Transforming the Cascade Of Hepatitis C Care

Transforming the Cascade of Hepatitis C Care

Several factors are barriers to effective Hepatitis C care: 1) The majority of Hepatitis C Virus (HCV)-positive patients (45-85 percent) are unaware that they are infected; 2) Only a small minority of those in need of treatment receive it; 3) Members of minorities and older patients are even less likely to receive needed care; and 4) Until recently, even those who were treated had a low chance of clearing the virus or achieving cure; 5) It is possible that older attitudes and expectation of futility might continue to persist among patients and provider in primary care settings.

Community Health Centers are often the most culturally appropriate and accessible choices, particularly for underserved populations, with the benefit of ongoing trust and relationships with patients. Therefore, these can be ideal places to deliver complex HCV care if they possess the needed expertise. However, most community-based primary care and community health centers lack access to Hepatitis C evaluation and treatment services, leading to a major public health problem.

Thus, investigators propose to implement and evaluate a pragmatic trial to implement and evaluate a multi-disciplinary model for HCV treatment at Currently, the treatment initiation rates at each of these sites is estimated as less than 10%. The investigators hypothesize that our project will increase the rate of participation in all the steps of the HCV care cascade and ultimately lead to more than doubled rates of treatment uptake

Study Overview

• Status: Completed
• Conditions: Hepatitis C, Chronic

Detailed Description

Primary Objective:

Determine uptake, effectiveness and safety of IFN-free, DAAs among "real world" patients, including those with multiple comorbidities, in the primary care setting.

Secondary Objective(s):

1. Demonstrate the transformation of the cascade of Hepatitis C Care at 3 primary care clinics in terms of changes from baseline in rates for rates of access to HCV care including HCV screening, evaluation, treatment consideration, treatment uptake, completion, loss to follow-up, and treatment success rate.
2. Advance understanding of hepatitis C related decision-making in the era of Interferon (IFN)-free Direct acting agents (DAAs) by examining the context, needs, motivators, barriers, and preferences among patients and providers to the delivery of hepatitis C treatment at primary care clinics

• Study Type: Observational
• Enrollment (Actual): 325

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15232
      • UPMC Shadyside Family Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients with detectable HCV RNA level, currently receiving care at any of these three community health centers

Description

Inclusion Criteria:

• All patients with detectable HCV RNA level, currently receiving care at any of these three community health centers

Exclusion Criteria:

• Criteria for automatic specialty referral (exclusion from treatment at community health centers) Child Turcotte Pugh Class B or C Any history of decompensated liver disease or hepatocellular carcinoma Evidence of renal disease (GFR <50) or coexisting autoimmune condition HIV of hepatitis B co-infection

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients achieving sustained viral response 12 weeks post treatment (SVR 12) over a three year intervention period.	measure percentage of patients moving through the cascade of care to cure of condition (SVR 12)	three years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rates of Hepatitis C Virus (HCV) screening	Percentage of at risk patients in the practice who have a completed HCV antibody test	three years
Rate of Chronic Hepatitis C evaluation	Percentage of patients with a positive HCV antibody test who have a HCV polymerase chain reaction (PCR) viral load completed	three years
Rate of treatment consideration	Percentage of consented patients with a positive HCV viral load who have a clinical evaluation and assessment of psychosocial readiness for treatment documented in the medical record	three years
Rate of treatment uptake	Percentage of patients recommended for treatment who begin medical treatment	three years
Rate of treatment completion	Percentage of patients that began treatment who complete the recommended course of therapy	three years
Rate of patients lost to follow up	Percent of consented patients with a positive HCV viral load who are lost to follow up	three years
Hepatitis C capacity building among family medicine physicians (provider practice and perceived confidence):	Endpoints related to HCV capacity building among family medicine physicians: Evaluate comfort and skill among family physicians to evaluate and treat HCV infection as measured on a qualitative survey of physicians	three years

Collaborators and Investigators

• Sponsor: University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): September 30, 2019
• Study Completion (Actual): January 14, 2021

Study Registration Dates

• First Submitted: February 27, 2017
• First Submitted That Met QC Criteria: July 20, 2017
• First Posted (Actual): July 21, 2017

Study Record Updates

• Last Update Posted (Actual): January 19, 2021
• Last Update Submitted That Met QC Criteria: January 14, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: cascade of care
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Hepatitis, Chronic; Hepatitis; Hepatitis A; Hepatitis C; Hepatitis C, Chronic
• Other Study ID Numbers: PRO16040427

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No