Gender Based ViolenceNCT03210454
Evaluation of Marketing Interventions in Colombia
A study testing Smallholder Marketing and Intimate Partner Violence (IPV) Prevention Training in people with Gender Based Violence and Intimate Partner Violence, run by Emory University at 1 site in Colombia.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Gender Based Violence, Intimate Partner Violence
- What is being tested?
- Smallholder Marketing and Intimate Partner Violence (IPV) Prevention Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,882 participants
- Where
- 1 siteColombia
- Study dates
- 2 Apr 2016to 31 Jul 2017
- Phase
- Interventional
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Women who have a husband/partner who is living elsewhere permanently
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation Of The Effect Of Marketing Interventions For Women On Economic Empowerment And Risk Of Intimate Partner Violence In Colombia
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.
Read the detailed 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.
- Conditions
- Gender Based Violence, Intimate Partner Violence
- Being tested
- Smallholder Marketing, Intimate Partner Violence (IPV) Prevention Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smallholder MarketingOther
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 TrainingOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group 1 | Experimental | Farmers associations, including men and women, will be randomized to receive the smallholder marketing intervention. Receives: 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. Receives: Other: Smallholder Marketing; Other: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence Physical and/or Sexual IPV
The number of new physical and/or sexual IPV encounters as reported in the study survey.
Measured: 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.
Measured: Baseline, End-Line (12 Months Post Intervention)
Secondary outcomes (8)
Incidence Physical IPV
The number of new physical IPV encounters reported.
Measured: Post-Baseline (12 Months)
Incidence Sexual IPV
The number of new sexual IPV encounters as reported in the study survey.
Measured: Post-Baseline (12 Months)
Incidence Psychological IPV
The number of new physiological IPV encounters as reported in the study survey.
Measured: Post-Baseline (12 Months)
Incidence Economic Coercion
The number of new encounters of economic coercion as reported in the study survey.
Measured: Post-Baseline (12 Months)
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.
Measured: Baseline, End-Line (12 Months Post Intervention)
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.
Measured: Baseline, End-Line (12 Months Post Intervention)
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.
Measured: Baseline, End-Line (12 Months Post Intervention)
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.
Measured: Baseline, End-Line (12 Months Post Intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2017
- Study start2 Apr 2016
- Primary completion31 Jul 2017
- Study completion31 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gender Based ViolenceStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The randomization occurs at the farmer's association level.
- Masking
- None (open label)
- Enrolment
- 1,882 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kathryn Yount, Emory University
- Investigators
- Kathryn Yount, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03210454
- Sponsor's protocol ID
- IRB00083606
- Status last verified
- Aug 2017
- First submitted
- 5 Jul 2017
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of The Effect Of Marketing Interventions For Women On Economic Empowerment And Risk Of Intimate Partner Violence In Colombia
- ClinicalTrials.gov ID
- NCT03210454
- Acronym / sponsor ID
- IRB00083606
- Conditions
- Gender Based Violence, Intimate Partner Violence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,882 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- 2 Apr 2016 (actual)
- Primary completion
- 31 Jul 2017 (actual)
- Study completion
- 31 Jul 2017 (actual)
- First posted
- 7 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The randomization occurs at the farmer's association level.
| Arm | Type | Receives |
|---|---|---|
| Treatment Group 1 | Experimental | Other: Smallholder MarketingFarmers associations, including men and women, will be randomized to receive the smallholder marketing intervention. |
| Treatment Group 2 | Experimental | Other: Smallholder Marketing, Other: Intimate Partner Violence (IPV) Prevention TrainingFarmers associations, including men and women, will be randomized to receive the smallholder marketing intervention combined with the 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Women who have a husband/partner who is living elsewhere permanently
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smallholder MarketingThe 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. | Other | Treatment Group 1, Treatment Group 2 |
| Intimate Partner Violence (IPV) Prevention TrainingIPV 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). | Other | Treatment Group 2 |
Primary outcome
Incidence Physical and/or Sexual IPV
Time frame: Post-Baseline (12 Months)
The number of new physical and/or sexual IPV encounters as reported in the study survey.
Change in Prevalence of Physical and/or Sexual IPV
Time frame: Baseline, End-Line (12 Months Post Intervention)
The difference in the number of physical or sexual IPV encounters between baseline and post intervention as reported in the study survey.
8 secondary outcomes
Incidence Physical IPV
Time frame: Post-Baseline (12 Months)
Incidence Sexual IPV
Time frame: Post-Baseline (12 Months)
Incidence Psychological IPV
Time frame: Post-Baseline (12 Months)
Incidence Economic Coercion
Time frame: Post-Baseline (12 Months)
Change in Prevalence of Physical IPV
Time frame: Baseline, End-Line (12 Months Post Intervention)
Change in Prevalence of Sexual IPV
Time frame: Baseline, End-Line (12 Months Post Intervention)
Change in Prevalence of Psychological IPV
Time frame: Baseline, End-Line (12 Months Post Intervention)
Change in Prevalence of Economic Coercion
Time frame: Baseline, End-Line (12 Months Post Intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathryn Yount, PhD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smallholder Marketing and Intimate Partner Violence (IPV) Prevention Training in people with Gender Based Violence and Intimate Partner Violence, run by Emory University at 1 site in Colombia.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 22 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence Physical and/or Sexual IPV (time frame: Post-Baseline (12 Months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Aug 2017.