Using Implementation Intentions to Increase Safe Sex Practices in MSM

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2013 by University of Sydney
Sponsor:
Collaborator:
The Albion Centre - South Eastern Sydney Local Health District
Information provided by (Responsible Party):
Ben Andrew, University of Sydney
ClinicalTrials.gov Identifier:
NCT01926418
First received: August 17, 2013
Last updated: August 19, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
HIV
Sex
Behavioral: Planning tasks

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Using Implementation Intentions to Increase Safe Sex Practices Among and Australian Sample of Men Who Have Sex With Men

Resource links provided by NLM:


Further study details as provided by University of Sydney:

Primary Outcome Measures:
  • Self reports of anal sex with and without condoms [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Variables in the Theory of Planned Behaviour: attitude, subjective norm, perceived behavioural control, and intention [ Time Frame: at baseline and 3 months later ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
Study Start Date: November 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

Other Names:
  • implementation intentions
  • executive function training
Experimental: Planning task
Participants will be asked to practice the Tower of Hanoi task four times per week for ten to fifteen minutes.
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.

Other Names:
  • implementation intentions
  • executive function training

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01926418

Contacts
Contact: Benjamin J. Andrew, DCP/MSc +61 414416906 band3675@uni.sydney.edu.au
Contact: Barbara Mullan, PhD +61 2 9351 6811 barbara.mullan@sydney.edu.au

Locations
Australia, New South Wales
The Albion Center
Sydney, New South Wales, Australia, 2010
Sponsors and Collaborators
University of Sydney
The Albion Centre - South Eastern Sydney Local Health District
Investigators
Principal Investigator: Barbara Mullan, PhD The University of Sydney
Principal Investigator: Benjamin J. Andrew, DCP/Msc The University of Sydney
Principal Investigator: John de Wit, PhD National Center in HIV Social Research
Principal Investigator: Kim Begley, PhD The Albion Center
  More Information

No publications provided

Responsible Party: Ben Andrew, Mr, University of Sydney
ClinicalTrials.gov Identifier: NCT01926418     History of Changes
Other Study ID Numbers: USydney
Study First Received: August 17, 2013
Last Updated: August 19, 2013
Health Authority: Australia: School of Psychology, The University of Sydney

Keywords provided by University of Sydney:
HIV
Condoms
Men who have sex with men
implementation intentions
executive function

ClinicalTrials.gov processed this record on July 28, 2014