NCT02176980

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
182

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 27, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
Last Updated

October 18, 2018

Status Verified

October 1, 2018

Enrollment Period

4 years

First QC Date

June 26, 2014

Last Update Submit

October 17, 2018

Conditions

Hepatitis C, Chronic; AUD

Keywords

HCVhepatitis Calcoholintegrated care

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Relapse rate at 12 months after consent

    12 months

  • Other alcohol use indicators

    3, 6 and 12 months

  • Illicit drug use

    3, 6 and 12 months

Other Outcomes (1)

  • Cost effectiveness analysis of the intervention versus brief alcohol counseling and referral out

    12 months

Study Arms (2)

Medical provider (MP) brief alcohol counseling & referral

ACTIVE COMPARATOR

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.

Behavioral: Brief alcohol counseling

Brief alcohol counseling & 6 months of HCV-alcohol treatment

EXPERIMENTAL

* 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.

Behavioral: Group and Individual Therapy Sessions

Interventions

Brief alcohol counselingBEHAVIORAL

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.

Medical provider (MP) brief alcohol counseling & referral
Group and Individual Therapy SessionsBEHAVIORAL

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.

Brief alcohol counseling & 6 months of HCV-alcohol treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • or older
  • English-speaking
  • OK to have HIV, substance use or other co-morbidities, or receiving HCV antiviral treatment

You may not qualify if:

  • Psychotic
  • Insurmountable transportation barriers (can receive individual therapy by phone but need appointments with HCV provider at 3 and 6 months and ideally some in-person group therapy)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (2)

  • 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.

    PMID: 22134784BACKGROUND

  • 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.

    PMID: 30006024BACKGROUND

MeSH Terms

Conditions

Hepatitis CBronchiolitis Obliterans Syndrome

Interventions

EthanolCounselingPopulation Groups

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesOrganizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host DiseaseImmune System Diseases

Intervention Hierarchy (Ancestors)

AlcoholsOrganic ChemicalsMental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesDemographyPopulation Characteristics

Study Officials

  • Andrew Muir, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2014

First Posted

June 27, 2014

Study Start

October 1, 2014

Primary Completion

September 30, 2018

Study Completion

September 30, 2018

Last Updated

October 18, 2018

Record last verified: 2018-10

Locations

US(1)