Design of an RCT evaluating zinc supplementation to prevent progression of HIV disease among heavy drinkers in the Russia ARCH cohort
We are conducting a double-blinded RCT in Russia (n=250) to evaluate the efficacy of zinc vs. placebo in improving markers of 1) mortality risk; 2) HIV disease progression; 3) cardiovascular risk; and 4) microbial translocation and inflammation. Participants, who are ART-naïve at enrollment and report recent heavy alcohol use, are randomized to zinc (15 mg men; 12 mg women) or placebo, daily for 18 months. Assessments occur at baseline, 6, 12, and 18 months. Adherence is measured using direct (riboflavin) and indirect (pill count, self-report) measures. Enrollment began in October 2013 and is expected to conclude by February 2015.
Russia with both high HIV prevalence and alcohol use provides a unique setting for this study. As HIV infection and alcohol use both result in pro-inflammatory states, this dual vulnerability is an ideal condition in which to study the effects of zinc on improving health outcomes. Russia’s many HIV-infected persons not as yet eligible for ART enables this study to examine the effects of zinc on inflammation separate from ART. Study design and protocol will be the focus of this presentation.
Learning Areas:Public health or related research
Describe the design of an RCT evaluating the efficacy of zinc supplementation on markers of mortality risk and HIV disease progression. Explain why Russia offers a unique setting to study the impact of zinc on inflammation. Describe how the study contributes to the international alcohol and HIV/AIDS body of research.
Keyword(s): Alcohol Use, HIV/AIDS
Qualified on the content I am responsible for because: I am a general internal medicine physician, cardiovascular epidemiologist, tenured associate professor of medicine, and director of the Vanderbilt Center for Clinical Cardiovascular outcomes Research and Trials Evaluation (V-C3REATE) within the Division of Cardiovascular Medicine at Vanderbilt. My research focuses on intersections between HIV infection, substance use, immune function, and cardiovascular disease outcomes. This work includes epidemiological studies, mechanistic studies, and randomized clinical trial within the Veterans Affairs Medical Centers and in St. Petersburg, Russia.
Any relevant financial relationships? No
I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines, and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed in my presentation.