ART Adherence: Observed Therapy and Enhanced Counseling

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DESCRIPTION (provided by applicant): The benefits of antiretroviral therapy (ART) are clear, however its effectiveness is dependent on strict adherence, which is difficult and not often accomplished by patients. The success of directly observed therapy (DOT) strategies for increasing treatment adherence in tuberculosis has led to calls for research exploring its potential efficacy for ART. However, DOT for ART is complicated by the need to continue medication for life, the current lack of truly once-a-day regimes where all doses can be observed, and the high cost. An alternative to observing every dose, called observed therapy (OT), has been offered as a potential solution and has some demonstrated efficacy. Great effort is currently focused on developing additional once daily ART medications with the goal of creating truly once-a-day regimes. As these regimes become available, it will be increasingly important to understand the relative merits and feasibility of OT in diverse community samples. Psycho educational interventions to increase adherence to therapy, especially those that increase motivation, have been shown to be effective in a number of contexts, including adherences to ART. Among the interventions that have been developed to increase motivation for change is a counseling approach known as Motivational Interviewing (MI). A number of controlled treatment outcomes studies have demonstrated the efficacy of MI counseling approaches for several health behaviors including adherence to ART. Because of its neutral and supportive stance, MI may be particularly effective in fostering enhancing motivation to adhere to ART. We propose a 5 year randomized controlled trial of patients starting a new ART regime assigned to enhanced counseling with observed therapy, enhanced counseling alone, or standard care with assessments conducted at baseline, 3, 6, and 12 months, and the primary test of adherence and secondary outcome of viral load assessed at 1 year. The specific aims of this study are as follows: 1) To determine whether enhanced counseling combined with observed therapy is more effective than enhanced counseling alone or standard care in increasing adherence to ART. 2) To determine whether enhanced counseling combined with observed therapy is more effective than enhanced counseling alone or standard care in decreasing viral load.; and 3) To evaluate the role of potential mediators and moderators on adherence and HIV RNA levels.