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Trial registered on ANZCTR


Registration number
ACTRN12608000499381
Ethics application status
Approved
Date submitted
26/06/2008
Date registered
30/09/2008
Date last updated
4/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Chlamydia Prevalence and Testing Project - a randomised controlled trial
Scientific title
Chlamydia prevalence and testing program targetting women aged 16 to 24 years in general practice
Secondary ID [1] 726 0
Nil
Universal Trial Number (UTN)
Trial acronym
CLASP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Genital chlamydia infection 3316 0
Condition category
Condition code
Infection 3476 3476 0 0
Sexually transmitted infections

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The randomisation unit is general practitioner (GP) clinic.
Intervention group: GPs will receive $5 reimbursement for each eligible women aged 16 to 24 years screened for chlamydia each year. The intervention will be in place for 6 months.
GPs will be expected to conduct chlamydia screening during a routine consultation with an eligible patient. Screening involves requesting a chlamydia test for the patient. It should take a couple of minutes to discuss with the patient during the consultation
Intervention code [1] 3055 0
Prevention
Comparator / control treatment
Control group: Will receive no payment.
Control group
Active

Outcomes
Primary outcome [1] 4380 0
The proportion of women aged 16 to 24 years consulting each general practice who have had at least one chlamydia test during the 6 months.
Timepoint [1] 4380 0
6 months after the intervention commencement
Secondary outcome [1] 7386 0
The prevalence of chlamydia among those tested at 6 months after intervention commencement.
Timepoint [1] 7386 0
6 months after intervention commencement

Eligibility
Key inclusion criteria
>250 women aged 16-24 years attending the GP clinic in the past year.
Minimum of 2 full time equivalent (EFT) GPs per clinic.
An electronic medical records database.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Clinics will be excluded from the project if they do not see more than 250 women aged 16 to 24 years per year.

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)
GP clinics will be randomly allocated to the treatment following their enrolment in the study and obtaining informed consent. Block randomisation in blocks was used to allocate the intervention. This was done by a statistician independently of the research assistants obtaining informed consent from the clinics.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
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
Recruiting
Date of first participant enrolment
Anticipated
15/05/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3921 0
Government body
Name [1] 3921 0
Department of Human Services
Country [1] 3921 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
University of Melbourne
Level 2, 723 Swanston St
Carlton VIC 3053
Country
Australia
Secondary sponsor category [1] 3159 0
None
Name [1] 3159 0
Address [1] 3159 0
Country [1] 3159 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5984 0
University of Melbourne
Ethics committee address [1] 5984 0
Ethics committee country [1] 5984 0
Australia
Date submitted for ethics approval [1] 5984 0
01/12/2005
Approval date [1] 5984 0
20/01/2006
Ethics approval number [1] 5984 0
050747

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28702 0
Address 28702 0
Country 28702 0
Phone 28702 0
Fax 28702 0
Email 28702 0
Contact person for public queries
Name 11859 0
Ms Jade Bilardi
Address 11859 0
580 Swanston St
Carlton Sth VIC 3053
Country 11859 0
Australia
Phone 11859 0
03 -93416263
Fax 11859 0
Email 11859 0
jbilardi@mshc.org.au
Contact person for scientific queries
Name 2787 0
Dr Jane Hocking
Address 2787 0
Key Centre for Women's Health in Society
University of Melbourne
level 2, 723 Swanston St
Carlton VIC 3053
Country 2787 0
Australia
Phone 2787 0
03-83440762
Fax 2787 0
Email 2787 0
jhocking@unimelb.edu.au

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
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Incentive payments to general practitioners aimed ... [More Details]

Documents added automatically
No additional documents have been identified.