NCT03265626

Brief Summary

Violence against women is a well understood devastating global pandemic, and human right violation. One in three women experienced intimate partner violence worldwide. In Ethiopia, the level of domestic violence against women is one of the highest in the world. However, Ethiopia is signatory for various conventions and incorporate into the constitution and other legal frameworks. Nevertheless, effective implementation of the existing policy documents, and engaging different stakeholders is very limited. There is paucity of evidence on piloting the feasibility of implementing community based preventive intervention programs. Therefore, the main aim of this study is to pilot feasibility and implement existing research evidence and policy documents at community level to prevent domestic violence against women in Awi zone, northwestern Ethiopia This study will be conducted in three districts of the Awi zone, Amhara regional state, Northwestern Ethiopia. General Objective:The overall aim of this study is to assess the outcome of community based interventions implementation to prevent domestic violence against women, enhance community response and determinants among women (15-49 years) in Awi Zone, Northwestern Ethiopia from November, 2017 to November, 2018. Specific Objectives

  • How can prevent domestic violence against women through community based intervention?
  • What are the bottlenecks of prevention intervention implementation at community level?
  • How can implementers engage stakeholders to mobilize community and resource to implement existing evidence based interventions to transform gender norm? Research Hypothesis
  • Null hypothesis (Ho): this community based prevention intervention will not have effect (difference) on the level of domestic violence against women as compared with control (standard program).
  • Alternative Hypothesis (HA): community based prevention intervention will have a better effect to make an improvement on the level of domestic violence against women than control (standard services).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,217

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 29, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

November 28, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

March 9, 2018

Status Verified

March 1, 2018

Enrollment Period

1 month

First QC Date

August 26, 2017

Last Update Submit

March 8, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change of the level of domesic violence against women from baseline to endline assessent

    The primary outcome is a change on domestic violence agaianst women. The main measure is the change in the prevalnce of domestic violence, engament of stakeholders, integration of the prevention intervention with existing community health program and the level of awarenss of the community about gender equality.

    12 month period from baseline assessment to endline interevntion evalaution

Study Arms (3)

Comprehensive (Intervention 1)

EXPERIMENTAL

A total of 586 study particpnats will be invloved on this comprehensive (main) experiment group.This arm will receive a comprehensive intervention package that include advocacy to local governors, community mobilization, awareness creation, training of community representatives and engagement partners. community mobilization through engaging husband as change agent to avert domestic violence in collaboration with community Health Extension Workers. The intervention will target married or cohabited women, partner, and community representatives (religious leaders, and elders). The intervention will be focused on physical, psychological and sexual violence, decision making, negotiation, communication on household matters, gender equality and equity norms, and their relationship with women's health. In addition, massive public information dissemination will be done in the intervention community.

Behavioral: Intervention 1: Comprehensive preventive intervention

Intervention 2

ACTIVE COMPARATOR

A total of 586 study particpnats will be invloved on this active comprator group. The intervention package such as advocacy to local governors, community mobilization, awareness creation and training of community representatives will be carried out for 12 months period.The main diffrence from the arm-1,here is no husband involvment in the interevntion targets. This intervention will be targeted married and cohabited women and community representatives (religious leaders, health care provider, police, politicians and associations). This group of participant will be selected from one urban and one rural Kebele in Banja District. Same tool and approach will be used to track the intervention progress.

Behavioral: Intervention 2: Awareness creation and community mobilization

Control/Comparator

OTHER

A total of 586 study partipants will be assigned to the control group that will receive the existing standard services from both urban and rural kebeles of the Guagussa Shikudad district. As comparator purpose, baseline and endline evaluation data will be taken. -No intervention package but standard service will be maintained

Other: available standard care

Interventions

aims to implement the existing evidence and policy documents Advocacy workshop to politicians, Community mobilization, Awareness creation on women,training community representative, Husband participation

Comprehensive (Intervention 1)

Advocacy politicians, Community mobilization, Awareness creation to women, Training community representative

Intervention 2

The standard care will be maintained but no other additional intevvenion designed by this study

Control/Comparator

Eligibility Criteria

Age15 Years - 49 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Both the intervention and control participants will be selected from the general population
  • All married and or cohabited women (15-49 year)
  • Got married and stayed with partner at least 12 months
  • Registered or recognized as permanent (at least 6 months)

You may not qualify if:

  • \- participants who are unable to respond due to severe physical or mental illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Awi zone administaration

Injibara, Amhara Regional State, Ethiopia

Location

Related Publications (1)

  • Semahegn A, Torpey K, Manu A, Assefa N, Ankomah A. Community based intervention to prevent domestic violence against women in the reproductive age in Northwestern Ethiopia: a protocol for quasi-experimental study. Reprod Health. 2017 Nov 21;14(1):155. doi: 10.1186/s12978-017-0414-2.

Study Officials

  • Augustine Ankomah, PhD

    University of Ghana

    STUDY CHAIR
  • Kwasi Torpey, MD, PhD

    University of Ghana

    STUDY CHAIR
  • Abubakar Manu, PhD

    University of Ghana

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Community based three arm quasi-experimental design will be employed using mixed methods (quantitative and qualitative). Study participants will be allocated to the intervention and control groups to piloting the feasibility and effectiveness of community based intervention to avert domestic violence against women (15-49 years). Married or cohabited women, husbands/partner, community representatives (such as leaders/local politicians, religious leaders and elders), health care providers, police, women association and women affair office representatives will be involved in this implementation research.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Candidate

Study Record Dates

First Submitted

August 26, 2017

First Posted

August 29, 2017

Study Start

November 28, 2017

Primary Completion

December 31, 2017

Study Completion

December 31, 2018

Last Updated

March 9, 2018

Record last verified: 2018-03

Locations