Using Implementation Intentions to Increase Safe Sex Practices in MSM

HIV Clinical Trial

Official title:

Using Implementation Intentions to Increase Safe Sex Practices Among and Australian Sample of Men Who Have Sex With Men

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01926418
• Other study ID #: USydney
• Status: Not yet recruiting
• Phase: N/A
• First received: August 17, 2013
• Last updated: August 19, 2013
• Start date: November 2013
• Est. completion date: December 2014

Study information

• Verified date: August 2013
• Source: University of Sydney
• Contact: Benjamin J. Andrew, DCP/MSc
• Phone: +61 414416906
• Email: band3675[@]uni.sydney.edu.au
• Is FDA regulated: No
• Health authority: Australia: School of Psychology, The University of Sydney
• Study type: Interventional

Clinical 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 Hanoi", in increasing condom use in this population.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: December 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV
• Sex

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Australia	The Albion Center	Sydney	New South Wales

Sponsors (2)

Lead Sponsor	Collaborator
University of Sydney	The Albion Centre - South Eastern Sydney Local Health District

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self reports of anal sex with and without condoms		3 months	No
Secondary	Variables in the Theory of Planned Behaviour: attitude, subjective norm, perceived behavioural control, and intention		at baseline and 3 months later	No