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
ACTRN12605000606684
Ethics application status
Approved
Date submitted
3/10/2005
Date registered
6/10/2005
Date last updated
6/10/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised Control trial (RCT) comparing Computer-assisted self-interviewing (CASI) with Face to Face (FTF) for sexual history taking of new clients in a sexual health centre.
Scientific title
A randomised Control trial (RCT) comparing Computer-assisted self-interviewing (CASI) with Face to Face (FTF) for sexual history taking of new clients in a sexual health centre to determine if there is a difference in the answers to sexual history questions.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sexual Health 737 0
Condition category
Condition code
Other 813 813 0 0

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The active group has the sexual history taken with Computer Assisted Interviewing.
Intervention code [1] 693 0
None
Comparator / control treatment
The control group has the sexual history taken by a clinician as part of standard care.
Control group
Active

Outcomes
Primary outcome [1] 1045 0
The primary outcome is the participants response to a questions asked during a sexual history (e.g. sex with same sex).
Timepoint [1] 1045 0
It is meausred in both active and control participants on the day of enrolment.
Secondary outcome [1] 1941 0
Response to other sexual history questions.
Timepoint [1] 1941 0
Measured on the day of enrolment.

Eligibility
Key inclusion criteria
Attending Melbourne sexual health centre, new client, able to read english.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not blinded
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 901 0
University
Name [1] 901 0
University of Melbourn
Country [1] 901 0
Australia
Primary sponsor type
Individual
Name
Christopher Fairley
Address
Country
Secondary sponsor category [1] 761 0
Individual
Name [1] 761 0
Robin Tideman
Address [1] 761 0
Country [1] 761 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2183 0
Melbourne Sexual Health Centre
Ethics committee address [1] 2183 0
Ethics committee country [1] 2183 0
Australia
Date submitted for ethics approval [1] 2183 0
Approval date [1] 2183 0
Ethics approval number [1] 2183 0
Ethics committee name [2] 2184 0
Alfred Hospital
Ethics committee address [2] 2184 0
Ethics committee country [2] 2184 0
Australia
Date submitted for ethics approval [2] 2184 0
Approval date [2] 2184 0
Ethics approval number [2] 2184 0

Summary
Brief summary
RCT of attendees to sexual health centre randomised to ACASI vs usual consultation
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36251 0
Address 36251 0
Country 36251 0
Phone 36251 0
Fax 36251 0
Email 36251 0
Contact person for public queries
Name 9882 0
Christopher Fairley
Address 9882 0
580 Swanston Street
Carlton VIC 3053
Country 9882 0
Australia
Phone 9882 0
+61 3 93416236
Fax 9882 0
Email 9882 0
[email protected]
Contact person for scientific queries
Name 810 0
Christopher Fairley
Address 810 0
580 Swanston Street
Carlton VIC 3053
Country 810 0
Australia
Phone 810 0
+61 3 93416236
Fax 810 0
Email 810 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.