Epidemiology of Chronic Hepatitis C and Disease Modelling

Completed

• Conditions: Hepatitis C
• Interventions: Other: Screening

• Registration Number: NCT03566563
• Lead Sponsor: Changi General Hospital

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

Study Timeline

• Study Start: 2017-02-21
• Study First Submitted: 2018-05-08
• Study First Submitted QC: 2018-06-21
• Study First Posted: 2018-06-25
• Primary Completion: 2020-02-07
• Study Completion: 2020-05-29
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-06
• Last Update Posted: 2020-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 520

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ex-Drug Users	Screening	These are ex drug users residing at halfway houses

Primary Outcome Measures

Name	Time	Method
HCV Sero-prevalence at Halfway Houses	24 months	The number of HCV Sero positive cases at Halfway Houses will be measured

Secondary Outcome Measures

Name	Time	Method
Linkage to Care	24 months	The number of patients linked to care will be compared between the intervention arm and conventional arm

Trial Locations

Locations (1)

Changi General Hospital; 🇸🇬 Singapore, Singapore