- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03236948
RCT of the Effectiveness of the WfWI Intervention in Afghanistan
July 28, 2017 updated by: Rachel Jewkes, Medical Research Council, South Africa
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
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1461
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
|
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
22 months post baseline
|
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.
|
22 months post baseline
|
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.
|
22 months post baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
22 months post baseline
|
Financial shock resilience
Time Frame: 22 months post baseline
|
One item assesses ability to mobilise cash in an emergency.
|
22 months post baseline
|
Monthly earnings
Time Frame: 22 months post baseline
|
A single item assesses women's past month earnings
|
22 months post baseline
|
Total savings
Time Frame: 22 months post baseline
|
A single item assesses women's total savings
|
22 months post baseline
|
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.
|
22 months post baseline
|
Suicidal ideation in past 4 weeks
Time Frame: 22 months post baseline
|
A single item assesses thoughts about suicide in past week.
|
22 months post baseline
|
Gender attitudes
Time Frame: 22 months post baseline
|
11 questions assess women's gender attitudes.
A mean score is created.
|
22 months post baseline
|
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.
|
22 months post baseline
|
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.
|
22 months post baseline
|
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
|
22 months post baseline
|
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.
|
22 months post baseline
|
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
|
22 months post baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Rachel Jewkes, PhD, Director Gender and Health Research Unit
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2016
Primary Completion (Anticipated)
November 1, 2018
Study Completion (Anticipated)
November 1, 2018
Study Registration Dates
First Submitted
July 28, 2017
First Submitted That Met QC Criteria
July 28, 2017
First Posted (Actual)
August 2, 2017
Study Record Updates
Last Update Posted (Actual)
August 2, 2017
Last Update Submitted That Met QC Criteria
July 28, 2017
Last Verified
July 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EC034-11-2015
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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