ViolenceNCT06119984
Community-based Intervention to Prevent Intimate Partner Violence in Rural Southwest, Nigeria
A study testing Community mobilization in people with Violence and Domestic Violence, run by Funmilola OlaOlorun at 1 site in Nigeria.
Trial summary
Background: Intimate partner violence is arguably the most prevalent, persistent and pernicious type of violence against women, all around the world. It also has significant repercussions for women's health, yet, in some parts of the world, considered an acceptable practice within intimate partner relationships. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Violence, Domestic Violence, Attitude
- What is being tested?
- Community mobilization
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,650 participants
- Where
- 1 siteNigeria
- Study dates
- 12 Jan 2021to 1 Dec 2022
- 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 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men aged 18 to 59 years
- Women aged 18 to 49 years
- Currently married or cohabiting with a partner
- had lived in the community for a minimum of one year.
Who cannot join
- Married/ cohabiting males or females
- does not speak either Yoruba or English
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Community-based Intervention to Address Social Norms Associated With Intimate Partner Violence in Rural Southwest, Nigeria
Background:
Intimate partner violence is arguably the most prevalent, persistent and pernicious type of violence against women, all around the world. It also has significant repercussions for women's health, yet, in some parts of the world, considered an acceptable practice within intimate partner relationships. Community-based interventions, on the other hand, offer promises as a strategy that can get community members involved in working to prevent IPV. This study evaluated a community mobilisation intervention to challenge attitudes toward IPV and prevent violence within intimate relationships.
Read more
Methods:
This mixed-method randomised community trial was conducted in selected rural communities in Oyo State, Nigeria, between January 2018 and April 2021. It employed a six-month community mobilisation intervention focused on creating awareness and challenging harmful social norms relating to IPV. In-depth interviews, focus group discussions and two cross-sectional surveys were conducted among men and women of reproductive age who were married at baseline and end line to estimate changes in key outcomes. Difference-in-difference regression models were estimated to compare changes in IPV levels in the intervention and control arms.
Conclusion:
This trial should demonstrate the effectiveness of community mobilisation interventions to change attitudes supportive of IPV and prevent women's experience of IPV.
Read the detailed description
Background: Intimate partner violence (IPV) is arguably the most pernicious, pervasive, and persistent form of violence against women worldwide. It is an abuse of women's fundamental human rights and a public health concern. Experience of IPV by women has been associated with a mixture of both noticeable and frequently unnoticed outcomes, negatively affecting their health and wellbeing.
The prevalence of IPV is high in sub-Saharan Africa, where it is considered an element of the unwritten rules underpinning intimate relationships. Interventions that challenge these social norms are still evolving; community mobilization interventions, on the other hand, offer some potential in moderating the attitudes that permit or promote IPV. This study evaluated the effect of a community mobilization intervention on attitudes toward social norms that influence IPV in selected rural communities of Oyo State, Nigeria.
Methods: In a randomised community trial conducted in 8 rural communities of Oyo State, Nigeria, a six-month community mobilization intervention that consisted of advocacy to stakeholders, community workshops and small group discussions in 6 selected communities was tested compared with no intervention in the 2 control communities.
To engender community participation and sustainability of the intervention the investigator recruited and trained members of the community as 'Model Couples'. Community leaders, community health workers were also engaged to speak against IPV. Both the 'Model couples' and community leaders addressed topics like gender and power dynamics, IPV and its consequences, law prohibiting all forms of violence against women, social norms that influence IPV, and need to take action for change.
The intervention was tested among women of reproductive age, using a convergent parallel mixed-methods design. The study outcomes were attitudes toward social norms associated with IPV and experience of IPV. For the collection of quantitative data, a modified WHO women's health questionnaire was used, while an interview guide was developed for the collection of the qualitative data.
Conclusion: This trial should show community mobilization intervention as a strategy that can reduce women's experience of IPV and change attitudes toward IPV.
- Conditions
- Violence, Domestic Violence, Attitude
- Being tested
- Community mobilization
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community mobilizationBehavioural
The intervention focused on creating awareness, challenging social norms, and promoting actions against violence. To achieve these, the following activities were undertaken: introductory meetings, selection and training of model couples, structured workshops and small group meetings.
| Study group | Role | What they receive |
|---|---|---|
| Community mobilization | Experimental | a six-month community mobilization intervention that consisted of advocacy to stakeholders, community workshops and small group discussions in intervention communities Receives: Behavioral: Community mobilization |
| No intervention | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attitudes towards social norms around intimate partner violence
Respondent agreed that a man is justified to beat his wife in seven scenarios provided. A score of 0 showed not supportive of physical IPV, while a score of 1 -7 showed attitude supportive of IPV
Measured: One year before the survey
Secondary outcomes (3)
Experience of intimate partner violence
Respondent answered yes to being physically, emotionally or sexually abused. A score of 0 showed no experience of IPV but a sore of more than 0 showed experience of IPV
Measured: One year before the survey
Perpetration of intimate partner violence
Respondent answered yes to physically, emotionally or sexually abusing his wife. A score of 0 showed no perpetration of IPV but a sore of more than 0 showed perpetration of IPV
Measured: One year before the survey
Community response to women's experience of of intimate partner violence
Community member agreed to intervening when they witnessed violence between couple
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start12 Jan 2021
- Primary completion1 Aug 2021
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 2,650 participants (actual)
Sponsor and investigators
- Lead sponsor
- Funmilola OlaOlorun
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ibadan
- Responsible party
- Sponsor-investigator, Funmilola OlaOlorun, University of Ibadan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06119984
- Sponsor's protocol ID
- SNIP Project
- Status last verified
- Oct 2023
- First submitted
- 7 Oct 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Community-based Intervention to Address Social Norms Associated With Intimate Partner Violence in Rural Southwest, Nigeria
- ClinicalTrials.gov ID
- NCT06119984
- Acronym / sponsor ID
- SNIP Project
- Conditions
- Violence, Domestic Violence, Attitude
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,650 participants (actual)
- Lead sponsor
- Funmilola OlaOlorunUniversity, hospital or other
- Collaborators
- University of Ibadan
- Study start
- 12 Jan 2021 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 7 Nov 2023 (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.
Background:
Intimate partner violence is arguably the most prevalent, persistent and pernicious type of violence against women, all around the world. It also has significant repercussions for women's health, yet, in some parts of the world, considered an acceptable practice within intimate partner relationships. Community-based interventions, on the other hand, offer promises as a strategy that can get community members involved in working to prevent IPV. This study evaluated a community mobilisation intervention to challenge attitudes toward IPV and prevent violence within intimate relationships.
Methods:
This mixed-method randomised community trial was conducted in selected rural communities in Oyo State, Nigeria, between January 2018 and April 2021. It employed a six-month community mobilisation intervention focused on creating awareness and challenging harmful social norms relating to IPV. In-depth interviews, focus group discussions and two cross-sectional surveys were conducted among men and women of reproductive age who were married at baseline and end line to estimate changes in key outcomes. Difference-in-difference regression models were estimated to compare changes in IPV levels in the intervention and control arms.
Conclusion:
This trial should demonstrate the effectiveness of community mobilisation interventions to change attitudes supportive of IPV and prevent women's experience of IPV.
Detailed description
Background: Intimate partner violence (IPV) is arguably the most pernicious, pervasive, and persistent form of violence against women worldwide. It is an abuse of women's fundamental human rights and a public health concern. Experience of IPV by women has been associated with a mixture of both noticeable and frequently unnoticed outcomes, negatively affecting their health and wellbeing.
The prevalence of IPV is high in sub-Saharan Africa, where it is considered an element of the unwritten rules underpinning intimate relationships. Interventions that challenge these social norms are still evolving; community mobilization interventions, on the other hand, offer some potential in moderating the attitudes that permit or promote IPV. This study evaluated the effect of a community mobilization intervention on attitudes toward social norms that influence IPV in selected rural communities of Oyo State, Nigeria.
Methods: In a randomised community trial conducted in 8 rural communities of Oyo State, Nigeria, a six-month community mobilization intervention that consisted of advocacy to stakeholders, community workshops and small group discussions in 6 selected communities was tested compared with no intervention in the 2 control communities.
To engender community participation and sustainability of the intervention the investigator recruited and trained members of the community as 'Model Couples'. Community leaders, community health workers were also engaged to speak against IPV. Both the 'Model couples' and community leaders addressed topics like gender and power dynamics, IPV and its consequences, law prohibiting all forms of violence against women, social norms that influence IPV, and need to take action for change.
The intervention was tested among women of reproductive age, using a convergent parallel mixed-methods design. The study outcomes were attitudes toward social norms associated with IPV and experience of IPV. For the collection of quantitative data, a modified WHO women's health questionnaire was used, while an interview guide was developed for the collection of the qualitative data.
Conclusion: This trial should show community mobilization intervention as a strategy that can reduce women's experience of IPV and change attitudes toward IPV.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Community mobilization | Experimental | Behavioral: Community mobilizationa six-month community mobilization intervention that consisted of advocacy to stakeholders, community workshops and small group discussions in intervention communities |
| No intervention | No intervention | – |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Men aged 18 to 59 years
- Women aged 18 to 49 years
- Currently married or cohabiting with a partner
- had lived in the community for a minimum of one year.
Key exclusion criteria (2 listed)
- Married/ cohabiting males or females
- does not speak either Yoruba or English
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 |
|---|---|---|
| Community mobilizationThe intervention focused on creating awareness, challenging social norms, and promoting actions against violence. To achieve these, the following activities were undertaken: introductory meetings, selection and training of model couples, structured workshops and small group meetings. | Behavioural | Community mobilization |
Primary outcome
Attitudes towards social norms around intimate partner violence
Time frame: One year before the survey
Respondent agreed that a man is justified to beat his wife in seven scenarios provided. A score of 0 showed not supportive of physical IPV, while a score of 1 -7 showed attitude supportive of IPV
3 secondary outcomes
Experience of intimate partner violence
Time frame: One year before the survey
Perpetration of intimate partner violence
Time frame: One year before the survey
Community response to women's experience of of intimate partner violence
Time frame: One year
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 7 Nov 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community mobilization in people with Violence and Domestic Violence, run by Funmilola OlaOlorun at 1 site in Nigeria.
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 2 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 7 Nov 2023. 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 Nigeria. 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?
Attitudes towards social norms around intimate partner violence (time frame: One year before the survey). 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 7 Nov 2023.