Hepatitis CNCT03231930
Rapid Point-of-care Testing for Hepatitis C in Community Clinics (RAPID-EC) Pilot Study
A study testing OraQuick HCV Ab test and Xpert HCV viral load test in people with Hepatitis C, run by Macfarlane Burnet Institute for Medical Research and Public Health Ltd at 3 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C
- What is being tested?
- OraQuick HCV Ab test and Xpert HCV viral load test
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 3 sitesAustralia
- Study dates
- 29 Jun 2017to 17 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Australia3 sites
Innerspace
Collingwood, Victoria, 3066
Health Works
Footscray, Victoria, 3011
North Richmond Community Health
Richmond, Victoria, 3121
About this study
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.
Read the detailed description
The introduction of direct-acting antiviral (DAA) therapies has meant the elimination of hepatitis C (HCV) as a public health issue in Australia is a very real possibility. The challenge that remains is to ensure that all people living with HCV can access testing to become aware of their status, and then get treated and cured. Given that people who inject drugs (PWID) account for the vast majority of new HCV infections in Australia, this group will be key to elimination efforts. Innovative approaches are needed to overcome the barriers to accessing health services that are faced by PWID.
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 PWID.
The Rapid-EC pilot study will be delivered by a multi-disciplinary team in three community clinics in Melbourne, Australia. After providing informed consent and receiving pre-test counselling, participants will undergo an OraQuick mouth swab test for the presence of HCV antibodies, which indicates whether a person has ever been exposed to HCV. This result is available in 20 minutes. If this test is positive they will then be offered a test for the presence of virus in the blood, known as a PCR or RNA test. The Xpert HCV RNA POC test uses a 5ml sample of blood from the vein and is run on the GeneXpert machine, which will be on-site at each clinic. This machine provides results in 105 minutes, allowing participants to receive a HCV diagnosis on the day of testing.
Both the OraQuick HCV Ab test and the Xpert HCV RNA test are highly accurate tests; however they are currently awaiting approval for diagnostic use in Australia. As such, standard-of-care testing will be performed for all participants to confirm the result and inform clinical care. Participants who have a positive HCV Ab result will have a follow-up visit with the study nurse where they will review all test results. Those who are found to have a current HCV infection (positive RNA result) will have an assessment of liver health and, where appropriate, commence HCV treatment from the clinic. Participants will be reimbursed for the time taken to complete the study.
To evaluate the impact of the study participants will be asked to complete two questionnaires: 1) at the beginning of the study to record demographics, risk behaviours, and previous experience of HCV testing; and 2) after completing the POC tests to provide feedback on their experience and preferences for testing. These responses, as well as clinical information collected by staff, will be de-identified. Data linkage with Medicare and Pharmaceutical Benefits Scheme data will be used to determine if the participant followed up with their healthcare provider and collected a prescription for HCV treatment.
This study will provide valuable insights into the feasibility and effects of offering POC testing for HCV, particularly the effect on uptake of testing and treatment. The results will inform a larger trial, with greater numbers of participants and sites, and the introduction of finger prick testing for HCV RNA, which is likely to become available for research use in towards the end of 2017.
- Conditions
- Hepatitis C
- Being tested
- OraQuick HCV Ab test, Xpert HCV viral load test
- Keywords
- Diagnosis, Point of Care Diagnostics, Hepatitis
- Medical subject headings
- Hepatitis C, Disease, Hepatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OraQuick HCV Ab testDevice
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.
Xpert HCV viral load testDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: OraQuick HCV Ab test; Device: Xpert HCV viral load test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The investigators will measure the total number of participants who undergo the Xpert HCV viral load test for HCV RNA. This will be recorded by site staff.
Measured: 6 months after commencing recruitment.
Number of participants with a positive HCV RNA test who attend their appointment with the doctor for treatment
The investigators will measure how many participants attend a follow-up appointment with their doctor to discuss treatment. This will be recorded by site staff.
Measured: 6 months after commencing recruitment.
Number of participants who obtain DAA therapy (ie medication is picked up from pharmacy)
The investigators will measure the number of participants who collect medication for treatment by accessing data from the Pharmaceutical Benefits Scheme, with participant consent.
Measured: Six months post completion of recruitment
Number of participants who achieve sustained virological response at 12 weeks post treatment (SVR12)
This will be measured using standard of care blood tests for HCV RNA at 12 weeks post completion of treatment, with results reviewed and recorded by site staff.
Measured: Six months post completion of recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2017
- Study start29 Jun 2017
- Primary completion1 Nov 2017
- Study completion17 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Macfarlane Burnet Institute for Medical Research and Public Health Ltd
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor
- Investigators
- Margaret Hellard, MBBS,PhD, Principal investigator, Burnet Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03231930
- Sponsor's protocol ID
- HREC/16/Alfred/165
- Status last verified
- Jul 2019
- First submitted
- 25 Jun 2017
- Last updated
- 15 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 31129023Latham 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.
PubMed 30801881
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Point-of-care Testing for Hepatitis C in Community Clinics (RAPID-EC) Pilot Study
- ClinicalTrials.gov ID
- NCT03231930
- Acronym / sponsor ID
- HREC/16/Alfred/165
- Conditions
- Hepatitis C
- Keywords
- Diagnosis, Point of Care Diagnostics, Hepatitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Macfarlane Burnet Institute for Medical Research and Public Health LtdUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- 29 Jun 2017 (actual)
- Primary completion
- 1 Nov 2017 (actual)
- Study completion
- 17 May 2018 (actual)
- First posted
- 27 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The introduction of direct-acting antiviral (DAA) therapies has meant the elimination of hepatitis C (HCV) as a public health issue in Australia is a very real possibility. The challenge that remains is to ensure that all people living with HCV can access testing to become aware of their status, and then get treated and cured. Given that people who inject drugs (PWID) account for the vast majority of new HCV infections in Australia, this group will be key to elimination efforts. Innovative approaches are needed to overcome the barriers to accessing health services that are faced by PWID.
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 PWID.
The Rapid-EC pilot study will be delivered by a multi-disciplinary team in three community clinics in Melbourne, Australia. After providing informed consent and receiving pre-test counselling, participants will undergo an OraQuick mouth swab test for the presence of HCV antibodies, which indicates whether a person has ever been exposed to HCV. This result is available in 20 minutes. If this test is positive they will then be offered a test for the presence of virus in the blood, known as a PCR or RNA test. The Xpert HCV RNA POC test uses a 5ml sample of blood from the vein and is run on the GeneXpert machine, which will be on-site at each clinic. This machine provides results in 105 minutes, allowing participants to receive a HCV diagnosis on the day of testing.
Both the OraQuick HCV Ab test and the Xpert HCV RNA test are highly accurate tests; however they are currently awaiting approval for diagnostic use in Australia. As such, standard-of-care testing will be performed for all participants to confirm the result and inform clinical care. Participants who have a positive HCV Ab result will have a follow-up visit with the study nurse where they will review all test results. Those who are found to have a current HCV infection (positive RNA result) will have an assessment of liver health and, where appropriate, commence HCV treatment from the clinic. Participants will be reimbursed for the time taken to complete the study.
To evaluate the impact of the study participants will be asked to complete two questionnaires: 1) at the beginning of the study to record demographics, risk behaviours, and previous experience of HCV testing; and 2) after completing the POC tests to provide feedback on their experience and preferences for testing. These responses, as well as clinical information collected by staff, will be de-identified. Data linkage with Medicare and Pharmaceutical Benefits Scheme data will be used to determine if the participant followed up with their healthcare provider and collected a prescription for HCV treatment.
This study will provide valuable insights into the feasibility and effects of offering POC testing for HCV, particularly the effect on uptake of testing and treatment. The results will inform a larger trial, with greater numbers of participants and sites, and the introduction of finger prick testing for HCV RNA, which is likely to become available for research use in towards the end of 2017.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: OraQuick HCV Ab test, Device: Xpert HCV viral load testRapid 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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;
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OraQuick HCV Ab testThe 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 | Intervention group |
| Xpert HCV viral load testThe 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. | Device | Intervention group |
Primary outcome
Number of participants at high risk for HCV infection who receive a HCV rapid point-of-care antibody test
Time frame: 6 months after commencing recruitment.
The investigators will measure the total number of participants who undergo the OraQuick test for HCV antibodies. This will be recorded by site staff.
4 secondary outcomes
Number of participants with a positive HCV antibody test who receive a rapid point-of-care RNA test
Time frame: 6 months after commencing recruitment.
Number of participants with a positive HCV RNA test who attend their appointment with the doctor for treatment
Time frame: 6 months after commencing recruitment.
Number of participants who obtain DAA therapy (ie medication is picked up from pharmacy)
Time frame: Six months post completion of recruitment
Number of participants who achieve sustained virological response at 12 weeks post treatment (SVR12)
Time frame: Six months post completion of recruitment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2019.
- Results publication: PubMed 31129023Williams 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.
- Results publication: PubMed 30801881Latham 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margaret Hellard, MBBS,PhD principal investigator
Burnet Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OraQuick HCV Ab test and Xpert HCV viral load test in people with Hepatitis C, run by Macfarlane Burnet Institute for Medical Research and Public Health Ltd at 3 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants at high risk for HCV infection who receive a HCV rapid point-of-care antibody test (time frame: 6 months after commencing recruitment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03231930, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2019.