Unhealthy alcohol use threatens the health benefits seen with antiretroviral therapy (ART) for HIV-infected (HIV+) patients. Although research has demonstrated the efficacy of brief interventions, motivational counseling, and medications to treat unhealthy alcohol use in HIV unifected patients, there is limited research or use of these treatments in HIV+ patients. We have demonstrated that integrated treatment of addiction in HIV clinics is feasible. Stepped care algorithms can facilitate the evaluation of varying intensities of treatments for unhealthy alcohol use:~The proposed study will compare onsite Integrated Stepped Care treatment (ISC) to treatment as usual (TAU) in three, linked, 6-month randomized clinical trails in 642 HIV+ patients with unhealthy alcohol use. Screened patients are randomized to ISC or TAU after determining that they meet criteria for either 1) at-risk drinking, 2) alcohol abuse or dependence or 3) moderate alcohol consumption in the presence of liver disease. ISC and TAU are tailored to the drinking category. ISC for at- risk drinkers and those with moderate alcohol use and liver disease begins with a brief intervention and is stepped up to Motivational Enhancement Therapy (MET) in those who meet predefined failure criteria. ISC for abuse or dependence begins with addiction psychiatrist management (ARM) including alcohol pharmacotherapy if not contraindicated. ARM is stepped up to include MET if predefined failure criteria are met. The study will test the hypothesis that ISC leads to decreased alcohol consumption and improved HIV biomarkers. Data analyses will be conducted on the intention to treat sample. 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 of this proposal include: 1) Integrated alcohol and HIV treatment;2) Stepped care;3) The use of the VACS Index as an expanded HIV biomarker and 4) Participation in COMpAAAS. The proposed study, conducted by an experienced team of HIV and addiction researchers, will help define the role of ISC HIV+ with unhealthy alcohol use.

Public Health Relevance

The goals of this study are to optimize the treatment of HIV disease by decreasing alcohol consumption, improving medication adherence, improving HIV immune markers, and promoting the prevention of HIV spread by decreasing sexual risk in patients with unhealthy alcohol use. The current project will serve to advance this area of research and expand the types of care that HIV-infected patients receive.

National Institute of Health (NIH)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Research Project--Cooperative Agreements (U01)
Project #
Application #
Study Section
Special Emphasis Panel (ZAA1-DD (04))
Program Officer
Roach, Deidra
Project Start
Project End
Budget Start
Budget End
Support Year
Fiscal Year
Total Cost
Indirect Cost
Yale University
Internal Medicine/Medicine
Schools of Medicine
New Haven
United States
Zip Code
Petersen, Maya; Yiannoutsos, Constantin T; Justice, Amy et al. (2014) Observational research on NCDs in HIV-positive populations: conceptual and methodological considerations. J Acquir Immune Defic Syndr 67 Suppl 1:S8-16
Dreifuss, Jessica A; Griffin, Margaret L; Frost, Katherine et al. (2013) Patient characteristics associated with buprenorphine/naloxone treatment outcome for prescription opioid dependence: Results from a multisite study. Drug Alcohol Depend 131:112-8
Fiellin, David A; McGinnis, Kathleen A; Maisto, Stephen A et al. (2013) Measuring alcohol consumption using Timeline Followback in non-treatment-seeking medical clinic patients with and without HIV infection: 7-, 14-, or 30-day recall. J Stud Alcohol Drugs 74:500-4