Overview

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

Status:
Recruiting

Trial end date:
2022-12-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

N/A

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Kirby Institute

Treatments:

Sofosbuvir
Velpatasvir

Criteria

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.