<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/NCT01689545</url>
  </required_header>
  <id_info>
    <org_study_id>5R01DA022962</org_study_id>
    <nct_id>NCT01689545</nct_id>
  </id_info>
  <brief_title>Prevention for Positives: An RCT Among Vietnamese HIV-positive IDU</brief_title>
  <official_title>Prevention for Positives: A Randomized Controlled Trial Among Vietnamese HIV-positive Injecting Drug Users</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins Bloomberg School of Public Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Johns Hopkins Bloomberg School of Public Health</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether a combined individual and structural level&#xD;
      stigma reduction intervention is effective in reducing high risk injecting and sexual&#xD;
      behaviors among HIV positive injecting drug users.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a randomized controlled trial among HIV-positive injecting drug users (IDUs) to&#xD;
      reduce high risk injecting and sexual behaviors in Thai Nguyen, Vietnam. We will be&#xD;
      conducting this study in collaboration with the Thai Nguyen Centre for Preventive Medicine&#xD;
      (CPM). We will compare standard HIV voluntary counseling and testing (VCT) to an intervention&#xD;
      that adds a continuum of psychosocial support for HIV-positive IDUs. The intervention&#xD;
      consists of a two-tiered approach that addresses structural and individual level barriers to&#xD;
      risk reduction: 1) The structural level of the intervention consists of community-based&#xD;
      programs and targets HIV stigma that is a primary obstacle to risk reduction for HIV-positive&#xD;
      individuals; 2) The individual level of the intervention consists of 2 HIV posttest&#xD;
      counseling sessions and 2 skill-building support groups for HIV-positive IDUs. Our research&#xD;
      questions for the overall project are:&#xD;
&#xD;
        1. What is the impact of perceived HIV-related stigma on disclosure, social support, and&#xD;
           coping among IDUs?&#xD;
&#xD;
        2. What roles do disclosure, social support, and coping play in facilitating the reduction&#xD;
           of HIV-risk behaviors&#xD;
&#xD;
        3. Are combined individual and structural level interventions more effective in reducing&#xD;
           injecting and sexual behaviors among HIV-positive IDUs than individual or structural&#xD;
           interventions alone and more effective than the standard HIV VCT?&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2007</start_date>
  <completion_date type="Actual">April 2013</completion_date>
  <primary_completion_date type="Actual">April 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>Factorial Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>HIV injecting risk behavior</measure>
    <time_frame>2 years</time_frame>
    <description>Change in self-reported use of new injecting equipment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>HIV sexual risk behavior</measure>
    <time_frame>2 years</time_frame>
    <description>Change in self-reported condom use during sexual intercourse</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>HIV incidence</measure>
    <time_frame>2 years</time_frame>
    <description>Change in HIV incidence among network members</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Perceived HIV-related stigma</measure>
    <time_frame>2 years</time_frame>
    <description>Change in self-reported perceived HIV-related stigma among index participants</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">2175</enrollment>
  <condition>HIV</condition>
  <arm_group>
    <arm_group_label>Individual level</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Structural level</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Combined individual &amp; structural level</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Individual level</intervention_name>
    <description>Index participants will participate in standard HIV VCT supplemented with 2 posttest counseling sessions, followed by 2 post-test skill-building support groups for HIV positive IDUs.</description>
    <arm_group_label>Combined individual &amp; structural level</arm_group_label>
    <arm_group_label>Individual level</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Structural level</intervention_name>
    <description>Community members will participate in 2 community-based HIV and IDU stigma videos combined with a series of visits with community outreach workers.</description>
    <arm_group_label>Combined individual &amp; structural level</arm_group_label>
    <arm_group_label>Structural level</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Individual level standard of care</intervention_name>
    <description>The education materials that are currently offered in Thai Nguyen will be delivered didactically by health workers on 1) the HIV situation in Vietnam; 2) consequences of drug use; 3) routes of HIV transmission; and 4) options for drug treatment.</description>
    <arm_group_label>Standard of Care</arm_group_label>
    <arm_group_label>Structural level</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Structural level standard of care</intervention_name>
    <description>Posters and billboards on HIV/AIDS transmission, leaflets on HIV/AIDS transmission available in health station, 15-minute monthly public broadcasts (via the village loudspeaker) on the consequences of HIV/AIDS and the number of HIV cases in the country and province will be delivered in communities.</description>
    <arm_group_label>Individual level</arm_group_label>
    <arm_group_label>Standard of Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Index participant&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  laboratory confirmed HIV positive diagnosis&#xD;
&#xD;
          -  able and wiling to bring an injecting network member for screening&#xD;
&#xD;
          -  injected drugs in previous 6 months&#xD;
&#xD;
          -  planned residence in Thai Nguyen for next 24 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  unwilling to provide locator information&#xD;
&#xD;
          -  unable to participate in group counseling sessions due to psychological disturbance,&#xD;
             cognitive impairment or threatening behavior&#xD;
&#xD;
          -  currently participating in other HIV or drug use intervention activities&#xD;
&#xD;
        Network member participant&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  laboratory confirmed HIV negative diagnosis&#xD;
&#xD;
          -  injected or shared drug paraphernalia in past 6 months&#xD;
&#xD;
          -  interacts at least once a week with index participant&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  unwilling to provide locator information&#xD;
&#xD;
          -  having psychological or cognitive impairment&#xD;
&#xD;
          -  currently participating in other HIV intervention&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Vivian F Go, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins Bloomberg School of Public Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Center for Preventive Medicine</name>
      <address>
        <city>Thai Nguyen</city>
        <country>Vietnam</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Vietnam</country>
  </location_countries>
  <verification_date>May 2014</verification_date>
  <study_first_submitted>September 18, 2012</study_first_submitted>
  <study_first_submitted_qc>September 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 21, 2012</study_first_posted>
  <last_update_submitted>June 4, 2014</last_update_submitted>
  <last_update_submitted_qc>June 4, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 5, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>HIV</keyword>
  <keyword>drug abuse</keyword>
  <keyword>social stigma</keyword>
  <keyword>Vietnam</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>HIV Seropositivity</mesh_term>
  </condition_browse>
  <!-- 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/NCT01689545
org study id: 5R01DA022962
nct id: NCT01689545
lead sponsor: 
has dmc: Yes
The purpose of this study is to determine whether a combined individual and structural level
      stigma reduction intervention is effective in reducing high risk injecting and sexual
      behaviors among HIV positive injecting drug users.
This study is a randomized controlled trial among HIV-positive injecting drug users (IDUs) to
      reduce high risk injecting and sexual behaviors in Thai Nguyen, Vietnam. We will be
      conducting this study in collaboration with the Thai Nguyen Centre for Preventive Medicine
      (CPM). We will compare standard HIV voluntary counseling and testing (VCT) to an intervention
      that adds a continuum of psychosocial support for HIV-positive IDUs. The intervention
      consists of a two-tiered approach that addresses structural and individual level barriers to
      risk reduction: 1) The structural level of the intervention consists of community-based
      programs and targets HIV stigma that is a primary obstacle to risk reduction for HIV-positive
      individuals; 2) The individual level of the intervention consists of 2 HIV posttest
      counseling sessions and 2 skill-building support groups for HIV-positive IDUs. Our research
      questions for the overall project are:

        1. What is the impact of perceived HIV-related stigma on disclosure, social support, and
           coping among IDUs?

        2. What roles do disclosure, social support, and coping play in facilitating the reduction
           of HIV-risk behaviors

        3. Are combined individual and structural level interventions more effective in reducing
           injecting and sexual behaviors among HIV-positive IDUs than individual or structural
           interventions alone and more effective than the standard HIV VCT?
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: HIV injecting risk behavior
time frame: 2 years
description: Change in self-reported use of new injecting equipment
measure: HIV sexual risk behavior
time frame: 2 years
description: Change in self-reported condom use during sexual intercourse
measure: HIV incidence
time frame: 2 years
description: Change in HIV incidence among network members
measure: Perceived HIV-related stigma
time frame: 2 years
description: Change in self-reported perceived HIV-related stigma among index participants
arm group label: Individual level
arm group type: Experimental
arm group label: Structural level
arm group type: Experimental
arm group label: Combined individual & structural level
arm group type: Experimental
arm group label: Standard of Care
arm group type: Active Comparator
intervention type: Behavioral
intervention name: Individual level
description: Index participants will participate in standard HIV VCT supplemented with 2 posttest counseling sessions, followed by 2 post-test skill-building support groups for HIV positive IDUs.
arm group label: Combined individual & structural level
arm group label: Individual level
intervention type: Behavioral
intervention name: Structural level
description: Community members will participate in 2 community-based HIV and IDU stigma videos combined with a series of visits with community outreach workers.
arm group label: Combined individual & structural level
arm group label: Structural level
intervention type: Behavioral
intervention name: Individual level standard of care
description: The education materials that are currently offered in Thai Nguyen will be delivered didactically by health workers on 1) the HIV situation in Vietnam; 2) consequences of drug use; 3) routes of HIV transmission; and 4) options for drug treatment.
arm group label: Standard of Care
arm group label: Structural level
intervention type: Behavioral
intervention name: Structural level standard of care
description: Posters and billboards on HIV/AIDS transmission, leaflets on HIV/AIDS transmission available in health station, 15-minute monthly public broadcasts (via the village loudspeaker) on the consequences of HIV/AIDS and the number of HIV cases in the country and province will be delivered in communities.
arm group label: Individual level
arm group label: Standard of Care
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Vivian F Go, PhD
role: Principal Investigator
affiliation: Johns Hopkins Bloomberg School of Public Health
facility: 
country: Vietnam
responsible party type: Sponsor
mesh term: HIV Seropositivity