ANZCTR - Registration

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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]

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

Rapid testing at the point of care

Condition category

Condition code

Infection

Acquired immune deficiency syndrome (AIDS / HIV)

Public Health

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]

Not applicable

Comparator / control treatment

Nil

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Patient acceptability of the process of rapid HIV testing.
Assessed via self-administered questionnaire.

Timepoint [1]

After rapid test performed and result delivered

Primary outcome [2]

Clinic staff acceptability of the process of rapid HIV testing.
Assessed via self-administered questionnaire.

Timepoint [2]

At the start and at the end of the study

Secondary outcome [1]

Barriers to HIV testing among subjects.
Assessed via self-administered questionnaire.

Timepoint [1]

At the time of rapid testing

Secondary outcome [2]

Patient flow.
Assessed via extraction of data from clinic database.

Timepoint [2]

At the end of the study

Secondary outcome [3]

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]

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?

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]

2000

Recruitment postcode(s) [2]

2010

Recruitment postcode(s) [3]

2150

Recruitment postcode(s) [4]

2065

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health & Medical Research Council

Address [1]

Level 1, 16 Marcus Clarke Street
Canberra ACT 2601

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

University

Name [1]

Centre for Social Research in Health

Address [1]

University of New South Wales
Sydney
NSW 2052

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

St Vincents Hospital Human Research Ethics Committee

Ethics committee address [1]

Research Office
Level 6, de Lacy Building
St Vincents Hospital
390 Victoria Street,
Darlinghurst NSW 2010

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

23/02/2011

Approval date [1]

21/06/2011

Ethics approval number [1]

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

Dr Damian Conway

Address

The Kirby Institute, Faculty of Medicine, Wallace Wurth Building, UNSW Australia, Sydney, NSW 2052

Country

Australia

Phone

+610293850900

Fax

+610293850920

[email protected]

Contact person for public queries

Name

Lucienne Bamford

Address

The Kirby Institute
Wallace Wurth Building
UNSW Medicine
UNSW Sydney
NSW 2052

Country

Australia

Phone

+61 02 9385 0900

Fax

+61 02 9385 0920

[email protected]

Contact person for scientific queries

Name

Damian Conway

Address

The Kirby Institute
Wallace Wurth Building
UNSW Medicine
UNSW Sydney
NSW 2052

Country

Australia

Phone

+61 02 9385 0900

Fax

+61 02 9385 0920

[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.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically