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TEMPO is an interventional cohort study recruiting injecting drug users attending needle and syringe programs (NSP) in Australia. Three hundred participants will be invited to on-site HCV testing with NSP integrated care for HCV treatment.
Participants will be screened for HCV using point-of-care testing and HCV positive participants will be offered treatment with Sofosbuvir/Velpatasvir. Of those who initiate treatment, participants will receive weekly peer-based support on-treatment and return at End of Treatment (ETR) and 12 weeks following end of treatment (SVR12) for clinical follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| People attending needle syringe programs in Australia | Experimental | Participants will be screened for Hepatitis C using the Finger-stick whole blood HCV RNA Point of Care GeneXpert. Participants with hepatitis C will be offered treatment with a pan-genotypic DAA HCV therapy- either 12 weeks of sofosbuvir/velpatasvir or 8 weeks of glecaprevir/pibrentasvir. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HCV RNA Point of Care | Device | Participants attending needle syringe programmes in Australia will be screened for hepatitis C using the finger-stick whole blood GeneXpert HCV RNA cartridge. |
| Measure | Description | Time Frame |
|---|---|---|
| Uptake of HCV DAA therapy among current PWID | Treatment uptake (i.e. proportion of participants initiating DAA therapy) | 4 Weeks |
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Inclusion criteria
Participants must meet all the following inclusion criteria to be eligible to participate in this study:
Exclusion criteria
1) For HCV RNA positive participants commencing treatment:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NUAA NSP | Sydney | New South Wales | 2010 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36863287 | Derived | Grebely J, Gilliver R, McNaughton T, Conway A, Cunningham E, Henderson C, Hadlow B, Molloy K, Doab A, Tillakeratne S, Pepolim L, Harrod ME, Dore GJ, Read P. Single-visit hepatitis C point-of-care testing, linkage to nursing care, and peer-supported treatment among people with recent injecting drug use at a peer-led needle and syringe program: The TEMPO Pilot Study. Int J Drug Policy. 2023 Apr;114:103982. doi: 10.1016/j.drugpo.2023.103982. Epub 2023 Feb 28. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 1, 2024 | |
| Reset | Jan 22, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 1, 2024 | Jan 22, 2025 |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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| ID | Term |
|---|---|
| C000611331 | sofosbuvir-velpatasvir drug combination |
| C000654128 | glecaprevir and pibrentasvir |
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| Sofosbuvir/velpatasvir | Drug | Participants with a detectable HCV RNA will be offered treatment with either glecaprevir/pibrentasvir or sofosbuvir/velpatasvir. |
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| Glecaprevir/pibrentasvir | Drug | Participants with a detectable HCV RNA will be offered treatment with either glecaprevir/pibrentasvir or sofosbuvir/velpatasvir. |
|
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| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |