Effect of Couple Based Violence Prevention Education on Intimate Partner Violence During Pregnancy in Southern, Ethiopia

NCT05856214 | Recruiting DMC

• 1 other identifier: Couple-Based Education
• Study Type: interventional
• Target: 852
• Locations: 1 country
• Sites: 1

Brief Summary

A significant proportion of women in Ethiopia suffer from violence by their intimate partner during pregnancy(IPVp), which has adverse maternal and newborn outcomes. Intervention addressing their intimate partners are not well-studied, particularly in Ethiopian setting. The investigators use a cluster randomized control study to evaluate the effectiveness of Couple-Based Violence Prevention Education(CBVPE). CBVPE is an intervention aimed to improve experience of violence during pregnancy, male partners knowledge, attitudes and controlling behavior towards intimate partner violacein this study kebeles found under each districts will be used as clusters. Sixteen clusters will be randomly assigned into one of two arms, each comprised of 216 couples. A total of 864 participants (432 pregnant women and 432 their male partners will be recruited for the study. women in the control group will receive the usual care provided by Health Extension Workers(HEWs), which is routine care. The intervention arm, wife and husband will be exposed to CBVPE that explores maternal health, intimate partner violence, adverse effects of violence during pregnancy, triggers of IPV, managing triggers of IPV, problem solving skills and health relationship. Our hypothesis is that CBVPE is superior to routine care in reducing and /or controlling intimate partner violence during pregnancy in HadiyaZone, Southwest Ethiopia. Structured interviewer administered questionnaire will be used to collect data at base-line and end-line.

Conditions

Intimate Partner Violence

Keywords

Intimate partner violence; Hadiya zone; Southwest Ethiopia

Outcome Measures

Primary Outcomes (1)

• The difference in the proportion of women who experience intimate partner violence during pregnancy

  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

Secondary Outcomes (1)

• The difference in the proportion of couples' attitudes, and husband's controlling behavior(AC) toward intimate partner violence

  8 months

Study Arms (1)

Couple-based violence prevention education(CBVPE)

EXPERIMENTAL

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

Behavioral: Couple-Based Violence Prevention education(CBVPE)

Interventions

Couple-Based Violence Prevention education(CBVPE) BEHAVIORAL

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.

Couple-based violence prevention education(CBVPE)

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jimma University: lead
• Wachemo University: collaborator

Study Sites (1)

1st Benara Health post

Hosa’ina, Central Ethiopia/Hadiya Zone, Ethiopia

RECRUITING

Related Publications (3)

• Agde ZD, Magnus JH, Assefa N, Wordofa MA. Effects of couple-based violence prevention education on male partners' knowledge, attitudes and controlling behavior related to intimate partner violence in rural Ethiopia: a cluster randomized controlled trial. Front Public Health. 2025 Mar 10;13:1506459. doi: 10.3389/fpubh.2025.1506459. eCollection 2025.

  PMID: 40129596 DERIVED

• Agde ZD, Magnus JH, Assefa N, Wordofa MA. Effectiveness of couple-based violence prevention education in reducing intimate partner violence during pregnancy in rural Ethiopia: A cluster randomized controlled trial. PLoS One. 2025 Jan 17;20(1):e0317667. doi: 10.1371/journal.pone.0317667. eCollection 2025.

  PMID: 39823488 DERIVED

• Agde ZD, H Magnus J, Assefa N, Wordofa MA. The protocol for a cluster randomized controlled trial to evaluate couple-based violence prevention education and its ability to reduce intimate partner violence during pregnancy in Southwest Ethiopia. PLoS One. 2024 May 13;19(5):e0303009. doi: 10.1371/journal.pone.0303009. eCollection 2024.

  PMID: 38739581 DERIVED

Study Officials

• Zeleke D Agde, MPH

  Department of population and family studies, Institute of Health, Jimma University, Ethiopia

  PRINCIPAL INVESTIGATOR

• Muluemebet A Wordofa, professor

  Department of population and family studies, Institute of health, Jimma University, Ethiopia

  STUDY CHAIR

• Nega A Kassa, Professor

  College of Medical and Health Sciences, Haramaya University, Ethiopia

  STUDY DIRECTOR

• Jeanette H Magnus, Professor

  University of Oslo

  STUDY DIRECTOR

Central Study Contacts

zeleke D Agde, MPH

CONTACT

+251910489741; zeledutamo@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Model Details: Single group assignment: intervention group vs Control group

Study Record Dates

• First Submitted: March 30, 2023
• First Posted: May 12, 2023
• Study Start: August 1, 2023
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: March 7, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Starting August,2024

Locations

ET (1)