Clinical Trials Directory

Trials / Completed

CompletedNCT03226509

Transforming the Cascade Of Hepatitis C Care

Transforming the Cascade of Hepatitis C Care

Status
Completed
Phase
Study type
Observational
Enrollment
325 (actual)
Sponsor
University of Pittsburgh · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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

Timeline

Start date
2016-09-01
Primary completion
2019-09-30
Completion
2021-01-14
First posted
2017-07-21
Last updated
2021-01-19

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03226509. Inclusion in this directory is not an endorsement.