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

Primary Purpose

Hepatitis C

Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
HCV RNA Point of Care
Sofosbuvir/velpatasvir
Glecaprevir/pibrentasvir
Sponsored by
Kirby Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Hepatitis C

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • NUAA NSP

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

People attending needle syringe programs in Australia

Arm Description

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.

Outcomes

Primary Outcome Measures

Uptake of HCV DAA therapy among current PWID
Treatment uptake (i.e. proportion of participants initiating DAA therapy)

Secondary Outcome Measures

Full Information

First Posted
March 26, 2018
Last Updated
January 13, 2023
Sponsor
Kirby Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03492112
Brief Title
A TEst and Treat Intervention aMong Current People Who Inject Drugs With HCV Attending Needle and Syringe PrOgrams
Acronym
TEMPO
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
September 10, 2019 (Actual)
Primary Completion Date
November 30, 2021 (Actual)
Study Completion Date
November 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kirby Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
People attending needle syringe programs in Australia
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
HCV RNA Point of Care
Other Intervention Name(s)
GeneXpert System
Intervention Description
Participants attending needle syringe programmes in Australia will be screened for hepatitis C using the finger-stick whole blood GeneXpert HCV RNA cartridge.
Intervention Type
Drug
Intervention Name(s)
Sofosbuvir/velpatasvir
Other Intervention Name(s)
Epclusa
Intervention Description
Participants with a detectable HCV RNA will be offered treatment with either glecaprevir/pibrentasvir or sofosbuvir/velpatasvir.
Intervention Type
Drug
Intervention Name(s)
Glecaprevir/pibrentasvir
Other Intervention Name(s)
Maviret
Intervention Description
Participants with a detectable HCV RNA will be offered treatment with either glecaprevir/pibrentasvir or sofosbuvir/velpatasvir.
Primary Outcome Measure Information:
Title
Uptake of HCV DAA therapy among current PWID
Description
Treatment uptake (i.e. proportion of participants initiating DAA therapy)
Time Frame
4 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
NUAA NSP
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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