ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12607000582459

Ethics application status

Approved

Date submitted

8/03/2007

Date registered

14/11/2007

Date last updated

7/12/2015

Type of registration

Retrospectively registered

Titles & IDs

Public title

Interactive, internet-based education and information for young people about Chlamydia trachomatis

Scientific title

For sexually active young people 16 - 25 years residing in Australia, does personal email interaction with a nurse or doctor over 6 months, compared with monthly automated emails over 6 months, increase the likelihood of receiving a Chlamydia test from a health provider?

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Genital Chlamydia trachomatis infection

Condition category

Condition code

Reproductive Health and Childbirth

Fertility including in vitro fertilisation

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Intervention: personal email interaction with doctor or nurse over 6 months. The number of emails and their content will vary according to the questions and issues raised by the participant, ie they will be tailored to the individual participant. Several attempts will be made to engage the participant in ongoing email interaction via weekly emails for one month, then monthly emails up until follow up at 6 months. The doctor/ nurse will try to form a clinical relationship with the participant via email and it is this relationship that is the crux of the intervention.

Intervention code [1]

Other interventions

Comparator / control treatment

Control: monthly automated emails over 6 months. These emails do not contain any information about Chlamydia nor do they invite direct contact with the doctor or nurse, rather they suggest that participants can find out more via the chlamydia website. Monthly emails are sent to remind the participant that they are still enrolled in the trial. At 6 months they are invited to complete the follow up questionnaire, and are then invited to contact the doctor or nurse directly if they have any questions about Chlamydia.

Control group

Active

Outcomes

Primary outcome [1]

Genital Chlamydia trachomatis infection test performed, by self-report.

Timepoint [1]

At baseline and at 6 month follow up in both groups

Secondary outcome [1]

Increased awareness of Chlamydia trachomatis infection, measured via an online quiz at baseline and 6 months later conducted on 2 separate websites including the trial website and another that linked to the trial website.

Timepoint [1]

At baseline and at 6 months.

Secondary outcome [2]

Prevalence of genital Chlamydia trachomatis infection among participants who undergo testing; this will be measured by number of self-reported positive tests divided by those who report via the questionnaire, having had a test at baseline and at follow up

Timepoint [2]

This will be measured at baseline and at 6 month follow up.

Secondary outcome [3]

Proportion of participants testing positive for Chlamydia testing receiving appropriate treatment and contact tracing. This will be measured by self-report on the baseline and follow up questionnaires

Timepoint [3]

This will be measured at baseline and 6 month follow up

Eligibility

Key inclusion criteria

Has had sexual intercourse (vaginal or anal)
Residing in Australia

Minimum age

16 Years

Maximum age

25 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Never had sexual intercourse
Not residing in Australia

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)

Eligible participants will be enrolled in the trial prior to allocation. Persons determining eligibility and enrolling subjects will be unaware, at the time of enrolment, which group the subject will be allocated to. Allocation is concealed by virtue of the fact that the only information known to the persons allocating is that participants meet both eligibility criteria. Data is downloaded from the website and imported into a Microsoft Access database. Eligibility is determined via an Access program query, a study number is then given, and allocation determined. At this point, at the time of allocation, the participant's name (optional and might not be provided), age, sex and email address are not known.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Simple randomization by using a computerized random number generator.

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

9/03/2007

Actual

5/03/2007

Date of last participant enrolment

Anticipated

Actual

4/01/2008

Date of last data collection

Anticipated

Actual

Sample size

Target

1000

Accrual to date

Final

704

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Department of Health and Ageing

Address [1]

Scarborough House
Atlantic St
Woden ACT

Country [1]

Australia

Primary sponsor type

University

Name

Department of General Practice, University of Sydney

Address

PO Box 154
Westmead NSW 2145

Country

Australia

Secondary sponsor category [1]

University

Name [1]

Sexually Transmitted Infections Research Centre

Address [1]

Marian Villa
Hawkesbury Rd
Westmead Hospital NSW

Country [1]

Australia

Secondary sponsor category [2]

Charities/Societies/Foundations

Name [2]

Inspire Foundation

Address [2]

102 Beattie St
Balmain NSW 2041

Country [2]

Australia

Secondary sponsor category [3]

University

Name [3]

Sexually Transmitted Infections Research Centre

Address [3]

Marian Villa
Hawkesbury Rd Westmead NSW 2145

Country [3]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Sydney Human Research Ethics Committee

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

26/10/2006

Ethics approval number [1]

9462

Summary

Brief summary

The aim is to promote testing for chlamydia among at-risk 16 – 25 year old Australians. A website about chlamydia will be developed in consultation with young people, and linked to an existing, evaluated health promotion website. Eligible visitors to the chlamydia website will be invited to participate in the study. 1,000 participants will be randomly allocated into one of two groups. The intervention group will be offered confidential email interaction with a nurse or doctor to discuss their needs and barriers surrounding testing for chlamydia. The control group will receive an automated email reply directing them back to the website for information. Both groups will complete a de-identified online questionnaire at baseline and 6 months. The main outcome measure will be whether chlamydia testing took place.

Trial website

Trial related presentations / publications

Kang M, Rochford A, Skinner SR, Mindel A, Webb M, Peat J, Usherwood T. Sexual behaviour, sexually transmitted infections and attitudes to chlamydia testing among a unique national sample of young Australians: baseline data from a randomised controlled trial. BMC Public Health 2014, 14:12

Kang M, Hillier L. Medieval wenches and other icky connotations: how young people’s constructions of sexually transmitted infections deepen our understanding of their sexual health. Journal of Adolescent Health 2014; 54(2) Supplement:S65.

Kang M, Rochford A, Skinner SR, Mindel A, Webb M, Peat J, Usherwood T. Facilitating chlamydia testing among young people: a randomised controlled trial in cyberspace. Sexually Transmitted Infections 2012; 88:568-573.

Kang M, Rochford A, Skinner SR, Mindel A, Webb M, Usherwood T. Getting Clued Up in cyberspace about chlamydia: a randomized controlled trial of an internet-based intervention. Journal of Adolescent Health 2009; 44(2) Supplement:S22.

Kang M, Rochford A, Mindel A, Skinner SR, Webb M, Hillier L and Usherwood T. 
Young people get clued up about chlamydia: an internet based randomised controlled trial [Oral presentation]. Australasian Sexual Health conference, 8 – 10 October 2007, Conrad Jupiters, Gold Coast, Queensland, Australia.

Kang M, Rochford A, Skinner R, Mindel A, Webb M, Usherwood T.
Getting Clued Up in cyberspace about chlamydia: a randomised controlled trial of an internet-based intervention [Poster]. Society for Adolescent Medicine Annual Meeting 25 – 28 March 2009, Los Angeles, California, USA.

Kang M, Rochford A, Skinner R, Mindel A, Webb M, Usherwood T.
Facilitating chlamydia testing among young people in cyberspace: a randomised controlled trial [Poster]. Australasian Sexual Health conference, 7 – 9 September 2009, Brisbane Convention and Exhibition Centre, Brisbane, Queensland, Australia.

Kang M, Rochford A, Skinner R, Mindel A, Webb M, Usherwood T.
Using the internet to educate young people and increase chlamydia testing: a randomised controlled trial [Oral presentation]. International Association for Adolescent Health World Congress 2009, 28 – 30 October 2009, Shangri-La Hotel, Kuala Lumpur, Malaysia.

Kang M, Rochford A, Skinner SR, Mindel A, Webb M, Peat J, Usherwood T. Young people’s attitudes to chlamydia testing: a unique national sample [Oral presentation]. Investing in Young People’s Health, Youth Health Conference, Fremantle, 14 – 15 November 2013.

Kang M, Hillier L. Medieval wenches and other icky connotations: how young people’s constructions of sexually transmitted infections deepen our understanding of their sexual health [Poster]. Society for Adolescent Health and Medicine annual meeting, Austin, Texas, USA.

Public notes

Contacts

Principal investigator

Name

Dr Melissa Kang

Address

PO Box 154
Westmead NSW 2145
Australia

Country

Australia

Phone

61298458246

Fax

melissa.kang@sydney.edu.au

Contact person for public queries

Name

Dr Melissa Kang

Address

PO Box 154
Westmead NSW 2145

Country

Australia

Phone

02 9845 8246

Fax

02 9845 8166

melissa.kang@sydney.edu.au

Contact person for scientific queries

Name

Dr Melissa Kang

Address

PO Box 154
Westmead NSW 2145

Country

Australia

Phone

02 9845 8246

Fax

02 9845 8166

melissa.kang@sydney.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

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Documents added automatically

No additional documents have been identified.

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