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

Hepatitis C Clinical Trial

— TEMPO  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03492112
• Other study ID #: VHCRP1705
• Status: Completed
• Phase: N/A
• Start date: September 10, 2019
• Est. completion date: November 30, 2021

Study information

• Verified date: January 2023
• Source: Kirby Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: November 30, 2021
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis C

Intervention

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

Locations

Country	Name	City	State
Australia	NUAA NSP	Sydney	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Kirby Institute

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Uptake of HCV DAA therapy among current PWID	Treatment uptake (i.e. proportion of participants initiating DAA therapy)	4 Weeks