Hazardous alcohol consumption is common in HIV-infected women and is associated with significant harm. The primary objective of this application is to evaluate whether a prescription medication will reduce hazardous alcohol consumption and its consequences in HIV-infected women. The central hypothesis is that women who receive active medication (vs. placebo medication) will decrease their alcohol consumption and have improved health outcomes.
The specific aims are to determine whether a drinking-reduction medication (naltrexone or topiramate), provided to HIV-infected women with hazardous drinking (>7 drinks/wk or >4 drinks/occasion) will result in reduced alcohol consumption and improved HIV-related outcomes (antiretroviral medication adherence, reduced HIV disease progression, and reduced risky sexual behavior).This study represents the clinical trial component of our Consortiums for HIV/AIDS and Alcohol-Related Outcomes Research Trials (CHAART), a series of three inter-related projects surrounding a central Core. We propose a randomized controlled trial involving 240 HIV-infected women with hazardous drinking recruited from outpatient clinics and research settings in Chicago IL, Washington DC, Jacksonville FL, and Brooklyn NY. Women will be randomized to receive medication or placebo for 4 months;main outcomes will be assessed at 2-months, 4-months, and 7-months. Many women in the trial will also be participants in the Women's Interagency HIV Study, a large ongoing cohort of HIV-infected women. The study will build upon a currently-established pilot study in which we have established the study procedures, identified key measures, and developed the research infrastructure needed to fully implement this multi-site, randomized clinical trial. The proposed work is innovative because pharmacologic treatment for alcohol has not been evaluated in HIV-infected women outside of substance abuse treatment settings, and alcohol medication will be chosen based on an individual assessment. The expected outcome supporting the effectiveness of this treatment would transform the approach to clinical management of hazardous drinking in clinics serving HIV-infected women, and could readily be adapted to women with other chronic disease.
This project has important public health relevance, because it addresses a common health risk factor (hazardous alcohol use) in a population at high risk for alcohol-related harm (HIV-infected women).
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