Re-engaging Patients With Hepatitis C Into Care
Hepatitis CChronicAims: To evaluate the impact of a letter, phone call and incentive in re-engaging patients with hepatitis C care. Outcomes of interest: Primary outcome of interest: - Attendance for assessment of liver disease within 4 months of being sent invitation letter. Secondary outcomes of interest: - Commencing treatment within 6 months of being sent invitation letter. Methods: Patient identification: The local copy of the Scottish Hepatitis C database holds data regarding patients referred to secondary care for treatment of their hepatitis C, and holds ethics approval for research on treatment and patient outcomes. This will be used to identify patients with hepatitis C infection that is untreated, treatment has been unsuccessful, or the patient has been treated but the outcome is unknown (due to non attendance for blood tests). The database has been cross checked with virus lab results, to ensure infection status is up to date. Finally, the patient data has been checked by NHS GG&C information team, to exclude patients who are deceased, or whom are no longer resident in NHS greater Glasgow and Clyde based on updated details obtained from SCIstore. Inclusion criteria: Patients (16 years and over) who have previously engaged with Hepatitis C services in Glasgow but who are either untreated, have been treated unsuccessfully, or have been treated but have not attended for blood tests to check for treatment success. Exclusion criteria: Patients with HIV. Patients no longer resident within NHS Greater Glasgow and Clyde area. Allocation to contact groups: Patients will be randomly distributed into 3 groups: Letter: Will be sent letter 1 (appendix) Letter plus telephone call: will be sent letter 2 (appendix) and be followed up with a telephone call from the treatment centre if no contact has been received after 4 weeks Letter plus incentive: will be sent letter 3 (appendix) Process: Patient letters will be sent out by GG&C public health. For all 3 groups the letter will be sent with the small Hepatitis C Scotland booklet "Hepatitis C treatments have changed". Letters will identify include the telephone number for the identified treatment centre which will be either, the last known treatment centre or a more local treatment centre were appropriate based on current residence. Primary and secondary outcomes measures will be collected via the Scottish Hepatitis C database. Lay Summary: This study will test whether a letter alone, a letter plus follow up phone call or a letter with offer of incentive, will be most effective in re-engaging patients who are known to have hepatitis C but not yet received treatment.
Cognitive Impairments in Chronic Hepatitis C Patients and Potential Reversibility With New Agents...
Hepatitis CThe overall aim of this study is to evaluate the prevalence of cognitive impairments and brain anomalies in Chronic Hepatitis C infected individuals and to investigate likely changes in cognition and brain structure and function after treatment with Direct-acting Antivirals (DAAs).
Eliminate Hepatitis C/EC Partnership Evaluation Protocol
Hepatitis CChronic Hepatitis c2 moreThe Eliminate Hepatitis C (EC) Partnership project is a multi-site, multi-year project aiming to enhance and extend hepatitis C virus (HCV) care and treatment among people who inject drugs (PWID) through nurse-led models of care in the community and the prison system. The project will implement and evaluate a health service intervention to enhance HCV response by improving health promotion, offering training and education to service providers, streamlining clinical pathways, utilising data systems and surveillance and implementing the results of ongoing research and evaluation. Health services data will be used to assess the impact of the EC nurse-led support, to enhance the clinical pathway and increase HCV testing, linkage to care and treatment uptake in community and prison settings. This will include provider and client interviews and a sentinel surveillance system (ACCESS) that will track and monitor impact indicators including HCV testing, linkage to care and treatment uptake at the service and population level. Overall, evaluation data will be used to monitor the uptake of HCV treatment in PWID, monitor the effectiveness of community- and prison-based treatment program and assess the cost and feasibility of treating >1160 PWID in community-/prison-based program and assess changes in HCV prevalence in Victoria and modelling the impact of treating PWID to inform HCV elimination models in Australia and globally.
Effect of Strategies for the Treatment of Chronic Hepatitis C in Colombia
Hepatitis CHepatitis C is a public health problem and the high cost of the Direct-Acting Antivirals (DAA) is one of the main limitations for treatment worldwide. In Colombia, the Ministry of Health and Social Protection (MoHSP) has made progress in addressing Hepatitis C problem in order to control the infection and resolve barriers to access to medicines. One of the strategies implemented was the purchase of DAA, in association with the PAHO, and the instauration of the Clinical Pathway for the treatment of chronic hepatitis C. The implementation of the Clinical Pathway has required the integration of health care processes and the respective report in the health information systems, allowing a high level of control in the monitoring of the Hepatitis C and the subsequent generation of indicators. However, there is limited information on the effects of the strategic purchase and the instauration of the Clinical Pathway on the costs of care, clinical outcomes and the quality of health care for patients with Hepatitis C in Colombia. The aim of this study is to establish the effect of strategic purchasing and the Clinical Pathway for the treatment of chronic Hepatitis C, in the clinical results, in the general costs and quality of health care of Hepatitis C patients in Colombia.
The Regression of Liver Fibrosis and Risk for Hepatocellular Carcinoma (ROLFH) Study
Chronic Hepatitis CChronic Hepatitis BThis study aims to demonstrate that patients with chronic hepatitis C (CHC) and B (CHB) experiencing regression of liver cirrhosis after effective antiviral therapy have decreased risk for hepatocellular carcinoma (HCC). Primary aim is to determine the incidence of HCC in patients with cirrhosis secondary to CHC and CHB, after treatment is provided, and to identify the magnitude of the decreased risk for HCC in patients experiencing regression of fibrosis. As a secondary aim, environmental risk factors for HCC development will be sought, in order to determine a subset of patients in whom it will be safe to stop surveillance.
Prospective Cohort Study: To Provide Evidence & Guidance in Hepatitis C Virus Screening, Comparing...
Chronic Hepatitis C Virus InfectionAlthough infection with the hepatitis C virus (HCV) can result in acute hepatitis; it more commonly progresses to chronic hepatitis. The acute process is most often asymptomatic. Acute HCV typically leads to chronic infection. Chronic HCV infection is usually slowly progressive. Approximately 5 to 20 percent of chronically infected individuals develop cirrhosis over a 20-30 year period of time. Chronic HCV is the most common cause of chronic liver disease, cirrhosis, hepatocellular carcinoma, and the most frequent indication for liver transplantation in the United States. Screening for chronic HCV infection is crucial because chronic HCV infection is often asymptomatic, effective treatment is available, and untreated disease carries a high risk of morbidity and mortality. Expert opinion, recommendations, and guidelines for HCV screening do not all agree. All guidelines recommend screening patients at increased risk for HCV (ie: typical risk factors). In 2012, the Centers for Disease Control and Prevention (CDC) recommended screening all persons born between 1945 and 1965. At least two studies suggest that screening persons born between 1945 and 1964 or 1946 to 1970, respectively, is cost-effective. The studies estimated that if patients found to be HCV positive were treated with pegylated interferon, ribavirin, and direct acting antiviral therapy (for patients with HCV genotype 1), it would cost $35,700 to 37,700 per quality adjusted life-year. Screening based upon a birth cohort in patients without risk factors may lead to more false positive results. Currently only 1 % of patients in the birth cohort of 1945-1965 who cared for by Intermountain Healthcare providers have been screened. Ambulatory care physicians are not effectively screening patients. It is unclear whether screening based on risk factors alone versus screening based upon risk factors and birth cohort most effectively manages the burden of chronic HCV infection for patients managed by Intermountain Healthcare providers. It is possible that the Intermountain Healthcare population differs in risk from the U.S. population,making guideline application less certain. A well-designed prospective cohort study is needed to understand the risks and benefits of different HCV screening strategies on diagnostic yield and clinical outcomes. The investigators hypothesize that screening based on a person's history of risk factors will detect chronic HCV infection in 2.7 % of the population tested; this would be according to national average. The investigators further hypothesize that screening based on birth cohort and risk factors will identify roughly the same percentage in the tested population. The investigators anticipate usable data within three months which should give us data to describe and publish the effectiveness of different screening strategies. The investigators will identify patients with chronic HCV infection through this initial study who now require treatment and management. The investigators believe this group could be followed inexpensively for clinical endpoints for many years. This would then definitively define the effectiveness of screening strategies based on good evidence. No study has evaluated clinical outcomes associated with the different screening strategies for chronic hepatitis c virus infection.
Effects of Genotypes on Interferon Signaling in Chronic Hepatitis C
Chronic Hepatitis CThe objective of this pilot project is to investigate the prognostic criteria for sensitivity of Chronic Hepatitis C (CHC) Genotype 1, patients to IFNa treatment. Signal transduction in peripheral blood mononuclear cell (PBMC) of control groups will be compared with that of CHC patients. For this study, 20 patients with Hepatitis C virus (HCV) infection who are to undergo standard antiviral therapy and 10 healthy donors (significant others of the HCV subject) will be enrolled. Signal transduction will be studied in peripheral blood of CHC subjects before the treatment, after 1 and 3 months of treatment, and 4-6 months following the completion of treatment.
Evaluation of Neurocognitive Performance in Drug Substituted Patients Under Hepatitis C Therapy...
Chronic Hepatitis C InfectionProspective, longitudinal multi-center study performed in 15 participating substitution centers in Germany. Aims: - Primary objective: To compare the impact of the different substitution drugs (methadone, buprenorphine, and suboxone) on the neurocognitive, emotional, and quality-of-life-related tolerability in opioid dependent patients under HCV treatment. - Secondary objective: To investigate if IFN therapy impairs efficacy (with respect to e.g. retention rates, concomitant drug use and in particular neurocognitive function) and tolerability of agonist maintenance treatment with methadone, buprenorphine, or suboxone
SIMpill Medication Dispensing Device in the Treatment of HCV
Chronic Hepatitis C VirusSubjects are being asked to participate in this study because they have genotype 1 Hepatitis C Virus (HCV) and will be taking the standard of care drugs pegylated interferon, ribavirin, and telaprevir as part of their routine care. The purpose of this study is to see if the SIMpill automated pill dispensing device can help subjects take their medications at the times the doctor has instructed them to take it. The SIMpill device is an automated pill dispensing device that records a time stamp each time the device is opened and a dose of medication is taken. Physicians can download this data and generate a precise account of when you have taken your medication. In addition, if a dose is missed, the SIMpill device can be set to automatically notify you by text message if a dose is overdue. The Simpill device is a new way to keep track of when you take your HCV medications and will also help remind you when you forget to take a dose. In addition, this information will help your doctors understand how taking medication on time effects the success of the therapy.
Vitamin D Deficiency in Subjects With Chronic Hepatitis C Compared to Healthy Volunteers
Chronic Hepatitis CThe objective of this study is to assess the prevalence of vitamin D deficiency in patients with chronic Hepatitis C compared to a matched control group of healthy individuals in the Sioux Falls area. It is the hypothesis of this study that vitamin D deficiency is more common in patients with chronic Hepatitis C compared to the healthy control group.