Trial Review

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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] 288088 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Genital Chlamydia trachomatis infection 2133 0
Condition category
Condition code
Reproductive Health and Childbirth 2229 2229 0 0
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] 1640 0
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] 3090 0
Genital Chlamydia trachomatis infection test performed, by self-report.
Timepoint [1] 3090 0
At baseline and at 6 month follow up in both groups
Secondary outcome [1] 5171 0
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] 5171 0
At baseline and at 6 months.
Secondary outcome [2] 5172 0
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] 5172 0
This will be measured at baseline and at 6 month follow up.
Secondary outcome [3] 5173 0
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] 5173 0
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?
No
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] 2779 0
Government body
Name [1] 2779 0
Department of Health and Ageing
Country [1] 2779 0
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] 2163 0
University
Name [1] 2163 0
Sexually Transmitted Infections Research Centre
Address [1] 2163 0
Marian Villa
Hawkesbury Rd
Westmead Hospital NSW
Country [1] 2163 0
Australia
Secondary sponsor category [2] 2164 0
Charities/Societies/Foundations
Name [2] 2164 0
Inspire Foundation
Address [2] 2164 0
102 Beattie St
Balmain NSW 2041
Country [2] 2164 0
Australia
Secondary sponsor category [3] 2511 0
University
Name [3] 2511 0
Sexually Transmitted Infections Research Centre
Address [3] 2511 0
Marian Villa
Hawkesbury Rd Westmead NSW 2145
Country [3] 2511 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4699 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 4699 0
Ethics committee country [1] 4699 0
Australia
Date submitted for ethics approval [1] 4699 0
Approval date [1] 4699 0
26/10/2006
Ethics approval number [1] 4699 0
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 27574 0
Dr Melissa Kang
Address 27574 0
PO Box 154
Westmead NSW 2145
Australia
Country 27574 0
Australia
Phone 27574 0
61298458246
Fax 27574 0
Email 27574 0
melissa.kang@sydney.edu.au
Contact person for public queries
Name 10829 0
Dr Melissa Kang
Address 10829 0
PO Box 154
Westmead NSW 2145
Country 10829 0
Australia
Phone 10829 0
02 9845 8246
Fax 10829 0
02 9845 8166
Email 10829 0
melissa.kang@sydney.edu.au
Contact person for scientific queries
Name 1757 0
Dr Melissa Kang
Address 1757 0
PO Box 154
Westmead NSW 2145
Country 1757 0
Australia
Phone 1757 0
02 9845 8246
Fax 1757 0
02 9845 8166
Email 1757 0
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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