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

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ClinicalTrials.gov Identifier: NCT03492112
Recruitment Status : Not yet recruiting
First Posted : April 10, 2018
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
Kirby Institute

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
Hepatitis C Device: HCV RNA Point of Care Drug: Sofosbuvir/velpatasvir Drug: Glecaprevir/pibrentasvir Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
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
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine


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 Name: GeneXpert System

Drug: Sofosbuvir/velpatasvir
Participants with a detectable HCV RNA will be offered treatment with either glecaprevir/pibrentasvir or sofosbuvir/velpatasvir.
Other Name: Epclusa

Drug: Glecaprevir/pibrentasvir
Participants with a detectable HCV RNA will be offered treatment with either glecaprevir/pibrentasvir or sofosbuvir/velpatasvir.
Other Name: Maviret




Primary Outcome Measures :
  1. Uptake of HCV DAA therapy among current PWID [ Time Frame: 4 Weeks ]
    Treatment uptake (i.e. proportion of participants initiating DAA therapy)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03492112


Contacts
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Contact: Clinical Project Coordinator +612 9385 0900 pmarks@kirby.unsw.edu.au

Sponsors and Collaborators
Kirby Institute

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Responsible Party: Kirby Institute
ClinicalTrials.gov Identifier: NCT03492112     History of Changes
Other Study ID Numbers: VHCRP1705
First Posted: April 10, 2018    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
RNA Virus Infections
Flaviviridae Infections
Sofosbuvir
Velpatasvir
Sofosbuvir-velpatasvir drug combination
Antiviral Agents
Anti-Infective Agents