Domestic ViolenceNCT01803932
Evaluation of a Male-focused Intervention to Prevent Intimate Partner Violence in a Conflict-affected Setting
A study testing Male-focused group violence prevention intervention in people with Domestic Violence, run by London School of Hygiene and Tropical Medicine at 1 site in Côte d’Ivoire.
Trial summary
Cluster randomized controlled trial to evaluate a male-focused primary prevention programme which used a men's only group discussion format to prevent intimate partner violence against women \& girls through fostering knowledge and behaviour changes by: (1) increasing men's knowledge on the impact of violence against… Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Domestic Violence
- What is being tested?
- Male-focused group violence prevention intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 601 participants
- Where
- 1 siteCôte d’Ivoire
- Study dates
- Sep 2008to Mar 2012
- 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 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 15+ years old
- males: participant in group intervention or selected as control
- females: female intimate partner of males in intervention or selected as control
- capable of completing face-to-face interview independently and without causing undue psychological distress
Who cannot join
- lack of informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Male-focused Primary Prevention Intervention to Prevent Intimate Partner Violence in a Conflict-affected Setting: A Cluster Randomized Controlled Trial in Cote d'Ivoire
Cluster randomized controlled trial to evaluate a male-focused primary prevention programme which used a men's only group discussion format to prevent intimate partner violence against women \& girls through fostering knowledge and behaviour changes by: (1) increasing men's knowledge on the impact of violence against women; (2) promoting gender equitable beliefs/behaviours within relationships; and (3) developing anger management techniques.
- Conditions
- Domestic Violence
- Being tested
- Male-focused group violence prevention intervention
- Keywords
- intimate partner violence, gender, primary prevention intervention, conflict, Cote d'Ivoire, Ivory Coast
- Medical subject headings
- Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Male-focused group violence prevention interventionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Behavioral intervention | Experimental | Male-focused group violence prevention intervention Receives: Behavioral: Male-focused group violence prevention intervention |
| Control communities | No intervention | Communities in which male-focused group prevention activities will not be conducted |
What is being measured
The primary outcome is the main question the study is designed to answer.
Past 12 months victimisation/perpetration of physical or sexual intimate partner violence
Measured: 1 year after intervention completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2013 (estimated)
- Study startSep 2008
- Primary completionNov 2010
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Domestic 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
- Single group
- Masking
- None (open label)
- Enrolment
- 601 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- International Rescue Committee
- Responsible party
- Principal investigator, Mazeda Hossain, London School of Hygiene and Tropical Medicine
- Investigators
- Mazeda Hossain, Principal investigator, London School of Hygiene and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01803932
- Sponsor's protocol ID
- InterveneDV-CI
- Status last verified
- Mar 2013
- First submitted
- 25 Feb 2013
- Last updated
- 4 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Hossain M, Zimmerman C, Kiss L, Abramsky T, Kone D, Bakayoko-Topolska M, Annan J, Lehmann H, Watts C. Working with men to prevent intimate partner violence in a conflict-affected setting: a pilot cluster randomized controlled trial in rural Cote d'Ivoire. BMC Public Health. 2014 Apr 10;14:339. doi: 10.1186/1471-2458-14-339.
PubMed 24716478
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Male-focused Primary Prevention Intervention to Prevent Intimate Partner Violence in a Conflict-affected Setting: A Cluster Randomized Controlled Trial in Cote d'Ivoire
- ClinicalTrials.gov ID
- NCT01803932
- Acronym / sponsor ID
- InterveneDV-CI
- Conditions
- Domestic Violence
- Keywords
- intimate partner violence, gender, primary prevention intervention, conflict, Cote d'Ivoire, Ivory Coast
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 601 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- International Rescue Committee
- Study start
- Sep 2008
- Primary completion
- Nov 2010 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 4 Mar 2013 (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.
Cluster randomized controlled trial to evaluate a male-focused primary prevention programme which used a men's only group discussion format to prevent intimate partner violence against women \& girls through fostering knowledge and behaviour changes by: (1) increasing men's knowledge on the impact of violence against women; (2) promoting gender equitable beliefs/behaviours within relationships; and (3) developing anger management techniques.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral intervention | Experimental | Behavioral: Male-focused group violence prevention interventionMale-focused group violence prevention intervention |
| Control communities | No intervention | –Communities in which male-focused group prevention activities will not be conducted |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 15+ years old
- males: participant in group intervention or selected as control
- females: female intimate partner of males in intervention or selected as control
- capable of completing face-to-face interview independently and without causing undue psychological distress
Key exclusion criteria (1 listed)
- lack of informed consent
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 |
|---|---|---|
| Male-focused group violence prevention intervention | Behavioural | Behavioral intervention |
Primary outcome
Past 12 months victimisation/perpetration of physical or sexual intimate partner violence
Time frame: 1 year after intervention completion
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 4 Mar 2013.
- Derived from this study: PubMed 24716478Hossain M, Zimmerman C, Kiss L, Abramsky T, Kone D, Bakayoko-Topolska M, Annan J, Lehmann H, Watts C. Working with men to prevent intimate partner violence in a conflict-affected setting: a pilot cluster randomized controlled trial in rural Cote d'Ivoire. BMC Public Health. 2014 Apr 10;14:339. doi: 10.1186/1471-2458-14-339.
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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.
Mazeda Hossain principal investigator
London School of Hygiene and Tropical Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Male-focused group violence prevention intervention in people with Domestic Violence, run by London School of Hygiene and Tropical Medicine at 1 site in Côte d’Ivoire.
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 4 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 4 Mar 2013. 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 Côte d’Ivoire. 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?
Past 12 months victimisation/perpetration of physical or sexual intimate partner violence (time frame: 1 year after intervention completion). 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 NCT01803932, which also lists 1 linked publication.
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 4 Mar 2013.