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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified November 2012 by Joyal Miranda, Centre hospitalier de l'Université de Montréal (CHUM).
Recruitment status was: Recruiting

Sponsor:

ClinicalTrials.gov Identifier:

NCT01726153

First Posted: November 14, 2012

Last Update Posted: November 14, 2012

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.

Information provided by (Responsible Party):

Joyal Miranda, Centre hospitalier de l'Université de Montréal (CHUM)

Purpose

The purpose of this study is to evaluate the efficacy of an online intervention in increasing condom use among HIV+ gay males.

Condition	Intervention	Phase
HIV	Behavioral: Condom-HIM	Early Phase 1


Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by Joyal Miranda, Centre hospitalier de l'Université de Montréal (CHUM):

Primary Outcome Measures:

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:

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:

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


Estimated Enrollment:	60
Study Start Date:	November 2012
Estimated Study Completion Date:	November 2013
Estimated Primary Completion Date:	November 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Eligibility

Information from the National Library of Medicine

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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:

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:

Contacts and Locations

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

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

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.


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 Submitted:	November 6, 2012
First Posted:	November 14, 2012
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

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