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RCT of the Effectiveness of the WfWI Intervention in Afghanistan

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ClinicalTrials.gov Identifier: NCT03236948
Recruitment Status : Unknown
Verified July 2017 by Rachel Jewkes, Medical Research Council, South Africa.
Recruitment status was:  Active, not recruiting
First Posted : August 2, 2017
Last Update Posted : August 2, 2017
Sponsor:
Collaborator:
Women for Women International (WfWI)
Information provided by (Responsible Party):
Rachel Jewkes, Medical Research Council, South Africa

Tracking Information
First Submitted Date  ICMJE July 28, 2017
First Posted Date  ICMJE August 2, 2017
Last Update Posted Date August 2, 2017
Actual Study Start Date  ICMJE October 2016
Estimated Primary Completion Date November 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 28, 2017)
  • Any past year physical intimate partner violence experienced amongst currently married women [ Time Frame: 22 months post baseline ]
    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 [ Time Frame: 22 months post baseline ]
    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 [ Time Frame: 22 months post baseline ]
    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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 28, 2017)
  • Household food insecurity in past four weeks [ Time Frame: 22 months post baseline ]
    Three items ask about household level food insecurity in the past 4 weeks. A mean score is calculated.
  • Financial shock resilience [ Time Frame: 22 months post baseline ]
    One item assesses ability to mobilise cash in an emergency.
  • Monthly earnings [ Time Frame: 22 months post baseline ]
    A single item assesses women's past month earnings
  • Total savings [ Time Frame: 22 months post baseline ]
    A single item assesses women's total savings
  • Life satisfaction [ Time Frame: 22 months post baseline ]
    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 [ Time Frame: 22 months post baseline ]
    A single item assesses thoughts about suicide in past week.
  • Gender attitudes [ Time Frame: 22 months post baseline ]
    11 questions assess women's gender attitudes. A mean score is created.
  • Married women's participation in household decision-making [ Time Frame: 22 months post baseline ]
    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 [ Time Frame: 22 months post baseline ]
    Seven items assess emotional abuse in the past year. A mean score is calculated.
  • Perceptions of husband cruelty amongst currently married women [ Time Frame: 22 months post baseline ]
    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 [ Time Frame: 22 months post baseline ]
    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 [ Time Frame: 22 months post baseline ]
    For married women, six items ask about their relationship and the mother-in-laws attitudes towards her
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE RCT of the Effectiveness of the WfWI Intervention in Afghanistan
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Individual level randomised trial, with intervention and control group
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Domestic Violence
  • Depressive Symptoms
  • Livelihoods
Intervention  ICMJE Behavioral: Women for Women International Intervention
Study Arms  ICMJE
  • Experimental: WfWI Intervention
    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.
    Intervention: Behavioral: Women for Women International Intervention
  • No Intervention: Control
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: July 28, 2017)
1461
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2018
Estimated Primary Completion Date November 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03236948
Other Study ID Numbers  ICMJE EC034-11-2015
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Rachel Jewkes, Medical Research Council, South Africa
Study Sponsor  ICMJE Medical Research Council, South Africa
Collaborators  ICMJE Women for Women International (WfWI)
Investigators  ICMJE
Principal Investigator: Rachel Jewkes, PhD Director Gender and Health Research Unit
PRS Account Medical Research Council, South Africa
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP