Hepatitis C Alcohol Reduction Treatment - Randomized Controlled Trial (Hep ART-RCT)

Status: Completed

Location: See location...

Intervention Type: Behavioral

Study Type: Interventional

Study Phase: Not Applicable

SUMMARY

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.

Eligibility

Participation Requirements

Sex: All

Minimum Age: 18

Healthy Volunteers: f

View:

• Ever HCV-infected chronic HCV

• Appropriate score on the Alcohol Use Disorder Identification Test (AUDIT)

‣ Females, ≥4

⁃ Males, ≥8

• 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

Locations

United States

North Carolina

Duke University Medical Center

Durham

Time Frame

Start Date: 2014-10

Completion Date: 2018-09-30

Participants

Target number of participants: 182

Treatments

Active_comparator: Medical provider (MP) brief alcohol counseling & referral

1. Screening of HCV-infected patients for alcohol use using the 10-item Alcohol Use Disorders Identification Test (AUDIT).~2. Patients self-administer the AUDIT.~3. HCV providers review the AUDIT with the patient.~4. If the patient is using any alcohol, the HCV provider conducts brief alcohol counseling using the FRAMES model, based on the evidence-based Screening, Brief Intervention, and Referral to Treatment (SBIRT) method.~5. Medical provider will explain the importance of alcohol abstinence in the presence of HCV infection.~6. Patient is referred to an alcohol treatment programs outside the liver clinic. Typical counseling will take the form of individual and group therapy.

Experimental: Brief alcohol counseling & 6 months of HCV-alcohol treatment

* Steps 1 through 5 as described in comparator arm above.~* 6 months of group therapy, offered weekly.~* 6 months of individual therapy, in person or by phone, offered every two weeks.~* Therapy content emphasizes interplay between alcohol use and liver health/HCV.~* Informal collaboration between HCV providers and addictions therapists.~* Shared EMR charting.~* Referral to study-provided psychiatry as needed.

Authors

Rae Jean Proeschold-Bell, Andrew Muir

Related Therapeutic Areas

Hepatitis C

Hepatitis

Hepatitis A

Hepatitis C Alcohol Reduction Treatment - Randomized Controlled Trial (Hep ART-RCT)

Similar Clinical Trials

The National Australian HCV Point-of-Care Testing Program: An Observational Cohort Study to Evaluate the Use of Finger-stick Point-of-care Hepatitis C Testing to Enhance Diagnosis and Treatment of HCV Infection - Minimal Dataset

The National Australian HCV Point-of-Care Testing Program: An Observational Cohort Study to Evaluate the Use of Finger-stick Point-of-care Hepatitis C Testing to Enhance Diagnosis and Treatment of HCV Infection - Minimal Dataset

Drug Injection Surveillance and Care Enhancement for Rural Northern New England (UH3)

Drug Injection Surveillance and Care Enhancement for Rural Northern New England (UH3)

The National Australian HCV Point-of-Care Testing Program: An Observational Cohort Study to Evaluate the Use of Finger-stick Point-of-care Hepatitis C Testing to Enhance Diagnosis and Treatment of HCV Infection

The National Australian HCV Point-of-Care Testing Program: An Observational Cohort Study to Evaluate the Use of Finger-stick Point-of-care Hepatitis C Testing to Enhance Diagnosis and Treatment of HCV Infection