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

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.
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Experimental: Condom-HIM
Individuals assigned to this arm must follow an on-line one session tailored intervention.
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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.
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- 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.
- 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.
- Change from Baseline in participants condom use at 2-weeks post-intervention Condom Use [ Time Frame: baseline and 2-weeks post intervention ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- are HIV-seropositive,
- Men who are having sex with men,
- engaging in unprotected anal intercourse with a partner who is serostatus negative or unknown
- age 18 years and older,
- ability to read English
- have access to a computer and internet.
Exclusion Criteria:

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