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临床试验/NCT03265626
NCT03265626Unknown不适用

Community Based Intervention to Prevent Domestic Violence Against Women in Ethiopia; a Protocol for Quasi-Experimental Implementation Research

Haramaya Unversity1 个研究点 分布在 1 个国家目标入组 1,217 人开始时间: 2017年11月28日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
1,217
试验地点
1
主要终点
Change of the level of domesic violence against women from baseline to endline assessent

研究概览

简要总结

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

  1. To assess the baseline level of domestic violence against women in the study area
  2. To identify associated factors of domestic violence against women
  3. To design intervention implementation strategy to tackle domestic violence against women
  4. To implement culturally appropriate/acceptable interventions to address bottlenecks and domestic violence against women
  5. To assess the outcome of community based intervention on domestic violence against women

Research questions

  • 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).

详细描述

Sample Size Determination The sample size is determined considering both the intervention and control group proportion. The sample size for dichotomous outcome is recommended based on an assumption of superiority trial hypothesis testing. The hypothesis of the researcher is that implementation of the new community based prevention intervention program to prevent domestic violence against women will have significant effect than the standard (existing) prevention program in public health point of view. So the corresponding null hypothesis (Ho) is that: the new community based preventive intervention is not more efficacious to prevent domestic violence against women than the comparison group based on public health relevance. In addition, the sample size is determined considering an assumption of 5% margin of error, 95% significance level and 80% power.

Where; N is the sample size of each group, P is prevalence in standard intervention/control arm, d: the real difference between two treatment effect (d= Po-Px); 22%-9%=13%=0.13); δ0: a statistical acceptable margin (5%); ɑ: is the significance level which is 95% confidence level (ɑ=1-0.95=0.05=1.645), ß: is 80% power (ß=1-0.8= 0.2 = 0.845, and adding Then, considering 10% for potential non-achieved rate compensation. The calculated sample size for a group is 364. Eventually, as a result of the complex sampling design (multistage, stratified and systematic sampling), design effect is considered increase power and precision of the study. Design effect was computed using a finding from complex sampling design study conducted in Ethiopia (Fagitalekoma district) reported that the prevalence of DVAW was 78%, and a clustered randomized control trial done in Uganda indicated that 22% of women experienced physical IPV in the standard intervention group. The final sample size for the three arms was 1,758 women that mean 586 for each group. The number of participant in the qualitative study will be determined by information saturation during interviews and or focused group discussions (FGD). A minimum of two FGD (one male group and one female group) which comprise 8 to 10 discussants will be held at each selected kebeles. The local leaders or other person who are in-charge will be participated on the selection of qualitative study participants until information saturation.

Sampling Procedure

Multistage, stratified and systematic sampling will be used to select study participant to this study. First, contextual assessment will be employed among purposefully selected study participants from Awi zonal admisntration, district offices and community representatives. Stakeholders such as local politicians, health office, women and children affair office in-charges, local leaders, police, health care providers, non-governmental organization representatives and other concerned bodies will be participated to involve on advocacy meeting and contextualization. Then, multi-stage stratified probability sampling methods will be used to select study sites (kebeles) in the three districts among nine districts in Awi zone. Three districts will be selected for three experimental group. One district will be selected for comprehensive intervention. The second district will be assigned for partial intervention group, and the third district will be taken as comparison (control). Then, six kebeles (two kebeles from each district) will be selected from three districts purposefully considering appropriateness for intervention, resource, and geographical proximity to control information contamination between intervention and control group.

Then, kebeles will be stratified into urban and rural Kebele in respective district. Stratification will use to control the awareness level, access to information, and community tradition gender norm variability between urban and rural dwellers. After that, proportional to size allocation (ni) of the sample size will be done to each stratum. Eventually, systematic sampling will be employed to select actual study participants at household level based on kth interval. Confidential code will be given strictly to households that will be selected for interview for intervention monitoring and endline evaluation purpose. In the meantime, if two married women present in one household with one husband (polygamy), only one woman will be selected using lottery method for interview.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
15 Years 至 49 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • 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)

排除标准

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

结局指标

主要结局

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

时间窗: 12 month period from baseline assessment to endline interevntion evalaution

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.

次要结局

未报告次要终点

研究者

发起方
Haramaya Unversity
申办方类型
Other
责任方
Principal Investigator
主要研究者

Agumasie Semahegn

PhD Candidate

Haramaya Unversity

研究点 (1)

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