NCT03492112

A TEst and Treat Intervention aMong Current People Who Inject Drugs With HCV Attending Needle and Syringe PrOgrams

A Non-randomized Trial to Evaluate a TEst and Treat Intervention Integrating Novel Point-of-care Hepatitis C RNA Testing, Linkage to Nursing Care, and Peer-supported Delivery of HCV Testing and Treatment aMong Current People Who Inject Drugs With HCV Attending Needle and Syringe PrOgrams

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Kirby Institute · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Hepatitis C

Interventions

Type	Name	Description
DEVICE	HCV RNA Point of Care	Participants attending needle syringe programmes in Australia will be screened for hepatitis C using the finger-stick whole blood GeneXpert HCV RNA cartridge.
DRUG	Sofosbuvir/velpatasvir	Participants with a detectable HCV RNA will be offered treatment with either glecaprevir/pibrentasvir or sofosbuvir/velpatasvir.
DRUG	Glecaprevir/pibrentasvir	Participants with a detectable HCV RNA will be offered treatment with either glecaprevir/pibrentasvir or sofosbuvir/velpatasvir.

Timeline

• Start date: 2019-09-10
• Primary completion: 2021-11-30
• Completion: 2021-11-30
• First posted: 2018-04-10
• Last updated: 2023-01-17

Locations

1 site across 1 country: Australia