Enhancing Access to Care for Chronic Hepatitis C Infected Populations in Hong Kong

NCT03993925 | Active Not Recruiting

• 1 other identifier: IN-HK-987-5354
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

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, 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.

Conditions

Chronic Hepatitis C; Intravenous Drug Usage

Keywords

chronic hepatitis C; people who inject drugs; access to care; prison inmates

Outcome Measures

Primary Outcomes (1)

• Proportion of newly diagnosed HCV patients being linked to care

  Newly diagnosed HCV patients will be linked to local hepatologists for further treatment

  24 months

Secondary Outcomes (2)

• Prevalence rate of HCV in various high risk populations in Hong Kong

  24 months

• Proportion of various genotypes of HCV in PWIDs

  24 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People who inject drugs (PWID): receiving substance abuse counselling or rehabilitation treatment programs in halfway house and rehabilitation centres run by Non-governmental organisations (NGOs) in Hong Kong. Prison inmates: currently institutionalised under the Correctional Services Department. People with substance abuse: previous history or currently active substance abuse

You may qualify if:

• 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
• Prison inmates
• People with substance abuse

You may not qualify if:

• Already on antiviral therapy for known HCV

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Man Fung Yuen

Hong Kong, Please Select One ..., Hong Kong

Location

Biospecimen

Retention: SAMPLES WITH DNA

Clotted blood will be stored for HCV RNA quantification and genotyping

MeSH Terms

Conditions

Hepatitis C, Chronic

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Man-Fung Yuen, DSc, MD, PhD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair Professor of Gastroenterology and Hepatology

Study Record Dates

• First Submitted: June 18, 2019
• First Posted: June 21, 2019
• Study Start: September 20, 2019
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 4, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)