<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01726153</url>
  </required_header>
  <id_info>
    <org_study_id>R0018767</org_study_id>
    <nct_id>NCT01726153</nct_id>
  </id_info>
  <brief_title>A Pilot Trial of an Individualized Web-Based Condom Use Intervention</brief_title>
  <official_title>A Pilot Randomized Control Trial (RCT) of an Individualized Condom-HIM Web-based Intervention for Condom USe Among HIV+ Gay Males</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre hospitalier de l'Université de Montréal (CHUM)</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre hospitalier de l'Université de Montréal (CHUM)</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the efficacy of an online intervention in increasing&#xD;
      condom use among HIV+ gay males.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">November 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline in participants self-efficacy in condom use at 2-weeks post-intervention</measure>
    <time_frame>baseline and 2-weeks post intervention</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in participants intention to use condoms at 2-weeks post-intervention</measure>
    <time_frame>Baseline and 2-weeks post intervention</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change from Baseline in participants condom use at 2-weeks post-intervention Condom Use</measure>
    <time_frame>baseline and 2-weeks post intervention</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>HIV</condition>
  <arm_group>
    <arm_group_label>Web sites</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Individuals assigned to this arm are given a list of websites where they can view additional information relating to condom use.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Condom-HIM</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Individuals assigned to this arm must follow an on-line one session tailored intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Condom-HIM</intervention_name>
    <description>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.</description>
    <arm_group_label>Condom-HIM</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. are HIV-seropositive,&#xD;
&#xD;
          2. Men who are having sex with men,&#xD;
&#xD;
          3. engaging in unprotected anal intercourse with a partner who is serostatus negative or&#xD;
             unknown&#xD;
&#xD;
          4. age 18 years and older,&#xD;
&#xD;
          5. ability to read English&#xD;
&#xD;
          6. have access to a computer and internet.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joyal Miranda, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ryerson University and Centre hospitalier de l'Universite de Montreal (CHUM)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ryerson University</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5B 2K3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 6, 2012</study_first_submitted>
  <study_first_submitted_qc>November 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 14, 2012</study_first_posted>
  <last_update_submitted>July 22, 2020</last_update_submitted>
  <last_update_submitted_qc>July 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Condom Use</keyword>
  <keyword>HIV+ gay males</keyword>
  <keyword>Intervention</keyword>
  <keyword>Tailored</keyword>
  <keyword>On-line</keyword>
  <keyword>Internet</keyword>
  <keyword>Web-based</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01726153
org study id: R0018767
nct id: NCT01726153
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the efficacy of an online intervention in increasing
      condom use among HIV+ gay males.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change from Baseline in participants self-efficacy in condom use at 2-weeks post-intervention
time frame: baseline and 2-weeks post intervention
description: 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.
measure: Change from Baseline in participants intention to use condoms at 2-weeks post-intervention
time frame: Baseline and 2-weeks post intervention
description: 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.
measure: Change from Baseline in participants condom use at 2-weeks post-intervention Condom Use
time frame: baseline and 2-weeks post intervention
arm group label: Web sites
arm group type: No Intervention
description: Individuals assigned to this arm are given a list of websites where they can view additional information relating to condom use.
arm group label: Condom-HIM
arm group type: Experimental
description: Individuals assigned to this arm must follow an on-line one session tailored intervention.
intervention type: Behavioral
intervention name: Condom-HIM
description: 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.
arm group label: Condom-HIM
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Joyal Miranda, PhD
role: Principal Investigator
affiliation: Ryerson University and Centre hospitalier de l'Universite de Montreal (CHUM)
facility: 
country: Canada
responsible party type: Sponsor