- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05856214
Effect of Couple Based Violence Prevention Education on Intimate Partner Violence During Pregnancy in Southern, Ethiopia
Effect of Couple-Based Violence Prevention Education on Intimate Partner Violence in Hadiya Zone, Southwest Ethiopia
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Violence during pregnancy is a possible risk to not only the pregnant mother but also the risk to that unborn child. IPV during pregnancy is associated with adverse maternal outcomes including emotional distress, depression, anxiety, insufficient or inconsistent prenatal care, inadequate gestational weight gain, higher rates of smoking, alcohol use, and mortality. In Ethiopia, intimate partner violence is one of the hidden epidemics, that needs appropriate intervention strategy. Couples in intervention arm 1 will be exposed to CBVPE, which explores intimate partner violence, consequences of violence during pregnancy, common triggers of IPV during pregnancy, the role of male partners in pregnancy, healthy relationships, and problem-solving skills. Couples in control arm 2, will receive the usual care provided by the Health Extension Workers. Our hypothesis is that women in intervention arm 1 will report less experience of intimate partner violence than participants in arm 2, the control group. Data will be collected at baseline and end line using a structured questionnaire. The study has the following specific objectives
- To evaluate the effect of couple-based violence prevention education on male partners' knowledge, attitudes, and controlling behavior towards IPV during pregnancy
- To compare the effect of couple-based violence prevention education on the experience of IPV during pregnancy
- To Compare the effect of couple-based violence prevention education on women's autonomy and self-efficacy
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: zeleke D Agde, MPH
- Phone Number: +251910489741
- Email: zeledutamo@gmail.com
Study Locations
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Central Ethiopia/Hadiya Zone
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Hosa'ina, Central Ethiopia/Hadiya Zone, Ethiopia
- Recruiting
- 1st Benara Health post
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Contact:
- Tereza Petros, BSc Nurse
- Phone Number: +251937252247
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Coupe whose wife is pregnant (trimester)
- Couple whose wife has at least one live birth
- Couple who lived in the study area at least six months before the study
- Couple whose wife's inter-pregnancy interval is less than two years
- Couple willing to be visited at home
Exclusion Criteria:
- Couple having a severe medical illness
- Couple with hearing or communication problems
- Couple with a plan to move out from the intervention and control clusters in the next 8 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Couple-based violence prevention education(CBVPE)
Couples in the intervention group will receive trainings on gender based violence, intimate partner violence, Consequences of violence during pregnancy, common triggers of intimate partner violence, a healthy relationship in marriage ,couples communication and conflict management
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Couples in the intervention group will receive training on violence against women including intimate partner violence, types, and consequences of intimate partner violence during pregnancy, managing triggers of intimate partner violence, healthy relationships, the role of male partners during pregnancy, and couples communication and problem-solving skills.
Training will be provided every fourth week by trained health extension workers for consecutive six months.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The difference in the proportion of women who experience intimate partner violence during pregnancy
Time Frame: 8 months
|
WHO Multi-country Study on Women's Health and Domestic Violence against Women questionnaire is adapted to assess intimate partner violence (IPV). Physical violence: the intentional use of physical forces by the husband (Slap, push, shove or pull hair, kick, drag or beat, attempt to choke or burn on purpose, threaten to use or actually use a gun, knife, or another weapon) Sexual violence: when a husband forces his wife to have sexual intercourse with him when she doesn't want to, forces her with threats, in any other way to perform sexual acts she does not want, and/or physically forces her to perform any other sexual acts she does not want to Psychological violence: when the husband says or does something to humiliate his wife in front of another person and /or threatens to hurt or harm someone she cares about and/or insult or make her feel bad about herself. IPV is when the woman experiences any physical and/or sexual and/or psychological violence in combination during pregnancy |
8 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The difference in the proportion of couples' attitudes, and husband's controlling behavior(AC) toward intimate partner violence
Time Frame: 8 months
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WHO Multi-country Study on Women's Health and Domestic Violence against Women questionnaire is adapted to assess couples' attitudes towards IPV during pregnancy.
Couples will be asked whether a husband is justified in hitting or beating his wife in 5 scenarios: If the wife goes out without telling the husband, if the wife neglects the children, if the wife argues with the husband if the wife refuses to have sex with husband, and if she burns the food.
The response will be coded as '1' if the participant agrees with at least one attitude question, otherwise will be coded as '0' Couples will be asked six controlling questions.
If the husband: is jealous if she talks with other men, accuses her of unfaithfulness, does not permit her to meet her friends, tries to limit her contact with family, insists on knowing where she is, and does not trust her with money.
Couples who responded "yes" to one or more of the control questions will be coded as 1.
Otherwise, it will be coded 'no' as 0.
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8 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Zeleke D Agde, MPH, Department of population and family studies, Institute of health, Jimma University, Ethiopia
- Study Chair: Muluemebet A Wordofa, professor, Department of population and family studies, Institute of health, Jimma University, Ethiopia
- Study Director: Nega A Kassa, Professor, College of Medical and Health Sciences, Haramaya University, Ethiopia
- Study Director: Jeanette H Magnus, Professor, University of Oslo
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Couple-Based Education
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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