NCT03210454

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,882

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 2, 2016

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 5, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 7, 2017

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2017

Completed
Last Updated

August 22, 2017

Status Verified

August 1, 2017

Enrollment Period

1.3 years

First QC Date

July 5, 2017

Last Update Submit

August 21, 2017

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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)

  • 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 Outcomes (8)

  • Incidence Physical IPV

    Post-Baseline (12 Months)

  • Incidence Sexual IPV

    Post-Baseline (12 Months)

  • Incidence Psychological IPV

    Post-Baseline (12 Months)

  • Incidence Economic Coercion

    Post-Baseline (12 Months)

  • Change in Prevalence of Physical IPV

    Baseline, End-Line (12 Months Post Intervention)

  • +3 more secondary outcomes

Other Outcomes (7)

  • Women's Attitudes Towards Gender

    End-Line (12 Months Post Intervention)

  • Change in Women's Economic Empowerment

    Baseline, End-Line (12 Months Post Intervention)

  • Change in Women's Attitudes Towards Gender

    Baseline, End-Line (12 Months Post Intervention)

  • +4 more other outcomes

Study Arms (3)

Treatment Group 1

EXPERIMENTAL

Farmers associations, including men and women, will be randomized to receive the smallholder marketing intervention.

Other: Smallholder Marketing

Treatment Group 2

EXPERIMENTAL

Farmers associations, including men and women, will be randomized to receive the smallholder marketing intervention combined with the intimate partner violence (IPV) prevention training.

Other: Smallholder MarketingOther: Intimate Partner Violence (IPV) Prevention Training

Comparison Group 3

NO INTERVENTION

Women involved with farmers's associations that work independently of World Food Programmes (WFP's) assistance.

Interventions

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.

Treatment Group 1Treatment Group 2

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).

Treatment Group 2

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

World Food Programme Colombia

Aurora, Bogota D.C., Colombia

Location

MeSH Terms

Interventions

Poliovirus Vaccine, Inactivated

Intervention Hierarchy (Ancestors)

Vaccines, InactivatedVaccinesBiological ProductsComplex MixturesPoliovirus VaccinesViral Vaccines

Study Officials

  • Kathryn Yount, PhD

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: The randomization occurs at the farmer's association level.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 5, 2017

First Posted

July 7, 2017

Study Start

April 2, 2016

Primary Completion

July 31, 2017

Study Completion

July 31, 2017

Last Updated

August 22, 2017

Record last verified: 2017-08

Locations