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Hepatitis C, ChronicNCT03226509

Transforming the Cascade Of Hepatitis C Care

An observational study of Hepatitis C, Chronic, run by University of Pittsburgh at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Hepatitis C, Chronic
How many people
325 participants
Where
1 siteUnited States
Study dates
1 Sep 2016to 14 Jan 2021
How long will I take part?
3 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UPMC Shadyside Family Health Center

    Pittsburgh, Pennsylvania, 15232

Other trials in United States

About this study

Official title: 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

Read the 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
Keywords
cascade of care
Medical subject headings
Hepatitis C, Chronic

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: three years

Secondary outcomes (7)

  1. Rates of Hepatitis C Virus (HCV) screening

    Percentage of at risk patients in the practice who have a completed HCV antibody test

    Measured: three years

  2. Rate of Chronic Hepatitis C evaluation

    Percentage of patients with a positive HCV antibody test who have a HCV polymerase chain reaction (PCR) viral load completed

    Measured: three years

  3. Rate of treatment consideration

    Percentage of consented patients with a positive HCV viral load who have a clinical evaluation and assessment of psychosocial readiness for treatment documented in the medical record

    Measured: three years

  4. Rate of treatment uptake

    Percentage of patients recommended for treatment who begin medical treatment

    Measured: three years

  5. Rate of treatment completion

    Percentage of patients that began treatment who complete the recommended course of therapy

    Measured: three years

  6. Rate of patients lost to follow up

    Percent of consented patients with a positive HCV viral load who are lost to follow up

    Measured: three years

  7. Hepatitis C capacity building among family medicine physicians (provider practice and perceived confidence):

    Endpoints related to HCV capacity building among family medicine physicians: Evaluate comfort and skill among family physicians to evaluate and treat HCV infection as measured on a qualitative survey of physicians

    Measured: three years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2017
  2. Study start1 Sep 2016
  3. Primary completion30 Sep 2019
  4. Study completion14 Jan 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
325 participants (actual)
Target duration
3 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT03226509
Sponsor's protocol ID
PRO16040427
Status last verified
Jan 2021
First submitted
27 Feb 2017
Last updated
19 Jan 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Hepatitis C, Chronic, run by University of Pittsburgh at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of patients achieving sustained viral response 12 weeks post treatment (SVR 12) over a three year intervention period. (time frame: three years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03226509.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2021.

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