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Domestic ViolencePhase 3NCT03236948

RCT of the Effectiveness of the WfWI Intervention in Afghanistan

A Phase 3 study testing Women for Women International Intervention in people with Domestic Violence and Depressive Symptoms, run by Medical Research Council, South Africa.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
What is being tested?
Women for Women International Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,461 participants
Where
No sites listed yet
Study dates
Oct 2016to Nov 2018
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

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

About this study

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

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.

Being tested
Women for Women International Intervention
Medical subject headings
Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Women for Women International InterventionBehavioural

Study groups in NCT03236948
Study groupRoleWhat they receive
WfWI InterventionExperimentalWomen 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.
Receives: Behavioral: Women for Women International Intervention
ControlNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 22 months post baseline

  2. 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.

    Measured: 22 months post baseline

  3. 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.

    Measured: 22 months post baseline

Secondary outcomes (12)

  1. 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.

    Measured: 22 months post baseline

  2. Financial shock resilience

    One item assesses ability to mobilise cash in an emergency.

    Measured: 22 months post baseline

  3. Monthly earnings

    A single item assesses women's past month earnings

    Measured: 22 months post baseline

  4. Total savings

    A single item assesses women's total savings

    Measured: 22 months post baseline

  5. Life satisfaction

    Life satisfaction is assessed using four-items derived from the Satisfaction With Life Scale. A mean score is produced.

    Measured: 22 months post baseline

  6. Suicidal ideation in past 4 weeks

    A single item assesses thoughts about suicide in past week.

    Measured: 22 months post baseline

  7. Gender attitudes

    11 questions assess women's gender attitudes. A mean score is created.

    Measured: 22 months post baseline

  8. 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.

    Measured: 22 months post baseline

  9. 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.

    Measured: 22 months post baseline

  10. 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

    Measured: 22 months post baseline

  11. 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.

    Measured: 22 months post baseline

  12. 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

    Measured: 22 months post baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Aug 2017
  2. Study startOct 2016
  3. Primary completionNov 2018 (estimated)
  4. Study completionNov 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Individual level randomised trial, with intervention and control group
Masking
None (open label)
Enrolment
1,461 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03236948
Sponsor's protocol ID
EC034-11-2015
Status last verified
Jul 2017
First submitted
28 Jul 2017
Last updated
2 Aug 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 32201622

  • 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.

    PubMed 31393873

  • 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.

    PubMed 29724222

  • 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.

    PubMed 29357843

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Women for Women International Intervention in people with Domestic Violence and Depressive Symptoms, run by Medical Research Council, South Africa.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Any past year physical intimate partner violence experienced amongst currently married women (time frame: 22 months post baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03236948, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2017.

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