TEMPO: Enhancing Hepatitis C Testing and Treatment Among People Who Inject Drugs Attending Needle and Syringe Programs

Sponsor
Kirby Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT04014179
Collaborator
(none)
3,300
18
4
40.2
183.3
4.6

Study Details

Study Description

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 and syringe program (NSP) services in Australia, 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 site

  3. HCV testing using standard of care at the NSP site

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Xpert HCV Viral Load Fingerstick
  • Diagnostic Test: Aptima HCV Quant DX Assay
N/A

Detailed Description

The TEMPO study will compare dried blood spot testing and point-of-care HCV RNA testing to standard of care as strategies to enhance HCV treatment uptake among people with HCV and recent injecting drug use attending NSP services. Peer support to enhance engagement and facilitate linkage to nursing care will be provided in the intervention arms of this study.

The study is a stepped, wedge cluster randomized controlled trial. The sites (clusters) will be primary NSPs which provide services to people who inject drugs and have capacity to provide hepatitis C treatment services. The sites will be located in Australia.

Twenty-two NSPs (the clusters)* will be randomly allocated to receive the intervention immediately (11 clusters) versus standard of care with delayed implementation (11 clusters). The immediate intervention arm will be randomized 1:1 to receive point-of-care HCV RNA testing (5 or 6 clusters)* or HCV RNA testing from dried blood spots (5 or 6 clusters). The delayed intervention arm will have a period of standard of care (based on the number of enrolled participants) and switch to receiving the intervention. The delayed intervention arm will then be randomized 1:1 to receive point-of-care HCV RNA testing (5 or 6 clusters) or HCV RNA testing from dried blood spots (5 or 6 clusters)*. As such, at the end of the study, there will be 11 clusters randomized to point-of-care HCV RNA testing or 11 clusters to HCV RNA testing from dried blood spots.

*Based on randomisation, there will be 5 sites using point-of-care and 6 sites using dried blood spots, or vice versa with 6 sites using point-of-care and 5 sites using dried blood spots.

At screening, participants will be tested for HCV infection with dried blood spot, point-of-care or standard of care, depending on cluster randomisation.

Screening in the intervention arm will continue until a total of 220 HCV RNA positive participants (~20 participants per site) are enrolled in the intervention arm (either dried blood spot and point-of-care). In the delayed intervention arm, 220 HCV RNA positive participants (~20 participants per site) will be enrolled in the control (standard of care) phase and then clusters/sites will be switched to intervention (either dried blood spot and point-of-care) - at which screening will continue until a total of 220 HCV RNA positive participants (~20 participants per site) are enrolled. Hence a total of 660 HCV RNA positive participants.

HCV RNA negative participants will have no further assessments or visits as part of the study protocol.

Participants who are HCV RNA positive will be enrolled in the follow-up cohort and will be assessed for treatment eligibility. If eligible, they will be treated as per standard of care with a pharmaceutical benefits scheme (PBS) approved pan-genotypic HCV DAA treatment. Participants will be encouraged to take the first dose on the day of treatment work-up where possible. On-treatment and post-treatment testing and monitoring will be based on the site investigator as per standard clinical practice.

All HCV RNA positive participants will be followed up at 12 weeks, 24 weeks and 12 months post enrolment.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
3300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
A Multi-centre, Practice-level, Stepped Wedge Cluster Randomized Controlled Trial to Compare Point-of-care HCV RNA Testing, Dried Blood Spot Testing, and Standard of Care to Enhance Treatment Uptake Among People With HCV Who Have Recently Injected Drugs Attending Needle and Syringe Programs: the TEMPO Study
Actual Study Start Date :
Jul 27, 2022
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Immediate Intervention (Dried Blood Spot)

Blood samples will be tested for HCV RNA from dried blood spot cards.

Diagnostic Test: 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.

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.

Diagnostic Test: 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.

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.

Diagnostic Test: 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.

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.

Diagnostic Test: 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.

Outcome Measures

Primary Outcome Measures

  1. Proportion of HCV RNA positive who initiate HCV treatment [12 weeks from Enrolment]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Exclusion criteria for participants:
  1. Is unable or unwilling to provide informed consent or abide by the requirements of the study.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bankstown NSP Bankstown New South Wales Australia 2200
2 WSLHD Drug Health - Blacktown NSP Blacktown New South Wales Australia 2148
3 Coffs Harbour Primary NSP Coffs Harbour New South Wales Australia 2450
4 Gosford NSP Gosford New South Wales Australia 2250
5 Kempsey Primary NSP Kempsey New South Wales Australia 2440
6 Lismore Primary NSP Lismore New South Wales Australia 2480
7 Liverpool Southwest NSP Liverpool New South Wales Australia 2170
8 WSLHD Drug Health - Mt Druitt NSP Mount Druitt New South Wales Australia 2770
9 Tweed Primary NSP Tweed Heads New South Wales Australia 2485
10 Orana Centre Wollongong New South Wales Australia 2500
11 Alcohol and Drug Harm Reduction Biala Brisbane Queensland Australia 4000
12 Severin Street NSP Cairns Queensland Australia 4870
13 Inala Inala Queensland Australia 4077
14 Kobi House Toowoomba Queensland Australia 4350
15 UC Adelaide Adelaide South Australia Australia 5000
16 Wonggangga Turtpandi Aboriginal Primary Health Care Services Adelaide South Australia Australia 5015
17 Northern DASSA Elizabeth South Australia Australia 5112
18 Noarlunga Health Precinct Noarlunga South Australia Australia 5168

Sponsors and Collaborators

  • Kirby Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kirby Institute
ClinicalTrials.gov Identifier:
NCT04014179
Other Study ID Numbers:
  • VHCRP1904
First Posted:
Jul 10, 2019
Last Update Posted:
Aug 23, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
Yes
Keywords provided by Kirby Institute
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 23, 2022