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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-10

Study Completion Date

2021-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Hepatitis C

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

HCV RNA Point of Care

Intervention Type DEVICE

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

Sofosbuvir/velpatasvir

Intervention Type DRUG

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

Glecaprevir/pibrentasvir

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DEVICE

Sofosbuvir/velpatasvir

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

Intervention Type DRUG

Glecaprevir/pibrentasvir

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

Intervention Type DRUG

Other Intervention Names

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GeneXpert System Epclusa Maviret

Eligibility Criteria

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Inclusion Criteria

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No