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Trial registered on ANZCTR


Registration number
ACTRN12610000297022
Ethics application status
Approved
Date submitted
10/04/2010
Date registered
13/04/2010
Date last updated
5/11/2018
Date data sharing statement initially provided
5/11/2018
Date results information initially provided
5/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Australian Chlamydia Control Effectiveness PIlot: a trial to determine whether annual chlamydia testing in general practice can lead to a reduction in chlamydia prevalence.
Scientific title
A randomised controlled trial to determine whether an intervention of annual chlamydia testing in general practice for sexually active men and women aged 16 to 29 years can lead to a reduction in chlamydia prevalence
Secondary ID [1] 1604 0
Nil
Universal Trial Number (UTN)
Trial acronym
ACCEPt
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infection with Chlamydia trachomatis 257122 0
Condition category
Condition code
Public Health 257277 257277 0 0
Epidemiology
Infection 257278 257278 0 0
Sexually transmitted infections

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
General practitioners will be provided with a multifaceted intervention to support increased chlamydia testing in general practice. The intervention includes computer alerts, incentive payments, educational package, register to recall patients for follow up tests and quarterly feedback on chlamydia testing performance. The trial will be of up to 4 years duration.
Intervention code [1] 256283 0
Early detection / Screening
Comparator / control treatment
General practitioners in the control group will be requested to conduct their usual chlamydia testing practice.
Control group
Active

Outcomes
Primary outcome [1] 258197 0
Chlamydia prevalence. A consecutive sample of men and women aged 16 to 29 years will be recruited prior to randomisation in each clinic and again at the conclusion of the trial. Men will be asked to provide a urine specimen and women a urine or self collected vaginal swab for chlamydia testing.
Timepoint [1] 258197 0
Measured at baseline and 4 years later at the conclusion of trial.
Secondary outcome [1] 263838 0
Incidence of pelvic inflammatory disease (PID). Diagnoses of PID will be extracted from each clinic's medical records software to determine the annual PID incidence and the cumulative incidence of PID at the conclusion of the trial 4 years later.
Timepoint [1] 263838 0
Measured throughout intervention period - annual PID incidence will be measured and a cumulative incidence measured at the conclusion of the trial after 4 years.
Secondary outcome [2] 263839 0
Chlamydia testing rates.

Chlamydia testing data will be extracted from the clinic medical records software and from the clinic pathology provider. Annual chlamydia testing rates will be calculated using the number of tests as the numerator and total number of patients seen at each clinic during the time frame as the denominator.
Timepoint [2] 263839 0
Calculated annually for 4 years.
Secondary outcome [3] 263840 0
An annual chlamydia retesting rate will be calculated for each clinic will be calculated for the 12 month period prior to commencement of the trial and then for each year of the trial till the end of the trial at 4 years.
Timepoint [3] 263840 0
An annual chlamydia retesting rate will be calculated for each clinic will be calculated for the 12 month period prior to commencement of the trial and then for each year of the trial till the end of the trial at 4 years.

Eligibility
Key inclusion criteria
The intervention will be allocated at the postcode area and all general practice clinics within the postcode will be invited to participated. All clinics will be eligible for participation. General practitioners (GPs) will be asked to screen sexually active men and women aged 16 to 29 years for chlamydia.
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Postcodes with a population of between 5000 to 30,000 16 to 29 year old adults will be selected on the basis of convenience. All GP clinics within each postcode will be invited to participate. GPs and practice managers will be sent a postcode informing them to expect further information about the study, this will be follow up by a newsletter about the study and then a phone call to arrange a face to face meeting about the study. Once enrolled and the baseline chlamydia prevalence survey is complete, all postcodes will be randomised to either intervention or control group. Allocation will involve contacting the holder of the allocation schedule who will be “off-site” or at central administration siteClinics will be informed via phone call and then via mail of their group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Postcodes (clusters) will be randomised to the trial intervention or control strategies using a minimisation approach. This will maximise the balance across several baseline variables. These variables will include:
* Estimated baseline chlamydia prevalence in each postcode;
* Estimated overall baseline testing rate in each postcode;
* Rural town, suburban and metropolitan geographical areas;
* Estimated percentage of population aged <30 years.

Geographical areas will be randomised at UNiversity of New South Wales as soon as data on all these variables, and specifically the estimated baseline chlamydia prevalence and testing rates, are available. This means that all areas do not have to be randomised at the same time, and the study does not need to wait until baseline chlamydia prevalence and testing rates are available for all areas. The randomised intervention can then commence in areas immediately, while other areas are performing baseline chlamydia surveys.
The randomisation sequence will be held by the statistician at UNiversity of New South Wales.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC

Funding & Sponsors
Funding source category [1] 256789 0
Government body
Name [1] 256789 0
Department of Health and Ageing
Address [1] 256789 0
Department of Health and Ageing
PO Box 9848
Canberra ACT 2601
MDP16
Country [1] 256789 0
Australia
Funding source category [2] 284547 0
Government body
Name [2] 284547 0
NHMRC
Address [2] 284547 0
Canberra
Country [2] 284547 0
Australia
Funding source category [3] 301102 0
Government body
Name [3] 301102 0
NSW Ministry of Health
Address [3] 301102 0
NSW STI Programs Unit
150 Albion Street
Surry Hills NSW 2010

Country [3] 301102 0
Australia
Funding source category [4] 301103 0
Government body
Name [4] 301103 0
Victorian Department of Health and Human Services
Address [4] 301103 0
Department of Health and Human Services
50 Lonsdale St
Melbourne Victoria 3000
Country [4] 301103 0
Australia
Primary sponsor type
University
Name
UNiversity of Melbourne
Address
Level 3, 207 Bouverie St
Carlton 3053
Victoria
Country
Australia
Secondary sponsor category [1] 256064 0
None
Name [1] 256064 0
Address [1] 256064 0
Not a sponsor of the trial
Country [1] 256064 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258814 0
RACGP Ethics Committee
Ethics committee address [1] 258814 0
Royal Australian College of General Practitioners

College House
1 Palmerston Crescent
South Melbourne, Vic 3205
Ethics committee country [1] 258814 0
Australia
Date submitted for ethics approval [1] 258814 0
13/07/2009
Approval date [1] 258814 0
25/03/2010
Ethics approval number [1] 258814 0
09_009

Summary
Brief summary
The overall design of ACCEPT for the purposes of the Department of Health and Ageing (DoHA) contract has been finalised and approved by ethics committees. The trial uses a cluster randomised controlled trial (RCT) design. Cluster randomisation is required because chlamydia is an infectious disease; randomising a group of people in the same geographic area (postcode) will allow the intervention to be delivered to people within the same social/sexual networks. The intervention aims to maximise the rate of regular chlamydia testing in people in the target age group who attend primary care services. The intervention will be randomised at the postcode level and all GP clinics and Aboriginal Community Controlled Health Services (ACCHS) in each postcode (estimated at 2-3 clinics on average) will be invited to participate. Overall, about 80% of postcodes will be selected from rural/regional areas based on the Rural, Remote and Metropolitan Areas classification (RRMA 3-7) so that the intervention can be applied to whole communities of people more likely to be in the same social/sexual network. Further, because young people often attend multiple clinics, randomising postcodes in rural areas and recruiting all clinics in the postcode, will allow the intervention to be applied to whole communities and facilitate data collection. The fundamental premise of this trial is that increased levels of testing can be achieved by providing a supportive intervention and that once levels of testing are increased high enough (more than 30%), the prevalence of chlamydia will fall.
Trial website
www.accept.org.au
Trial related presentations / publications
Jane S Hocking, Meredith Temple-Smith, Rebecca Guy, Basil Donovan, Sabine Braat, Matthew Law, Jane Gunn, David Regan, Alaina Vaisey, Liliana Bulfone, John Kaldor, Christopher K Fairley*, Nicola Low. Population effectiveness of opportunistic chlamydia
testing in primary care in Australia: a cluster-randomised controlled trial. Lancet - in press October 2018.

Yeung A, Hocking J, Guy R, Fairley CK, Smith K, Vaisey A, Donovan B, Imrie J, Gunn J, Temple-Smith M. 'It Opened My Eyes'-examining the impact of a multifaceted chlamydia testing intervention on general practitioners using Normalization Process Theory. Fam Pract. 2018 Sep 18;35(5):626-632

Lorch R, Hocking JS, Temple-Smith M, Law M, Yeung A, Wood A, Vaisey A, Donovan B, Fairley C, Kaldor J, Guy R. The chlamydia knowledge, awareness and testing practices of Australian general practitioners and practice nurses: survey findings from the Australian Chlamydia Control Effectiveness Pilot (ACCEPt). BMC Fam Pract. 2013 Nov 13;14(1):169.

Yeung A, Temple-Smith M, Fairley CK, Vaisey A, Guy R, Law M, Low N, Bingham A, Gunn J, Kaldor J, Donovan, B, Hocking JS. Chlamydia trachomatis prevalence in young people attending primary care services in rural and regional Australia: a cross-sectional survey. Med J Aust 2014; Feb 17;200(3):170-5.
Public notes

Contacts
Principal investigator
Name 31035 0
Prof Jane Hocking
Address 31035 0
Melbourne School of Population and Global Health
University of Melbourne'3/207 Bouverie St
Carlton, 3053, Victoria
Country 31035 0
Australia
Phone 31035 0
+61 3 83440762
Fax 31035 0
Email 31035 0
jhocking@unimelb.edu.au
Contact person for public queries
Name 14282 0
Prof Jane Hocking
Address 14282 0
Centre for Epidemiology and Biostatistics, University of Melbourne, 3/207 Bouverie St, Carlton, 3053, Victoria
Country 14282 0
Australia
Phone 14282 0
+61 3-8344 0762
Fax 14282 0
Email 14282 0
jhocking@unimelb.edu.au
Contact person for scientific queries
Name 5210 0
Prof Jane Hocking
Address 5210 0
Centre for Epidemiology and Biostatistics, University of Melbourne, 3/207 Bouverie St, Carlton, 3053, Victoria
Country 5210 0
Australia
Phone 5210 0
+61 3-8344 0762
Fax 5210 0
Email 5210 0
jhocking@unimelb.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not identified in original ethics application.
What supporting documents are/will be available?
Study protocol
How or where can supporting documents be obtained?
Type [1] 89 0
Study protocol
Citation [1] 89 0
Link [1] 89 0
Email [1] 89 0
Other [1] 89 0
http://accept.org.au/images/Protocol/THELANCET-D-12-09010.pdf
Attachment [1] 89 0
Summary results
Have study results been published in a peer-reviewed journal?
Yes
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary