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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
10/05/2018
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 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 men that have sex with men (MSM), people born in Africa or Asia and people who's sexual partners live in Africa or Asia. Information about the trial is translated into Arabic, French, Indonesian, Khmer, Portuguese, Chinese, Spanish, Thai and Vietnamese.

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, or;
• People who have ever injected drugs,

(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. The kits distributed in these settings are by trained peer educators and clinicians.

Testing in phase 2 will include HCV RNA testing for those participants that identify a history of injecting drug use or identify as Aboriginal or Torres Strait Islander.

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). The NSW state reference laboratory for HIV will assess the performance of the DBS HIV test using (3rd generation enzyme immunoassay (EIA) for detection of HIV-1/2 antibodies), and the validation of 4th generation EIA (HIV-1/2 Ab/Ag) in comparison to 3rd generation EIA.

HCV testing will use the Aptima HCV Quant Dx assay, which is an in vitro nucleic acid amplification test (NAAT) for the detection and quantitation of HCV RNA, and run using the fully automated Panther system.

Results will be delivered via SMS or email as indicated during data collection at enrolment, The statewide service NSW Sexual Health Infolink will provide clinical governance for result delivery.

Any samples where HIV or HCV is detected will be asked to call NSW Sexual Health Infolink for their results, support and linkage to medical care.

The key study outcomes and their definitions are listed below to be assessed by the study group which involves clinicians, researches from the University of NSW and community based groups such as ACON, The NSW Users and AIDS Association (NUAA), The Australian Federation of AIDS Organisations (AFAO) and Pozhet.

This study has been approved by the Aboriginal Health and Medical Research Council.


Intervention code [1] 294794 0
Early detection / Screening
Comparator / control treatment
No control group
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
End of 2020.
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
End of 2020.
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
End of 2020
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
End of 2020
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
End of 2020
Secondary outcome [5] 323960 0
To assess the performance of the DBS HIV test used (3rd generation enzyme immunoassay (EIA) for detection of HIV-1/2 antibodies), and the validation of 4th generation EIA (HIV-1/2 Ab/Ag) in comparison to 3rd generation EIA, assessed by review of database.
Timepoint [5] 323960 0
End of 2020
Secondary outcome [6] 324006 0
To assess the performance of the DBS HCV test used for HCV RNA, assessed by comparison with follow up conventional testing.
Timepoint [6] 324006 0
End of 2020
Secondary outcome [7] 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 [7] 346703 0
End of 2020
Secondary outcome [8] 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 [8] 346704 0
End of 2020

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 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 from regions of high HIV prevalence*
*People with current or previous sexual partners from regions of high HIV prevalence*
*For the purposes of this study considered to be Africa and Asia
*People who identify as Aboriginal or Torres Strait Islander, or;
*People who have ever injected drugs,

Minimum age
16 Years
Maximum age
No limit
Gender
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 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.

The sample size related to the laboratory evaluation of 3rd generation DBS compared to 4th generation was also calculated. To provide sensitivity and specificity estimates with confidence intervals of +/-10%, at least 60 positive and negative samples are required. Based on the 860 samples expected in the DBS pilot program we expect a HIV positivity of 1% (9 positive tests, 851 negative, of which 1-2 may be acute infections). Therefore to meet the required sample size of 60 acute infections and 60 established infections, most samples will be sourced from other blood samples tested at the laboratory for other purposes.
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
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] 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
Address [1] 293628 0
73 Miller Street North Sydney NSW 2060
Country [1] 293628 0
Australia
Primary sponsor type
Government body
Name
NSW Ministry of Health
Address
73 Miller Street, North Sydney NSW 2060
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 testing currently involve people attending clinics or community testing sites. The purpose of the Dried Blood Spot (DBS) HIV 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 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.
Trial website
https://www.hivtest.health.nsw.gov.au/
Trial related presentations / publications
Public notes
Attachments [1] 884 884 0 0

Contacts
Principal investigator
Name 65974 0
Ms Jo Holden
Address 65974 0
NSW Ministry of Health
73 Miller Street,
North Sydney
NSW
2060
Country 65974 0
Australia
Phone 65974 0
+ 61 2 9391 9216
Fax 65974 0
Email 65974 0
jhold@doh.health.nsw.gov.au
Contact person for public queries
Name 65975 0
Mr Brett Hadlow
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
Brett.hadlow@health.nsw.gov.au
Contact person for scientific queries
Name 65976 0
A/Prof Anna McNulty
Address 65976 0
Sydney Sexual Health Centre
Address: PO Box 1614, Sydney NSW 2011
Country 65976 0
Australia
Phone 65976 0
+61 2 9382 7476
Fax 65976 0
Email 65976 0
Anna.McNulty@SESIAHS.HEALTH.NSW.GOV.AU

No information has been provided regarding IPD availability
Summary results
No Results