Epidemiology of Chronic Hepatitis C and Disease Modelling (EPIC)

October 6, 2020 updated by: Changi General Hospital

Epidemiology of Chronic Hepatitis C and Modelling for Disease Burden Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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

Study Type

Observational

Enrollment (Actual)

520

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 529889
        • Changi General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Halfway House (HH) residents are largely former injecting drug users who have a high prevalence of Hepatitis C. Typically upon release from prisons, there are housed at HH as an interim step prior to re-integration back into society. The prevalence of Hepatitis C within this community allows the estimation of the national prevalence of Hepatitis C in the country.

Description

Inclusion Criteria:

  • Former Drug Users residing in Halfway Houses

Exclusion Criteria:

  • Age below 21 years
  • Residents of Halfway Houses who have never used drugs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Ex-Drug Users
These are ex drug users residing at halfway houses
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
Other Names:
  • Models of Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HCV Sero-prevalence at Halfway Houses
Time Frame: 24 months
The number of HCV Sero positive cases at Halfway Houses will be measured
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Linkage to Care
Time Frame: 24 months
The number of patients linked to care will be compared between the intervention arm and conventional arm
24 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease burden estimation
Time Frame: 24 months
The number of HCV positive cases in Singapore will be estimated
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changi General Hospital

Collaborators

National University Hospital, Singapore

Investigators

  • Principal Investigator: Prem H Thurairajah, PhD, Changi General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 21, 2017

Primary Completion (Actual)

February 7, 2020

Study Completion (Actual)

May 29, 2020

Study Registration Dates

First Submitted

May 8, 2018

First Submitted That Met QC Criteria

June 21, 2018

First Posted (Actual)

June 25, 2018

Study Record Updates

Last Update Posted (Actual)

October 8, 2020

Last Update Submitted That Met QC Criteria

October 6, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016/2804

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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