Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12605000760673
Ethics application status
Approved
Date submitted
21/11/2005
Date registered
22/11/2005
Date last updated
22/11/2005
Type of registration
Prospectively registered

Titles & IDs
Public title
The impact of text and email messaging on the sexual risk behaviour of young men and women: a randomised controlled trial
Scientific title
The impact of text and email messaging on the sexual risk behaviour of young men and women: a randomised controlled trial
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sexual health 916 0
Condition category
Condition code
Public Health 983 983 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Assigned to receive both sms and email messages.
SMS - The intervention group will receive messages on their mobile phones at different times and on different days of the week. Message content and style will match the technology and age group.
Email - The intervention group will receive email messages such as: "If you have recently had unprotected sex with a new partner, you may be at risk of chlamydia infection and should consider being tested." SMS and email messages will also include contraception information, relevant web pages, and phone numbers for sexual health services.
The intervention will last for 12 months.
Intervention code [1] 768 0
None
Comparator / control treatment
Assigned to receive no messages.
The intervention will last for 12 months.
Control group
Active

Outcomes
Primary outcome [1] 1305 0
Significantly increased self reported (and validated by contacting doctor) chlamydia testing during the intervention period in participants receiving the intervention
Timepoint [1] 1305 0
Secondary outcome [1] 2337 0
Significantly increased self reported condom use with casual or new partners during the intervention period in participants receiving the intervention.
Timepoint [1] 2337 0
Secondary outcome [2] 2338 0
Significantly increased rate of primary health care attendance for contraception advice on the part of female participants receiving the intervention.
Timepoint [2] 2338 0

Eligibility
Key inclusion criteria
Sufficient English speaking ability, own a mobile phone, have an email address and internet access, Victorian resident.
Minimum age
16 Years
Maximum age
29 Years
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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
random computer number generation
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
Not yet recruiting
Date of first participant enrolment
Anticipated
29/01/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
340
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1080 0
Government body
Name [1] 1080 0
AUSTRALIAN HEALTH MINISTERS ADVISORY COUNCIL
Country [1] 1080 0
Australia
Primary sponsor type
Other
Name
Macfarlane Burnet Institute for Medical Research and Public Health
Address
Country
Australia
Secondary sponsor category [1] 941 0
Government body
Name [1] 941 0
Melbourne Sexual Health Centre, Family Planning Victoria
Address [1] 941 0
Country [1] 941 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2383 0
Burnet Institute
Ethics committee address [1] 2383 0
Ethics committee country [1] 2383 0
Australia
Date submitted for ethics approval [1] 2383 0
Approval date [1] 2383 0
Ethics approval number [1] 2383 0

Summary
Brief summary
Australia has rising numbers of sexually transmissible infections, high levels of unprotected sex among young adults & a high teenage abortion rate. To address these public health priorities, we will use mobile phone text messaging (aka SMS) & email to send sexual health & contraception information to young men & women. A randomised controlled trial of the impact of text & email messages on sexual risk-taking will enable rigorous analysis of their efficacy and cost-effectiveness, & provide valuable data about how these cheap technologies could be used on a larger scale.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35582 0
Address 35582 0
Country 35582 0
Phone 35582 0
Fax 35582 0
Email 35582 0
Contact person for public queries
Name 9957 0
Megan Lim
Address 9957 0
Macfarlane Burnet Institute for Medical Research and Public Health
Centre for Epidemiology and Population Health
GPO Box 2284
Melbourne VIC 3001
Country 9957 0
Australia
Phone 9957 0
+61 3 92822188
Fax 9957 0
+61 3 92822138
Email 9957 0
[email protected]
Contact person for scientific queries
Name 885 0
Megan Lim
Address 885 0
Macfarlane Burnet Institute for Medical Research and Public Health
Centre for Epidemiology and Population Health
GPO Box 2284
Melbourne VIC 3001
Country 885 0
Australia
Phone 885 0
+61 3 92822188
Fax 885 0
+61 3 92822138
Email 885 0
[email protected]

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.