Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000411640
Ethics application status
Approved
Date submitted
6/09/2005
Date registered
15/09/2005
Date last updated
19/01/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
Chlamydia screening in general practice - a randomised controlled trial
Scientific title
A computer alert to increase chlamydia testing of high risk women in general practice: a cluster randomised controlled trial
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Genital chlamydia infection 519 0
Condition category
Condition code
Infection 596 596 0 0

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention group: The software package, Medical Director, will be programmed to show an alert prompting GPs to discuss chlamydia testing with female patients aged between 16 and 24 years of age.
The intervention will be in place for 12 months.
Intervention code [1] 367 0
Early detection / Screening
Comparator / control treatment
Control group: Will receive no alert.
Control group
Active

Outcomes
Primary outcome [1] 692 0
The proportion of all women aged 16 to 24 years of age consulting each general practice who have at least one chlamydia test during the 12 months.
Timepoint [1] 692 0
Secondary outcome [1] 1432 0
The proportion of all women aged 16 to 24 years having at least one chlamydia test.
Timepoint [1] 1432 0
During the 12 months who test positive for chlamydia.

Eligibility
Key inclusion criteria
The general practice must use Medical Director as its medical records database.The general practice must be located within metropolitan Melbourne.
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
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The random allocation sequence will be concealed until
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The random allocation sequence will be generated using the
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
76
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 650 0
Government body
Name [1] 650 0
NHMRC
Country [1] 650 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Country
Australia
Secondary sponsor category [1] 546 0
None
Name [1] 546 0
None
Address [1] 546 0
Country [1] 546 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 35360 0
Address 35360 0
Country 35360 0
Phone 35360 0
Fax 35360 0
Email 35360 0
Contact person for public queries
Name 9556 0
Professor Christopher Fairley
Address 9556 0
Sexual Health Unit
School of Population Health
University of Melbourne
580 Swanston St
Carlton Sth VIC 3053
Country 9556 0
Australia
Phone 9556 0
+61 3 93416236
Fax 9556 0
+61 3 93476757
Email 9556 0
cfairley@unimelb.edu.au
Contact person for scientific queries
Name 484 0
Jane Hocking
Address 484 0
School of Population Health
University of Melbourne
5/207 Bouverie St
Carlton Sth VIC 3053
Country 484 0
Australia
Phone 484 0
+61 3 83449324
Fax 484 0
Email 484 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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.