Clinical trial NCT05856214: Effect of Couple Based Violence Prevention Education on Intimate Partner Violence During Pregnancy in Southern, Ethiopia
Official title: Effect of Couple-Based Violence Prevention Education on Intimate Partner Violence in Hadiya Zone, Southwest Ethiopia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intimate Partner Violence
Keywords: Intimate partner violence
Hadiya zone
Southwest Ethiopia
Lead sponsor: Jimma University
Sponsor class: OTHER
Collaborators: name: Wachemo University
First posted: 2023-05-12
Enrollment: 852
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group assignment: intervention group vs Control group
Primary purpose: PREVENTION

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.

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

1. To evaluate the effect of couple-based violence prevention education on male partners' knowledge, attitudes, and controlling behavior towards IPV during pregnancy
2. To compare the effect of couple-based violence prevention education on the experience of IPV during pregnancy
3. To Compare the effect of couple-based violence prevention education on women's autonomy and self-efficacy

Eligibility criteria: 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

Primary outcomes:
measure: The difference in the proportion of women who experience intimate partner violence during pregnancy
timeFrame: 8 months
Secondary outcomes:
measure: The difference in the proportion of couples' attitudes, and husband's controlling behavior(AC) toward intimate partner violence
timeFrame: 8 months
Other outcomes:
Locations:
city: Hosa'ina
country: Ethiopia
facility: 1st Benara Health post
state: Central Ethiopia/Hadiya Zone
Study officials:
affiliation: Department of population and family studies, Institute of Health, Jimma University, Ethiopia
name: Zeleke D Agde, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of population and family studies, Institute of health, Jimma University, Ethiopia
name: Muluemebet A Wordofa, professor
role: STUDY_CHAIR
affiliation: College of Medical and Health Sciences, Haramaya University, Ethiopia
name: Nega A Kassa, Professor
role: STUDY_DIRECTOR
affiliation: University of Oslo
name: Jeanette H Magnus, Professor
role: STUDY_DIRECTOR
References: