IMPACT Study

 

Principal Investigator

 Jeffrey Samet, MD, MA, MPH

Key Personnel

Elena Blokhina, MD, PhD, Co-Investigator

Christine Chaisson, MPH, Data Manager

Debbie Cheng, ScD, Biostatistician

Evgeny Krupitsky, MD, PhD, DMSci, Co-Investigator & Russian PI

Dmitry Lioznov, MD, PhD, Co-Investigator

Alexander Walley, MD, MSc, Co-Investigator

Edwin Zvartau, MD, PhD, DMSci, Co-Investigator, & Russian Project Director

Project Manager

Carly Bridden, MA, MPH
617-414-5768
Carly.Bridden@bmc.org

Staff

Sharon Coleman, Statistical Analyst

Emily Quinn, Statistical Analyst

Local Russian team

Grant Abstract

Drug abuse plays a prominent role in the HIV epidemic in Russia; nearly 80% of cases are attributed to injection drug use. A history of drug use or continued use after an HIV diagnosis can lead to negative health consequences. Drug use may hinder efforts to engage patients in medical care including use of antiretroviral treatment (ART). A direct physiologic impact of drugs of abuse on HIV disease progression has not been clearly documented despite immunologic findings suggesting a rational basis for such an association. Hence, a variety of factors associated with drug use may place the HIV-infected drug user at increased risk for more rapid HIV disease progression. However, evidence of an independent association between drug abuse and HIV disease progression has not been clearly demonstrated. The primary goal of this research initiative is to investigate the relationship between drug abuse and HIV disease progression by utilizing a currently developing cohort of 700 HIV-infected adults in Russia, many with a prior history of injection drug use. This 1-year R21 pilot study, “Drug Use IMPACT” (Investigating and Measuring Progression to AIDS in a Cohort Trial),  will lay important groundwork for the design of a future longitudinal research initiative that can more definitively assess the relationship between drug use and HIV disease progression. The Specific Aims are:

  1. Use an existing cohort of HIV-infected Russians to assess markers of HIV disease progression (i.e., CD4 cell count, HIV viral load [HIV RNA]) and confounding factors.
  2. Estimate the effect size of drug use on markers of HIV disease progression, controlling for ART use, baseline CD4 cell count, HIV RNA (for CD4 outcome), alcohol use, depression, and sociodemographics.
  3. Explore potential mechanisms by which drug use worsens HIV disease progression (e.g. reduced access to ART, increased alcohol use, depression, and HCV co-infection).

We will recruit 100 subjects from an existing NIH study and collect additional self-report data on medication adherence and drug use. We will collect biological samples to assess CD4 cell count, HIV RNA, and drug use (urine toxicology on all and hair toxicology on a subsample). These data will be combined with data already available on the cohort (e.g. alcohol use, demographics). We hypothesize that illicit drug use is independently associated with more rapid HIV disease progression, as measured by CD4 cell count and HIV viral load. The data generated from this study will allow us to conduct preliminary tests of this hypothesis. Specifically, it will provide important effect size estimates that will be useful for designing a future cohort study that follows subjects longitudinally over several years to fully characterize the relationship between drug abuse and HIV disease progression. The primary analysis will be on any current drug use; however, the effects of specific drug use characteristics (i.e., specific drug, route of administration, exposure duration) will be explored in secondary analyses.

Presentations

Samet JH, Cheng DM, Bridden C, Quinn E, Walley AY, Lioznov D, Zvartau E, Blokhina E, Krupitsky E. Impact of Drug Use on HIV Disease Progression. Presented at 2012 CPDD.