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

NCT03231930 | Completed DMC FDA Device

• 1 other identifier: HREC/16/Alfred/165
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

Diagnosis; Point of Care Diagnostics; Hepatitis

Outcome Measures

Primary Outcomes (1)

• Number of participants at high risk for HCV infection who receive a HCV rapid point-of-care antibody test

  The investigators will measure the total number of participants who undergo the OraQuick test for HCV antibodies. This will be recorded by site staff.

  6 months after commencing recruitment.

Secondary Outcomes (4)

• Number of participants with a positive HCV antibody test who receive a rapid point-of-care RNA test

  6 months after commencing recruitment.

• Number of participants with a positive HCV RNA test who attend their appointment with the doctor for treatment

  6 months after commencing recruitment.

• Number of participants who obtain DAA therapy (ie medication is picked up from pharmacy)

  Six months post completion of recruitment

• Number of participants who achieve sustained virological response at 12 weeks post treatment (SVR12)

  Six months post completion of recruitment

Study Arms (1)

Intervention group

EXPERIMENTAL

Rapid point of care testing will be done using the OraQuick HCV Ab test and the Xpert HCV RNA viral load test. All participants will undergo rapid point of care testing for hepatitis C antibodies using the OraQuick test with oral fluid, followed by point of care testing for the detection of hepatitis C virus RNA using the Cepheid Xpert HCV viral load test on the GeneXpert system. Participants who are found to have current HCV infection will be worked up for treatment at the clinic and referred to appropriate practitioners for HCV treatment. As these tests are not yet licensed for diagnostic use in Australia, confirmatory testing using standard laboratory tests will be performed for all participants.

Device: OraQuick HCV Ab test; Device: Xpert HCV viral load test

Interventions

OraQuick HCV Ab test DEVICE

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.

Intervention group

Xpert HCV viral load test DEVICE

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.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged ≥18 years;
• Attendance for any reason at either the primary health care services participating in the study
• Not currently engaged in care for treatment of hepatitis C infection, and not received a diagnosis of hepatitis C infection (with positive HCV RNA) in the preceding 3 months;

You may not qualify if:

• Pregnancy or breastfeeding at time of HCV antiviral treatment;
• Evidence of any condition, therapy, laboratory abnormality or other circumstance (current or prior) that may confound the study's results, or interfere with participation for the full duration of the study, such that it is not in the best interest of the participant.

Sponsors & Collaborators

• Macfarlane Burnet Institute for Medical Research and Public Health Ltd: lead
• Gilead Sciences: collaborator

Study Sites (3)

Innerspace

Collingwood, Victoria, 3066, Australia

Location

Health Works

Footscray, Victoria, 3011, Australia

Location

North Richmond Community Health

Richmond, Victoria, 3121, Australia

Location

Related Publications (2)

• Williams B, Howell J, Doyle J, Thompson AJ, Draper B, Layton C, Latham N, Bramwell F, Membrey D, Mcpherson M, Roney J, Stoove M, Hellard ME, Pedrana A. Point-of-care hepatitis C testing from needle and syringe programs: An Australian feasibility study. Int J Drug Policy. 2019 Oct;72:91-98. doi: 10.1016/j.drugpo.2019.05.012. Epub 2019 May 22.

  PMID: 31129023 RESULT

• Latham NH, Pedrana A, Doyle JS, Howell J, Williams B, Higgs P, Thompson AJ, Hellard ME. Community-based, point-of-care hepatitis C testing: perspectives and preferences of people who inject drugs. J Viral Hepat. 2019 Jul;26(7):919-922. doi: 10.1111/jvh.13087. Epub 2019 Apr 1.

  PMID: 30801881 RESULT

MeSH Terms

Conditions

Hepatitis C; Disease; Hepatitis

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Margaret Hellard, MBBS,PhD

  Burnet Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants will receive the same intervention, which is rapid point of care testing for hepatitis C antibodies using the OraQuick test with oral fluid , followed by point of care testing for the detection of hepatitis C virus RNA using the Cepheid Xpert HCV RNA viral load test on the GeneXpert system. Participants who are found to have current HCV infection will be worked up for treatment at ths clinic and referred to appropriate practitioners for HCV treatment. All results will be confirmed with standard laboratory testing as these devices are not yet approved for diagnostic use in Australia.

Study Record Dates

• First Submitted: June 25, 2017
• First Posted: July 27, 2017
• Study Start: June 29, 2017
• Primary Completion: November 1, 2017
• Study Completion: May 17, 2018
• Last Updated: July 15, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (3)