- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01926418
Using Implementation Intentions to Increase Safe Sex Practices in MSM
Using Implementation Intentions to Increase Safe Sex Practices Among and Australian Sample of Men Who Have Sex With Men
Study Overview
Detailed Description
The purpose of this study is two-fold. The first part of the study aims to assess the validity of a theory of health behaviour, known as the Theory of Planned Behaviour (TPB) in predicting condom use in and Australian sample of men who have sex with men (MSM). The TPB states that a person's intention to use condoms is the best predictor of their actual condom use behaviour. The TPB indicates that intention is predicted by an individual's attitude towards condom use, whether they believe their family and friends feel that they should use condoms (known as "subjective norm"), and how much control the person feels that they have over condom use (known as perceived behavioral control). In order to measure this, participants will be asked to complete questions regarding their attitudes, subjective norm, perceived behavioral control, intention towards condom use, and actual condom use behavior. It is expected that the TPB will be successful in predicting condom use in this population.
The second part of the study aims to assess whether two different interventions are effective in increasing condom use among men who have sex with men (MSM).
The first intervention is known as "implementation intentions" and asks that participants specify when, where and how they might increase their condom use in the future (e.g. by buying condoms). It is predicted that in making this plan that the likelihood of preparing to use condoms will increase as will actual condom use.
The second intervention asks participants to practice a task several times per week that is thought to improve planning ability. The task is known as "The Tower of Hanoi" which is a computer based program that requires participants to shift discs across three different pegs in and ordered and planned way. It is thought that this practice can improve an individual's planning ability. It is thought that this planning ability may then generalise to other tasks such as planning to use condoms. It is predicted that this intervention will increase actual condom use among this population.
A control group that receives no intervention will also be employed.
Measures of the TPB will be taken at baseline and three months after the interventions have taken place to assess any changes to the variables thought to predict condom use, and any changes in condom use behavior. It is expected that the the TPB variables will all increase in the intervention groups.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New South Wales
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Sydney, New South Wales, Australia, 2010
- The Albion Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Men who have sex with men
- Adults (over 18 years old)
- Sexually active
Exclusion Criteria:
- Women
- Minors (under 18 years old)
- Those who have never been sexually active
- Those unable to provide consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
NO_INTERVENTION: Control
The control group receives the TPB questionnaires but receives no intervention
|
|
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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.
|
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.
Other Names:
|
|
EXPERIMENTAL: Planning task
Participants will be asked to practice the Tower of Hanoi task four times per week for ten to fifteen minutes.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Self reports of anal sex with and without condoms
Time Frame: 3 months
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Variables in the Theory of Planned Behaviour: attitude, subjective norm, perceived behavioural control, and intention
Time Frame: at baseline and 3 months later
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at baseline and 3 months later
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Barbara Mullan, PhD, University of Sydney
- Principal Investigator: Benjamin J. Andrew, DCP/Msc, University of Sydney
- Principal Investigator: John de Wit, PhD, National Center in HIV Social Research
- Principal Investigator: Kim Begley, PhD, The Albion Center
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- USydney
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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