Skip to main content
OpenTrials
Completed

NCT Number: NCT03492112

A TEst and Treat Intervention 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hepatitis C Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NUAA NSP

Sydney, New South Wales, 2010, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

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.

Other names: GeneXpert System

sofosbuvir/velpatasvir

Drug

Participants with a detectable HCV RNA will be offered treatment with either glecaprevir/pibrentasvir or sofosbuvir/velpatasvir.

Other names: Epclusa

Glecaprevir/Pibrentasvir

Drug

Participants with a detectable HCV RNA will be offered treatment with either glecaprevir/pibrentasvir or sofosbuvir/velpatasvir.

Other names: Maviret

Primary outcomes

  1. Uptake of HCV DAA therapy among current PWID

    Time frame: 4 Weeks

    Treatment uptake (i.e. proportion of participants initiating DAA therapy)

Sponsors and collaborators

Lead sponsor

Kirby Institute

Other Gov

Registry information

Official study 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

Acronym: TEMPO

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 10, 2018
Registry last updated
Jan 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.