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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03236948
Other study ID # EC034-11-2015
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received July 28, 2017
Last updated July 28, 2017
Start date October 2016
Est. completion date November 2018

Study information

Verified date July 2017
Source Medical Research Council, South Africa
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 1461
Est. completion date November 2018
Est. primary completion date November 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility 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 Design


Intervention

Behavioral:
Women for Women International Intervention


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Medical Research Council, South Africa Women for Women International (WfWI)

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 22 months post baseline
Primary 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. 22 months post baseline
Primary 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. 22 months post baseline
Secondary 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. 22 months post baseline
Secondary Financial shock resilience One item assesses ability to mobilise cash in an emergency. 22 months post baseline
Secondary Monthly earnings A single item assesses women's past month earnings 22 months post baseline
Secondary Total savings A single item assesses women's total savings 22 months post baseline
Secondary Life satisfaction Life satisfaction is assessed using four-items derived from the Satisfaction With Life Scale. A mean score is produced. 22 months post baseline
Secondary Suicidal ideation in past 4 weeks A single item assesses thoughts about suicide in past week. 22 months post baseline
Secondary Gender attitudes 11 questions assess women's gender attitudes. A mean score is created. 22 months post baseline
Secondary 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. 22 months post baseline
Secondary 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. 22 months post baseline
Secondary 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 22 months post baseline
Secondary 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. 22 months post baseline
Secondary 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 22 months post baseline
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