Preventing Intimate-partner Violence: Impact Evaluation of Engaging Men Through Accountable Practice in Eastern DRC

May 16, 2018 updated by: World Bank
The objective of the study is to evaluate the impact of Engaging Men in Accountable Practice (EMAP) on the prevention of violence against women and girls in North and South Kivu (DRC). The study is conducted jointly by the World Bank's Africa Gender Innovation Lab and the International Rescue Committee (IRC). EMAP is a program developed and implemented by the IRC to engage men to reflect on how to reduce and prevent intimate partner violence through 16 weekly group discussion sessions. The study is a cluster randomized control trial in which two groups of 25 self-selected men in 15 communities receive the EMAP intervention while in 15 other communities, 50 self-selected men receive an alternative intervention. Key outcomes examined include: (i) Experience of past year physical, sexual and psychological violence reported by women whose partners are EMAP participants; (ii) Participant's gender attitudes and behaviors, conflict and hostility management skills; (iii) Power sharing and communication within the couple.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1387

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Congo, The Democratic Republic of the
      • Bukavu, Congo, The Democratic Republic of the
        • International Rescue Committee
      • Goma, Congo, The Democratic Republic of the
        • International Rescue Committee

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Age 20 or older but preferably at least 25;
  • Resident of their village, having lived in the community for a minimum of six months with plans to continue living there for at least the coming six months;
  • Ability to participate actively in group work and reflection activities;
  • Commitment to attend meetings, sessions and other activities regularly without incentives;
  • Commitment to non-violence toward women and girls for the duration of the EMAP intervention;

Exclusion Criteria:

  • Involved in the IRC-led adolescent girl intervention (COMPASS).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: EMAP Treatment
Engaging Men through Accountable Practice: 30 communities are matched into 15 pairs on a set of socio-demographic characteristic and within each pair, 15 treatment sites are randomly selected. Within each treatment community, all adult men (20+ years old) are eligible to participate in the EMAP intervention. A random draw of 50 participants determines who will participate in EMAP in case more than 50 eligible men express interest.
Behavioral: Engaging Men through Accountable Practice
Engaging Men through Accountable Practice aims to engage men as agents of change through structured, weekly discussions with committed groups of men. It aims to address entrenched views of gender roles and identify positive models of masculinity. The approach follows a structured series of discussions designed to explore existing understandings of masculinity and create more positive models of what it means to be a 'good' man, promoting self-reflection and pushing men to analyze and change their own power and privilege. This methodology begins with a series of discussions with women to inform men's dialogue groups, and includes continuous feedback loops with women throughout the process so that the work with men is grounded in, and accountable to, women's views and objectives.
Other: Control
In the 15 control sites, the male participants will receive an alternative intervention focused on a non-gender topic of 16 weekly sessions for men only.
Other: Alternative intervention
Control communities will receive an alternative intervention focused on a non-gender topic of 16 weekly sessions for men only.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in baseline prevalence of intimate-partner violence
Time Frame: Baseline, 12 months follow-up
Change in the % of women who self-report experience of violence by their male partner. The women interviewed are the partners of the male study participants.
Baseline, 12 months follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in acceptability of intimate partner violence
Time Frame: Baseline, 12 months follow-up
Change in the % of women (partners of participants) and men (participants) who report that violence is acceptable in at least one of the situations listed in the survey.
Baseline, 12 months follow-up
Change in intention to commit violence
Time Frame: Baseline, 12 months follow-up
Change in the % of male participants who report that they are likely to become violent in a list of situations. Scale used: Proximal Antecedents to Violent Episodes.
Baseline, 12 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
World Bank

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
International Rescue Committee

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Julia Vaillant, PhD, World Bank

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 4, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 6, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 21, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P149394

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

The World Bank has an open data policy, and the de-identified, anonymized data will be published online after the study is completed.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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