NCT01726153

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at below P25 for not_applicable hiv

Timeline
Completed

Started Nov 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

November 6, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 14, 2012

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

July 24, 2020

Status Verified

November 1, 2012

Enrollment Period

1 year

First QC Date

November 6, 2012

Last Update Submit

July 22, 2020

Conditions

Keywords

Condom UseHIV+ gay malesInterventionTailoredOn-lineInternetWeb-based

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline in participants self-efficacy in condom use at 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.

    baseline and 2-weeks post intervention

Secondary Outcomes (1)

  • Change from Baseline in participants intention to use condoms at 2-weeks post-intervention

    Baseline and 2-weeks post intervention

Other Outcomes (1)

  • Change from Baseline in participants condom use at 2-weeks post-intervention Condom Use

    baseline and 2-weeks post intervention

Study Arms (2)

Web sites

NO INTERVENTION

Individuals assigned to this arm are given a list of websites where they can view additional information relating to condom use.

Condom-HIM

EXPERIMENTAL

Individuals assigned to this arm must follow an on-line one session tailored intervention.

Behavioral: Condom-HIM

Interventions

Condom-HIMBEHAVIORAL

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.

Condom-HIM

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ryerson University

Toronto, Ontario, M5B 2K3, Canada

Location

Related Publications (1)

  • Miranda J, Cote J, Godin G, Blais M, Otis J, Gueheneuc 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.

Study Officials

  • Joyal Miranda, PhD

    Ryerson University and Centre hospitalier de l'Universite de Montreal (CHUM)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2012

First Posted

November 14, 2012

Study Start

November 1, 2012

Primary Completion

November 1, 2013

Study Completion

November 1, 2014

Last Updated

July 24, 2020

Record last verified: 2012-11

Locations