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
Recruitment status was Recruiting
Sponsor:
Centre hospitalier de l'Université de Montréal (CHUM)
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
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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:
- 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
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
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 March 02, 2015