<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/NCT02202824</url>
  </required_header>
  <id_info>
    <org_study_id>MH096620-S1</org_study_id>
    <nct_id>NCT02202824</nct_id>
  </id_info>
  <brief_title>Measuring Beliefs and Norms About Violence Against Women</brief_title>
  <official_title>Measuring Beliefs and Norms About Violence Against Women in Rural Uganda: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Mbarara University of Science and Technology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of our study was to determine the extent to which contextual information about&#xD;
      the circumstances of intimate partner violence affects participants' responses to questions&#xD;
      about their personal attitudes toward intimate partner violence.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In national studies conducted throughout sub-Saharan Africa, survey data indicate that there&#xD;
      is widespread acceptance of intimate partner violence by both men and women (Alio et al.,&#xD;
      2011, Mann &amp; Takyi, 2009, Rani et al., 2004, Uthman et al., 2009). For women, the proximate&#xD;
      context of gender-unequal norms has important public health impacts. Men who report beliefs&#xD;
      consistent with gender-unequal norms are more likely to be perpetrators of sexual violence&#xD;
      (Shannon et al., 2012). Women are more likely to be victimized when they and their partners&#xD;
      report concordant beliefs about the acceptability of intimate partner violence (Alio et al.,&#xD;
      2011). And finally, women who live in areas characterized by gender-unequal norms about&#xD;
      intimate partner violence are at greater risk for having their reproductive health&#xD;
      compromised (Hung et al., 2012, Tsai &amp; Subramanian, 2012). Accurate measurement of norms&#xD;
      about intimate partner violence therefore has important implications for understanding the&#xD;
      health risk environment for women.&#xD;
&#xD;
      The Demographic and Health Surveys (DHS), which are nationally representative surveys&#xD;
      conducted worldwide, have served as an important source of information on norms about&#xD;
      intimate partner violence. However, a cross-country analysis of DHS data showed that minor&#xD;
      deviations in survey wording may account for substantial cross-country variation in the&#xD;
      extent to which women provide survey responses consistent with acceptance of intimate partner&#xD;
      violence (Yount et al., 2011). Furthermore, in-depth interviews conducted among Bangladeshi&#xD;
      women suggest that affirmative responses to DHS-style questions may better reflect their&#xD;
      perceptions of prevailing norms or their individualized assumptions about contextual details&#xD;
      rather than true beliefs about their acceptance of intimate partner violence (Schuler &amp;&#xD;
      Islam, 2008, Schuler et al., 2011). Taken together, these lines of inquiry suggest important&#xD;
      limitations in the accuracy with which the DHS measure women's attitudes towards intimate&#xD;
      partner violence.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</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>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Personal attitudes toward intimate partner violence (5-item scale)</measure>
    <time_frame>Baseline</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Perceived norms about intimate partner violence (5-item scale)</measure>
    <time_frame>Baseline</time_frame>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">1557</enrollment>
  <condition>Domestic Violence</condition>
  <arm_group>
    <arm_group_label>Survey questionnaire version 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Study participants will receive version 1 of the survey questionnaire</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Survey questionnaire version 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Study participants will receive version 2 of the survey questionnaire</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Survey questionnaire version 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Study participants will receive version 3 of the survey questionnaire</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Survey questionnaire</intervention_name>
    <description>Each of the scale versions elicits personal attitudes toward intimate partner violence and perceived norms about intimate partner violence, in a different fashion</description>
    <arm_group_label>Survey questionnaire version 1</arm_group_label>
    <arm_group_label>Survey questionnaire version 2</arm_group_label>
    <arm_group_label>Survey questionnaire version 3</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults aged 18 years and older&#xD;
&#xD;
          -  Emancipated minors aged 16-18 years&#xD;
&#xD;
          -  Considers Nyakabare Parish their primary place of residence&#xD;
&#xD;
          -  Capable of providing informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Minors younger than 18 years, with the exception of emancipated minors&#xD;
&#xD;
          -  Does not consider Nyakabare Parish their primary place of residence&#xD;
&#xD;
          -  Unable to communicate with research staff, e.g., due to deafness, mutism, or aphasia&#xD;
&#xD;
          -  Persons with psychosis, neurological damage, acute intoxication, or an intelligence&#xD;
             quotient less than 70, as determined in the field by non-clinical research staff in&#xD;
             consultation with a supervisor&#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>Alexander C Tsai, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Bernard Kaukhikire, MBA</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mbarara University of Science and Technology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mbarara University of Science and Technology</name>
      <address>
        <city>Mbarara</city>
        <country>Uganda</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Uganda</country>
  </location_countries>
  <verification_date>November 2015</verification_date>
  <study_first_submitted>July 26, 2014</study_first_submitted>
  <study_first_submitted_qc>July 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 29, 2014</study_first_posted>
  <last_update_submitted>November 29, 2015</last_update_submitted>
  <last_update_submitted_qc>November 29, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 2, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Alexander Tsai</investigator_full_name>
    <investigator_title>Assistant in Psychiatry</investigator_title>
  </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/NCT02202824
org study id: MH096620-S1
nct id: NCT02202824
lead sponsor: 
collaborator: 
has dmc: No
The objective of our study was to determine the extent to which contextual information about
      the circumstances of intimate partner violence affects participants' responses to questions
      about their personal attitudes toward intimate partner violence.
In national studies conducted throughout sub-Saharan Africa, survey data indicate that there
      is widespread acceptance of intimate partner violence by both men and women (Alio et al.,
      2011, Mann & Takyi, 2009, Rani et al., 2004, Uthman et al., 2009). For women, the proximate
      context of gender-unequal norms has important public health impacts. Men who report beliefs
      consistent with gender-unequal norms are more likely to be perpetrators of sexual violence
      (Shannon et al., 2012). Women are more likely to be victimized when they and their partners
      report concordant beliefs about the acceptability of intimate partner violence (Alio et al.,
      2011). And finally, women who live in areas characterized by gender-unequal norms about
      intimate partner violence are at greater risk for having their reproductive health
      compromised (Hung et al., 2012, Tsai & Subramanian, 2012). Accurate measurement of norms
      about intimate partner violence therefore has important implications for understanding the
      health risk environment for women.

      The Demographic and Health Surveys (DHS), which are nationally representative surveys
      conducted worldwide, have served as an important source of information on norms about
      intimate partner violence. However, a cross-country analysis of DHS data showed that minor
      deviations in survey wording may account for substantial cross-country variation in the
      extent to which women provide survey responses consistent with acceptance of intimate partner
      violence (Yount et al., 2011). Furthermore, in-depth interviews conducted among Bangladeshi
      women suggest that affirmative responses to DHS-style questions may better reflect their
      perceptions of prevailing norms or their individualized assumptions about contextual details
      rather than true beliefs about their acceptance of intimate partner violence (Schuler &
      Islam, 2008, Schuler et al., 2011). Taken together, these lines of inquiry suggest important
      limitations in the accuracy with which the DHS measure women's attitudes towards intimate
      partner violence.
allocation: Randomized
intervention model: Parallel Assignment
masking: Double (Participant, Outcomes Assessor)
measure: Personal attitudes toward intimate partner violence (5-item scale)
time frame: Baseline
measure: Perceived norms about intimate partner violence (5-item scale)
time frame: Baseline
arm group label: Survey questionnaire version 1
arm group type: Experimental
description: Study participants will receive version 1 of the survey questionnaire
arm group label: Survey questionnaire version 2
arm group type: Experimental
description: Study participants will receive version 2 of the survey questionnaire
arm group label: Survey questionnaire version 3
arm group type: Experimental
description: Study participants will receive version 3 of the survey questionnaire
intervention type: Other
intervention name: Survey questionnaire
description: Each of the scale versions elicits personal attitudes toward intimate partner violence and perceived norms about intimate partner violence, in a different fashion
arm group label: Survey questionnaire version 1
arm group label: Survey questionnaire version 2
arm group label: Survey questionnaire version 3
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Alexander C Tsai, MD, PhD
role: Principal Investigator
affiliation: Massachusetts General Hospital
last name: Bernard Kaukhikire, MBA
role: Principal Investigator
affiliation: Mbarara University of Science and Technology
facility: 
country: Uganda
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Alexander Tsai
investigator title: Assistant in Psychiatry