Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12612001236886
Ethics application status
Approved
Date submitted
21/11/2012
Date registered
22/11/2012
Date last updated
18/04/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Rapid HIV testing in men who have sex with men in sexual health clinics in Sydney
Scientific title
Patient acceptability, staff acceptability and performance of rapid HIV testing in men who have sex with men in sexual health clinics in Sydney
Secondary ID [1] 273368 0
Nil known
Universal Trial Number (UTN)
Nil
Trial acronym
The Sydney Rapid HIV Test Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV testing 279149 0
Rapid testing at the point of care 279150 0
Condition category
Condition code
Infection 279339 279339 0 0
Acquired immune deficiency syndrome (AIDS / HIV)
Public Health 288211 288211 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Rapid HIV testing at the point of care using the Alere Determine HIV-1/2 Ag/Ab Combo rapid test.
Rapid test takes 20 minutes to produce a result after the patient specimen is applied with result provided and patient questionnaire completed (once only) within same clinic visit.
Recruiting for at least 12 months from October 2011.
Intervention code [1] 283709 0
Not applicable
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 279939 0
Patient acceptability of the process of rapid HIV testing.
Assessed via self-administered questionnaire.
Timepoint [1] 279939 0
After rapid test performed and result delivered
Primary outcome [2] 279940 0
Clinic staff acceptability of the process of rapid HIV testing.
Assessed via self-administered questionnaire.
Timepoint [2] 279940 0
At the start and at the end of the study
Secondary outcome [1] 294813 0
Barriers to HIV testing among subjects.
Assessed via self-administered questionnaire.
Timepoint [1] 294813 0
At the time of rapid testing
Secondary outcome [2] 294814 0
Patient flow.
Assessed via extraction of data from clinic database.
Timepoint [2] 294814 0
At the end of the study
Secondary outcome [3] 294815 0
Rapid test performance.
Assessed via comparison of results of the Alere Determine HIV-1/2 Ag/Ab Combo rapid test with results of gold standard conventional laboratory serology tests: Abbott Architect HIV Ag/Ab Combo, Biorad Genscreen HIV antigen and HIV Western blot. Specificity and negative predictive value of rapid test calculated using STATA statistics program.
Timepoint [3] 294815 0
At the end of the study

Eligibility
Key inclusion criteria
Men who have sex with men
Aged 18 years or over
HIV testing is indicated
Able to consent to study procedures
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Known to be HIV positive
Not fluent in English

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
25/10/2011
Actual
25/10/2011
Date of last participant enrolment
Anticipated
31/12/2012
Actual
30/07/2013
Date of last data collection
Anticipated
Actual
30/07/2013
Sample size
Target
1000
Accrual to date
Final
2468
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 4730 0
2000
Recruitment postcode(s) [2] 4731 0
2010
Recruitment postcode(s) [3] 4732 0
2150
Recruitment postcode(s) [4] 4733 0
2065

Funding & Sponsors
Funding source category [1] 284189 0
Government body
Name [1] 284189 0
National Health & Medical Research Council
Country [1] 284189 0
Australia
Primary sponsor type
University
Name
The Kirby Institute
Address
Faculty of Medicine, Wallace Wurth Building, UNSW Australia, Sydney, NSW 2052
Country
Australia
Secondary sponsor category [1] 269147 0
None
Name [1] 269147 0
Address [1] 269147 0
Country [1] 269147 0
Other collaborator category [1] 277193 0
University
Name [1] 277193 0
Centre for Social Research in Health
Address [1] 277193 0
University of New South Wales
Sydney
NSW 2052
Country [1] 277193 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286156 0
St Vincents Hospital Human Research Ethics Committee
Ethics committee address [1] 286156 0
Research Office
Level 6, de Lacy Building
St Vincents Hospital
390 Victoria Street,
Darlinghurst NSW 2010
Ethics committee country [1] 286156 0
Australia
Date submitted for ethics approval [1] 286156 0
23/02/2011
Approval date [1] 286156 0
21/06/2011
Ethics approval number [1] 286156 0
HREC/11/SVH/16

Summary
Brief summary
This cross-sectional study is the first to assess the use of rapid HIV tests in a clinical setting in New South Wales (NSW). The study will assess acceptability of the process of rapid HIV testing for gay, bisexual and other men who have sex with men (MSM) among patients and staff in public sexual health clinics in Sydney. The study will also assess barriers to HIV testing; patient flow in clinics during the study; and the performance of the rapid test compared to conventional laboratory HIV serology. The patient and staff surveys used in this study were piloted with patients and staff during development. The study aims to recruit at least 1000 MSM subjects across four sites: Sydney Sexual Health Centre, Albion Street Centre, Clinic 16 Royal North Shore Hospital and Parramatta Sexual Health Clinic. The rapid test used in the study is the Alere Determine HIV 1&2 Antigen/Antibody Combo assay which produces a result 20 minutes after the patient specimen is applied. MSM attending for screening will be identified through triage and provided with information regarding the study. Eligible MSM who consent will receive pre-test discussion and have specimens taken for sexually transmitted infection screening, rapid HIV testing and conventional HIV serology. Rapid test results are provided to subjects during their visit with counsellor support for reactive results when required. The recruitment period will be at least 12 months from October 2011.
Trial website
http://www.sti-program-grant.org.au/
Trial related presentations / publications
4. Conway DP, Holt M, Couldwell DL, Smith DE, Davies SC, McNulty A, Keen P, Cunningham P, Guy R on behalf of the Sydney Rapid HIV Test Study. Barriers to HIV testing and characteristics associated with never testing among gay and bisexual men attending sexual health clinics in Sydney. Journal of the International AIDS Society. 2015, 18:20221. URL: http://dx.doi.org/10.7448/IAS.18.1.20221

5. Conway DP, Guy R, Davies SC, Couldwell DL, McNulty A, Smith DE, Cunningham P, Keen P, Holt M on behalf of the Sydney Rapid HIV Test Study. Rapid HIV testing is highly acceptable and preferred among high-risk gay and bisexual men after implementation in Sydney sexual health clinics. PLOS One. 2015, 10(4): e0123814. URL: http://dx.doi.org/10.1371/journal.pone.0123814

6. Conway DP, Guy R, McNulty A, Couldwell DL, Davies SC, Smith DE, Keen P, Cunningham P, Holt M on behalf of the Sydney Rapid HIV Test Study. Effect of testing experience and profession on provider acceptability of rapid HIV testing after implementation in public sexual health clinics in Sydney. HIV Medicine. 2015, 16: 280–287. URL: http://dx.doi.org/10.1111/hiv.12209
Public notes

Contacts
Principal investigator
Name 33380 0
Dr Damian Conway
Address 33380 0
The Kirby Institute, Faculty of Medicine, Wallace Wurth Building, UNSW Australia, Sydney, NSW 2052
Country 33380 0
Australia
Phone 33380 0
+610293850900
Fax 33380 0
+610293850920
Email 33380 0
[email protected]
Contact person for public queries
Name 16627 0
Ms Lucienne Bamford
Address 16627 0
The Kirby Institute
Wallace Wurth Building
UNSW Medicine
UNSW Sydney
NSW 2052
Country 16627 0
Australia
Phone 16627 0
+61 02 9385 0900
Fax 16627 0
+61 02 9385 0920
Email 16627 0
[email protected]
Contact person for scientific queries
Name 7555 0
Dr Damian Conway
Address 7555 0
The Kirby Institute
Wallace Wurth Building
UNSW Medicine
UNSW Sydney
NSW 2052
Country 7555 0
Australia
Phone 7555 0
+61 02 9385 0900
Fax 7555 0
+61 02 9385 0920
Email 7555 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



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.