HIVNCT01926418
Using Implementation Intentions to Increase Safe Sex Practices in MSM
A study testing Planning tasks in people with HIV and Sex, run by University of Sydney at 1 site in Australia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- What is being tested?
- Planning tasks
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteAustralia
- Study dates
- Nov 2013to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men who have sex with men
- Adults (over 18 years old)
- Sexually active
Who cannot join
- Women
- Minors (under 18 years old)
- Those who have never been sexually active
- Those unable to provide consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using Implementation Intentions to Increase Safe Sex Practices Among and Australian Sample of Men Who Have Sex With Men
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.
Read the 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.
- Being tested
- Planning tasks
- Keywords
- HIV, Condoms, Men who have sex with men, implementation intentions, executive function
- Medical subject headings
- Coitus, Homosexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Planning tasksBehavioural
Also called implementation intentions, executive function training
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | The control group receives the TPB questionnaires but receives no intervention |
| Implementation intentions | Experimental | 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. Receives: Behavioral: Planning tasks |
| Planning task | Experimental | Participants will be asked to practice the Tower of Hanoi task four times per week for ten to fifteen minutes. Receives: Behavioral: Planning tasks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self reports of anal sex with and without condoms
Measured: 3 months
Secondary outcomes (1)
Variables in the Theory of Planned Behaviour: attitude, subjective norm, perceived behavioural control, and intention
Measured: at baseline and 3 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2013 (estimated)
- Study startNov 2013
- Primary completionJul 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sydney
- Sponsor type
- University, hospital or other
- Collaborators
- The Albion Centre - South Eastern Sydney Local Health District
- Responsible party
- Principal investigator, Ben Andrew, University of Sydney
- Investigators
- Barbara Mullan, PhD, Principal investigator, University of SydneyBenjamin J. Andrew, DCP/Msc, Principal investigator, University of SydneyJohn de Wit, PhD, Principal investigator, National Center in HIV Social ResearchKim Begley, PhD, Principal investigator, The Albion Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01926418
- Sponsor's protocol ID
- USydney
- Status last verified
- Aug 2013
- First submitted
- 17 Aug 2013
- Last updated
- 20 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Implementation Intentions to Increase Safe Sex Practices Among and Australian Sample of Men Who Have Sex With Men
- ClinicalTrials.gov ID
- NCT01926418
- Acronym / sponsor ID
- USydney
- Keywords
- HIV, Condoms, Men who have sex with men, implementation intentions, executive function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University of SydneyUniversity, hospital or other
- Collaborators
- The Albion Centre - South Eastern Sydney Local Health District
- Study start
- Nov 2013
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 20 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –The control group receives the TPB questionnaires but receives no intervention |
| Implementation intentions | Experimental | Behavioral: Planning tasksParticipants 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. |
| Planning task | Experimental | Behavioral: Planning tasksParticipants will be asked to practice the Tower of Hanoi task four times per week for ten to fifteen minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men who have sex with men
- Adults (over 18 years old)
- Sexually active
Key exclusion criteria (4 listed)
- Women
- Minors (under 18 years old)
- Those who have never been sexually active
- Those unable to provide consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Planning tasksAlso: implementation intentions, executive function trainingImplementation 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. | Behavioural | Implementation intentions, Planning task |
Primary outcome
Self reports of anal sex with and without condoms
Time frame: 3 months
1 secondary outcome
Variables in the Theory of Planned Behaviour: attitude, subjective norm, perceived behavioural control, and intention
Time frame: at baseline and 3 months later
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara Mullan, PhD principal investigator
University of Sydney
Benjamin J. Andrew, DCP/Msc principal investigator
University of Sydney
John de Wit, PhD principal investigator
National Center in HIV Social Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Planning tasks in people with HIV and Sex, run by University of Sydney at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Benjamin J. Andrew, DCP/MSc (+61 414416906, band3675@uni.sydney.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self reports of anal sex with and without condoms (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2013.