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

Study Overview
=================
Brief 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.

Official Title
-----------------
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

Conditions
-----------------
Hepatitis C

Intervention / Treatment
-----------------
* Device: HCV RNA Point of Care
* Drug: Sofosbuvir/velpatasvir
* Drug: Glecaprevir/pibrentasvir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Participants must meet all the following inclusion criteria to be eligible to participate in this study: Participants have voluntarily signed the informed consent form; 18 years of age or older; Current injecting drug use (previous month); HCV RNA positive participants commencing treatment must be eligible to initiate therapy with Sofosbuvir/Velpatasvir; and 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: 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; Any contraindicated medication in the Sofosbuvir/Velpatasvir product information; Has previous HCV DAA treatment experience Has a fibroscan score > 12.5 Kpa HIV co-infection HBV co-infection Is female and is pregnant or breastfeeding Is unable or unwilling to provide informed consent or abide by the requirements of the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: People attending needle syringe programs in Australia<br>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. | Device: HCV RNA Point of Care<br>* Participants attending needle syringe programmes in Australia will be screened for hepatitis C using the finger-stick whole blood GeneXpert HCV RNA cartridge.<br>* Other names: GeneXpert System;Drug: Sofosbuvir/velpatasvir<br>* Participants with a detectable HCV RNA will be offered treatment with either glecaprevir/pibrentasvir or sofosbuvir/velpatasvir.<br>* Other names: Epclusa;Drug: Glecaprevir/pibrentasvir<br>* Participants with a detectable HCV RNA will be offered treatment with either glecaprevir/pibrentasvir or sofosbuvir/velpatasvir.<br>* Other names: Maviret;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uptake of HCV DAA therapy among current PWID | Treatment uptake (i.e. proportion of participants initiating DAA therapy) | 4 Weeks |