NCT01926418

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P25-P50 for not_applicable hiv

Timeline
Completed

Started Nov 2013

Shorter than P25 for not_applicable hiv

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 20, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

August 20, 2013

Status Verified

August 1, 2013

Enrollment Period

8 months

First QC Date

August 17, 2013

Last Update Submit

August 19, 2013

Conditions

Keywords

HIVCondomsMen who have sex with menimplementation intentionsexecutive function

Outcome Measures

Primary Outcomes (1)

  • Self reports of anal sex with and without condoms

    3 months

Secondary Outcomes (1)

  • Variables in the Theory of Planned Behaviour: attitude, subjective norm, perceived behavioural control, and intention

    at baseline and 3 months later

Study Arms (3)

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.

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.

Behavioral: Planning tasks

Interventions

Planning tasksBEHAVIORAL

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.

Also known as: implementation intentions, executive function training
Implementation intentionsPlanning task

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men who have sex with men
  • Adults (over 18 years old)
  • Sexually active

You may not qualify if:

  • Women
  • Minors (under 18 years old)
  • Those who have never been sexually active
  • Those unable to provide consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Albion Center

Sydney, New South Wales, 2010, Australia

Location

MeSH Terms

Conditions

CoitusHomosexuality

Condition Hierarchy (Ancestors)

Sexual BehaviorBehaviorSexuality

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Benjamin J. Andrew, DCP/MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mr

Study Record Dates

First Submitted

August 17, 2013

First Posted

August 20, 2013

Study Start

November 1, 2013

Primary Completion

July 1, 2014

Study Completion

December 1, 2014

Last Updated

August 20, 2013

Record last verified: 2013-08

Locations