EPIC: Epidemiology of Chronic Hepatitis C and Disease Modelling

Sponsor
Changi General Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03566563
Collaborator
National University Hospital, Singapore (Other)
520
1
39.2
13.3

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Screening

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 Design

Study Type:
Observational
Actual Enrollment :
520 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Epidemiology of Chronic Hepatitis C and Modelling for Disease Burden Study
Actual Study Start Date :
Feb 21, 2017
Actual Primary Completion Date :
Feb 7, 2020
Actual Study Completion Date :
May 29, 2020

Arms and Interventions

Arm 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
  • Outcome Measures

    Primary Outcome Measures

    1. HCV Sero-prevalence at Halfway Houses [24 months]

      The number of HCV Sero positive cases at Halfway Houses will be measured

    Secondary Outcome Measures

    1. Linkage to Care [24 months]

      The number of patients linked to care will be compared between the intervention arm and conventional arm

    Other Outcome Measures

    1. Disease burden estimation [24 months]

      The number of HCV positive cases in Singapore will be estimated

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • Former Drug Users residing in Halfway Houses
    Exclusion Criteria:
    • Age below 21 years

    • Residents of Halfway Houses who have never used drugs

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Changi General Hospital Singapore Singapore 529889

    Sponsors and Collaborators

    • Changi General Hospital
    • National University Hospital, Singapore

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Changi General Hospital
    ClinicalTrials.gov Identifier:
    NCT03566563
    Other Study ID Numbers:
    • 2016/2804
    First Posted:
    Jun 25, 2018
    Last Update Posted:
    Oct 8, 2020
    Last Verified:
    Oct 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Changi General Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 8, 2020