Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000459820
Ethics application status
Approved
Date submitted
24/04/2012
Date registered
24/04/2012
Date last updated
27/02/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Web-based Personal Health Management System to Promote Sexually Transmissible Infections (STI) screening
Scientific title
A randomised controlled trial to assess the effectiveness of a web-based personal health management system in increasing the uptake of Sexually Transmissible Infections (STI) screening and engagement with health services for sexual health concerns in young people.
Secondary ID [1] 280383 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Uptake of Sexually Transmissible Infections (STI) screening in young people aged 18-29 286362 0
Condition category
Condition code
Public Health 286604 286604 0 0
Health service research
Public Health 286605 286605 0 0
Health promotion/education
Infection 286606 286606 0 0
Sexually transmitted infections

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
* healthy.me is an online system developed at the Centre for Health Informatics, University of New South Wales, Sydney, Australia. It contains information about sexual health and STI screening; an online tool for consumers to book an appointment at the University Health Service for sexual health concerns or STI screening; and an online personal health record for participants to record their appointments, medications and other health-related information. * All participants are required to complete a 5-minute mandatory online tutorial about the healthy.me system before commencing the study. * Following completion of the online tutorial, the frequency in which the healthy.me system will be used is at the discretion of the participants. * Duration of study is expected to be 3-6 months. Period of access to the website will vary depending on date of participant enrolment.
Intervention code [1] 284746 0
Early detection / Screening
Intervention code [2] 284747 0
Behaviour
Intervention code [3] 284748 0
Prevention
Comparator / control treatment
Participants in the control group receive access to the healthy.me system and delayed access to the sexual health content on healthy.me by approximately 3 months.
Control group
Active

Outcomes
Primary outcome [1] 287020 0
Primary Outcome 1: number of participants who receive testing for sexually transmitted infections during the study period.
Timepoint [1] 287020 0
Timepoint: Study completion (measured via self-reports and, potentially, de-identified clinical audit)
Secondary outcome [1] 297217 0
Secondary Outcome 1: number of participants who access health services for sexual health concerns during the study period.
Timepoint [1] 297217 0
Timepoint: Study completion (measured via self-reports and, potentially, de-identified clinical audit)
Secondary outcome [2] 297218 0
Secondary Outcome 2: number of participants who experience a change in their perceptions, attitudes or readiness regarding screening for sexually transmitted infections during the study period.
Timepoint [2] 297218 0
Timepoint: Study completion (measured via self-reports)
Secondary outcome [3] 297219 0
Secondary Outcome 3: patterns of usage of healthy.me (e.g. number and timing of enquiries, duration of interactive sessions, uptake of specific functions, such as accessing online information, posting on the forum, appointment booking function, and other personal health record functions).
Timepoint [3] 297219 0
Timepoint: Study completion (measured via system logs)

Eligibility
Key inclusion criteria
1. Aged 18-29
2. Access to the Internet and email on a monthly basis
Minimum age
18 Years
Maximum age
29 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
nil

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)
* The intervention will not modify in any way the standard procedures of healthcare provision by the University Health Service
* Interested healthcare consumers are directed to a website with detailed information about the study, where they can provide consent and self-enrol into the study online. * Allocation to control or intervention group will be concealed according to a computer generated block randomization list. (Investigators will be blinded in the group allocation process).
* The randomization sequence generation, participant recruitment and the group allocation processes in this study are computerised and do not involve human interventions from the investigators.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
* Eligible healthcare consumers are randomly assigned to the intervention or control group using a computer generated random number sequence in randomly assigned blocks with intervention allocation ratio of 1:1.
* The block randomisation sequence is pre-generated using a computerized random-number generator before commencing participant recruitment. * For each level of strata, a random sequence of study group allocations is generated and each level of strata is numbered consecutively.
* As each consumer completes the online study enrolment process, he/she receives the next consecutive number in his or her stratum, which automatically assigns the consumer to the intervention or control group without additional intervention from the investigators.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
8/03/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
360
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285152 0
University
Name [1] 285152 0
Centre for Health Informatics
Country [1] 285152 0
Australia
Primary sponsor type
University
Name
Centre for Health Informatics
Address
Centre for Health Informatics, Australian Institute of Health Innovation, University of New South Wales, UNSW Sydney NSW 2052, Australia
Country
Australia
Secondary sponsor category [1] 284014 0
None
Name [1] 284014 0
Address [1] 284014 0
Country [1] 284014 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287168 0
University of New South Wales (UNSW) Human Research Ethics Committee (HREC)
Ethics committee address [1] 287168 0
Ethics committee country [1] 287168 0
Australia
Date submitted for ethics approval [1] 287168 0
Approval date [1] 287168 0
10/05/2010
Ethics approval number [1] 287168 0
10109

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34104 0
Prof Enrico Coiera
Address 34104 0
Centre for Health Informatics, Australian Institute of Health Innovation, University of New South Wales, UNSW Sydney NSW 2052, Australia
Country 34104 0
Australia
Phone 34104 0
+61 2 9385 3586
Fax 34104 0
+61 2 9385 8692
Email 34104 0
[email protected]
Contact person for public queries
Name 17351 0
Nathan Mortimer
Address 17351 0
Centre for Health Informatics, Australian Institute of Health Innovation, University of New South Wales, UNSW Sydney NSW 2052, Australia
Country 17351 0
Australia
Phone 17351 0
+61 4 3962 7051
Fax 17351 0
nil
Email 17351 0
[email protected]
Contact person for scientific queries
Name 8279 0
Annie Lau
Address 8279 0
Centre for Health Informatics, Australian Institute of Health Innovation, University of New South Wales, UNSW Sydney NSW 2052, Australia
Country 8279 0
Australia
Phone 8279 0
+ 61 2 9385 8891
Fax 8279 0
+ 61 2 9385 8692
Email 8279 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.