Epidemiology of Chronic Hepatitis C and Disease Modelling

NCT ID: NCT03566563

Last Updated: 2020-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

520 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-02-21

Study Completion Date

2020-05-29

Brief Summary

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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.

Detailed Description

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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

Conditions

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Hepatitis C

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Ex-Drug Users

These are ex drug users residing at halfway houses

Screening

Intervention Type 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

Interventions

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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

Intervention Type OTHER

Other Intervention Names

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Models of Care

Eligibility Criteria

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Inclusion Criteria

* Former Drug Users residing in Halfway Houses

Exclusion Criteria

* Age below 21 years
* Residents of Halfway Houses who have never used drugs
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National University Hospital, Singapore

OTHER

Sponsor Role collaborator

Changi General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Prem H Thurairajah, PhD

Role: PRINCIPAL_INVESTIGATOR

Changi General Hospital

Locations

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Changi General Hospital

Singapore, , Singapore

Site Status

Countries

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Singapore

Other Identifiers

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2016/2804

Identifier Type: -

Identifier Source: org_study_id

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