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Trial registered on ANZCTR


Registration number
ACTRN12610000430033
Ethics application status
Approved
Date submitted
23/05/2010
Date registered
27/05/2010
Date last updated
19/04/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Do homosexual men test more frequently for human immunodeficiency virus (HIV) with rapid tests? A randomised controlled trial.
Scientific title
Do homosexual men using rapid human immunodeficiency virus (HIV) tests compared to conventional HIV serology, test more frequently?
Secondary ID [1] 251815 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV testing 257414 0
Condition category
Condition code
Infection 257562 257562 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ongoing access to rapid HIV tests (available to intervention group only at Melbourne Sexual Health Centre) for 18 months trial period. Using Determine HIV1/2 Ag/Ab Combo rapid test (Alere). This immunochromatographic test uses a fingerprick blood sample and provides a result in 20 minutes.
Intervention code [1] 256516 0
Early detection / Screening
Intervention code [2] 256560 0
Prevention
Comparator / control treatment
Conventional laboratory-based third-generation human immunodeficiency virus (HIV) enzyme immunoassay available from Melbourne Sexual Health Centre or similar assays from general practitioners. This test requires a blood sample from venepuncture and results are available in several days to one week. The intervention (rapid test) is only available at Melbourne Sexual Health Centre.
Control group
Active

Outcomes
Primary outcome [1] 258476 0
Frequency (incidence) of testing over 18 months measured by on-line questionnaire for tests outside our clinic and by clinic records for tests in our clinic.
Timepoint [1] 258476 0
18 months from randomisation
Secondary outcome [1] 264268 0
Frequency of testing for other sexually transmitted infections is determined from medical records - consent obtained at enrolment.
Timepoint [1] 264268 0
18 months from randomisation

Eligibility
Key inclusion criteria
Men with male sexual partner within past year
Requesting HIV test on day of enrolment
HIV test within past two years
HIV negative at last test
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
known HIV infection

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A research assistant, not associated with the trial will place each study allocation into a sealed envelope. All sealed envelopes will be stored in an office and sequentially taken for each new recruit. The research nurse recruiting patients will be unaware of the study group until the envelope is opened in front the patient.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be be randomised using a randomised block design with two sequences per block to ensure there would be equal numbers in each arm of the trial.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
28/06/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257029 0
Hospital
Name [1] 257029 0
Melbourne Sexual Health Centre
Country [1] 257029 0
Australia
Primary sponsor type
Hospital
Name
Alfred Health
Address
Commercial Rd, Prahran, 3181, Victoria
Country
Australia
Secondary sponsor category [1] 256285 0
None
Name [1] 256285 0
Address [1] 256285 0
Country [1] 256285 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259044 0
Alfred Hospital Human Research Ethics Committee
Ethics committee address [1] 259044 0
Commercial Rd, Prahran, 3181, Victoria
Ethics committee country [1] 259044 0
Australia
Date submitted for ethics approval [1] 259044 0
24/05/2010
Approval date [1] 259044 0
Ethics approval number [1] 259044 0

Summary
Brief summary
At present, about 50% of homosexual men have HIV tests at least once per year. Increasing this proportion is predicted to reduce the rate of HIV transmission in the population, due to changes in sexual behaviour brought about by diagnosis. Rapid HIV tests are not currently approved or available for general use in Australia, but these may prove more accepatable because patients do not need to return for a second consultation for their result and a less invasive sample is required. This study is a randomised trial of the effect of making rapid HIV tests available to men having sex with men (MSM) on the frequency with which they have HIV tests.
Consenting HIV-negative MSM requesting an HIV test at Melbourne Sexual Health Centre (MSHC) will be randomised in equal proportion to either onging access to a rapid test for 18 months or to standard laboratory-based serology (which requires them to return for their result in a week).
This is not blinded; both groups are sent three-monthly reminders by e-mail and SMS, reminding them of their study allocation, and asking them to complete six-monthly questionnaires on sexual behaviour and whether they have had HIV tests elsewhere.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31189 0
Address 31189 0
Country 31189 0
Phone 31189 0
Fax 31189 0
Email 31189 0
Contact person for public queries
Name 14436 0
Dr Tim Read
Address 14436 0
580 Swanston St
Carlton 3053
Victoria
Country 14436 0
Australia
Phone 14436 0
+61 3 93416200
Fax 14436 0
+61 3 93476757
Email 14436 0
[email protected]
Contact person for scientific queries
Name 5364 0
Dr Tim Read
Address 5364 0
580 Swanston St
Carlton 3053
Victoria
Country 5364 0
Australia
Phone 5364 0
+61 3 93416200
Fax 5364 0
+61 3 93476757
Email 5364 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.