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Rapid Point-of-care Testing for Hepatitis C in Community Clinics (RAPID-EC) Pilot Study

NCT03231930 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 174

Last updated 2019-07-15

No results posted yet for this study

Summary

The Rapid-EC pilot study will determine feasibility of providing rapid point-of-care (POC) testing for HCV in community clinics, and whether the availability of POC testing increases uptake of testing, engagement in care and completion of treatment among people who inject drugs.

The POC tests being utilised in this study are the OraQuick mouth swab test for the presence of HCV antibodies, and the Xpert HCV RNA viral load test using serum.

Conditions

  • Hepatitis C

Interventions

DEVICE

OraQuick HCV Ab test

The OraQuick HCV point of care test involves the collection of oral fluid and provides an accurate result in approximately 20 minutes. The test involves a clinic nurse or community health worker providing pre-test counselling, then providing an oral swab to study participants, then reading the result and counselling the participant about their HCV antibody test result.

DEVICE

Xpert HCV viral load test

The Cepheid Xpert HCV RNA test (Xpert® HCV Viral Load test) is a reverse transcriptase polymerase-based chain reaction amplification technology (RT-PCR) and provides an accurate HCV RNA load within 2 hours (105 minutes), using a serum sample. This test will be performed for participants who have a positive OraQuick HCV antibody result.

Sponsors & Collaborators

  • Gilead Sciences

    collaborator INDUSTRY

  • Macfarlane Burnet Institute for Medical Research and Public Health Ltd

    lead OTHER

Principal Investigators

  • Margaret Hellard, MBBS,PhD · Burnet Institute

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-06-29
Primary Completion
2017-11-01
Completion
2018-05-17
FDA Device
Yes

Countries

  • Australia

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03231930 on ClinicalTrials.gov