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Trial record 18 of 27 for:    " October 31, 2012":" November 30, 2012"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2012 by Centre hospitalier de l'Université de Montréal (CHUM).
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Joyal Miranda, Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier:
NCT01726153
First received: November 6, 2012
Last updated: November 9, 2012
Last verified: November 2012
  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
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:


Further study details as provided by 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: November 6, 2012
Last Updated: November 9, 2012
Health Authority: Canada: Ethics Review Committee

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

ClinicalTrials.gov processed this record on November 25, 2014