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

Sponsor
Kirby Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT03492112
Collaborator
(none)
300
Enrollment
1
Location
1
Arm
50.7
Anticipated Duration (Months)
5.9
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
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
Actual Study Start Date :
Sep 10, 2019
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Uptake of HCV DAA therapy among current PWID [4 Weeks]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 NUAA NSP Sydney New South Wales Australia 2010

    Sponsors and Collaborators

    • Kirby Institute

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kirby Institute
    ClinicalTrials.gov Identifier:
    NCT03492112
    Other Study ID Numbers:
    • VHCRP1705
    First Posted:
    Apr 10, 2018
    Last Update Posted:
    Aug 22, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hepatitis C
    Hepatitis
    Sofosbuvir
    Sofosbuvir-velpatasvir drug combination
    Velpatasvir

    Study Results

    No Results Posted as of Aug 22, 2022