<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/NCT01690442</url>
  </required_header>
  <id_info>
    <org_study_id>AAAD2056</org_study_id>
    <nct_id>NCT01690442</nct_id>
  </id_info>
  <brief_title>HIV Prevention for Injecting Drug Users in Kazakhstan</brief_title>
  <official_title>Couples Based HIV/STI Prevention for Injecting Drug Users in Kazakhstan</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Columbia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Columbia University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The proposed study addresses a significant public health threat of HIV, HCV and other STIs&#xD;
      among a very high risk population of active IDUs and their sexual partners in Kazakhstan a&#xD;
      region that is experiencing one of the fastest rising HIV epidemics in the world. There is a&#xD;
      race to develop and implement effective HIV preventive interventions for IDUs and their&#xD;
      sexual partners to stem the spread of HIV, HCV and other STIs in Almaty, Shu and other&#xD;
      Central Asian towns along drug trafficking routes. The proposed study will test the&#xD;
      effectiveness of a couplesbased HIV/STI risk reduction intervention to decrease new cases of&#xD;
      HIV and Hepatitis C (HCV) and incidence of sexually transmitted infections (STIs), as well as&#xD;
      to reduce unsafe injection practices and increase condom use among injecting drug users&#xD;
      (IDUs) and their heterosexual, intimate partners in Kazakhstan.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The proposed study will rigorously test the efficacy of an innovative, couplesbased HIV/STI&#xD;
      risk reduction intervention to decrease new cases of HIV and Hepatitis C (HCV) and incidence&#xD;
      of sexually transmitted infections (STIs), as well as to reduce unsafe injection practices&#xD;
      and increase condom use among injecting drug users (IDUs) and their heterosexual intimate&#xD;
      partners in Kazakhstan. Central Asia has experienced one of the fastest growing HIV/AIDS&#xD;
      epidemics due to a sharp increase in injection drug use. For the proposed study, the&#xD;
      participants will be 400 IDUs and their heterosexual intimate partners. These 400 couples&#xD;
      will be randomized to one of two interventions: a 5session couplesbased HIV/STI risk&#xD;
      reduction intervention or a 5session couplesbased wellness promotion intervention, which will&#xD;
      serve as a control condition. Participants will be assessed with repeated measures at&#xD;
      baseline, 3, 6, and 12months postintervention. The primary behavioral outcomes are&#xD;
      selfreported proportion of injection acts in which needles or syringes are shared in the past&#xD;
      90 days and proportion of condom protected acts of sexual intercourse in the past 90 days.&#xD;
      The primary biological outcomes are the rate of new HIV and HCV cases, and the cumulative&#xD;
      incidence of Chlamydia, gonorrhea, and syphilis over the 12month postintervention period. The&#xD;
      proposed study will advance the understanding of HIV/HCV/STI risk reduction among IDUs and&#xD;
      thereby may help to stem the rising epidemic of HIV, HCV, and STIs in Kazakhstan and Central&#xD;
      Asia.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2008</start_date>
  <completion_date type="Actual">November 2012</completion_date>
  <primary_completion_date type="Actual">November 2012</primary_completion_date>
  <phase>Phase 2</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>The proportion of condom protected acts of vaginal and anal intercourse</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>The number of incidents of unclean syringes or needles in the past 90 days</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of injection acts in which unclean needles or syringes were used in the past 90 days</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>The number of acts of unprotected vaginal and anal intercourse during the 90 days prior to the assessment period</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of people participants shared needles or syringes with in the past 90 days</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">600</enrollment>
  <condition>HIV</condition>
  <condition>AIDS</condition>
  <arm_group>
    <arm_group_label>Couples Based HIV/STI Risk Reduction Intervention (CHSR)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention includes a combination of empowerment and couple self-efficacy building strategies, which are employed to help couples overcome resistance to risk reduction.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Renaissance Wellness Promotion (WP)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This intervention employs a psychoeducational approach to promote wellness, focusing on: maintaining a healthy diet on a low budget, exercising and fitness, stress reducing strategies and specific health related issues that affect IDUs, such as overdose.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Couples Based HIV/STI Risk Reduction Intervention (CHSR)</intervention_name>
    <description>The intervention includes a combination of empowerment and couple self-efficacy building strategies, which are employed to help couples overcome resistance to risk reduction.</description>
    <arm_group_label>Couples Based HIV/STI Risk Reduction Intervention (CHSR)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Renaissance Wellness Promotion (WP)</intervention_name>
    <description>This intervention employs a psychoeducational approach to promote wellness, focusing on: maintaining a healthy diet on a low budget, exercising and fitness, stress reducing strategies and specific health related issues that affect IDUs, such as overdose.</description>
    <arm_group_label>Renaissance Wellness Promotion (WP)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Couples are eligible to participate if both partners are aged 18 or older&#xD;
&#xD;
          -  both partners identify each other as their main partner of the opposite sex and&#xD;
             someone whom the participant considers a boy/girlfriend, spouse, lover and/ or parent&#xD;
             of his/her child&#xD;
&#xD;
          -  the relationship has existed at least 3 months&#xD;
&#xD;
          -  each partner intends to remain together for at least 12 months&#xD;
&#xD;
          -  at least one partner reports having had unprotected vaginal or anal intercourse with&#xD;
             the other partner at least once in the previous 90 days&#xD;
&#xD;
          -  at least one partner reports injecting drugs in the past 90 days&#xD;
&#xD;
          -  neither partner has plans to relocate beyond a reasonable distance from the study site&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Couples are excluded if either partner shows evidence of significant psychiatric,&#xD;
             physical or neurological impairment that would limit effective participation as&#xD;
             confirmed on a MiniMental State Examination and/or Quick Test&#xD;
&#xD;
          -  either partner reports severe physical violence perpetrated by the other partner in&#xD;
             the past year on the Revised Conflict Tactics Scale&#xD;
&#xD;
          -  either partner is unable to commit to participate in the study through to completion&#xD;
&#xD;
          -  either partner reports that the couple is planning a pregnancy within the next 18&#xD;
             months&#xD;
&#xD;
          -  either partner is not fluent in Russian as determined during Informed Consent&#xD;
&#xD;
          -  both partners do not meet all eligibility criteria or meet one or more exclusion&#xD;
             criteria&#xD;
      </textblock>
    </criteria>
    <gender>All</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>Nabila El-Bassel</last_name>
    <role>Principal Investigator</role>
    <affiliation>Columbia University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Global Health Research Center of Central Asia</name>
      <address>
        <city>Almaty</city>
        <country>Kazakhstan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Kazakhstan</country>
  </location_countries>
  <verification_date>February 2014</verification_date>
  <study_first_submitted>September 19, 2012</study_first_submitted>
  <study_first_submitted_qc>September 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 21, 2012</study_first_posted>
  <last_update_submitted>February 25, 2014</last_update_submitted>
  <last_update_submitted_qc>February 25, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 27, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Columbia University</investigator_affiliation>
    <investigator_full_name>Nabila El-Bassel, PhD</investigator_full_name>
    <investigator_title>Director of the Social Intervention Group, Global Health Research Center of Central Asia</investigator_title>
  </responsible_party>
  <keyword>HIV</keyword>
  <keyword>AIDS</keyword>
  <keyword>Prevention</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/NCT01690442
org study id: AAAD2056
nct id: NCT01690442
lead sponsor: 
has dmc: Yes
The proposed study addresses a significant public health threat of HIV, HCV and other STIs
      among a very high risk population of active IDUs and their sexual partners in Kazakhstan a
      region that is experiencing one of the fastest rising HIV epidemics in the world. There is a
      race to develop and implement effective HIV preventive interventions for IDUs and their
      sexual partners to stem the spread of HIV, HCV and other STIs in Almaty, Shu and other
      Central Asian towns along drug trafficking routes. The proposed study will test the
      effectiveness of a couplesbased HIV/STI risk reduction intervention to decrease new cases of
      HIV and Hepatitis C (HCV) and incidence of sexually transmitted infections (STIs), as well as
      to reduce unsafe injection practices and increase condom use among injecting drug users
      (IDUs) and their heterosexual, intimate partners in Kazakhstan.
The proposed study will rigorously test the efficacy of an innovative, couplesbased HIV/STI
      risk reduction intervention to decrease new cases of HIV and Hepatitis C (HCV) and incidence
      of sexually transmitted infections (STIs), as well as to reduce unsafe injection practices
      and increase condom use among injecting drug users (IDUs) and their heterosexual intimate
      partners in Kazakhstan. Central Asia has experienced one of the fastest growing HIV/AIDS
      epidemics due to a sharp increase in injection drug use. For the proposed study, the
      participants will be 400 IDUs and their heterosexual intimate partners. These 400 couples
      will be randomized to one of two interventions: a 5session couplesbased HIV/STI risk
      reduction intervention or a 5session couplesbased wellness promotion intervention, which will
      serve as a control condition. Participants will be assessed with repeated measures at
      baseline, 3, 6, and 12months postintervention. The primary behavioral outcomes are
      selfreported proportion of injection acts in which needles or syringes are shared in the past
      90 days and proportion of condom protected acts of sexual intercourse in the past 90 days.
      The primary biological outcomes are the rate of new HIV and HCV cases, and the cumulative
      incidence of Chlamydia, gonorrhea, and syphilis over the 12month postintervention period. The
      proposed study will advance the understanding of HIV/HCV/STI risk reduction among IDUs and
      thereby may help to stem the rising epidemic of HIV, HCV, and STIs in Kazakhstan and Central
      Asia.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: The proportion of condom protected acts of vaginal and anal intercourse
time frame: 12 months
measure: The number of incidents of unclean syringes or needles in the past 90 days
time frame: 12 months
measure: Proportion of injection acts in which unclean needles or syringes were used in the past 90 days
time frame: 12 months
measure: The number of acts of unprotected vaginal and anal intercourse during the 90 days prior to the assessment period
time frame: 12 months
measure: Number of people participants shared needles or syringes with in the past 90 days
time frame: 12 months
arm group label: Couples Based HIV/STI Risk Reduction Intervention (CHSR)
arm group type: Experimental
description: The intervention includes a combination of empowerment and couple self-efficacy building strategies, which are employed to help couples overcome resistance to risk reduction.
arm group label: Renaissance Wellness Promotion (WP)
arm group type: Active Comparator
description: This intervention employs a psychoeducational approach to promote wellness, focusing on: maintaining a healthy diet on a low budget, exercising and fitness, stress reducing strategies and specific health related issues that affect IDUs, such as overdose.
intervention type: Behavioral
intervention name: Couples Based HIV/STI Risk Reduction Intervention (CHSR)
description: The intervention includes a combination of empowerment and couple self-efficacy building strategies, which are employed to help couples overcome resistance to risk reduction.
arm group label: Couples Based HIV/STI Risk Reduction Intervention (CHSR)
intervention type: Behavioral
intervention name: Renaissance Wellness Promotion (WP)
description: This intervention employs a psychoeducational approach to promote wellness, focusing on: maintaining a healthy diet on a low budget, exercising and fitness, stress reducing strategies and specific health related issues that affect IDUs, such as overdose.
arm group label: Renaissance Wellness Promotion (WP)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Nabila El-Bassel
role: Principal Investigator
affiliation: Columbia University
facility: 
country: Kazakhstan
responsible party type: Principal Investigator
investigator affiliation: Columbia University
investigator full name: Nabila El-Bassel, PhD
investigator title: Director of the Social Intervention Group, Global Health Research Center of Central Asia