ANZCTR - Registration

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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

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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Infection with Chlamydia trachomatis

Condition category

Condition code

Public Health

Epidemiology

Infection

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]

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]

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]

Measured at baseline and 4 years later at the conclusion of trial.

Secondary outcome [1]

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]

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]

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]

Calculated annually for 4 years.

Secondary outcome [3]

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]

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

Sex

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

1/05/2010

Actual

16/08/2010

Date of last participant enrolment

Anticipated

Actual

15/12/2012

Date of last data collection

Anticipated

Actual

15/12/2016

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW,QLD,SA,VIC

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Department of Health and Ageing

Address [1]

Department of Health and Ageing
PO Box 9848
Canberra ACT 2601
MDP16

Country [1]

Australia

Funding source category [2]

Government body

Name [2]

NHMRC

Address [2]

Canberra

Country [2]

Australia

Funding source category [3]

Government body

Name [3]

NSW Ministry of Health

Address [3]

NSW STI Programs Unit
150 Albion Street
Surry Hills NSW 2010

Country [3]

Australia

Funding source category [4]

Government body

Name [4]

Victorian Department of Health and Human Services

Address [4]

Department of Health and Human Services
50 Lonsdale St
Melbourne Victoria 3000

Country [4]

Australia

Primary sponsor type

University

Name

UNiversity of Melbourne

Address

Level 3, 207 Bouverie St
Carlton 3053
Victoria

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Not a sponsor of the trial

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

RACGP Ethics Committee

Ethics committee address [1]

Royal Australian College of General Practitioners
 
College House
1 Palmerston Crescent
South Melbourne, Vic 3205

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

13/07/2009

Approval date [1]

25/03/2010

Ethics approval number [1]

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

Prof Jane Hocking

Address

Melbourne School of Population and Global Health
University of Melbourne'3/207 Bouverie St
Carlton, 3053, Victoria

Country

Australia

Phone

+61 3 83440762

Fax

jhocking@unimelb.edu.au

Contact person for public queries

Name

Jane Hocking

Address

Centre for Epidemiology and Biostatistics, University of Melbourne, 3/207 Bouverie St, Carlton, 3053, Victoria

Country

Australia

Phone

+61 3-8344 0762

Fax

jhocking@unimelb.edu.au

Contact person for scientific queries

Name

Jane Hocking

Address

Centre for Epidemiology and Biostatistics, University of Melbourne, 3/207 Bouverie St, Carlton, 3053, Victoria

Country

Australia

Phone

+61 3-8344 0762

Fax

jhocking@unimelb.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Not identified in original ethics application.

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
89	Study protocol				http://accept.org.au/images/Protocol/THELANCET-D-1... [More Details]

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Population effectiveness of opportunistic chlamydia testing in primary care in Australia: a cluster-randomised controlled trial.	2018	https://dx.doi.org/10.1016/S0140-6736%2818%2931816-6

N.B. These documents automatically identified may not have been verified by the study sponsor.

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