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RCT of the Effectiveness of the WfWI Intervention in Afghanistan

Primary Purpose

Domestic Violence, Depressive Symptoms, Livelihoods

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Women for Women International Intervention
Sponsored by
Medical Research Council, South Africa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Domestic Violence

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Women should be in the lowest economic level (earning less than US$1.25/day)
  • Unemployed
  • No in education/school
  • Not involved in a similar programme
  • Able to provide informed consent

Exclusion Criteria:

  • Not mentally incapacitated, so as unable to provide informed consent
  • Already been part of the WfWI intervention previously

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    WfWI Intervention

    Control

    Arm 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.

    Outcomes

    Primary Outcome Measures

    Any past year physical intimate partner violence experienced amongst currently married women
    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.
    Past year severe physical intimate partner violence experience amongst currently married women
    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.
    Depressive symptomology
    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.

    Secondary Outcome Measures

    Household food insecurity in past four weeks
    Three items ask about household level food insecurity in the past 4 weeks. A mean score is calculated.
    Financial shock resilience
    One item assesses ability to mobilise cash in an emergency.
    Monthly earnings
    A single item assesses women's past month earnings
    Total savings
    A single item assesses women's total savings
    Life satisfaction
    Life satisfaction is assessed using four-items derived from the Satisfaction With Life Scale. A mean score is produced.
    Suicidal ideation in past 4 weeks
    A single item assesses thoughts about suicide in past week.
    Gender attitudes
    11 questions assess women's gender attitudes. A mean score is created.
    Married women's participation in household decision-making
    Five items are asked about women's ability to participate in household decisions. A mean score is created.
    Any emotional abuse in the past year amongst currently married women
    Seven items assess emotional abuse in the past year. A mean score is calculated.
    Perceptions of husband cruelty amongst currently married women
    Five items ask about married women's perceptions of her husband and his attitudes and relationship towards her. A mean score is created
    Mother-in-law or abuse in the past 12 months amongst currently married women
    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.
    Perceptions of mother-in-law cruelty amongst currently married women
    For married women, six items ask about their relationship and the mother-in-laws attitudes towards her

    Full Information

    First Posted
    July 28, 2017
    Last Updated
    July 28, 2017
    Sponsor
    Medical Research Council, South Africa
    Collaborators
    Women for Women International (WfWI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03236948
    Brief Title
    RCT of the Effectiveness of the WfWI Intervention in Afghanistan
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 2016 (Actual)
    Primary Completion Date
    November 2018 (Anticipated)
    Study Completion Date
    November 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Medical Research Council, South Africa
    Collaborators
    Women for Women International (WfWI)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Domestic Violence, Depressive Symptoms, Livelihoods

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Model Description
    Individual level randomised trial, with intervention and control group
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    1461 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    WfWI Intervention
    Arm Type
    Experimental
    Arm 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 Title
    Control
    Arm Type
    No Intervention
    Intervention Type
    Behavioral
    Intervention Name(s)
    Women for Women International Intervention
    Primary Outcome Measure Information:
    Title
    Any past year physical intimate partner violence experienced amongst currently married women
    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.
    Time Frame
    22 months post baseline
    Title
    Past year severe physical intimate partner violence experience amongst currently married women
    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.
    Time Frame
    22 months post baseline
    Title
    Depressive symptomology
    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.
    Time Frame
    22 months post baseline
    Secondary Outcome Measure Information:
    Title
    Household food insecurity in past four weeks
    Description
    Three items ask about household level food insecurity in the past 4 weeks. A mean score is calculated.
    Time Frame
    22 months post baseline
    Title
    Financial shock resilience
    Description
    One item assesses ability to mobilise cash in an emergency.
    Time Frame
    22 months post baseline
    Title
    Monthly earnings
    Description
    A single item assesses women's past month earnings
    Time Frame
    22 months post baseline
    Title
    Total savings
    Description
    A single item assesses women's total savings
    Time Frame
    22 months post baseline
    Title
    Life satisfaction
    Description
    Life satisfaction is assessed using four-items derived from the Satisfaction With Life Scale. A mean score is produced.
    Time Frame
    22 months post baseline
    Title
    Suicidal ideation in past 4 weeks
    Description
    A single item assesses thoughts about suicide in past week.
    Time Frame
    22 months post baseline
    Title
    Gender attitudes
    Description
    11 questions assess women's gender attitudes. A mean score is created.
    Time Frame
    22 months post baseline
    Title
    Married women's participation in household decision-making
    Description
    Five items are asked about women's ability to participate in household decisions. A mean score is created.
    Time Frame
    22 months post baseline
    Title
    Any emotional abuse in the past year amongst currently married women
    Description
    Seven items assess emotional abuse in the past year. A mean score is calculated.
    Time Frame
    22 months post baseline
    Title
    Perceptions of husband cruelty amongst currently married women
    Description
    Five items ask about married women's perceptions of her husband and his attitudes and relationship towards her. A mean score is created
    Time Frame
    22 months post baseline
    Title
    Mother-in-law or abuse in the past 12 months amongst currently married women
    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.
    Time Frame
    22 months post baseline
    Title
    Perceptions of mother-in-law cruelty amongst currently married women
    Description
    For married women, six items ask about their relationship and the mother-in-laws attitudes towards her
    Time Frame
    22 months post baseline

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Women should be in the lowest economic level (earning less than US$1.25/day) Unemployed No in education/school Not involved in a similar programme Able to provide informed consent Exclusion Criteria: Not mentally incapacitated, so as unable to provide informed consent Already been part of the WfWI intervention previously
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Rachel Jewkes, PhD
    Organizational Affiliation
    Director Gender and Health Research Unit
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    32201622
    Citation
    Gibbs A, Corboz J, Chirwa E, Mann C, Karim F, Shafiq M, Mecagni A, Maxwell-Jones C, Noble E, Jewkes R. The impacts of combined social and economic empowerment training on intimate partner violence, depression, gender norms and livelihoods among women: an individually randomised controlled trial and qualitative study in Afghanistan. BMJ Glob Health. 2020 Mar 16;5(3):e001946. doi: 10.1136/bmjgh-2019-001946. eCollection 2020.
    Results Reference
    derived
    PubMed Identifier
    31393873
    Citation
    Gibbs A, Said N, Corboz J, Jewkes R. Factors associated with 'honour killing' in Afghanistan and the occupied Palestinian Territories: Two cross-sectional studies. PLoS One. 2019 Aug 8;14(8):e0219125. doi: 10.1371/journal.pone.0219125. eCollection 2019.
    Results Reference
    derived
    PubMed Identifier
    29724222
    Citation
    Gibbs A, Corboz J, Jewkes R. Factors associated with recent intimate partner violence experience amongst currently married women in Afghanistan and health impacts of IPV: a cross sectional study. BMC Public Health. 2018 May 3;18(1):593. doi: 10.1186/s12889-018-5507-5.
    Results Reference
    derived
    PubMed Identifier
    29357843
    Citation
    Gibbs A, Corboz J, Shafiq M, Marofi F, Mecagni A, Mann C, Karim F, Chirwa E, Maxwell-Jones C, Jewkes R. An individually randomized controlled trial to determine the effectiveness of the Women for Women International Programme in reducing intimate partner violence and strengthening livelihoods amongst women in Afghanistan: trial design, methods and baseline findings. BMC Public Health. 2018 Jan 22;18(1):164. doi: 10.1186/s12889-018-5029-1.
    Results Reference
    derived

    Learn more about this trial

    RCT of the Effectiveness of the WfWI Intervention in Afghanistan

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