Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01926418




Registration number
NCT01926418
Ethics application status
Date submitted
17/08/2013
Date registered
20/08/2013
Date last updated
20/08/2013

Titles & IDs
Public title
Using Implementation Intentions to Increase Safe Sex Practices in MSM
Scientific title
Using Implementation Intentions to Increase Safe Sex Practices Among and Australian Sample of Men Who Have Sex With Men
Secondary ID [1] 0 0
USydney
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV 0 0
Sex 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Behaviour - Planning tasks

No Intervention: Control - The control group receives the TPB questionnaires but receives no intervention

Experimental: Implementation intentions - Participants are asked to specify when, where and how they will use condoms in the future. They will be sent weekly email reminders of their implementation intentions.

Experimental: Planning task - Participants will be asked to practice the Tower of Hanoi task four times per week for ten to fifteen minutes.


Behaviour: Planning tasks
Implementation intentions: Participants are asked to specify when, where and how they plan to use condoms in the future.
Executive function training aims to improve planning ability and therefore aims to increase condom use planning.
Intervention code [1] 0 0
Behaviour
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Self reports of anal sex with and without condoms
Timepoint [1] 0 0
3 months
Secondary outcome [1] 0 0
Variables in the Theory of Planned Behaviour: attitude, subjective norm, perceived behavioural control, and intention
Timepoint [1] 0 0
at baseline and 3 months later

Eligibility
Key inclusion criteria
- Men who have sex with men

- Adults (over 18 years old)

- Sexually active
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Women

- Minors (under 18 years old)

- Those who have never been sexually active

- Those unable to provide consent

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)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2014
Actual
Sample size
Target
180
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
The Albion Center - Sydney
Recruitment postcode(s) [1] 0 0
2010 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
University of Sydney
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The Albion Centre - South Eastern Sydney Local Health District
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to assess the utility of the Theory of Planned Behavior in
predicting condom use among men who have sex with men. It also aims to assess the utility of
two interventions, one known as "implementation intentions", the other involves the practice
of a planning task known as "the tower of Hanoi", in increasing condom use in this
population.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01926418
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Barbara Mullan, PhD
Address 0 0
University of Sydney
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Benjamin J. Andrew, DCP/MSc
Address 0 0
Country 0 0
Phone 0 0
+61 414416906
Fax 0 0
Email 0 0
band3675@uni.sydney.edu.au
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01926418