Transforming the Cascade Of Hepatitis C Care

NCT ID: NCT03226509

Last Updated: 2021-01-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 325 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-09-01
• Study Completion Date: 2021-01-14

Brief Summary

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

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

Conditions

Hepatitis C, Chronic

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Norman Randall Kolb

Principle Investigator; Associate Program Director UPMC Shadyside Family Medicine Residency

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

UPMC Shadyside Family Health Center

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

PRO16040427

Identifier Type: -

Identifier Source: org_study_id