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A Pilot Trial of an Individualized Web-Based Condom Use Intervention

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ClinicalTrials.gov Identifier: NCT01726153
Recruitment Status : Unknown
Verified November 2012 by Joyal Miranda, Centre hospitalier de l'Université de Montréal (CHUM).
Recruitment status was:  Recruiting
First Posted : November 14, 2012
Last Update Posted : November 14, 2012
Sponsor:
Information provided by (Responsible Party):
Joyal Miranda, Centre hospitalier de l'Université de Montréal (CHUM)

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study is to evaluate the efficacy of an online intervention in increasing condom use among HIV+ gay males.

Condition or disease Intervention/treatment Phase
HIV Behavioral: Condom-HIM Early Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Pilot Randomized Control Trial (RCT) of an Individualized Condom-HIM Web-based Intervention for Condom USe Among HIV+ Gay Males
Study Start Date : November 2012
Estimated Primary Completion Date : November 2013
Estimated Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
No Intervention: Web sites
Individuals assigned to this arm are given a list of websites where they can view additional information relating to condom use.
Experimental: Condom-HIM
Individuals assigned to this arm must follow an on-line one session tailored intervention.
 Behavioral: Condom-HIM
The tailored on-line Condom-HIM intervention is composed of a single session involving activities to increase individuals self-efficacy and intention to use condoms.


Outcome Measures
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Primary Outcome Measures :
  1. Change from Baseline in participants self-efficacy in condom use at 2-weeks post-intervention [ Time Frame: baseline and 2-weeks post intervention ]
    The Self-Efficacy for condom use measure contains a set of items to rate participant's belief that they will be able to use condoms every time they have anal sex in a variety of situations. A four-point response scale, ranging from 'strongly agree' (0) to 'strongly disagree' (4) is used. The psychometric properties of the measure have been examined and have been shown to have good internal consistency with Cronbach's alpha coefficient of 0.96.


Secondary Outcome Measures :
  1. Change from Baseline in participants intention to use condoms at 2-weeks post-intervention [ Time Frame: Baseline and 2-weeks post intervention ]
    The intention to use condoms measure asks participants their intention to consistently use condoms. The psychometric properties of the measure have been examined and have shown to have good internal consistency with Cronbach's alpha coefficient of 0.89.


Other Outcome Measures:
  1. Change from Baseline in participants condom use at 2-weeks post-intervention Condom Use [ Time Frame: baseline and 2-weeks post intervention ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. are HIV-seropositive,
  2. Men who are having sex with men,
  3. engaging in unprotected anal intercourse with a partner who is serostatus negative or unknown
  4. age 18 years and older,
  5. ability to read English
  6. have access to a computer and internet.

Exclusion Criteria:

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01726153


Contacts
Contact: Joyal Miranda, PhD 416-979-5000 ext 7850 joyal.miranda@ryerson.ca

Locations
Canada, Ontario
Ryerson University Recruiting
Toronto, Ontario, Canada, M5B 2K3
Contact: Joyal Miranda, PhD    416-979-5000 ext 7850    joyal.miranda@ryerson.ca   
Principal Investigator: Joyal Miranda, PhD         
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Investigators
Principal Investigator: Joyal Miranda, PhD Ryerson University and Centre hospitalier de l'Universite de Montreal (CHUM)
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Joyal Miranda, Assistant Professor, Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT01726153     History of Changes
Other Study ID Numbers: R0018767
First Posted: November 14, 2012    Key Record Dates
Last Update Posted: November 14, 2012
Last Verified: November 2012

Keywords provided by Joyal Miranda, Centre hospitalier de l'Université de Montréal (CHUM):
Condom Use
HIV+ gay males
Intervention
Tailored
 On-line
Internet
Web-based