title: Increasing antiviral treatment through integrated hepatitis C care: a randomized multicenter trial.
abstract: Most individuals infected with the hepatitis C have not received antiviral treatment, with mental health and substance abuse problems being the primary barrier. Interventions have been developed to address these barriers among HCV patients considered "high-risk" for antiviral treatment. We present the design and methods of a prospective, randomized controlled multisite trial being conducted in the Veterans Affairs Healthcare System. The study employed a parallel design and the three study sites randomized a total of 364 VA patients with HCV to either Integrated Care (IC) or Usual Care (UC). The IC intervention consisted of a mental health provider (MHP) performing a) brief interventions to address risk factors; b) collaborative consultation with the HCV treatment clinicians; and c) case management prior to and during antiviral treatment. Clinical outcomes were abstracted from patient medical records and self-report questionnaires were completed at baseline, 4-months, 16-months, and 22-months after enrollment. The primary outcome of the study was sustained viral response (SVR). Secondary clinical outcomes were HCV treatment initiation and completion rates. Other secondary outcomes included substance use, depression, PTSD symptoms, quality of life, healthcare satisfaction, and healthcare utilization. The Integrated Care intervention has the potential to transform HCV antiviral treatment by increasing the number of HCV-infected individuals that can be successfully treated.
authors.affiliation: VA San Diego Healthcare System, USA. egroessl@ucsd.edu
authors.forename: Erik J
authors.initials: EJ
authors.lastname: Groessl
authors.forename: Marisa
authors.initials: M
authors.lastname: Sklar
authors.forename: Ramsey C
authors.initials: RC
authors.lastname: Cheung
authors.forename: Norbert
authors.initials: N
authors.lastname: Bräu
authors.forename: Samuel B
authors.initials: SB
authors.lastname: Ho
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000627:therapeutic use*; D019090:Case Management; D019033:Delivery of Health Care, Integrated / Q000379:methods*; D005260:Female; D019698:Hepatitis C, Chronic / Q000150:complications / Q000188:drug therapy* / Q000523:psychology; D006801:Humans; D008297:Male; D001523:Mental Disorders / Q000150:complications / Q000523:psychology*; D008605:Mental Health Services; D008875:Middle Aged; D017060:Patient Satisfaction; D011788:Quality of Life; D012307:Risk Factors; D013313:Stress Disorders, Post-Traumatic / Q000150:complications / Q000523:psychology; D019966:Substance-Related Disorders / Q000150:complications / Q000523:psychology*; D016896:Treatment Outcome; D014481:United States; D014493:United States Department of Veterans Affairs; D055815:Young Adult
chemical_list: D000998:Antiviral Agents
keywords: Brief interventions; Case management; Hepatitis C; Integrated care; Mental health; Substance use