NCT00722423

Brief Summary

This is a prospective randomized controlled trial comparing two different clinic models for patients with hepatitis C. These patients commonly have mental health problems that are barriers to receiving HCV treatment. Patients giving informed consent will be randomized to a usual care HCV clinic vs. a HCV clinic with the addition of an on-site mental health practitioner who will address psychiatric and substance use issues with the goal of enabling patients to undergo effective antiviral therapy. The major outcome of the study is the number of patients in each group who are "cured" with antiviral therapy. Patients in both groups receive current standard of care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
364

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

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

July 23, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 25, 2008

Completed
9 months until next milestone

Study Start

First participant enrolled

May 1, 2009

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

October 15, 2015

Completed
Last Updated

October 15, 2015

Status Verified

September 1, 2015

Enrollment Period

4.2 years

First QC Date

July 23, 2008

Results QC Date

March 24, 2015

Last Update Submit

September 16, 2015

Conditions

Hepatitis C

Keywords

Hepatitis Cintegrated carealpha interferonmental health

Outcome Measures

Primary Outcomes (1)

  • Sustained Virologic Response Rates

    Virus not detected by PCR assay

    12-24 weeks post-treatment

Secondary Outcomes (1)

  • Antiviral Treatment Rate

    12-24 weeks post-treatment

Study Arms (2)

Integrated Care Model

EXPERIMENTAL

Integrated Care

Behavioral: Integrated care model

Usual Care Model

EXPERIMENTAL

Usual Care

Behavioral: Usual Care Model

Interventions

Integrated care modelBEHAVIORAL

The integrated care intervention follows a manualized protocol consisting of a series of brief intervention tailored to the patients' main barriers to treatment along with a case management approach in which the integrated care mental health provider actively tracks each patients progress through the evaluation and treatment process. The integrated care mental health provider can be a clinical nurse specialist, psychologist, or licensed clinical social worker that has experience and training in the provision of psychiatric and SUD interventions. They will receive additional training on the integrated care protocol. Data will be collected at baseline, pre-treatment, and post-treatment intervals.

Integrated Care Model
Usual Care ModelBEHAVIORAL
Usual Care Model

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic hepatitis C. This is defined as the documentation of the presence of circulating hepatitis C virus by a positive hepatitis C Polymerase Chain Reaction test that is compatible with chronic hepatitis. (Note: no requirement is made for the presence of abnormal liver function tests).
  • Patients may be treatment na ve or have received and failed prior antiviral treatment.
  • Age 18-75 years.
  • Patient must be able to give informed consent.
  • All antiviral treatments are administered according to accept standards of care at each site, with appropriate pre-treatment evaluation and on-treatment management and precautions. Liver biopsies are an accepted standard of care for patients with chronic hepatitis C and are obtained as clinically indicated.
  • Patients must meet screening criteria for "high risk" for mental health and substance use problems. "High risk HCV patient" is defined as a patient with Beck Depression Inventory-II\>10 at screening; active drug use indicated by positive urine screen, self-reported use within 6 months on drug use questionnaire or AUDIT-C test \>4, or positive PTSD screen.

You may not qualify if:

  • Patient unable or unwilling to participate.
  • Decompensated liver disease, with active or recent encephalopathy, variceal bleeding, or ascites or CHILD-PUGH class B or C. (Note: patients with a history of decompensated cirrhosis in the past with resolution who are otherwise antiviral treatment candidates in the opinion of the treating physician will be considered candidates.)
  • Other significant near term life-threatening diseases (malignancy, unstable angina, severe chronic obstructive pulmonary disease, pulmonary fibrosis, etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

VA Palo Alto Health Care System (154C)

Palo Alto, California, 94304-1290, United States

Location

VA San Diego Healthcare System, San Diego

San Diego, California, 92161, United States

Location

VA Medical Center, Bronx

The Bronx, New York, 10468, United States

Location

Related Publications (3)

  • Groessl EJ, Sklar M, Cheung RC, Brau N, Ho SB. Increasing antiviral treatment through integrated hepatitis C care: a randomized multicenter trial. Contemp Clin Trials. 2013 Jul;35(2):97-107. doi: 10.1016/j.cct.2013.05.002. Epub 2013 May 10.

    PMID: 23669414BACKGROUND

  • Ho SB, Brau N, Cheung R, Liu L, Sanchez C, Sklar M, Phelps TE, Marcus SG, Wasil MM, Tisi A, Huynh L, Robinson SK, Gifford AL, Asch SM, Groessl EJ. Integrated Care Increases Treatment and Improves Outcomes of Patients With Chronic Hepatitis C Virus Infection and Psychiatric Illness or Substance Abuse. Clin Gastroenterol Hepatol. 2015 Nov;13(11):2005-14.e1-3. doi: 10.1016/j.cgh.2015.02.022. Epub 2015 Feb 24.

    PMID: 25724704RESULT

  • Groessl EJ, Liu L, Sklar M, Ho SB. HCV Integrated Care: A Randomized Trial to Increase Treatment Initiation and SVR with Direct Acting Antivirals. Int J Hepatol. 2017;2017:5834182. doi: 10.1155/2017/5834182. Epub 2017 Jul 27.

    PMID: 28819570DERIVED

MeSH Terms

Conditions

Hepatitis CPsychological Well-Being

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesPersonal SatisfactionBehavior

Results Point of Contact

Title
Dr. Samuel B. Ho
Organization
VA San Diego Healthcare System
Samuel.Ho2@va.gov
8586423280

Study Officials

  • Samuel B Ho, MD

    VA San Diego Healthcare System, San Diego

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2008

First Posted

July 25, 2008

Study Start

May 1, 2009

Primary Completion

July 1, 2013

Study Completion

May 1, 2014

Last Updated

October 15, 2015

Results First Posted

October 15, 2015

Record last verified: 2015-09

Locations

US(3)