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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01726153
Recruitment Status : Completed
First Posted : November 14, 2012
Last Update Posted : July 24, 2020
Sponsor:
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual 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
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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.




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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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:

-


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


Locations
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Canada, Ontario
Ryerson University
Toronto, Ontario, Canada, M5B 2K3
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Investigators
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Principal Investigator: Joyal Miranda, PhD Ryerson University and Centre hospitalier de l'Universite de Montreal (CHUM)
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT01726153    
Other Study ID Numbers: R0018767
First Posted: November 14, 2012    Key Record Dates
Last Update Posted: July 24, 2020
Last Verified: November 2012
Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM):
Condom Use
HIV+ gay males
Intervention
Tailored
On-line
Internet
Web-based