Enhancing Access to Care for Chronic Hepatitis C Infected Populations in Hong Kong
Study Details
Study Description
Brief Summary
In the current era of highly effective direct acting antiviral (DAA) therapy, the remaining obstacles to elimination of chronic HCV infection are identification of the high-risk groups, linkage to continued care and prevention of re-infection. It is estimated that 70-80% of patients with chronic HCV are unaware of their infection. Besides, public health education is limited and most patients are not aware that the current standard-of-care is highly effective, well tolerated and no longer require weekly subcutaneous injections. From a survey in Hong Kong in 2014, among 234 newly diagnosed HCV patients, only 20% agreed to undergo treatment. There is no universal screening programme for chronic hepatitis C infection in Hong Kong. and known high-risk patients include people who inject drugs (PWID), persons with certain medical conditions including those on hemodialysis, HIV infected, those with prior transfusion or organ transplantation. In this study, the investigators plan to reach out to PWIDs in rehabilitation programs to provide rapid point-of-care screening for chronic hepatitis C infection, and to provide linkage to care for those diagnosed with chronic hepatitis C.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Detailed Description
Existing data on HCV sero-prevalence in these patients in Hong Kong is however fragmented especially in non-hospitalized persons. From the year 2014 surveillance report prepared by Department of Health (DH), anti-HCV prevalence rate among PWID under DH's methadone clinics was 46.2%. Two major issues remain in view of the high seroprevalence rate in this subgroup. Firstly, HCV RNA positivity was not reported and it is unknown whether these patients are still chronically infected. Many of patients are not directed to subsequent confirmatory tests and if they are chronically infected, they need to be linked to care. Secondly, data does not exist for PWID who are receiving substance abuse counselling or rehabilitation treatment programs under agencies which are not run by DH or the Hong Kong Hospital Authority. These are run by non-governmental organizations (NGOs), such as Barnabas Charitable Service Association providing training centre and half-way house for residence, and religious organizations providing rehabilitation centres. These subjects belong to high-risk group of harbouring undiagnosed chronic HCV and thus should be tested and linked to care.
Traditionally, the first step in screening for HCV utilizes enzyme immunoassay for the antibody against HCV. Fortunately, newer rapid diagnostic tests (RDT) can be used as a tool to screen subjects by providing point-of-care diagnosis on site. For instance, the OraQuick® HCV test (OraSure Technologies, Inc) is FDA-approved and CLIA-waived, with more than 98% sensitivity and specificity for qualitative detection of anti-HCV antibody in finger stick or venepuncture whole blood. As the volume of blood required is much smaller, subjects only need a finger stick for testing and results will be available within 20-40min. Subjects having positive results from RDT will proceed with venepuncture for collection of whole blood which will be sent back to our laboratory for confirmatory testing of anti-HCV antibody and HCV RNA.
Upon confirmation of diagnosis, subjects should be linked to care for further management. Ideally, all patients with chronic HCV should be treated regardless of severity of liver disease unless liver decompensation has developed necessitating liver transplantation before treatment or limited lifespan is expected even with DAA treatment. In Hong Kong, due to limited health care resources and lack of comprehensive insurance coverage schemes, DAA cannot be universally prescribed to every patient. Risk stratification is the strategy adopted by the Hospital Authority to prioritize those patients with more advanced liver disease, as defined by advanced liver fibrosis (F3) or cirrhosis (F4), to receive subsidized DAA treatment. If all patients with different risk profiles are linked to care in the same manner, those with more advanced disease will suffer from delayed assessment and subsequent treatment due to the long waiting time (in terms of 1-2 years) to be seen by specialist. The investigators propose to set up an integrated linkage-to-care clinic for all patients with newly diagnosed chronic HCV. Patients will be assessed in a timely manner. A dedicated research nurse will provide counselling and education to the patients. The nurse will then arrange on-site liver stiffness measurement with Fibroscan®, as well as phlebotomy for liver function test assessment. Patients with F3/F4 or significantly impaired liver function shall be directed to specialist via a fast track protocol to facilitate timely treatment, instead of the routine clinic appointment.
The mission of our department is to promote health in the field of Hepatology. The investigators have a team of dedicated professionals to provide high-quality services to patients in our community. Besides, our team actively participates in various kinds of liver-related basic science and clinical studies with numerous scientific contributions, and therefore is very experienced and well equipped with laboratory back up for liver-related research. The investigators have previously conducted a large-scale population-based study in 10,256 Hong Kong subjects for detection of seroprevalence rates of viral hepatitis, which showed that sero-prevalence rate of HCV to be 0.5% in the general community. The investigators are determined to fill the knowledge gap of the rate of chronic HCV infection in high-risk groups.
This is a prospective cohort study. The investigators will form an outreach team and conduct visits to the halfway house and rehabilitation centres run by non-governmental organisations (NGOs). The investigators will perform rapid diagnostic test (RDT) in these people who injected drugs (PWIDs) who have already started rehabilitation in these institutions. The investigators plan to conduct site visits every 4 - 8 weeks. The consent and potential impact of this study will be explained to subjects, followed by obtaining consent and blood taking. Subjects will also be asked to fill in a questionnaire, including information on age, gender, place of birth, ethnic origin, chronic medical illness, prior viral hepatitis infection, history of receiving HCV treatment and risk factors for contracting HCV (e.g. prior transfusion, intravenous drug use, tooth extraction or gum surgery, skin tattooing). Subjects will then have finger stick, which will be used for RDT as a point-of-care HCV screening test. If the RDT result is positive, the subject will then proceed with formal venepuncture for whole blood, which will be tested for confirmatory anti-HCV and HCV RNA (HCV genotype will also be determined for HCV RNA positive samples) in our own laboratory. The investigators will actively contact subjects confirmed with the diagnosis of chronic HCV. The research nurse will contact them to attend the integrated linkage-to-care clinic for counselling, education and risk stratification. During the clinic visits, risk stratification according to the liver status will be done by 1) physical examinations to document the clinical liver status, 2) comprehensive blood investigations including liver function tests, platelet counts and clotting profiles and 3) Fibroscan® to assess the fibrosis status.
Study Design
Outcome Measures
Primary Outcome Measures
- Proportion of newly diagnosed HCV patients being linked to care [24 months]
Newly diagnosed HCV patients will be linked to local hepatologists for further treatment
Secondary Outcome Measures
- Prevalence rate of HCV in PWIDs [24 months]
Prevalence rate of chronic hepatitis C infection in people who inject drugs who have entered into rehabilitation program
- Proportion of various genotypes of HCV in PWIDs [24 months]
Proportion of participants with various genotypes of chronic hepatitis C infection among PWIDs in Hong Kong
Eligibility Criteria
Criteria
Inclusion Criteria:
- People who inject drugs (PWID) who are receiving substance abuse counselling or rehabilitation treatment programs in halfway house and rehabilitation centres run by Non-governmental organisations (NGOs) in Hong Kong
Exclusion Criteria:
- Already on antiviral therapy for known HCV
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Man Fung Yuen | Hong Kong | Please Select One ... | Hong Kong |
Sponsors and Collaborators
- The University of Hong Kong
Investigators
- Principal Investigator: Man-Fung Yuen, DSc, MD, PhD, The University of Hong Kong
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IN-HK-987-5354