Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000036213
Ethics application status
Approved
Date submitted
15/10/2007
Date registered
19/01/2009
Date last updated
19/01/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Randomised controlled trial of paper, online and text message diaries for sexual health data collection from young people
Scientific title
Randomised controlled trial of paper, online and text message diaries for sexual health data collection from young people
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
sexual health 2461 0
Condition category
Condition code
Public Health 2560 2560 0 0
Epidemiology

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Three methodologies of collecting sexual health data in the form of a diary are being compared - paper based, online, SMS (text message). Each will complete diaries weekly for 3 months (13 weeks).
Intervention code [1] 2188 0
Not applicable
Comparator / control treatment
There are 3 different study arms, as described above.
Control group
Active

Outcomes
Primary outcome [1] 3466 0
The number of diaries submitted by participants of the 13 expected (response rate) and completeness of all questions in each diary as determined by whether or not each question was answered.
Timepoint [1] 3466 0
3 months
Secondary outcome [1] 5782 0
Participants acceptability and opinions of diary use determined by a questionnaire giving a range of statements about the diaries for example "the diaries were easy to complete" "the diaries were convenient" which can be rated between strongly disagree and strongly agree
Timepoint [1] 5782 0
3 months
Secondary outcome [2] 8706 0
Comparability and reliability of diary information to endpoint questionnaire. Determined by total number of partners, frequency of sex and frequency of condom use, over the sum of the diary period, correlated (using kendall tau) to the total number of partners, frequency of sex and frequency of condom use reported in the retrospective questionnaire (at the endpoint of the study, i.e. 3 months after baseline)
Timepoint [2] 8706 0
3 months

Eligibility
Key inclusion criteria
Age 16-29
English language
Valid mobile phone and email
Self perception of being likely to have sexual intercourse in the 3 month study period
Minimum age
16 Years
Maximum age
29 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Age not 16-29
English language not spoken
No valid mobile phone and email
Self perception of being unlikely to have sexual intercourse in the 3 month study period

Study design
Purpose
Psychosocial
Duration
Longitudinal
Selection
Convenience sample
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/01/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2705 0
Self funded/Unfunded
Name [1] 2705 0
Country [1] 2705 0
Primary sponsor type
Other
Name
Burnet Institute
Address
85 Commercial Rd
Melbourne 3004
Country
Australia
Secondary sponsor category [1] 2450 0
University
Name [1] 2450 0
Monash University
Address [1] 2450 0
83 Commercial Rd
Melbourne 3004
Country [1] 2450 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4624 0
Victorian Department of Human Services HREC
Ethics committee address [1] 4624 0
Ethics committee country [1] 4624 0
Australia
Date submitted for ethics approval [1] 4624 0
18/09/2007
Approval date [1] 4624 0
Ethics approval number [1] 4624 0
91/07

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

Contacts
Principal investigator
Name 28116 0
Address 28116 0
Country 28116 0
Phone 28116 0
Fax 28116 0
Email 28116 0
Contact person for public queries
Name 11273 0
Megan Lim
Address 11273 0
Burnet Institute
85 Commercial Rd
Melbourne 3004
Country 11273 0
Australia
Phone 11273 0
+61 3 92822188
Fax 11273 0
Email 11273 0
[email protected]
Contact person for scientific queries
Name 2201 0
Megan Lim
Address 2201 0
Burnet Institute
85 Commercial Rd
Melbourne 3004
Country 2201 0
Australia
Phone 2201 0
+61 3 92822188
Fax 2201 0
Email 2201 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.