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Trial registered on ANZCTR


Registration number
ACTRN12614000760673
Ethics application status
Approved
Date submitted
24/03/2014
Date registered
17/07/2014
Date last updated
5/01/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised trial of allowing men who have sex with men to have human immunodeficiency virus (HIV) and syphilis tests between clinic consultations.
Scientific title
Will men having sex with men who are allowed to have human immunodeficiency virus (HIV) and syphilis tests between clinical consultations, have them more frequently?
Secondary ID [1] 284329 0
None.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV 291482 0
Syphilis. 291483 0
Condition category
Condition code
Infection 291848 291848 0 0
Acquired immune deficiency syndrome (AIDS / HIV)
Infection 291849 291849 0 0
Sexually transmitted infections

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
For one year, participants in the intervention arm will be allowed to have HIV and syphilis serology at either MSHC (unlimited) or Melbourne Pathology (maximum 6) whenever they choose, without needing another clinical consultation.
Intervention code [1] 289050 0
Early detection / Screening
Comparator / control treatment
Usual care. Tests can only be requested at a clinical consultation. Note that after the one year trial period members of the control group are entitled to a similar intervention (unlimited testing without consultations) but at MSHC only. This will be reported separately and is not part of the main study.
Control group
Active

Outcomes
Primary outcome [1] 291762 0
Rate of HIV testing. Testing will be ascertained from clinic and laboratory records and responses to questionnaires.
Timepoint [1] 291762 0
One year.
Secondary outcome [1] 307446 0
Rate of syphilis testing. Testing will be ascertained from clinic and laboratory records and responses to questionnaires.
Timepoint [1] 307446 0
One year
Secondary outcome [2] 307447 0
Rate of HIV testing over two six month periods.Testing will be ascertained from clinic and laboratory records and responses to questionnaires.
Timepoint [2] 307447 0
0 - 6 months and 6 - 12 months. Testing will be ascertained from clinic and laboratory records and responses to questionnaires. Questionnaires are sent at 6 months for the 0 - 6 months period, and at 12 months for the 6 - 12 months period.
Secondary outcome [3] 307449 0
Time to first HIV test. Testing will be ascertained from clinic and laboratory records and from questionnaires.
Timepoint [3] 307449 0
Time of first HIV test.
Secondary outcome [4] 307450 0
Rate of clinical consultations. This will be determined from clinic data.
Timepoint [4] 307450 0
One year.
Secondary outcome [5] 307451 0
Quality of life will be assessed using the SF12 questionnaire.
Timepoint [5] 307451 0
One year.
Secondary outcome [6] 309396 0
Acceptability will be measured by questions about the testing process with responses recorded on a Likert scale.
Timepoint [6] 309396 0
One year.

Eligibility
Key inclusion criteria
Sex with a man in the past year.
Negative at last HIV test, if had one.
Had an HIV test within six weeks or having one on day of visit.
Plan to remain in Victoria for most of the next year.
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 researcher not associated with the trial will put test allocations into 422 sealed envelopes. All sealed envelopes will be locked in an office, with access restricted to the study team, and sequentially taken for each new recruit. The coordinator recruiting patients will be unaware of the study group until the envelope is opened in front of the patient.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised in blocks to ensure 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
The incidence rate ratio of HIV testing in the two study arms will be calculated. A recent study of HIV testing by the target population at our clinic found a rate of 1.6 tests per year with a standard deviation of 1.4. Assuming 80% power (p=0.05, 2 sided) and using this testing frequency in the control arm we will need 192 participants in each arm to detect an increase in testing of twice a year or more (up from 1.6 per year). We added 10% to allow for losses to follow-up and HIV infection.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
16/06/2014
Actual
24/07/2014
Date of last participant enrolment
Anticipated
Actual
22/04/2015
Date of last data collection
Anticipated
Actual
31/05/2016
Sample size
Target
422
Accrual to date
Final
422
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 2232 0
The Alfred - Prahran

Funding & Sponsors
Funding source category [1] 288965 0
Government body
Name [1] 288965 0
National Health and Medical Research Council
Country [1] 288965 0
Australia
Primary sponsor type
Government body
Name
National Health and Medical Research Council
Address
Level 1
16 Marcus Clarke Street
Canberra ACT 2601
Country
Australia
Secondary sponsor category [1] 287646 0
None
Name [1] 287646 0
Address [1] 287646 0
Country [1] 287646 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290776 0
Alfred Hospital Human Research Ethics Committee
Ethics committee address [1] 290776 0
The Alfred
PO Box 315
Prahran Victoria 3181
Ethics committee country [1] 290776 0
Australia
Date submitted for ethics approval [1] 290776 0
24/03/2014
Approval date [1] 290776 0
06/05/2014
Ethics approval number [1] 290776 0
143/14

Summary
Brief summary
Men having sex with men attending Melbourne Sexual Health Centre (MSHC) who volunteer will be randomised to usual care OR the availability of additional HIV and syphilis serology tests whenever they choose, for up to one year. They can have these at MSHC or at Melbourne Pathology. The primary outcome is the frequency of HIV testing and participants will be followed for one year. Controls will have the usual access to HIV and syphilis testing at clinical consultations. In the second year controls will be able to have tests without consulations only at MSHC.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 47234 0
Dr Tim Read
Address 47234 0
Melbourne Sexual Health Centre
580 Swanston St,
Carlton,
Victoria 3053
Country 47234 0
Australia
Phone 47234 0
+61438002565
Fax 47234 0
Email 47234 0
[email protected]
Contact person for public queries
Name 47235 0
Sandra Walker
Address 47235 0
Melbourne Sexual Health Centre
580 Swanston St,
Carlton,
Victoria 3053
Country 47235 0
Australia
Phone 47235 0
+61393416247
Fax 47235 0
Email 47235 0
[email protected]
Contact person for scientific queries
Name 47236 0
Tim Read
Address 47236 0
Melbourne Sexual Health Centre
580 Swanston St,
Carlton,
Victoria 3053
Country 47236 0
Australia
Phone 47236 0
+61438002565
Fax 47236 0
Email 47236 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
SourceTitleYear of PublicationDOI
EmbaseHIV testing with and without a clinical consultation among men who have sex with men: A randomized controlled trial.2018https://dx.doi.org/10.1097/QAI.0000000000001688
N.B. These documents automatically identified may not have been verified by the study sponsor.