,000 copies/ml. Also, patients on the FIRST and MDR-HIV studies are
assessed for changes in viral load, resistance, CD4 cell counts, adherence, and other
factors.
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Intervention Model: Factorial Assignment, Primary Purpose: Treatment
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