Transforming the Cascade Of Hepatitis C Care

NCT03226509 | Completed

• 1 other identifier: PRO16040427
• Study Type: observational
• Target: 325
• Locations: 1 country
• Sites: 1

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

Conditions

Hepatitis C, Chronic

Keywords

cascade of care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Rates of Hepatitis C Virus (HCV) screening

  three years

• Rate of Chronic Hepatitis C evaluation

  three years

• Rate of treatment consideration

  three years

• Rate of treatment uptake

  three years

• Rate of treatment completion

  three years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

UPMC Shadyside Family Health Center

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Hepatitis C, Chronic

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator; Associate Program Director UPMC Shadyside Family Medicine Residency

Study Record Dates

• First Submitted: February 27, 2017
• First Posted: July 21, 2017
• Study Start: September 1, 2016
• Primary Completion: September 30, 2019
• Study Completion: January 14, 2021
• Last Updated: January 19, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)