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

January 13, 2023 updated by: Kirby Institute

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

101

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2010
        • NUAA NSP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: People attending needle syringe programs in Australia
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
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
Drug: Sofosbuvir/velpatasvir
Participants with a detectable HCV RNA will be offered treatment with either glecaprevir/pibrentasvir or sofosbuvir/velpatasvir.
Other Names:
  • Epclusa
Drug: Glecaprevir/pibrentasvir
Participants with a detectable HCV RNA will be offered treatment with either glecaprevir/pibrentasvir or sofosbuvir/velpatasvir.
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
Time Frame: 4 Weeks
Treatment uptake (i.e. proportion of participants initiating DAA therapy)
4 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kirby Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 10, 2019

Primary Completion (Actual)

November 30, 2021

Study Completion (Actual)

November 30, 2021

Study Registration Dates

First Submitted

March 26, 2018

First Submitted That Met QC Criteria

April 2, 2018

First Posted (Actual)

April 10, 2018

Study Record Updates

Last Update Posted (Estimate)

January 16, 2023

Last Update Submitted That Met QC Criteria

January 13, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VHCRP1705

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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