Clinical trial NCT01926418: Using Implementation Intentions to Increase Safe Sex Practices in MSM
Official title: Using Implementation Intentions to Increase Safe Sex Practices Among and Australian Sample of Men Who Have Sex With Men
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HIV
Sex
Keywords: HIV
Condoms
Men who have sex with men
implementation intentions
executive function
Lead sponsor: University of Sydney
Sponsor class: OTHER
Collaborators: name: The Albion Centre - South Eastern Sydney Local Health District
First posted: 2013-08-20
Enrollment: 180
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Self reports of anal sex with and without condoms
timeFrame: 3 months
Secondary outcomes:
measure: Variables in the Theory of Planned Behaviour: attitude, subjective norm, perceived behavioural control, and intention
timeFrame: at baseline and 3 months later
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: The Albion Center
state: New South Wales
Study officials:
affiliation: University of Sydney
name: Barbara Mullan, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sydney
name: Benjamin J. Andrew, DCP/Msc
role: PRINCIPAL_INVESTIGATOR
affiliation: National Center in HIV Social Research
name: John de Wit, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Albion Center
name: Kim Begley, PhD
role: PRINCIPAL_INVESTIGATOR
References: