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

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.

Inclusion criteria

Participants must meet all the following inclusion criteria to be eligible to participate in this study:

1. Participants have voluntarily signed the informed consent form;
2. 18 years of age or older;
3. Current injecting drug use (previous month);
4. HCV RNA positive participants commencing treatment must be eligible to initiate therapy with Sofosbuvir/Velpatasvir; and
5. In the opinion of the Investigator, the participant is suitable for NSP-based HCV treatment delivery.

Exclusion criteria

1) For HCV RNA positive participants commencing treatment:

1. Any clinically significant condition or history known to contraindicate the use of Sofosbuvir/Velpatasvir or would not be suitable for management within a NSP-based treatment setting;
2. Any contraindicated medication in the Sofosbuvir/Velpatasvir product information;
3. Has previous HCV DAA treatment experience
4. Has a fibroscan score > 12.5 Kpa
5. HIV co-infection
6. HBV co-infection
7. Is female and is pregnant or breastfeeding
8. Is unable or unwilling to provide informed consent or abide by the requirements of the study.