Epidemiology of Chronic Hepatitis C and Disease Modelling

Hepatitis C Clinical Trial

— EPIC  

Official title:

Epidemiology of Chronic Hepatitis C and Modelling for Disease Burden Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03566563
• Other study ID #: 2016/2804
• Status: Completed
• Start date: February 21, 2017
• Est. completion date: May 29, 2020

Study information

• Verified date: October 2020
• Source: Changi General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Hepatitis C (HCV) is a major health problem amongst people who inject drugs (PWID) and have limited contact with health care services. Halfway houses (HH) serve to reintegrate former drug users into society. Strategies to eliminate HCV must focus on screening for HCV amongst HH. Linkage to care for PWID population is an issue globally.

The aim is to determine the sero-prevalence, demographics, disease distribution and factors associated with the risk of HCV transmission amongst former drug users at Halfway Houses. The secondary aim would be to determine the best models of care that can be used to link these individuals to existing healthcare services in a pragmatic, randomised fashion

Halfway Houses are invited to participate in a program of HCV education, point-of-care screening using Oraquick test and staging with Fibroscan® by a small mobile team of healthcare workers. A detailed survey regarding illicit drug injecting practices is performed. Those who are tested positive are referred to medical care.

It is anticipated that the prevalence of Hepatitis C within the drug injecting population along with the stages of liver disease such that models for disease burden can be determined.

Description:

This is a pragmatic observational study of point of care HCV screening in the halfway house resident /PWID population.

In the secondary aim the HCV positive subjects are randomised to traditional referral pathway (HCV positive cases attend primary care facilities to get referral to specialist clinic in hospital) and 'direct' open access where the HCV positive cases has direct open access to specialist clinic as above (by passing primary care physicians). We observe the no. of subjects being linkage to specialist care, and HCV treatment

Recruitment information / eligibility

• Status: Completed
• Enrollment: 520
• Est. completion date: May 29, 2020
• Est. primary completion date: February 7, 2020
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Former Drug Users residing in Halfway Houses

Exclusion Criteria:

• Age below 21 years

• Residents of Halfway Houses who have never used drugs

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic

Intervention

Other:
• Screening
Patients tested positive for Hepatitis C will be referred to Hospital through the conventional health care services and by an alternative direct access method to determine if this improves linkage to care

Locations

Country	Name	City	State
Singapore	Changi General Hospital	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
Changi General Hospital	National University Hospital, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Disease burden estimation	The number of HCV positive cases in Singapore will be estimated	24 months
Primary	HCV Sero-prevalence at Halfway Houses	The number of HCV Sero positive cases at Halfway Houses will be measured	24 months
Secondary	Linkage to Care	The number of patients linked to care will be compared between the intervention arm and conventional arm	24 months