NCT03492112

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 10, 2018

Completed
1.4 years until next milestone

Study Start

First participant enrolled

September 10, 2019

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2021

Completed
Last Updated

January 17, 2023

Status Verified

January 1, 2023

Enrollment Period

2.2 years

First QC Date

March 26, 2018

Last Update Submit

January 13, 2023

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (1)

  • Uptake of HCV DAA therapy among current PWID

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

    4 Weeks

Study Arms (1)

People attending needle syringe programs in Australia

EXPERIMENTAL

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 CareDrug: Sofosbuvir/velpatasvirDrug: Glecaprevir/pibrentasvir

Interventions

HCV RNA Point of CareDEVICE

Participants attending needle syringe programmes in Australia will be screened for hepatitis C using the finger-stick whole blood GeneXpert HCV RNA cartridge.

Also known as: GeneXpert System
People attending needle syringe programs in Australia
Sofosbuvir/velpatasvirDRUG

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

Also known as: Epclusa
People attending needle syringe programs in Australia
Glecaprevir/pibrentasvirDRUG

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

Also known as: Maviret
People attending needle syringe programs in Australia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants have voluntarily signed the informed consent form;
  • 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.

You may not qualify if:

  • \) 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NUAA NSP

Sydney, New South Wales, 2010, Australia

Location

Related Publications (1)

  • Grebely J, Gilliver R, McNaughton T, Conway A, Cunningham E, Henderson C, Hadlow B, Molloy K, Doab A, Tillakeratne S, Pepolim L, Harrod ME, Dore GJ, Read P. Single-visit hepatitis C point-of-care testing, linkage to nursing care, and peer-supported treatment among people with recent injecting drug use at a peer-led needle and syringe program: The TEMPO Pilot Study. Int J Drug Policy. 2023 Apr;114:103982. doi: 10.1016/j.drugpo.2023.103982. Epub 2023 Feb 28.

    PMID: 36863287DERIVED

MeSH Terms

Conditions

Hepatitis C

Interventions

sofosbuvir-velpatasvir drug combinationglecaprevir and pibrentasvir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2018

First Posted

April 10, 2018

Study Start

September 10, 2019

Primary Completion

November 30, 2021

Study Completion

November 30, 2021

Last Updated

January 17, 2023

Record last verified: 2023-01

Locations

AU(1)