<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/NCT03236948</url>
  </required_header>
  <id_info>
    <org_study_id>EC034-11-2015</org_study_id>
    <nct_id>NCT03236948</nct_id>
  </id_info>
  <brief_title>RCT of the Effectiveness of the WfWI Intervention in Afghanistan</brief_title>
  <official_title>Individually Randomised Control Trial Evaluation of the Effectiveness of the Women for Women International (WfWI) Intervention in Afghanistan for Intimate Partner Violence Prevention Among Married Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical Research Council, South Africa</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Women for Women International (WfWI)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Medical Research Council, South Africa</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an individually randomised control trial to assess the effectiveness of a livelihoods&#xD;
      and social empowerment intervention, delivered by Women for Women International, on married&#xD;
      women's experiences of intimate partner violence in Afghanistan. It has a 22 month follow up.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">October 2016</start_date>
  <completion_date type="Anticipated">November 2018</completion_date>
  <primary_completion_date type="Anticipated">November 2018</primary_completion_date>
  <phase>Phase 3</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>
    <intervention_model_description>Individual level randomised trial, with intervention and control group</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Any past year physical intimate partner violence experienced amongst currently married women</measure>
    <time_frame>22 months post baseline</time_frame>
    <description>Physical intimate partner violence is assessed using five items based on the WHO VAW scale. A positive response to any item leads to a person being classified as experiencing in the past year.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Past year severe physical intimate partner violence experience amongst currently married women</measure>
    <time_frame>22 months post baseline</time_frame>
    <description>Severe physical intimate partner violence experience is assessed using 5 items. Past year severe physical IPV is assessed as positive if a person responds to two (or more) items as once, or one item as few (or more), essentially creating a more than once categorization.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Depressive symptomology</measure>
    <time_frame>22 months post baseline</time_frame>
    <description>Past week depressive symptomology is assessed by the Centre for Epidemiological Studies Depression (CESD) scale, with the full twenty items. A mean score will be calculated.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Household food insecurity in past four weeks</measure>
    <time_frame>22 months post baseline</time_frame>
    <description>Three items ask about household level food insecurity in the past 4 weeks. A mean score is calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Financial shock resilience</measure>
    <time_frame>22 months post baseline</time_frame>
    <description>One item assesses ability to mobilise cash in an emergency.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Monthly earnings</measure>
    <time_frame>22 months post baseline</time_frame>
    <description>A single item assesses women's past month earnings</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total savings</measure>
    <time_frame>22 months post baseline</time_frame>
    <description>A single item assesses women's total savings</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Life satisfaction</measure>
    <time_frame>22 months post baseline</time_frame>
    <description>Life satisfaction is assessed using four-items derived from the Satisfaction With Life Scale. A mean score is produced.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Suicidal ideation in past 4 weeks</measure>
    <time_frame>22 months post baseline</time_frame>
    <description>A single item assesses thoughts about suicide in past week.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gender attitudes</measure>
    <time_frame>22 months post baseline</time_frame>
    <description>11 questions assess women's gender attitudes. A mean score is created.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Married women's participation in household decision-making</measure>
    <time_frame>22 months post baseline</time_frame>
    <description>Five items are asked about women's ability to participate in household decisions. A mean score is created.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Any emotional abuse in the past year amongst currently married women</measure>
    <time_frame>22 months post baseline</time_frame>
    <description>Seven items assess emotional abuse in the past year. A mean score is calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceptions of husband cruelty amongst currently married women</measure>
    <time_frame>22 months post baseline</time_frame>
    <description>Five items ask about married women's perceptions of her husband and his attitudes and relationship towards her. A mean score is created</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mother-in-law or abuse in the past 12 months amongst currently married women</measure>
    <time_frame>22 months post baseline</time_frame>
    <description>A single item assesses whether mother-in-laws have hit the woman in the past 12 months and another item assesses whether siblings have hit the woman in the past 12 months, an affirmative response to either item would indicate abuse.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceptions of mother-in-law cruelty amongst currently married women</measure>
    <time_frame>22 months post baseline</time_frame>
    <description>For married women, six items ask about their relationship and the mother-in-laws attitudes towards her</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1461</enrollment>
  <condition>Domestic Violence</condition>
  <condition>Depressive Symptoms</condition>
  <condition>Livelihoods</condition>
  <arm_group>
    <arm_group_label>WfWI Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Women receive the WfWI intervention. This comprises of three main components. First, a social empowerment and health intervention. Second a livelihood strengthening intervention, including numeracy training, and vocational training. Third, a cash transfer conditional on attendance at the intervention to cover costs of attendance and provide start-up capital. The intervention is delivered over 12 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Women for Women International Intervention</intervention_name>
    <arm_group_label>WfWI Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women should be in the lowest economic level (earning less than US$1.25/day)&#xD;
&#xD;
          -  Unemployed&#xD;
&#xD;
          -  No in education/school&#xD;
&#xD;
          -  Not involved in a similar programme&#xD;
&#xD;
          -  Able to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not mentally incapacitated, so as unable to provide informed consent&#xD;
&#xD;
          -  Already been part of the WfWI intervention previously&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rachel Jewkes, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Director Gender and Health Research Unit</affiliation>
  </overall_official>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 28, 2017</study_first_submitted>
  <study_first_submitted_qc>July 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 2, 2017</study_first_posted>
  <last_update_submitted>July 28, 2017</last_update_submitted>
  <last_update_submitted_qc>July 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical Research Council, South Africa</investigator_affiliation>
    <investigator_full_name>Rachel Jewkes</investigator_full_name>
    <investigator_title>Director Gender and Health Research Unit</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03236948
org study id: EC034-11-2015
nct id: NCT03236948
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is an individually randomised control trial to assess the effectiveness of a livelihoods
      and social empowerment intervention, delivered by Women for Women International, on married
      women's experiences of intimate partner violence in Afghanistan. It has a 22 month follow up.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Individual level randomised trial, with intervention and control group
primary purpose: Prevention
masking: None (Open Label)
measure: Any past year physical intimate partner violence experienced amongst currently married women
time frame: 22 months post baseline
description: Physical intimate partner violence is assessed using five items based on the WHO VAW scale. A positive response to any item leads to a person being classified as experiencing in the past year.
measure: Past year severe physical intimate partner violence experience amongst currently married women
time frame: 22 months post baseline
description: Severe physical intimate partner violence experience is assessed using 5 items. Past year severe physical IPV is assessed as positive if a person responds to two (or more) items as once, or one item as few (or more), essentially creating a more than once categorization.
measure: Depressive symptomology
time frame: 22 months post baseline
description: Past week depressive symptomology is assessed by the Centre for Epidemiological Studies Depression (CESD) scale, with the full twenty items. A mean score will be calculated.
measure: Household food insecurity in past four weeks
time frame: 22 months post baseline
description: Three items ask about household level food insecurity in the past 4 weeks. A mean score is calculated.
measure: Financial shock resilience
time frame: 22 months post baseline
description: One item assesses ability to mobilise cash in an emergency.
measure: Monthly earnings
time frame: 22 months post baseline
description: A single item assesses women's past month earnings
measure: Total savings
time frame: 22 months post baseline
description: A single item assesses women's total savings
measure: Life satisfaction
time frame: 22 months post baseline
description: Life satisfaction is assessed using four-items derived from the Satisfaction With Life Scale. A mean score is produced.
measure: Suicidal ideation in past 4 weeks
time frame: 22 months post baseline
description: A single item assesses thoughts about suicide in past week.
measure: Gender attitudes
time frame: 22 months post baseline
description: 11 questions assess women's gender attitudes. A mean score is created.
measure: Married women's participation in household decision-making
time frame: 22 months post baseline
description: Five items are asked about women's ability to participate in household decisions. A mean score is created.
measure: Any emotional abuse in the past year amongst currently married women
time frame: 22 months post baseline
description: Seven items assess emotional abuse in the past year. A mean score is calculated.
measure: Perceptions of husband cruelty amongst currently married women
time frame: 22 months post baseline
description: Five items ask about married women's perceptions of her husband and his attitudes and relationship towards her. A mean score is created
measure: Mother-in-law or abuse in the past 12 months amongst currently married women
time frame: 22 months post baseline
description: A single item assesses whether mother-in-laws have hit the woman in the past 12 months and another item assesses whether siblings have hit the woman in the past 12 months, an affirmative response to either item would indicate abuse.
measure: Perceptions of mother-in-law cruelty amongst currently married women
time frame: 22 months post baseline
description: For married women, six items ask about their relationship and the mother-in-laws attitudes towards her
arm group label: WfWI Intervention
arm group type: Experimental
description: Women receive the WfWI intervention. This comprises of three main components. First, a social empowerment and health intervention. Second a livelihood strengthening intervention, including numeracy training, and vocational training. Third, a cash transfer conditional on attendance at the intervention to cover costs of attendance and provide start-up capital. The intervention is delivered over 12 months.
arm group label: Control
arm group type: No Intervention
intervention type: Behavioral
intervention name: Women for Women International Intervention
arm group label: WfWI Intervention
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Rachel Jewkes, PhD
role: Principal Investigator
affiliation: Director Gender and Health Research Unit
responsible party type: Principal Investigator
investigator affiliation: Medical Research Council, South Africa
investigator full name: Rachel Jewkes
investigator title: Director Gender and Health Research Unit
mesh term: Depression
sharing ipd: No