COVID-19 studies are our top priority. For all other trials, there is a 4-week delay in processing a trial submitted to the ANZCTR and additional delays for updates of registered trials. We appreciate your patience.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03492112




Registration number
NCT03492112
Ethics application status
Date submitted
26/03/2018
Date registered
10/04/2018
Date last updated
13/11/2019

Titles & IDs
Public title
A TEst and Treat Intervention aMong Current People Who Inject Drugs With HCV Attending Needle and Syringe PrOgrams
Scientific 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
Secondary ID [1] 0 0
VHCRP1705
Universal Trial Number (UTN)
Trial acronym
TEMPO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - HCV RNA Point of Care
Treatment: Drugs - Sofosbuvir/velpatasvir
Treatment: Drugs - Glecaprevir/pibrentasvir

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.


Treatment: Devices: 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.

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

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

Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Uptake of HCV DAA therapy among current PWID - Treatment uptake (i.e. proportion of participants initiating DAA therapy)
Timepoint [1] 0 0
4 Weeks

Eligibility
Key inclusion 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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.

Study design
Purpose of the study
Screening
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
NUAA NSP - Sydney
Recruitment postcode(s) [1] 0 0
2010 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
Kirby Institute
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT03492112
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Clinical Project Coordinator
Address 0 0
Country 0 0
Phone 0 0
+612 9385 0900
Fax 0 0
Email 0 0
pmarks@kirby.unsw.edu.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03492112