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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04014179




Registration number
NCT04014179
Ethics application status
Date submitted
7/07/2019
Date registered
10/07/2019
Date last updated
23/02/2021

Titles & IDs
Public title
Enhancing Hepatitis C Testing and Treatment Among People Who Inject Drugs Attending Needle and Syringe Programs
Scientific title
A Multi-centre, Practice-level, Cluster Randomized, Parallel-group Controlled Trial to Compare Point-of-care Hepatitis C RNA Testing to Dried Blood Spot Testing to Enhance Treatment Uptake Among People With HCV Who Have Recently Injected Drugs Attending Needle and Syringe Programs: the TEMPO Study
Secondary ID [1] 0 0
VHCRP1904
Universal Trial Number (UTN)
Trial acronym
TEMPO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C 0 0
Hepatitis C, Chronic 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
Diagnosis / Prognosis - Xpert HCV Viral Load Fingerstick
Diagnosis / Prognosis - Aptima HCV Quant DX Assay

Experimental: Immediate Intervention (Dried Blood Spot) - Blood samples will be tested for HCV RNA from dried blood spot cards.

Experimental: Immediate intervention (Point-of-care testing) - Blood samples will be tested for HCV RNA using the Xpert HCV Viral Load Fingerstick point-of-care assay.

Active Comparator: Delayed intervention (Dried Blood Spot) - There will be a period of business as usual, that is, sites will continue with standard of care for HCV RNA testing, then switch to intervention for HCV RNA testing from dried blood spots.

Active Comparator: Delayed intervention (Point-of-care testing) - There will be a period of business as usual, that is, sites will continue with standard of care for HCV RNA testing, then switch to intervention for HCV RNA testing using the point-of-care assay.


Diagnosis / Prognosis: Xpert HCV Viral Load Fingerstick
The Cepheid Xpert HCV Viral Load (VL) Fingerstick assay is an in vitro nucleic acid amplification test designed for the quantitation of Hepatitis C Virus (HCV) DNA in human whole blood using the automated GeneXpert Systems. The HCV RNA result from the Xpert test will be used to initiate HCV treatment.

Diagnosis / Prognosis: Aptima HCV Quant DX Assay
The Aptima HCV Quant Dx assay is a real-time transcription-mediated amplification test.
The assay is used for both detection and quantitation of hepatitis C virus (HCV) RNA in fresh and frozen human serum and plasma from HCV-infected individuals, and in this study from dried blood spots. The HCV RNA result from the Aptima assay will be used to initiate HCV treatment.

Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of HCV RNA positive who initiate HCV treatment - To compare the proportion of HCV RNA positive participants who initiate HCV treatment at 12 weeks following enrolment between those who receive point-of-care HCV RNA testing, dried blood spot testing, and standard of care.
Timepoint [1] 0 0
12 weeks from Enrolment

Eligibility
Key inclusion criteria
Inclusion criteria for participants:

Attendees of the NSP service are eligible for inclusion if the following criteria are met:

1. Provided written informed consent

2. = 18 years of age

3. Recent injecting drug use - defined as self-reported use within the previous six
months.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria for participants:

a. Is unable or unwilling to provide informed consent or abide by the requirements of the
study.

Study design
Purpose of the study
Health Services Research
Allocation to intervention
Randomised controlled trial
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet 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)
ACT,NSW,QLD,SA,WA
Recruitment hospital [1] 0 0
NSP Civic - Canberra
Recruitment hospital [2] 0 0
Bankstown NSP - Bankstown
Recruitment hospital [3] 0 0
WSLHD Drug Health - Blacktown NSP - Blacktown
Recruitment hospital [4] 0 0
NSP Phillip - Canberra
Recruitment hospital [5] 0 0
Coffs Harbour Primary NSP - Coffs Harbour
Recruitment hospital [6] 0 0
Gosford NSP - Gosford
Recruitment hospital [7] 0 0
Kempsey NSP - Kempsey
Recruitment hospital [8] 0 0
Lismore Primary NSP - Lismore
Recruitment hospital [9] 0 0
Liverpool Southwest NSP - Liverpool
Recruitment hospital [10] 0 0
WSLHD Drug Health - Mt Druitt NSP - Mount Druitt
Recruitment hospital [11] 0 0
Tweed NSP - Tweed Heads
Recruitment hospital [12] 0 0
Orana Centre - Wollongong
Recruitment hospital [13] 0 0
Alcohol and Drug Harm Reduction Biala - Brisbane
Recruitment hospital [14] 0 0
Severin Street NSP - Cairns
Recruitment hospital [15] 0 0
Inala - Inala
Recruitment hospital [16] 0 0
Kobi House - Toowoomba
Recruitment hospital [17] 0 0
UC Adelaide - Adelaide
Recruitment hospital [18] 0 0
Wonggangga Turtpandi Aboriginal Primary Health Care Services - Adelaide
Recruitment hospital [19] 0 0
Northern DASSA - Elizabeth
Recruitment hospital [20] 0 0
Noarlunga Health Precinct - Noarlunga
Recruitment hospital [21] 0 0
Peer based harm reduction Bunbury - Bunbury
Recruitment hospital [22] 0 0
Peer based harm reduction Perth - Perth
Recruitment postcode(s) [1] 0 0
2606 - Canberra
Recruitment postcode(s) [2] 0 0
2200 - Bankstown
Recruitment postcode(s) [3] 0 0
2148 - Blacktown
Recruitment postcode(s) [4] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [5] 0 0
2250 - Gosford
Recruitment postcode(s) [6] 0 0
2440 - Kempsey
Recruitment postcode(s) [7] 0 0
2480 - Lismore
Recruitment postcode(s) [8] 0 0
2170 - Liverpool
Recruitment postcode(s) [9] 0 0
2770 - Mount Druitt
Recruitment postcode(s) [10] 0 0
2485 - Tweed Heads
Recruitment postcode(s) [11] 0 0
2500 - Wollongong
Recruitment postcode(s) [12] 0 0
4000 - Brisbane
Recruitment postcode(s) [13] 0 0
4870 - Cairns
Recruitment postcode(s) [14] 0 0
4077 - Inala
Recruitment postcode(s) [15] 0 0
4350 - Toowoomba
Recruitment postcode(s) [16] 0 0
5000 - Adelaide
Recruitment postcode(s) [17] 0 0
5015 - Adelaide
Recruitment postcode(s) [18] 0 0
5112 - Elizabeth
Recruitment postcode(s) [19] 0 0
5168 - Noarlunga
Recruitment postcode(s) [20] 0 0
6230 - Bunbury
Recruitment postcode(s) [21] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Christchurch
Country [2] 0 0
New Zealand
State/province [2] 0 0
Otago

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

Ethics approval
Ethics application status

Summary
Brief summary
This project aims to evaluate two strategies of Hepatitis C virus (HCV) testing compared to
standard of care among people who inject drugs at needle syringe (NSP) or needle exchanges
(NEX) program services in Australia and New Zealand, to see if it can improve the number of
people who start treatment following an HCV diagnosis:

1. HCV testing from collected dried blood spots sent to a central laboratory

2. HCV testing using a point-of-care device at the NSP/NEX site

3. HCV testing using standard of care at the NSP/NEX site
Trial website
https://clinicaltrials.gov/show/NCT04014179
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
Elise Tu, PhD
Address 0 0
Country 0 0
Phone 0 0
61-2-9385-9000
Fax 0 0
Email 0 0
etu@kirby.unsw.edu.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04014179