Tele-HCV for Hepatitis C

Phase-Based Estimates
1
Effectiveness
1
Safety
Central City Concern, Portland, OR
Hepatitis C+1 More
Tele-HCV - Other
Eligibility
18+
All Sexes
Eligible conditions
Hepatitis C

Study Summary

This study is evaluating whether a telemedicine approach to treating hepatitis C may be effective.

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Eligible Conditions

  • Hepatitis C
  • Hepatitis

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Tele-HCV will improve 1 primary outcome and 3 secondary outcomes in patients with Hepatitis C. Measurement will happen over the course of 4 weeks.

12 weeks post treatment
Viral Response
36 weeks post treatment
Treatment Completion
4 weeks
Treatment Initiation
Week 36
Engagement in harm reduction resources

Trial Safety

Trial Design

2 Treatment Groups

Community Linkage to Care
Tele-HCV Treatment

This trial requires 300 total participants across 2 different treatment groups

This trial involves 2 different treatments. Tele-HCV is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Tele-HCV Treatment
Other
Participants allocated to telemedicine intervention arm are scheduled for treatment assessment by a study clinician. For a majority of participants, this will also be the treatment initiation visit. If additional studies are necessary for routine treatment decision making, peers will assist participants in navigating health system barriers and arrangement of second telemedicine visit.
Community Linkage to Care
Other
Participants allocated to the community linkage-to-care arm will complete screening, be offered enrollment, and undergo informed consent as in the telemedicine arm. Following study inclusion and enrollment, research staff will refer the participant to a local community health clinic to engage in hepatitis C care and seek treatment.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 36 weeks post treatment
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 36 weeks post treatment for reporting.

Who is running the study

Principal Investigator
P. T. K.
Prof. P. Todd Korthuis, MD
Oregon Health and Science University

Closest Location

Central City Concern - Portland, OR

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The study found that a significant percent of adults reporting recreational opioid use had not injected the drugs. show original
The text states that people who have chronic active hepatitis C (defined as positive HCV RNA) are likely to experience a number of health problems show original
People are seeking treatment for hepatitis C infection. show original
We expect that all subjects in our study will be able to communicate in English show original
have health insurance There are people who enrolled in health insurance and there are people who have health insurance. show original
The text states that the person lives in the study area. show original
are age 18 or greater

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can hepatitis c be cured?

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No cure exists for Hepatitis C. Current therapy provides a long-term suppression of HCV RNA levels and is the best treatment available. However, it is recommended that treatment be continued indefinitely to prevent progression to cirrhosis or hepatocellular carcinoma.

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What causes hepatitis c?

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There is a clear and consistent association between alcoholism and hepatitis C. Infection can occur via sexual activity, with or without condoms due to the fact that blood-borne pathogens may be deposited in the female reproductive tract following sexual intercourse. Furthermore, hepatitis C is associated with increased likelihoods of concurrent and subsequent alcoholic-associated cirrhosis. There are no major behavioral risk factors that can increase the likelihood of acquiring hepatitis C. In fact, some studies have found that heterosexuals living under conditions of high socioeconomic deprivation may be at an increased risk for hepatitis C.

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What are common treatments for hepatitis c?

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Noninvasive blood testing is available to screen for hepatitis B and HCV infection. In cases of positive serum screen for HBV, the blood is usually discarded (or sent to a laboratory); however, in HCV-infected individuals, antivirals may be prescribed to control infection. The number of HCV treatments are not static and will change over time with more data accumulated from different research disciplines. Newer therapies may increase the number of patients’ lives being saved.

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What is hepatitis c?

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Hepatitis C accounts for about 80% of the chronic viral hepatitis in Hong Kong. The seroprevalence of hepatitis C virus doubled over five years. Older age and male gender, but not a positive serology, were independent risk factors for hepatitis C.

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How many people get hepatitis c a year in the United States?

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While HCV is one of the most common diseases, it remains a relatively rare cause of acute hepatitis in the community. Because of its high fatality rates, hepatitis C has become a major public health cause, making it necessary to screen and to treat. However, some health care practitioners may not have adequate knowledge and training concerning this disease.

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What are the signs of hepatitis c?

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Many people with HCV do not show any symptoms. Hepatic symptoms are commonly described as malaise and abdominal pain. Some symptoms show that advanced liver disease may be present such as jaundice and aflatoxemia. Patients with HCV often develop fatigue and loss of appetite. The main indicator of cirrhosis is the presence of ascites. As cirrhosis of the liver progresses, patients develop esophageal varices, spontaneous bacterial peritonitis, ascites, and liver failure. If cirrhosis is left untreated, the patient may experience severe bleeding in the stomach or intestines. Hepatitis C is associated with a significantly high risk of liver cancer or of worsening of decompensated cirrhosis.

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How does tele-hcv work?

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At the current time in the USA, the only options for testing if a person is positive for hepatitis C virus are either through lab testing or through testing that is performed within the hospital. The use of internet-based testing is a possible future way to test whether a person has contracted hepatitis C virus. The CDC states online tests for hepatitis C virus are accurate to 90% accuracy, the only caveat being there is a small chance that the user may receive an incorrect result. Tele-hcv utilizes the user to fill out an agreement form with the user's physician.

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How serious can hepatitis c be?

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HCV infections can be fatal, but death is uncommon, and many live with chronic disabling disease. Complications arising from serious, chronic liver disease are common in HCV-infected patients such as hepatic decompensation and hepatocellular carcinoma. The prevalence of cirrhosis and its consequences are increased in patients with genotype 1 and the progression of liver disease is more marked in Asians. Chronic active viral hepatitis appears to be a poor surrogate for determining the liver transplantation-free survival in HCV-infected patients.

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Does hepatitis c run in families?

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Results from a recent clinical trial of this survey suggest that genetic factors play a role in hepatitis C recurrence in a large percentage of infected patients, justifying genetic studies of this virus in high-risk groups in an effort to identify patients who can be monitored more closely in the context of the therapeutic and prophylactic approaches to the disease.

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Have there been any new discoveries for treating hepatitis c?

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For the first time, we present the first data about an epigenetic role of the cannabinoid receptor 1 (CB1) in the hepatic fibrosis of hepatitis C. CB1 receptors have a previously known role in the modulation of cellular cholesterol homeostasis, which could lead to an enhanced hepatic injury in viral-associated viral hepatitis. The data imply that epigenetic research is a major target in the treatment of hepatic inflammatory processes such as hepatitis C.

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What is the average age someone gets hepatitis c?

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On average hepatitis C affects an average of 37 yr old and for many patients, the disease has a gradual onset and a more insidious, insidious onset than the flu or other viral symptoms. For many it usually has no visible symptoms at all and only becomes diagnosed once the patients doctors notice the mildly elevated liver enzymes. For many patients they become aware of the damage they are doing to themselves only when they notice their cognitive decline or memory loss.

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Get access to this novel treatment for Hepatitis C by sharing your contact details with the study coordinator.