With over 25% of HIV-infected individuals co-infected with HCV, chronic liver disease is one the leading causes of death among persons with HIV. The majority of HIV-HCV co-infected persons continue to drink and alcohol has an adverse effect on the course of chronic HCV infection, causing more rapid progression of liver fibrosis, even at low levels of ingestion. There have been few drinking reduction trials that compare known efficacious interventions in HIV populations, and none targeting the HIV population with comorbid HCV, where the stakes of any drinking are high. Despite dramatic improvements in the treatment of HCV, only a small minority of HIV-HCV co-infected persons receives therapy due to a variety of barriers, most prominently alcohol. Medical authorities generally recommend complete abstinence from alcohol as recent evidence suggests there may be no safe level of alcohol consumption for co-infected persons. Brief behavioral interventions are the only viable approach to reduce drinking across the large and heterogeneous group of HIV-HCV drinkers in "real world" settings. Two types of brief intervention, Brief Advice (BA) and Motivational Interviewing (MI), have been shown to be efficacious in reducing drinking in non-HIV samples. Our goal is to determine whether offering counseling beyond Brief Advice, namely MI, has greater alcohol reduction effects. In the proposed randomized trial, all 300 HIV-HCV co-infected participants will receive BA delivered by their HIV PCP during a regular HIV visit and will then be randomized to either a 30-minute Motivational Interviewing Intervention with a Behavioral Counselor (MI) or to HIV clinic treatment-as-usual. After this initial meeting, drinking "check-in" (MI or BA) sessions will then be provided telephonically every three months for 18 months, with a final assessment at 24 months. Our primary outcome is drinks per week. We propose three Aims:
Aim 1 : To conduct a randomized controlled trial to compare the effectiveness of MI versus BA in reducing drinking among 300 HIV-HCV co-infected primary care patients;
Aim 2 : To compare the effectiveness of MI vs. BA on liver outcomes (FIB4, APRI, initiation of HCV treatment);
Aim 3 : To conduct a cost effectiveness analysis (CEA) of MI versus BA. Efficacious brief interventions focusing on reduction in alcohol use have neither targeted HCV-HIV co-infected persons nor addressed low levels of use. This proposal links alcohol use explicitly to liver disease progression and intervenes with drinking behaviors consistently over time paralleling chronic HCV infection. Both interventions being tested can be readily integrated into a variety of HIV treatment settings and are sustainable, could impact the care of co-infected persons nationwide.

Public Health Relevance

Over 25% of HIV patients are co-infected with hepatitis C virus (HCV), and the majority of these persons drink alcohol, placing them at high risk for cirrhosis and liver-related death. This comparative effectiveness research will compare two well-known and efficacious brief alcohol interventions, Brief Advice and Motivation Interviewing, in reducing drinking among HIV-HCV co-infected patients. This would be the first comparative effectiveness trial targeting this population, addressing low levels of alcohol use, and longitudinally linking alcohol to liver disease progression in HIV clinical practice.

Agency
National Institute of Health (NIH)
Institute
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Type
Research Project (R01)
Project #
1R01AA023726-01
Application #
8839916
Study Section
Special Emphasis Panel (ZAA1-DD (05))
Program Officer
Bryant, Kendall
Project Start
2014-09-20
Project End
2019-06-30
Budget Start
2014-09-20
Budget End
2015-06-30
Support Year
1
Fiscal Year
2014
Total Cost
$508,387
Indirect Cost
$77,752
Name
Butler Hospital (Providence, RI)
Department
Type
DUNS #
069847804
City
Providence
State
RI
Country
United States
Zip Code
02906