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Completed

NCT Number: NCT03566563

Epidemiology of Chronic Hepatitis C and Disease Modelling

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.

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Key information

Conditions

Hepatitis C Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Changi General Hospital

Singapore, 529889

About this study

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Former Drug Users residing in Halfway Houses

Exclusion criteria

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

Treatment and study plan

Screening

Other

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

Primary outcomes

  1. HCV Sero-prevalence at Halfway Houses

    Time frame: 24 months

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

Secondary outcomes

  1. Linkage to Care

    Time frame: 24 months

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

Other outcomes

  1. Disease burden estimation

    Time frame: 24 months

    The number of HCV positive cases in Singapore will be estimated

Sponsors and collaborators

Lead sponsor

Changi General Hospital

Other

Collaborators

  • National University Hospital, Singapore

Registry information

Official study title

Epidemiology of Chronic Hepatitis C and Modelling for Disease Burden Study

Acronym: EPIC

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jun 25, 2018
Registry last updated
Oct 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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