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| Name | Class |
|---|---|
| University of North Carolina, Chapel Hill | OTHER |
| Durham VA Medical Center | FED |
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Subjects are being asked to take part in a research study to test two levels of alcohol services for patients with hepatitis C virus (HCV) who drink alcohol. The two levels differ in intensity of alcohol services and in whether or not they include a focus on liver health. The study will look at which level of alcohol services best decreases alcohol use among patients with HCV.
For people infected with hepatitis C virus (HCV), alcohol use increases the risk of hepatocellular carcinoma and progressive liver fibrosis, which can lead to cirrhosis and liver-related mortality. Integrated models of care that incorporate treatment for alcohol use, substance use, and mental health comorbidities have been called for, but few empirically tested models exist.
In an R21 study, we developed and manualized an integrated behavioral-medical treatment model for patients with HCV who consume alcohol. Investigators successfully implemented a standardized alcohol screening in a liver clinic using the Alcohol Use Disorders Identification Test (AUDIT) instrument; recruited 60 patients; retained participants in group and individual therapy; integrated care between an addictions therapist and medical providers; and achieved an 85% six-month interview response rate. The alcohol abstinence rate improved from 0% at baseline to 44% at 6 months. Mean Addiction Severity Index scores were reduced by 50% for alcohol from .24 to .12, and decreased for drug use from .05 to .03. The percentage of heavy drinkers decreased from 47% to 24% (Proeschold-Bell et al., 2011).
This study will conduct a randomized controlled trial that compares medical provider-delivered brief alcohol counseling plus our on-site six-month integrated treatment to brief alcohol counseling plus outside alcohol treatment referral in 279 HCV-infected patients with qualifying AUDIT alcohol scores at baseline. Participants in both arms will be treated at the Duke and UNC Liver Clinics and the Durham Veterans Affairs Medical Center. Outcome variables will be assessed at baseline, 3, 6, and 12 months. The aims are to 1) evaluate alcohol abstinence; 2) determine differences in secondary outcomes between study arms; and 3) conduct a cost effectiveness analysis. Investigators hypothesize that the intervention will significantly improve alcohol abstinence rates and significantly decrease relapse rates compared to the comparison. Investigators further hypothesize that intervention participants will report fewer drinks per week than comparison participants, have fewer positive drug screens than comparison participants, and meet the $50,000 per quality-adjusted life year gained standard established in the health economics literature.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medical provider (MP) brief alcohol counseling & referral | Active Comparator |
|
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| Brief alcohol counseling & 6 months of HCV-alcohol treatment | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brief alcohol counseling | Behavioral | Medical provider gives feedback on how the patient's alcohol use may affect their current and future health, noting that it is the patient's responsibility to change behavior; giving advice to stop drinking based on medical concern; giving a menu of options for cutting down on drinking; expressing empathy; and reinforcing the patient's self-efficacy to change. |
| Measure | Description | Time Frame |
|---|---|---|
| Alcohol abstinence rates at 6 months after consent | Investigators will compare the two treatment arms on occurrence and amount of past 180 days of drinking using the timeline follow-back method, allowing the investigators to assess change in number of drinking days, periods of abstinence, and total grams of alcohol consumed. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Relapse rate at 12 months after consent | Investigators will compare the two treatment arms on periods of abstinence and number of drinking days using the timeline follow-back method for the 180 days between 6 and 12 months since study consent. | 12 months |
| Other alcohol use indicators |
| Measure | Description | Time Frame |
|---|---|---|
| Cost effectiveness analysis of the intervention versus brief alcohol counseling and referral out | The incremental cost-effectiveness ratio (ICER) will be absolute difference in costs divided by the absolute difference in various effectiveness measures between the 2 interventions. | 12 months |
Inclusion criteria
Ever HCV-infected chronic HCV
Appropriate score on the Alcohol Use Disorder Identification Test (AUDIT)
Consumed alcohol in past 60 days
Not currently attending alcohol treatment services more than once every two weeks. If you attend treatment services at least once every two weeks, you must have either drunk alcohol heavily in the past 2 weeks or have drunk alcohol at least 7 of the past 14 days or your medical provider must have assessed that you would benefit from alcohol treatment services offered by this study
* Patient at one of the 3 clinic sites
18 or older
English-speaking
OK to have HIV, substance use or other co-morbidities, or receiving HCV antiviral treatment
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Muir, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22134784 | Background | Proeschold-Bell RJ, Patkar AA, Naggie S, Coward L, Mannelli P, Yao J, Bixby P, Muir AJ. An integrated alcohol abuse and medical treatment model for patients with hepatitis C. Dig Dis Sci. 2012 Apr;57(4):1083-91. doi: 10.1007/s10620-011-1976-4. Epub 2011 Dec 2. | |
| 30006024 | Background | Proeschold-Bell RJ, Evon DM, Makarushka C, Wong JB, Datta SK, Yao J, Patkar AA, Mannelli P, Hodge T, Naggie S, Wilder JM, Fried MW, Niedzwiecki D, Muir AJ. The Hepatitis C-Alcohol Reduction Treatment (Hep ART) intervention: Study protocol of a multi-center randomized controlled trial. Contemp Clin Trials. 2018 Sep;72:73-85. doi: 10.1016/j.cct.2018.07.003. Epub 2018 Jul 10. |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| D003376 | Counseling |
| D044382 | Population Groups |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
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|
| Group and Individual Therapy Sessions | Behavioral | Session content integrates HCV and alcohol issues in treatment, liver health, and personal realms. Sessions include psychoeducational content on how alcohol affects the liver among people with HCV; HCV stigma; family issues around drinking and the HCV diagnosis; nutrition; life goals and positive affect; and alcohol reduction strategies. |
|
At 3, 6 and 12 months, investigators will assess the number of heavy drinking days and grams of alcohol consumed and compare between the two treatment arms. |
| 3, 6 and 12 months |
| Illicit drug use | At 3, 6 and 12 months, investigators will assess illicit drug use based on positive/negative urine toxicology screens and compare between the two treatment arms. | 3, 6 and 12 months |
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D003710 | Demography |
| D011154 | Population Characteristics |