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History of Changes for Study: NCT01726153
A Pilot Trial of an Individualized Web-Based Condom Use Intervention
Latest version (submitted July 22, 2020) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 November 9, 2012 None (earliest Version on record)
2 July 22, 2020 Recruitment Status, Study Status, Sponsor/Collaborators, Contacts/Locations and Study Design
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Study NCT01726153
Submitted Date:  November 9, 2012 (v1)

Open or close this module Study Identification
Unique Protocol ID: R0018767
Brief Title: A Pilot Trial of an Individualized Web-Based Condom Use Intervention
Official Title: A Pilot Randomized Control Trial (RCT) of an Individualized Condom-HIM Web-based Intervention for Condom USe Among HIV+ Gay Males
Secondary IDs:
Open or close this module Study Status
Record Verification: November 2012
Overall Status: Recruiting
Study Start: November 2012
Primary Completion: November 2013 [Anticipated]
Study Completion: November 2013 [Anticipated]
First Submitted: November 6, 2012
First Submitted that
Met QC Criteria:
November 9, 2012
First Posted: November 14, 2012 [Estimate]
Last Update Submitted that
Met QC Criteria:
November 9, 2012
Last Update Posted: November 14, 2012 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Responsible Party: Principal Investigator
Investigator: Joyal Miranda
Official Title: Assistant Professor
Affiliation: Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
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:
Open or close this module Conditions
Conditions: HIV
Keywords: Condom Use
HIV+ gay males
Intervention
Tailored
On-line
Internet
Web-based
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Prevention
Study Phase: Early Phase 1
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 60 [Anticipated]
Open or close this module Arms and Interventions
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.
Open or close this module Outcome Measures
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 ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: Male
Gender Based:
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:

-

Open or close this module Contacts/Locations
Central Contact Person: Joyal Miranda, PhD
Telephone: 416-979-5000 Ext. 7850
Email: joyal.miranda@ryerson.ca
Study Officials: Joyal Miranda, PhD
Principal Investigator
Ryerson University and Centre hospitalier de l'Universite de Montreal (CHUM)
Locations: Canada, Ontario
Ryerson University
[Recruiting]
Toronto, Ontario, Canada, M5B 2K3
Contact:Contact: Joyal Miranda, PhD 416-979-5000 Ext. 7850 joyal.miranda@ryerson.ca
Contact:Principal Investigator: Joyal Miranda, PhD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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