Enhancing Hepatitis C Testing and Treatment Among People Who Inject Drugs Attending Needle and Syringe Programs
Enhancing Hepatitis C Testing and Treatment Among People Who Inject Drugs Attending Needle and Syringe Programs
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
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 stepped, wedge 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 and New
 Zealand.

 Twenty six NSPs (the clusters)* will be randomly allocated to receive the intervention
 immediately (13 clusters) versus standard of care with delayed implementation (13 clusters).
 The immediate intervention arm will be randomized 1:1 to receive point-of-care HCV RNA
 testing (6 or 7 clusters)* or HCV RNA testing from dried blood spots (6 or 7 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 (6 or 7 clusters)* or
 HCV RNA testing from dried blood spots (6 or 7 clusters)*. As such, at the end of the study,
 there will be 13 clusters randomized to point-of-care HCV RNA testing or 13 clusters to HCV
 RNA testing from dried blood spots.

 *Based on randomisation, there will be 6 sites using point-of-care and 7 sites using dried
 blood spots, or vice versa with 7 sites using point-of-care and 6 sites using dried blood
 spots.

 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 260 HCV RNA positive
 participants (~20 participants per site) are enrolled in the intervention arm (either dried
 blood spot and point-of-care). In the delayed intervention arm, 260 HCV RNA positive
 participants (~20 participants per site) will be enrolled in the control (standard of care)
 phase and then clusters/sites will be switched to intervention (either dried blood spot and
 point-of-care) - at which screening will continue until a total of 260 HCV RNA positive
 participants (~20 participants per site) are enrolled. Hence a total of 780 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.
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.