Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT03993925 |
| Other study ID # |
IN-HK-987-5354 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 20, 2019 |
| Est. completion date |
December 31, 2026 |
Study information
| Verified date |
November 2022 |
| Source |
The University of Hong Kong |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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, people with substance abuse or prison inmates 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.
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 these high-risk populations in Hong Kong. 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. 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.
This is a prospective cohort study. The investigators will form an outreach team and conduct
visits to the relevant premises. The investigators will perform rapid diagnostic test (RDT)
in high-risk populations. 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. For institutionalised subjects, the invesrigators will conduct
additional site visits for prescription and verification of SVR.
