Alcohol abuse has been associated with poor adherence to medications, and alcohol abusers are at increased risk of infection. With effective antiretroviral therapy now available for HIV infection and with substantial risk of viral resistance if medications are not taken as prescribed, adherence to HIV treatment regimens is essential. Practical proven approaches to enhance adherence to antiretroviral medications in HIV-infected alcohol-abusing patients are needed. The investigators propose to test an intervention which incorporates strategies to improve adherence to HIV medications in a cohort of alcohol abusers with HIV disease. In this project, the ADHERE (Adherence to Drugs for HIV, an Experimental Randomized Enhancement) study, they will expand an NIAAA-funded observational cohort of alcohol-abusing HIV-infected patients from 120 to 240 and randomize half of the participants to standard care and half to an intervention to enhance medication adherence. We have developed an intervention with four components: addressing alcohol problems based on a patient's readiness for behavioral change, distributing a practical aid to facilitate pill taking, enhancing a patient's perception of medication efficacy, and providing individualized assistance with pill-taking tailored to a patient's specific circumstances. These components will be delivered by a nurse in the clinical setting (1 hour initial counseling and two 15-30 minute booster sessions) and three home visits. The cohort will be assessed prior to randomization and at 3, 6, and 12 months post-randomization regarding medication adherence, clinical, laboratory, and health status outcomes. In addition, the Medication Events Monitoring System (MEMS) will be used to record the time and date of medication bottle openings at randomization and 1, 2 ,3, and 12 months post-randomization. These activities will allow us to: a) compare short and long-term medication adherence between those with and without the intervention; b) assess the impact of medication adherence on patient outcomes, and c) evaluate the relationship between changes in alcohol severity and adherence over time. Four hypotheses will be tested: III. Degree of adherence is directly correlated with patient outcomes. IV. Improvements in adherence persist as long as decreases in alcohol severity persist. The ADHERE study will enable us to develop a generalizable intervention to enhance antiretroviral medication adherence in patients with a history of alcohol abuse and test its efficacy in terms of important clinical outcomes.
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