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

Study Overview
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Brief Summary
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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 and syringe program (NSP) services in Australia, to see if it can improve the number of people who start treatment following an HCV diagnosis: HCV testing from collected dried blood spots sent to a central laboratory HCV testing using a point-of-care device at the NSP site HCV testing using standard of care at the NSP site

Detailed Description
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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 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 cluster randomized controlled trial. The sites (clusters) will be primary NSPs which provide services to people who inject drugs and have capacity to provide hepatitis C treatment services. The sites will be located in Australia. Eighteen NSPs (the clusters) will be randomly allocated to receive point-of-care HCV RNA testing (6 clusters), dried blood spot testing (6 clusters) or standard of care (6 clusters). 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 will continue until a total of 150 HCV RNA positive participants ( 25 participants per site) are enrolled in the dried blood spot arm, 150 HCV RNA positive participants are enrolled in the point-of-care arm, and 150 participants are enrolled in the standard of care arm. Hence a total of 450 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.

Official Title
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A Multi-centre, Practice-level, Cluster Randomized Controlled Trial to Compare Point-of-care HCV RNA Testing, Dried Blood Spot Testing, and Standard of Care to Enhance Treatment Uptake Among People With HCV Who Have Recently Injected Drugs Attending Needle and Syringe Programs: the TEMPO Study

Conditions
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Hepatitis C, Hepatitis C, Chronic

Intervention / Treatment
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* Diagnostic Test: Xpert HCV Viral Load Fingerstick
* Diagnostic Test: Aptima HCV Quant DX Assay


Participation Criteria
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Eligibility Criteria
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Inclusion criteria for participants: Attendees of the NSP service are eligible for inclusion if the following criteria are met: Provided written informed consent ≥ 18 years of age 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dried Blood Spot (Intervention)<br>Blood samples will be tested for HCV RNA from dried blood spot cards. | Diagnostic Test: Aptima HCV Quant DX Assay<br>* 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.<br>|
| Experimental: Point-of-care RNA (Intervention)<br>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<br>* 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.<br>|
| No Intervention: Standard of Care (Control)<br>Sites will continue with their standard of care for hepatitis C testing. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of HCV RNA positive who initiate HCV treatment | 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. | 12 weeks from Enrolment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis C Virus, Needle and Syringe Programs