Clinical trial NCT03226509: Transforming the Cascade Of Hepatitis C Care
Official title: Transforming the Cascade of Hepatitis C Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C, Chronic
Keywords: cascade of care
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2017-07-21
Enrollment: 325
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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

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

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

Primary outcomes:
measure: Percentage of patients achieving sustained viral response 12 weeks post treatment (SVR 12) over a three year intervention period.
timeFrame: three years
Secondary outcomes:
measure: Rates of Hepatitis C Virus (HCV) screening
timeFrame: three years
measure: Rate of Chronic Hepatitis C evaluation
timeFrame: three years
measure: Rate of treatment consideration
timeFrame: three years
measure: Rate of treatment uptake
timeFrame: three years
measure: Rate of treatment completion
timeFrame: three years
measure: Rate of patients lost to follow up
timeFrame: three years
measure: Hepatitis C capacity building among family medicine physicians (provider practice and perceived confidence):
timeFrame: three years
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Shadyside Family Health Center
state: Pennsylvania
Study officials:
References: