Clinical trial NCT04014179: Enhancing Hepatitis C Testing and Treatment Among People Who Inject Drugs Attending Needle and Syringe Programs
Official title: A Multi-centre, Practice-level, 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hepatitis C
Hepatitis C, Chronic
Keywords: Hepatitis C Virus, Needle and Syringe Programs
Lead sponsor: Kirby Institute
Sponsor class: OTHER_GOV
First posted: 2019-07-10
Enrollment: 2700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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

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 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.

Eighteen NSPs (the clusters) will be randomly allocated to receive point-of-care HCV RNA testing (6 clusters), dried blood spot testing (6 clusters) or standard of care (6 clusters).

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 will continue until a total of 150 HCV RNA positive participants (\~25 participants per site) are enrolled in the dried blood spot arm, 150 HCV RNA positive participants are enrolled in the point-of-care arm, and 150 participants are enrolled in the standard of care arm. Hence a total of 450 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.

Eligibility 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.

Exclusion criteria for participants:

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

Primary outcomes:
measure: Proportion of HCV RNA positive who initiate HCV treatment
timeFrame: 12 weeks from Enrolment
Secondary outcomes:
Other outcomes:
Locations:
city: Bankstown
country: Australia
facility: Bankstown NSP
state: New South Wales
city: Blacktown
country: Australia
facility: WSLHD Drug Health - Blacktown NSP
state: New South Wales
city: Coffs Harbour
country: Australia
facility: Coffs Harbour Primary NSP
state: New South Wales
city: Gosford
country: Australia
facility: Gosford NSP
state: New South Wales
city: Grafton
country: Australia
facility: Grafton Primary NSP
state: New South Wales
city: Kempsey
country: Australia
facility: Kempsey Primary NSP
state: New South Wales
city: Lismore
country: Australia
facility: Lismore Primary NSP
state: New South Wales
city: Liverpool
country: Australia
facility: Liverpool Southwest NSP
state: New South Wales
city: Mount Druitt
country: Australia
facility: WSLHD Drug Health - Mt Druitt NSP
state: New South Wales
city: Tweed Heads
country: Australia
facility: Tweed Primary NSP
state: New South Wales
city: Wollongong
country: Australia
facility: Orana Centre
state: New South Wales
city: Brisbane
country: Australia
facility: Alcohol and Drug Harm Reduction Biala
state: Queensland
city: Cairns
country: Australia
facility: Severin St NSP (Youth Link)
state: Queensland
city: Inala
country: Australia
facility: Inala
state: Queensland
city: Toowoomba
country: Australia
facility: Kobi House
state: Queensland
city: Adelaide
country: Australia
facility: UC Adelaide
state: South Australia
city: Adelaide
country: Australia
facility: Wonggangga Turtpandi Aboriginal Primary Health Care Services
state: South Australia
city: Elizabeth
country: Australia
facility: Northern DASSA
state: South Australia
city: Noarlunga
country: Australia
facility: Noarlunga Health Precinct
state: South Australia
Study officials:
References: