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

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.

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.

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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