Intimate Partner ViolenceNCT02765139
Preventing Intimate-partner Violence: Impact Evaluation of Engaging Men Through Accountable Practice in Eastern DRC
A study testing Engaging Men through Accountable Practice and Alternative intervention in people with Intimate Partner Violence and Domestic Violence, run by World Bank at 2 sites in Democratic Republic of the Congo.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 20 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Intimate Partner Violence, Domestic Violence, Family Relations
- What is being tested?
- Engaging Men through Accountable Practice and Alternative intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,387 participants
- Where
- 2 sitesDemocratic Republic of the Congo
- Study dates
- Feb 2016to Dec 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 20 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- Involved in the IRC-led adolescent girl intervention (COMPASS).
Trial locations and contacts
2 sites in 1 country.
Democratic Republic of the Congo2 sites
International Rescue Committee
Bukavu
International Rescue Committee
Goma
About this study
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.
- Being tested
- Engaging Men through Accountable Practice, Alternative intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Engaging Men through Accountable PracticeBehavioural
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.
Alternative interventionOther
Control communities will receive an alternative intervention focused on a non-gender topic of 16 weekly sessions for men only.
| Study group | Role | What they receive |
|---|---|---|
| EMAP Treatment | Experimental | 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. Receives: Behavioral: Engaging Men through Accountable Practice |
| Control | Other | 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. Receives: Other: Alternative intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in baseline prevalence of intimate-partner violence
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.
Measured: Baseline, 12 months follow-up
Secondary outcomes (2)
Change in acceptability of intimate partner violence
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.
Measured: Baseline, 12 months follow-up
Change in intention to commit violence
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.
Measured: Baseline, 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2016 (estimated)
- Study startFeb 2016
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intimate Partner ViolenceStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,387 participants (actual)
Sponsor and investigators
- Lead sponsor
- World Bank
- Sponsor type
- University, hospital or other
- Collaborators
- International Rescue Committee
- Responsible party
- Sponsor
- Investigators
- Julia Vaillant, PhD, Principal investigator, World Bank
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02765139
- Sponsor's protocol ID
- P149394
- Status last verified
- May 2018
- First submitted
- 4 May 2016
- Last updated
- 21 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The World Bank has an open data policy, and the de-identified, anonymized data will be published online after the study is completed.
Publications
Gurbuz Cuneo A, Vaillant J, Koussoube E, Pierotti RS, Falb K, Kabeya R. Prevention, Cessation, or harm reduction: Heterogeneous effects of an intimate partner violence prevention program in eastern Democratic Republic of the Congo. PLoS One. 2023 Mar 8;18(3):e0282339. doi: 10.1371/journal.pone.0282339. eCollection 2023.
PubMed 36888613Vaillant J, Koussoube E, Roth D, Pierotti R, Hossain M, Falb KL. Engaging men to transform inequitable gender attitudes and prevent intimate partner violence: a cluster randomised controlled trial in North and South Kivu, Democratic Republic of Congo. BMJ Glob Health. 2020 May;5(5):e002223. doi: 10.1136/bmjgh-2019-002223.
PubMed 32467354
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Intimate-partner Violence: Impact Evaluation of Engaging Men Through Accountable Practice in Eastern DRC
- ClinicalTrials.gov ID
- NCT02765139
- Acronym / sponsor ID
- P149394
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,387 participants (actual)
- Lead sponsor
- World BankUniversity, hospital or other
- Collaborators
- International Rescue Committee
- Study start
- Feb 2016
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 6 May 2016 (estimated)
- 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 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EMAP Treatment | Experimental | Behavioral: Engaging Men through Accountable PracticeEngaging 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. |
| Control | Other | Other: Alternative interventionIn 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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;
Key exclusion criteria (1 listed)
- Involved in the IRC-led adolescent girl intervention (COMPASS).
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 |
|---|---|---|
| Engaging Men through Accountable PracticeEngaging 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. | Behavioural | EMAP Treatment |
| Alternative interventionControl communities will receive an alternative intervention focused on a non-gender topic of 16 weekly sessions for men only. | Other | Control |
Primary outcome
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.
2 secondary outcomes
Change in acceptability of intimate partner violence
Time frame: Baseline, 12 months follow-up
Change in intention to commit violence
Time frame: Baseline, 12 months follow-up
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 21 May 2018.
- Derived from this study: PubMed 36888613Gurbuz Cuneo A, Vaillant J, Koussoube E, Pierotti RS, Falb K, Kabeya R. Prevention, Cessation, or harm reduction: Heterogeneous effects of an intimate partner violence prevention program in eastern Democratic Republic of the Congo. PLoS One. 2023 Mar 8;18(3):e0282339. doi: 10.1371/journal.pone.0282339. eCollection 2023.
- Derived from this study: PubMed 32467354Vaillant J, Koussoube E, Roth D, Pierotti R, Hossain M, Falb KL. Engaging men to transform inequitable gender attitudes and prevent intimate partner violence: a cluster randomised controlled trial in North and South Kivu, Democratic Republic of Congo. BMJ Glob Health. 2020 May;5(5):e002223. doi: 10.1136/bmjgh-2019-002223.
- Individual participant dataSharing planned: Yes. The World Bank has an open data policy, and the de-identified, anonymized data will be published online after the study is completed.
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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.
Julia Vaillant, PhD principal investigator
World Bank
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Engaging Men through Accountable Practice and Alternative intervention in people with Intimate Partner Violence and Domestic Violence, run by World Bank at 2 sites in Democratic Republic of the Congo.
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 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 21 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Democratic Republic of the Congo. 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?
Change in baseline prevalence of intimate-partner violence (time frame: Baseline, 12 months follow-up). 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 NCT02765139, which also lists 2 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 21 May 2018.