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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 : 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)

Tracking Information
First Submitted Date  ICMJE November 6, 2012
First Posted Date  ICMJE November 14, 2012
Last Update Posted Date July 24, 2020
Study Start Date  ICMJE November 2012
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 9, 2012)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 9, 2012)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: November 9, 2012)
Change from Baseline in participants condom use at 2-weeks post-intervention Condom Use [ Time Frame: baseline and 2-weeks post intervention ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Pilot Trial of an Individualized Web-Based Condom Use Intervention
Official Title  ICMJE A Pilot Randomized Control Trial (RCT) of an Individualized Condom-HIM Web-based Intervention for Condom USe Among HIV+ Gay Males
Brief Summary The purpose of this study is to evaluate the efficacy of an online intervention in increasing condom use among HIV+ gay males.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE HIV
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Condom-HIM
Publications * Miranda J, Côté J, Godin G, Blais M, Otis J, Guéhéneuc YG, Fadel G, Barton L, Fowler S. An Internet-Based Intervention (Condom-Him) to Increase Condom Use Among HIV-Positive Men Who Have Sex With Men: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2013 Oct 16;2(2):e39. doi: 10.2196/resprot.2723.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 9, 2012)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2014
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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:

-

Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01726153
Other Study ID Numbers  ICMJE R0018767
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Centre hospitalier de l'Université de Montréal (CHUM)
Original Responsible Party Joyal Miranda, Centre hospitalier de l'Université de Montréal (CHUM), Assistant Professor
Current Study Sponsor  ICMJE Centre hospitalier de l'Université de Montréal (CHUM)
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Joyal Miranda, PhD Ryerson University and Centre hospitalier de l'Universite de Montreal (CHUM)
PRS Account Centre hospitalier de l'Université de Montréal (CHUM)
Verification Date November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP