NCT03566563

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
520

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 21, 2017

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 8, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 25, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 7, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 29, 2020

Completed
Last Updated

October 8, 2020

Status Verified

October 1, 2020

Enrollment Period

3 years

First QC Date

May 8, 2018

Last Update Submit

October 6, 2020

Conditions

Hepatitis C

Keywords

Community ScreeningHalfway housePeople who inject drugsSubstance usersReleased prisoners

Outcome Measures

Primary Outcomes (1)

  • HCV Sero-prevalence at Halfway Houses

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

    24 months

Secondary Outcomes (1)

  • Linkage to Care

    24 months

Other Outcomes (1)

  • Disease burden estimation

    24 months

Study Arms (1)

Ex-Drug Users

These are ex drug users residing at halfway houses

Other: Screening

Interventions

ScreeningOTHER

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

Also known as: Models of Care
Ex-Drug Users

Eligibility Criteria

Age21 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Former Drug Users residing in Halfway Houses

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changi General Hospital

Singapore, 529889, Singapore

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosisHealth SurveysSurveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesDiagnostic ServicesPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthPublic Health Practice

Study Officials

  • Prem H Thurairajah, PhD

    Changi General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2018

First Posted

June 25, 2018

Study Start

February 21, 2017

Primary Completion

February 7, 2020

Study Completion

May 29, 2020

Last Updated

October 8, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)