Consortium to improve OutcoMes in hiv/Aids, Alcohol, Aging, & multiSubstance use (COMpAAAS)
Overview: COMpAAAS extends work b e g u n b y the Veterans Aging Cohort Study (VACS)
characterizing modifiable effects of alcohol, MSU, HCV, and depression among HIV+. Our
mission is to optimize health care for HIV+ harmed by alcohol, multisubstance use (MSU), HCV
infection, and depression through coordinated, and integrated observational, intervention studies,
and OR modeling. VACS includes a waiver cohort of 40,594 HIV infected individuals (HIV+) 1:2
demographically matched to 81,188 uninfected individuals (HIV-) and a nested, 9 site
c o n s e n t e d sample (VACS 9) of 7312 HIV+/-. VACS has >10 years of in-depth, longitudinal
data on alcohol, substance use, and health outcomes. Our Center at the West Haven VA
Medical Center coordinates an international team of collaborators and investigators.
Observation: Among HIV+ drinkers, MSU is the norm (64% also use tobacco, opioids, or
cocaine), but we do not know its implications for alcohol treatment. We will characterize
long-term (>10 year) longitudinal patterns and consequences of alcohol and MSU and explore
whether individually tailored health information on risks of alcohol and MSU increases
motivation to change compared to generic advice to curtail use. W e have developed and
validated the VACS Index (based on clinical biomarkers) and created a calculator
(http://vacs.med.yale.edu). I nnovations include focus on alcohol and MSU, use of the VACS
Index, creation of a risk calculator, electronic surveys and a Web-Based format to collect TLFB
data on alcohol and MSU.
Intervention: COMpAAAS compares onsite Integrated Stepped Care treatment (ISC) to
treatment as usual (TAU) in three, linked, 6-month randomized clinical trials in 642 HIV+
patients with unhealthy alcohol use. Screened patients are randomized to ISC or TAU after
determining that they meet criteria for: 1) at-risk drinking, 2) alcohol abuse or dependence or
3) moderate alcohol consumption in the presence of liver disease. This study will test the
hypothesis that ISC leads to decreased alcohol consumption and improved HIV biomarkers.
The primary outcome is change in alcohol consumption assessed by self report. Secondary
outcomes include change in the VACS Index, ART adherence, and sexual risk behaviors.
Novel aspects include: Integrated alcohol and HIV treatment; Stepped care; use of the VACS
Index as an expanded HIV biomarker and participation in COMpAAAS. This study will help
define the role of ISC HIV+ with unhealthy alcohol use.
OR Modeling: Effective interventions are often not implemented. To address this problem,
COMpAAAS integrates comparative effectiveness research and operations research to
consider portfolios of interventions that can address these intertwined health behaviors
(alcohol, multi-substance use, depression) simultaneously or in a sequenced, prioritized
progression. This research model aims to improve methods by encouraging greater “crosswalk” between modeling, observational data analysis, and trial design; and by identify patient
groups that may particularly benefit from interventions, or tailoring results to the needs of
particular stakeholders.
Amy C. Justice, MD, PhD
Consortium PD
Director, Observation
Core
amy.justice2@va.gov
David A. Fiellin, MD
Director, Intervention
Core
david.fiellin@yale.edu
R. Scott Braithwaite, MD, MSc,
FACP
Director, Operations Research
Core
scott.braithwaite@nyumc.org