A Study of Two Adherence Plans to Help HIV-Positive Patients Take Their Medications Correctly

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.