Clinical trial NCT03566563: Epidemiology of Chronic Hepatitis C and Disease Modelling
Official title: Epidemiology of Chronic Hepatitis C and Modelling for Disease Burden Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C
Keywords: Community Screening
Halfway house
People who inject drugs
Substance users
Released prisoners
Lead sponsor: Changi General Hospital
Sponsor class: OTHER
Collaborators: name: National University Hospital, Singapore
First posted: 2018-06-25
Enrollment: 520
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Eligibility criteria: Inclusion Criteria:

* Former Drug Users residing in Halfway Houses

Exclusion Criteria:

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

Primary outcomes:
measure: HCV Sero-prevalence at Halfway Houses
timeFrame: 24 months
Secondary outcomes:
measure: Linkage to Care
timeFrame: 24 months
Other outcomes:
measure: Disease burden estimation
timeFrame: 24 months
Locations:
city: Singapore
country: Singapore
facility: Changi General Hospital
Study officials:
affiliation: Changi General Hospital
name: Prem H Thurairajah, PhD
role: PRINCIPAL_INVESTIGATOR
References: