Transforming the Cascade Of Hepatitis C Care
| Status: | Recruiting |
|---|---|
| Conditions: | Hepatitis, Hepatitis, Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/30/2018 |
| Start Date: | September 1, 2016 |
| End Date: | March 1, 2020 |
| Contact: | Norman R Kolb, MD |
| Email: | kolbnr@upmc.edu |
| Phone: | 412 623-6631 |
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
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
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
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
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
We found this trial at
1
site
5215 Centre Avenue
Pittsburgh, Pennsylvania 15232
Pittsburgh, Pennsylvania 15232
Phone: 412-623-2532
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