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

NCT03492112 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2023-01-17

No results posted yet for this study

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.

Conditions

  • Hepatitis C

Interventions

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.

DRUG

Sofosbuvir/velpatasvir

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

DRUG

Glecaprevir/pibrentasvir

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

Sponsors & Collaborators

  • Kirby Institute

    lead OTHER_GOV

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-10
Primary Completion
2021-11-30
Completion
2021-11-30

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03492112 on ClinicalTrials.gov