Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000673448
Ethics application status
Approved
Date submitted
19/05/2016
Date registered
24/05/2016
Date last updated
31/05/2024
Date data sharing statement initially provided
15/09/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot program for human immunodeficiency virus (HIV) and hepatitis C (HCV) testing in New South Wales (NSW) via home and community based Dried Blood Spot (DBS) self-sampling.
Scientific title
NSW Dried Blood Spot Self-Sampling HIV And Hepatitis C Testing Pilot Program
Secondary ID [1] 289250 0
Nil known
Universal Trial Number (UTN)
U1111-1183-0554
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV 298826 0
Hepatitis C 307795 0
Condition category
Condition code
Public Health 298886 298886 0 0
Epidemiology
Infection 298898 298898 0 0
Acquired immune deficiency syndrome (AIDS / HIV)
Infection 298899 298899 0 0
Sexually transmitted infections

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The primary objective of the program is to reach priority populations who are testing infrequently for HIV and hepatitis C (HCV) via both postal(1) and community(2) based dried blood spot testing.

1) Priority populations to be targeted via postal tests in Phase 1: are people that self-select as belonging to one of the following risk groups: men that have sex with men (MSM), people with a transgender history (or their current/previous partners), and people born in regions of high prevalence (or their current/previous partners) and people whose current or previous sexual partners are from one of the above groups. Information about the trial is translated into Chinese.

In addition to individuals in risk groups identified in Phase 1, Phase 2 will also include individuals who are also of one or more of the following risk groups:
• People who identify as Aboriginal or Torres Strait Islander;
• People who have ever injected drugs
• People that are currently or have ever been incarcerated
• People who are or have been clients of community corrections services
• People who are using or have used drug and alcohol services or mental health services
• People who are or have been homeless
* People from Africa or the Middle East or regions of high HCV prevalence


(2) Population to be targeted in community-based settings are needle and syringe exchanges, gays saunas and sex on premises venues, rural and remote aboriginal communities, community outreach services and drug and alcohol or mental health services that find it difficult to offer conventional laboratory or rapid HIV and/ or HCV testing. Assisted testing in these settings is by trained peer educators and clinicians.

Testing in phase 2 will include HCV RNA testing for those participants that self-select as belonging to one of the following groups: people who identify as Aboriginal or Torres Strait Islander, people who have ever injected drugs, people who are currently or have ever been incarcerated, people who are or have been clients of community corrections services, people who are using or have used drug and alcohol services or mental health services, people who are or have been homeless and people from Africa, the Middle East or regions of high HCV prevalence.

The sample is collected via a sterile lancet finger prick with blood collected on a Whatman protein saver 903 card and then returned by post. Please see sample collection instructions attached for how the self-sampling will occur,

Samples will returned by post and tested at the NSW state reference laboratory for HIV and Hep C if applicable (St. Vincent's Darlinghurst).

HIV testing will be performed with the Abbott Alinity i automated anaylser, HIV antigen/antibody combo assay.

HCV testing will be performed with the Hologic Panther, Aptima HCV Quant Dx assay which is an in vitro nucleic acid amplification test (NAAT) performed on automated platforms.

Phase 1 results will be delivered by phone, SMS or email as indicated during data collection at enrolment by the statewide service NSW Sexual Health Infolink (SHIL) which is under the clinical governance of the Director of Sydney Sexual Health Centre. Phase 2 results will be either be delivered by SHIL or by sites themselves under local clinical governance arrangements. Any participants who have samples where HIV or HCV is detected will be provided support and linkage to medical care.

VENEPUNCTURE SUBSTUDY
At selected clinics, participants will be asked to provide a paired sample of blood (5ml) collected via venepuncture by a healthcare professional. This will be optional for participants. Up to 1300 participants will be enrolled in the venepuncture sub study. Participants can take part in the DBS HIV and HCV study without providing this sample. The primary objective of this sub-study is to compare the analytical performance of DBS as a sample type for the diagnosis of hepatitis C (antibody and RNA) to standard of care (venous-collected samples). All samples will be tested at NSW Health Pathology laboratories. Results delivery will be as per standard of care by NSW Health Pathology to the service ordering the tests. Participants will not receive HCV treatment as part of this study. Participants that are RNA positive will be linked to standard of care to assess for HCV treatment eligibility. Reactive DBS hepatitis C results will not need a confirmatory test as the sample will be paired to a venous sample tested as per standard of care.

The primary objective of this sub-study is to compare the analytical performance of DBS as a sample type for the diagnosis of hepatitis C (antibody and RNA) to standard of care (venous-collected samples).

The key study outcomes and their definitions are listed below to be assessed by the Steering Committee which involves clinicians, scientists from the NSW HIV Reference Laboratory, researchers from the University of NSW, policy staff from the NSW Ministry of Health and representatives from registered sites such as Kirketon Road Clinic.

This study has been approved by the St Vincent's Human Research Ethics Committee, Aboriginal Health and Medical Research Council, Justice Health Ethics Committee and Corrective Services Ethics Committee.
Intervention code [1] 294794 0
Early detection / Screening
Comparator / control treatment
At selected sites, participants will be invited to provide a DBS (finger prick sample) which will be processed and tested in parallel with matched venous blood plasma (from the same patient) for HCV RNA using the Cobas HIV 6800/8800 assay, following the manufacturer's instructions.

Similarly, the DBS sample card will be processed and tested in parallel with matched venous blood plasma (from the same patient) for the presence of anti-HCV antibodies using the Alinity i Anti-HCV assay, as per manufacturer's instructions. Reactive plasma samples will be centrifuged at 10,000g for 10 min and tested in duplicate.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 298356 0
To assess the feasibility of DBS self-sampling HIV and HCV testing (return rate, number of DBS tests done, re-testing rate, mode of distribution of DBS self-sampling kits)
Timepoint [1] 298356 0
10/02/2025
Secondary outcome [1] 323927 0
To assess the reach of DBS self-sampling (characteristics of people who use the program – demographics, sexual risk behaviour and past testing history) via analysis of participant information entered into a secure SQL database at enrollment.
Timepoint [1] 323927 0
10/02/2025
Secondary outcome [2] 323957 0
To evaluate the outcomes of DBS self-sampling HIV testing (HIV positivity, CD4 count at diagnosis, linkage to care) Measured via study data base analysis.
Timepoint [2] 323957 0
10/02/2025
Secondary outcome [3] 323958 0
To evaluate the outcomes of DBS self-sampling HCV testing (HCV positivity, linkage to care) Measured via study data base analysis
Timepoint [3] 323958 0
10/02/2025
Secondary outcome [4] 323959 0
To assess the acceptability of DBS self-sampling HIV testing from the perspective of the participant, assessed by client survey conducted online.
Timepoint [4] 323959 0
10/02/2025
Secondary outcome [5] 324006 0
To assess the performance of the DBS HCV test used for HCV RNA, assessed by comparison with follow up conventional testing.
Timepoint [5] 324006 0
10/02/2025
Secondary outcome [6] 346703 0
To assess the costs per test and costs per HIV infection diagnosed, Assessed by calculating all cost relating to staffing, delivery of the kit, laboratory testing, result communication and follow-up.
Timepoint [6] 346703 0
10/02/2025
Secondary outcome [7] 346704 0
To assess the costs per test and costs per HCV infection diagnosed, Assessed by calculating all cost relating to staffing, delivery of the kit, laboratory testing, result communication and follow-up.
Timepoint [7] 346704 0
10/02/2025
Secondary outcome [8] 435781 0
The primary objective of this sub-study is to compare the
analytical performance of DBS as a sample type for the diagnosis
of hepatitis C (antibody and RNA) to standard of care (venous collected
samples).
Timepoint [8] 435781 0
Secondary outcome [9] 435782 0
The primary objective of this sub-study is to compare the
analytical performance of DBS as a sample type for the diagnosis
of hepatitis C (antibody and RNA) to standard of care (venous collected
samples).
Timepoint [9] 435782 0
Substudy sample collection will continue until 1300 paired samples are collected.

Eligibility
Key inclusion criteria
1. Individuals aged 16 years or older who reside in NSW
2. Ability to provide independent informed consent to participate in the study, including consent to the provision of a dried blood spot sample for HIV or hepatitis C testing, willingness to complete a brief acceptability survey, and willingness to participate in and comply with the pilot program, namely the completion of registration details


*Gay and other men who have sex with men (MSM)
*People with a transgender history
*People from regions of high HIV or hepatitis C prevalence*
*People with current or previous sexual partners from regions of high HIV prevalence*

*People who identify as Aboriginal or Torres Strait Islander,
*People who have ever injected drugs, or are attended or have attended drug and alcohol services
*People with a history of incarceration (or currently incarcerated) or who are/have been clients of community correction services
*People who are or have attended mental health services
*People who are or have been homeless
*People from regions of high HCV prevalence
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Individuals who do not meet the inclusion criteria outlined above
Participants who are excluded will be informed they cannot access HIV or hepatitis C testing via the DBS website and will be directed to a local GP or sexual health clinic for testing and sexual health review.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised 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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The sample size will focus on the primary objective of the program of reaching high-risk populations who are testing infrequently. Based on behavioural surveys, we assume that 19% of gay men had their last HIV test more than 2 years ago or never, and among CALD populations 40% had never tested. Therefore, to determine if the DBS program is able to reach a 5% or greater proportion of infrequent testers than behavioural surveys, then at least 400 gay and bisexually active men and at least 460 heterosexuals from CALD populations is required for HIV testing.

An additional 1000 dual HIV/HCV tests will be performed.

In terms of statistical analysis, descriptive analyses (counts and proportions) will be conducted and relevant outcomes stratified by demographic group, risk behaviour and distribution pathway. Chi-squared tests will be used to assess if there are statistical differences in these outcomes according to these stratifications.
Standard deviations will be calculated for means, and interquartile ranges for medians. Also t-test and Ranksum tests will be used to see differences in means and medians across different participant groups.
Sensitivity and specificity will be calculated using standard methods with 95% confidence intervals presented using binomial approximation tests.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
20/06/2016
Actual
1/11/2016
Date of last participant enrolment
Anticipated
10/02/2025
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
18000
Accrual to date
26148
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 5815 0
Sydney Hospital and Sydney Eye Hospital - Sydney
Recruitment postcode(s) [1] 13254 0
2000 - Sydney

Funding & Sponsors
Funding source category [1] 293628 0
Government body
Name [1] 293628 0
NSW Ministry of Health
Country [1] 293628 0
Australia
Primary sponsor type
Government body
Name
NSW Ministry of Health
Address
1 Reserve Road, St Leonards NSW 2065
Country
Australia
Secondary sponsor category [1] 292460 0
None
Name [1] 292460 0
Address [1] 292460 0
Country [1] 292460 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295066 0
St. Vincent Hospital Sydney
Ethics committee address [1] 295066 0
390 Victoria Street
Darlinghurst
NSW 2010
Ethics committee country [1] 295066 0
Australia
Date submitted for ethics approval [1] 295066 0
12/11/2015
Approval date [1] 295066 0
08/02/2016
Ethics approval number [1] 295066 0
15/260

Summary
Brief summary
Most options for HIV and hepatitis C testing currently involve people attending clinics or community testing sites. The purpose of the Dried Blood Spot (DBS) HIV/hep C testing pilot is to increase access to testing by providing people with ways to collect their own blood samples in the comfort of their own home. It offers significant advantages to conventional blood testing such as providing added convenience, privacy and confidentiality.

This study also aims to assess whether DBS is an effective and manageable option for increasing access to HIV and hepatitis C testing among priority populations in NSW. It will also assess who is likely to use the program as well as ascertaining participants’ perspectives on the testing process.

Addition of a sub-study for validation of hepatitis C testing

Participants will be recruited from selected sites participating in the HIV and HCV Dried Blood Spot Testing Pilot with a focus on sites with high testing volumes.

Clinic staff will identify participants and offer participation in the sub-study. After providing consent, participants complete a capillary blood finger-stick DBS sample and a venous blood sample. The paired identically labelled samples will be sent to the Serology & Virology Division, NSW Health Pathology, Randwick (SAViD NSWHP) for testing.

Results delivery will be as per standard of care by NSW Health Pathology to the service ordering the tests. Participants will not receive HCV treatment as part of this study. Participants that are RNA positive will be linked to standard of care to assess for HCV
treatment eligibility.
Trial website
https://www.health.nsw.gov.au/dbstest/Pages/order.aspx (Home Testers), also accessed by https:/www.DBStest.health.nsw.gov.au/
https://www.health.nsw.gov.au/dbstest/pages/sites.aspx (Registered Sites)
Trial related presentations / publications
Public notes
Attachments [1] 884 884 0 0
/AnzctrAttachments/370729-Collection instructions v1.6.doc
Attachments [2] 890 890 0 0
/AnzctrAttachments/370729-H15 98833-2 DBS Patient Acceptability v1.7.pdf

Contacts
Principal investigator
Name 65974 0
Ms Bianca Prain
Address 65974 0
NSW Ministry of Health 1 Reserve Rd, St Leonards NSW 2065
Country 65974 0
Australia
Phone 65974 0
+ 61 2 9391 9216
Fax 65974 0
Email 65974 0
[email protected]
Contact person for public queries
Name 65975 0
Nigel Carrington
Address 65975 0
Sydney Sexual Health Centre
Address: PO Box 1614, Sydney NSW 2011
Country 65975 0
Australia
Phone 65975 0
+61 2 9382 7527
Fax 65975 0
Email 65975 0
[email protected]
Contact person for scientific queries
Name 65976 0
Associate Professor Philip Cunningham
Address 65976 0
St Vincent's Centre for Applied Medical Research, St Vincent's Hospital
405 Liverpool St, Darlinghurst NSW 2011
Country 65976 0
Australia
Phone 65976 0
+61 2 8382 4900
Fax 65976 0
Email 65976 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.