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

Summary

Participation Requirements

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 services. Peer support to enhance engagement and facilitate linkage to nursing c...

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.

Tracking Information