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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03210454
Other study ID # IRB00083606
Secondary ID
Status Completed
Phase N/A
First received July 5, 2017
Last updated August 21, 2017
Start date April 2, 2016
Est. completion date July 31, 2017

Study information

Verified date August 2017
Source Emory University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The proposed project seeks to implement a cluster-randomized controlled trial (RCT) to measure the impact of increasing women´s incomes and providing gender equality trainings on women´s empowerment and risk of intimate partner violence (IPV) in Colombia. This project will be the first in Latin America to evaluate rigorously the impact of a marketing intervention, alone and combined with IPV prevention training. The knowledge generated from this evaluation has the potential to identify the most effective solutions to empower women, as well as to drive transformative change in current approaches to reduce IPV and promote gender equality in highly vulnerable populations in Colombia, and worldwide.


Description:

The proposed project seeks to implement a cluster-randomized controlled trial (RCT) to measure the impact of increasing women´s incomes and providing gender equality trainings on women´s empowerment and risk of intimate partner violence (IPV) in Colombia. This project will be the first in Latin America to evaluate rigorously the impact of a marketing intervention, alone and combined with IPV prevention training. The knowledge generated from this evaluation has the potential to identify the most effective solutions to empower women, as well as to drive transformative change in current approaches to reduce IPV and promote gender equality in highly vulnerable populations in Colombia, and worldwide.

The goal of the project is to estimate the impact of generating livelihood opportunities and providing gender-based violence (GBV) training to reduce IPV among women in Colombia. This will generate much needed evidence on the most effective approach to empower women smallholder farmers and reduce their exposure to IPV. Investigators will conduct a cluster randomized controlled trial targeting approximately 100 smallholder farmers' associations and approximately 2700 women. Results will inform and strengthen future programming of humanitarian assistance and can be replicated in humanitarian interventions in other parts of the world.

The experimental operational research will compare two programmatic modalities and their impact on women's risk of exposure to IPV, against a comparison group where no intervention takes place. The modalities will include: (1) providing a stable income for women, and (2) providing a stable income and IPV trainings to women. The evaluation will take place in five departments: Cauca, Valle de Cauca, Meta, Caquetá, and Nariño.


Recruitment information / eligibility

Status Completed
Enrollment 1882
Est. completion date July 31, 2017
Est. primary completion date July 31, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- Women currently married or living together with a man as if married

- Males or females who are active within the farmer's association are eligible to participate

Exclusion Criteria:

- Women who have a husband/partner who is living elsewhere permanently

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Smallholder Marketing
The smallholder marketing intervention involves product purchasing (e.g., bananas, beans, goats, eggs) from smallholder farmers' associations through WFP's large procurement procedures. WFP is will also provide technical training on topics such as sustainable farming practices, quality control, and business practices.
Intimate Partner Violence (IPV) Prevention Training
IPV prevention training involves 24 hours of gender training (gender equality and rights, economic empowerment, gender-based violence prevention), and 8 hours of nutrition and food security training (with a focus on gender).

Locations

Country Name City State
Colombia World Food Programme Colombia Aurora Bogotá

Sponsors (1)

Lead Sponsor Collaborator
Emory University

Country where clinical trial is conducted

Colombia, 

Outcome

Type Measure Description Time frame Safety issue
Other Women's Attitudes Towards Gender General attitudes towards gender will be qualitatively collected via interview from women post intervention. End-Line (12 Months Post Intervention)
Other Change in Women's Economic Empowerment Changes in women's thoughts on economic empowerment will be qualitatively collected via interview. Baseline, End-Line (12 Months Post Intervention)
Other Change in Women's Attitudes Towards Gender Differences in general attitudes towards gender will be qualitatively collected via interview from women from baseline to post intervention. Baseline, End-Line (12 Months Post Intervention)
Other Household Food Insecurity Access to adequate amounts of food for the household will be assessed via interview. End-Line (12 Months Post Intervention)
Other Change in Household Food Insecurity Change in access to adequate amounts of food for the household from baseline to end-line will be assessed via interview. Baseline, End-Line (12 Months Post Intervention)
Other Total Personal and Household Income The total income generated for a household will be collected via interview. End-Line (12 Months Post Intervention)
Other Change in Total Personal and Household Income The difference in the total income generated for a household from baseline to end-line. Baseline, End-Line (12 Months Post Intervention)
Primary Incidence Physical and/or Sexual IPV The number of new physical and/or sexual IPV encounters as reported in the study survey. Post-Baseline (12 Months)
Primary Change in Prevalence of Physical and/or Sexual IPV The difference in the number of physical or sexual IPV encounters between baseline and post intervention as reported in the study survey. Baseline, End-Line (12 Months Post Intervention)
Secondary Incidence Physical IPV The number of new physical IPV encounters reported. Post-Baseline (12 Months)
Secondary Incidence Sexual IPV The number of new sexual IPV encounters as reported in the study survey. Post-Baseline (12 Months)
Secondary Incidence Psychological IPV The number of new physiological IPV encounters as reported in the study survey. Post-Baseline (12 Months)
Secondary Incidence Economic Coercion The number of new encounters of economic coercion as reported in the study survey. Post-Baseline (12 Months)
Secondary Change in Prevalence of Physical IPV The difference in the number of physical IPV encounters between baseline and post intervention as reported in the study survey. Baseline, End-Line (12 Months Post Intervention)
Secondary Change in Prevalence of Sexual IPV The difference in the number of sexual IPV encounters between baseline and post intervention as reported in the study survey. Baseline, End-Line (12 Months Post Intervention)
Secondary Change in Prevalence of Psychological IPV The difference in the number of psychological IPV encounters between baseline and post intervention as reported in the study survey. Baseline, End-Line (12 Months Post Intervention)
Secondary Change in Prevalence of Economic Coercion The difference in the number of economic coercion encounters between baseline and post intervention as reported in the study survey. Baseline, End-Line (12 Months Post Intervention)
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