<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/NCT01661504</url>
  </required_header>
  <id_info>
    <org_study_id>1202009793</org_study_id>
    <nct_id>NCT01661504</nct_id>
  </id_info>
  <brief_title>Evaluating Violence Against Women Screening in Mexico</brief_title>
  <official_title>Evaluating Violence Against Women Screening in Mexico</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Innovations for Poverty Action</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Mexican National Institute of Public Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Yale University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The overall goal of this proposed study is to develop the state of knowledge in the area of&#xD;
      gender-based violence and reproductive health by conducting a randomized controlled trial to&#xD;
      improve the health care provider's capacity to screen for intimate partner violence and to&#xD;
      mitigate associated risk among women health clinic patrons of reproductive age (ages18-44)&#xD;
      with recent experiences of physical or sexual partner violence in Mexico City and its&#xD;
      surrounding area.&#xD;
&#xD;
      The specific research objectives are as follows:&#xD;
&#xD;
        1. To increase mid-level health care providers' capacity to identify Intimate Partner&#xD;
           Violence (IPV) and assist women with risk mitigation&#xD;
&#xD;
        2. Utilizing a randomized controlled trial, to assess the impact of an enhanced health care&#xD;
           worker screening and counselling program on (a) past year severe IPV (sexual or&#xD;
           physical), including severe IPV; (b) reproductive coercion (c) use of community-based&#xD;
           resources and safety planning; and (d) quality of life; versus minimum standard of care&#xD;
&#xD;
        3. To qualitatively examine which programmatic components may serve as mechanisms for&#xD;
           observed changes stated in the second objective&#xD;
&#xD;
        4. To synthesize study findings and a) create recommendations for clinic-based intervention&#xD;
           programs to address IPV in low and middle income countries and b) disseminate&#xD;
           information as reports, presentation, and peer-reviewed publications&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2013</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</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>Screening</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Intimate Partner Violence Victimization from Baseline</measure>
    <time_frame>12 months</time_frame>
    <description>Participants will be followed up at 3 months and at 15 months post-baseline to assess intimate partner violence victimization as measured by an adapted Conflict Tactics Scale - 2. This will allow for a 12 month follow-up from the booster counseling session in the intervention group which occurs at 3 months post-baseline.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Quality of Life Score</measure>
    <time_frame>past month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Use of Community Resources</measure>
    <time_frame>12 months</time_frame>
    <description>Adapted Community Resources Checklist</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Safety Planning</measure>
    <time_frame>12 Months</time_frame>
    <description>Adapted Safety Behavior Checklist</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Reproductive Coercion</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">959</enrollment>
  <condition>Domestic Violence</condition>
  <arm_group>
    <arm_group_label>Referral Card Only</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Women participants at control clinics will be given a referral card containing general information on IPV and a list of resources specific to their community</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Integrated Screening</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention arm will consist of the following components (described in detail below): a) integrated IPV/Sexual and Reproductive Health Screening, b) supportive care, c) safety planning and harm reduction counseling, d) supported referrals, e) booster counseling sessions at 3 months post-baseline / initial counseling</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Integrated Screening</intervention_name>
    <description>The intervention arm will consist of the following components (described in detail below): a) integrated IPV/Sexual and Reproductive Health Screening, b) supportive care, c) safety planning and harm reduction counseling, d) supported referrals, e) booster counseling sessions</description>
    <arm_group_label>Integrated Screening</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ages 18-44&#xD;
&#xD;
          -  Currently in heterosexual relationship with a male partner&#xD;
&#xD;
          -  Responds in affirmative to past year sexual or physical violence&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cognitive impairment (slurred speech, inability to follow directions)&#xD;
&#xD;
          -  Seeking treatment for life threatening emergency care&#xD;
&#xD;
          -  Intends to relocate within 2 years.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>44 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jhumka Gupta, ScD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale School of Public Health</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Claudia Diaz Olavarrieta, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Institute of Public Health - Mexico</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kathryn L Falb, ScD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale School of Public Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Health Clinics associated with Ministry of Health in Mexico City</name>
      <address>
        <city>Mexico City</city>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <link>
    <url>http://bmcpublichealth.biomedcentral.com/articles/10.1186/1471-2458-14-772</url>
    <description>protocol paper (published)</description>
  </link>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>August 2, 2012</study_first_submitted>
  <study_first_submitted_qc>August 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 9, 2012</study_first_posted>
  <last_update_submitted>September 1, 2021</last_update_submitted>
  <last_update_submitted_qc>September 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 10, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT01661504
org study id: 1202009793
nct id: NCT01661504
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The overall goal of this proposed study is to develop the state of knowledge in the area of
      gender-based violence and reproductive health by conducting a randomized controlled trial to
      improve the health care provider's capacity to screen for intimate partner violence and to
      mitigate associated risk among women health clinic patrons of reproductive age (ages18-44)
      with recent experiences of physical or sexual partner violence in Mexico City and its
      surrounding area.

      The specific research objectives are as follows:

        1. To increase mid-level health care providers' capacity to identify Intimate Partner
           Violence (IPV) and assist women with risk mitigation

        2. Utilizing a randomized controlled trial, to assess the impact of an enhanced health care
           worker screening and counselling program on (a) past year severe IPV (sexual or
           physical), including severe IPV; (b) reproductive coercion (c) use of community-based
           resources and safety planning; and (d) quality of life; versus minimum standard of care

        3. To qualitatively examine which programmatic components may serve as mechanisms for
           observed changes stated in the second objective

        4. To synthesize study findings and a) create recommendations for clinic-based intervention
           programs to address IPV in low and middle income countries and b) disseminate
           information as reports, presentation, and peer-reviewed publications
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: Single (Participant)
measure: Change in Intimate Partner Violence Victimization from Baseline
time frame: 12 months
description: Participants will be followed up at 3 months and at 15 months post-baseline to assess intimate partner violence victimization as measured by an adapted Conflict Tactics Scale - 2. This will allow for a 12 month follow-up from the booster counseling session in the intervention group which occurs at 3 months post-baseline.
measure: Change in Quality of Life Score
time frame: past month
measure: Change in Use of Community Resources
time frame: 12 months
description: Adapted Community Resources Checklist
measure: Change in Safety Planning
time frame: 12 Months
description: Adapted Safety Behavior Checklist
measure: Change in Reproductive Coercion
time frame: 12 months
arm group label: Referral Card Only
arm group type: No Intervention
description: Women participants at control clinics will be given a referral card containing general information on IPV and a list of resources specific to their community
arm group label: Integrated Screening
arm group type: Experimental
description: The intervention arm will consist of the following components (described in detail below): a) integrated IPV/Sexual and Reproductive Health Screening, b) supportive care, c) safety planning and harm reduction counseling, d) supported referrals, e) booster counseling sessions at 3 months post-baseline / initial counseling
intervention type: Behavioral
intervention name: Integrated Screening
description: The intervention arm will consist of the following components (described in detail below): a) integrated IPV/Sexual and Reproductive Health Screening, b) supportive care, c) safety planning and harm reduction counseling, d) supported referrals, e) booster counseling sessions
arm group label: Integrated Screening
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 44 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jhumka Gupta, ScD
role: Principal Investigator
affiliation: Yale School of Public Health
last name: Claudia Diaz Olavarrieta, PhD
role: Principal Investigator
affiliation: National Institute of Public Health - Mexico
last name: Kathryn L Falb, ScD
role: Principal Investigator
affiliation: Yale School of Public Health
facility: 
country: Mexico
url: http://bmcpublichealth.biomedcentral.com/articles/10.1186/1471-2458-14-772
description: protocol paper (published)
responsible party type: Sponsor