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Enhancing Hepatitis C Testing and Treatment Among People Who Inject Drugs Attending Needle and Syringe Programs (TEMPO)

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ClinicalTrials.gov Identifier: NCT04014179
Recruitment Status : Not yet recruiting
First Posted : July 10, 2019
Last Update Posted : September 3, 2020
Sponsor:
Information provided by (Responsible Party):
Kirby Institute

Brief Summary:

This project aims to evaluate two strategies of Hepatitis C virus (HCV) testing compared to standard of care among people who inject drugs at needle syringe (NSP) or needle exchanges (NEX) program services in Australia and New Zealand, to see if it can improve the number of people who start treatment following an HCV diagnosis:

  1. HCV testing from collected dried blood spots sent to a central laboratory
  2. HCV testing using a point-of-care device at the NSP/NEX site
  3. HCV testing using standard of care at the NSP/NEX site

Condition or disease Intervention/treatment Phase
Hepatitis C Hepatitis C, Chronic Diagnostic Test: Xpert HCV Viral Load Fingerstick Diagnostic Test: Aptima HCV Quant DX Assay Not Applicable

Detailed Description:

The TEMPO study will compare dried blood spot testing and point-of-care HCV RNA testing to standard of care as strategies to enhance HCV treatment uptake among people with HCV and recent injecting drug use attending NSP/NEX services. Peer support to enhance engagement and facilitate linkage to nursing care will be provided in the intervention arms of this study.

The study is a stepped, wedge cluster randomized controlled trial. The sites (clusters) will be primary NSP/NEXs which provide services to people who inject drugs and have capacity to provide hepatitis C treatment services. The sites will be located in Australia and New Zealand.

Twenty NSP/NEXs (the clusters)* will be randomly allocated to receive the intervention immediately (10 clusters) versus standard of care with delayed implementation (10 clusters). The immediate intervention arm will be randomized 1:1 to receive point-of-care HCV RNA testing (5 clusters) or HCV RNA testing from dried blood spots (5 clusters). The delayed intervention arm will have a period of standard of care (based on the number of enrolled participants) and switch to receiving the intervention. The delayed intervention arm will then be randomized 1:1 to receive point-of-care HCV RNA testing (5 clusters) or HCV RNA testing from dried blood spots (5 clusters). As such, at the end of the study, there will be 10 clusters randomized to point-of-care HCV RNA testing or 10 clusters to HCV RNA testing from dried blood spots.

*More than 20 NSP/NEXs may be assigned to the study and randomised as described above.

At screening, participants will be tested for HCV infection with dried blood spot, point-of-care or standard of care, depending on cluster randomisation.

Screening in the intervention arm will continue until a total of 150 HCV RNA positive participants are enrolled in dried blood spot and 150 HCV RNA positive participants are enrolled in point-of-care. A total of 300 HCV RNA participants in the intervention arm. In the delayed implementation arm, 200 HCV RNA positive participants will be enrolled and then clusters/sites will be switched to intervention - at which screening will continue until a total of 150 HCV RNA positive participants are enrolled in dried blood spot and 150 HCV RNA positive participants are enrolled in point-of-care. Hence a total of 800 HCV RNA positive participants.

HCV RNA negative participants will have no further assessments or visits as part of the study protocol.

Participants who are HCV RNA positive will be enrolled in the follow-up cohort and will be assessed for treatment eligibility. If eligible, they will be treated as per standard of care with a pharmaceutical benefits scheme (PBS) approved pan-genotypic HCV DAA treatment. Participants will be encouraged to take the first dose on the day of treatment work-up where possible. On-treatment and post-treatment testing and monitoring will be based on the site investigator as per standard clinical practice.

All HCV RNA positive participants will be followed up at 12 weeks, 24 weeks and 12 months post enrolment.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: A Multi-centre, Practice-level, Cluster Randomized, Parallel-group Controlled Trial to Compare Point-of-care Hepatitis C RNA Testing to Dried Blood Spot Testing to Enhance Treatment Uptake Among People With HCV Who Have Recently Injected Drugs Attending Needle and Syringe Programs: the TEMPO Study
Estimated Study Start Date : November 2020
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Immediate Intervention (Dried Blood Spot)
Blood samples will be tested for HCV RNA from dried blood spot cards.
Diagnostic Test: Aptima HCV Quant DX Assay

The Aptima HCV Quant Dx assay is a real-time transcription-mediated amplification test.

The assay is used for both detection and quantitation of hepatitis C virus (HCV) RNA in fresh and frozen human serum and plasma from HCV-infected individuals, and in this study from dried blood spots. The HCV RNA result from the Aptima assay will be used to initiate HCV treatment.


Experimental: Immediate intervention (Point-of-care testing)
Blood samples will be tested for HCV RNA using the Xpert HCV Viral Load Fingerstick point-of-care assay.
Diagnostic Test: Xpert HCV Viral Load Fingerstick
The Cepheid Xpert HCV Viral Load (VL) Fingerstick assay is an in vitro nucleic acid amplification test designed for the quantitation of Hepatitis C Virus (HCV) DNA in human whole blood using the automated GeneXpert Systems. The HCV RNA result from the Xpert test will be used to initiate HCV treatment.

Active Comparator: Delayed intervention (Dried Blood Spot)
There will be a period of business as usual, that is, sites will continue with standard of care for HCV RNA testing, then switch to intervention for HCV RNA testing from dried blood spots.
Diagnostic Test: Aptima HCV Quant DX Assay

The Aptima HCV Quant Dx assay is a real-time transcription-mediated amplification test.

The assay is used for both detection and quantitation of hepatitis C virus (HCV) RNA in fresh and frozen human serum and plasma from HCV-infected individuals, and in this study from dried blood spots. The HCV RNA result from the Aptima assay will be used to initiate HCV treatment.


Active Comparator: Delayed intervention (Point-of-care testing)
There will be a period of business as usual, that is, sites will continue with standard of care for HCV RNA testing, then switch to intervention for HCV RNA testing using the point-of-care assay.
Diagnostic Test: Xpert HCV Viral Load Fingerstick
The Cepheid Xpert HCV Viral Load (VL) Fingerstick assay is an in vitro nucleic acid amplification test designed for the quantitation of Hepatitis C Virus (HCV) DNA in human whole blood using the automated GeneXpert Systems. The HCV RNA result from the Xpert test will be used to initiate HCV treatment.




Primary Outcome Measures :
  1. Proportion of HCV RNA positive who initiate HCV treatment [ Time Frame: 12 weeks from Enrolment ]
    To compare the proportion of HCV RNA positive participants who initiate HCV treatment at 12 weeks following enrolment between those who receive point-of-care HCV RNA testing, dried blood spot testing, and standard of care.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria for participants:

Attendees of the NSP service are eligible for inclusion if the following criteria are met:

  1. Provided written informed consent
  2. ≥ 18 years of age
  3. Recent injecting drug use - defined as self-reported use within the previous six months.

Exclusion criteria for participants:

a. Is unable or unwilling to provide informed consent or abide by the requirements of the study.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04014179


Contacts
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Contact: Elise Tu, PhD 61-2-9385-9000 etu@kirby.unsw.edu.au

Locations
Show Show 26 study locations
Sponsors and Collaborators
Kirby Institute
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Responsible Party: Kirby Institute
ClinicalTrials.gov Identifier: NCT04014179    
Other Study ID Numbers: VHCRP1904
First Posted: July 10, 2019    Key Record Dates
Last Update Posted: September 3, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Kirby Institute:
Hepatitis C Virus, Needle Syringe Programs, Needle Exchanges
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic