<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03265626</url>
  </required_header>
  <id_info>
    <org_study_id>HaramayaU</org_study_id>
    <nct_id>NCT03265626</nct_id>
  </id_info>
  <brief_title>Community Based Intervention to Prevent Domestic Violence Against Women in Ethiopia; a Protocol for Quasi-Experimental Implementation Research</brief_title>
  <official_title>Community Based Intervention to Prevent Domestic Violence Against Women in Ethiopia; a Protocol for Quasi-Experimental Implementation Research</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Haramaya Unversity</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>World Health Organization</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Ghana</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Haramaya Unversity</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Violence against women is a well understood devastating global pandemic, and human right&#xD;
      violation. One in three women experienced intimate partner violence worldwide. In Ethiopia,&#xD;
      the level of domestic violence against women is one of the highest in the world. However,&#xD;
      Ethiopia is signatory for various conventions and incorporate into the constitution and other&#xD;
      legal frameworks. Nevertheless, effective implementation of the existing policy documents,&#xD;
      and engaging different stakeholders is very limited. There is paucity of evidence on piloting&#xD;
      the feasibility of implementing community based preventive intervention programs. Therefore,&#xD;
      the main aim of this study is to pilot feasibility and implement existing research evidence&#xD;
      and policy documents at community level to prevent domestic violence against women in Awi&#xD;
      zone, northwestern Ethiopia This study will be conducted in three districts of the Awi zone,&#xD;
      Amhara regional state, Northwestern Ethiopia.&#xD;
&#xD;
      General Objective:The overall aim of this study is to assess the outcome of community based&#xD;
      interventions implementation to prevent domestic violence against women, enhance community&#xD;
      response and determinants among women (15-49 years) in Awi Zone, Northwestern Ethiopia from&#xD;
      November, 2017 to November, 2018.&#xD;
&#xD;
      Specific Objectives&#xD;
&#xD;
        1. To assess the baseline level of domestic violence against women in the study area&#xD;
&#xD;
        2. To identify associated factors of domestic violence against women&#xD;
&#xD;
        3. To design intervention implementation strategy to tackle domestic violence against women&#xD;
&#xD;
        4. To implement culturally appropriate/acceptable interventions to address bottlenecks and&#xD;
           domestic violence against women&#xD;
&#xD;
        5. To assess the outcome of community based intervention on domestic violence against women&#xD;
&#xD;
      Research questions&#xD;
&#xD;
        -  How can prevent domestic violence against women through community based intervention?&#xD;
&#xD;
        -  What are the bottlenecks of prevention intervention implementation at community level?&#xD;
&#xD;
        -  How can implementers engage stakeholders to mobilize community and resource to implement&#xD;
           existing evidence based interventions to transform gender norm?&#xD;
&#xD;
      Research Hypothesis&#xD;
&#xD;
        -  Null hypothesis (Ho): this community based prevention intervention will not have effect&#xD;
           (difference) on the level of domestic violence against women as compared with control&#xD;
           (standard program).&#xD;
&#xD;
        -  Alternative Hypothesis (HA): community based prevention intervention will have a better&#xD;
           effect to make an improvement on the level of domestic violence against women than&#xD;
           control (standard services).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Sample Size Determination The sample size is determined considering both the intervention and&#xD;
      control group proportion. The sample size for dichotomous outcome is recommended based on an&#xD;
      assumption of superiority trial hypothesis testing. The hypothesis of the researcher is that&#xD;
      implementation of the new community based prevention intervention program to prevent domestic&#xD;
      violence against women will have significant effect than the standard (existing) prevention&#xD;
      program in public health point of view. So the corresponding null hypothesis (Ho) is that:&#xD;
      the new community based preventive intervention is not more efficacious to prevent domestic&#xD;
      violence against women than the comparison group based on public health relevance. In&#xD;
      addition, the sample size is determined considering an assumption of 5% margin of error, 95%&#xD;
      significance level and 80% power.&#xD;
&#xD;
      Where; N is the sample size of each group, P is prevalence in standard intervention/control&#xD;
      arm, d: the real difference between two treatment effect (d= Po-Px); 22%-9%=13%=0.13); δ0: a&#xD;
      statistical acceptable margin (5%); ɑ: is the significance level which is 95% confidence&#xD;
      level (ɑ=1-0.95=0.05=1.645), ß: is 80% power (ß=1-0.8= 0.2 = 0.845, and adding Then,&#xD;
      considering 10% for potential non-achieved rate compensation. The calculated sample size for&#xD;
      a group is 364. Eventually, as a result of the complex sampling design (multistage,&#xD;
      stratified and systematic sampling), design effect is considered increase power and precision&#xD;
      of the study. Design effect was computed using a finding from complex sampling design study&#xD;
      conducted in Ethiopia (Fagitalekoma district) reported that the prevalence of DVAW was 78%,&#xD;
      and a clustered randomized control trial done in Uganda indicated that 22% of women&#xD;
      experienced physical IPV in the standard intervention group. The final sample size for the&#xD;
      three arms was 1,758 women that mean 586 for each group. The number of participant in the&#xD;
      qualitative study will be determined by information saturation during interviews and or&#xD;
      focused group discussions (FGD). A minimum of two FGD (one male group and one female group)&#xD;
      which comprise 8 to 10 discussants will be held at each selected kebeles. The local leaders&#xD;
      or other person who are in-charge will be participated on the selection of qualitative study&#xD;
      participants until information saturation.&#xD;
&#xD;
      Sampling Procedure&#xD;
&#xD;
      Multistage, stratified and systematic sampling will be used to select study participant to&#xD;
      this study. First, contextual assessment will be employed among purposefully selected study&#xD;
      participants from Awi zonal admisntration, district offices and community representatives.&#xD;
      Stakeholders such as local politicians, health office, women and children affair office&#xD;
      in-charges, local leaders, police, health care providers, non-governmental organization&#xD;
      representatives and other concerned bodies will be participated to involve on advocacy&#xD;
      meeting and contextualization. Then, multi-stage stratified probability sampling methods will&#xD;
      be used to select study sites (kebeles) in the three districts among nine districts in Awi&#xD;
      zone. Three districts will be selected for three experimental group. One district will be&#xD;
      selected for comprehensive intervention. The second district will be assigned for partial&#xD;
      intervention group, and the third district will be taken as comparison (control). Then, six&#xD;
      kebeles (two kebeles from each district) will be selected from three districts purposefully&#xD;
      considering appropriateness for intervention, resource, and geographical proximity to control&#xD;
      information contamination between intervention and control group.&#xD;
&#xD;
      Then, kebeles will be stratified into urban and rural Kebele in respective district.&#xD;
      Stratification will use to control the awareness level, access to information, and community&#xD;
      tradition gender norm variability between urban and rural dwellers. After that, proportional&#xD;
      to size allocation (ni) of the sample size will be done to each stratum. Eventually,&#xD;
      systematic sampling will be employed to select actual study participants at household level&#xD;
      based on kth interval. Confidential code will be given strictly to households that will be&#xD;
      selected for interview for intervention monitoring and endline evaluation purpose. In the&#xD;
      meantime, if two married women present in one household with one husband (polygamy), only one&#xD;
      woman will be selected using lottery method for interview.&#xD;
&#xD;
      Regarding to qualitative study, purposive sampling method will be used to select study&#xD;
      participants for in-depth interview, key informant interview (KII) and FGD. The community&#xD;
      leaders will be consulted and actively involved on the recruitment of the most knowledgeable&#xD;
      and respected community representatives for in-depth interview, key informant interview (KII)&#xD;
      and FGD. The purpose of the study will be explained in detail to the community leaders who&#xD;
      will participate on the recruitment of qualitative study participants. It will be conducted&#xD;
      to assess individual perception towards DVAW mainly focused on sex negotiation, decision&#xD;
      making, community gender norm, and wife beating attitudes with in the community. In addition,&#xD;
      community sanction (response) against DVAW will be assessed qualitatively. It will mainly&#xD;
      involve by taking from people who are in position (authority) such as local leaders,&#xD;
      religious fathers, elders, police, women affair office, women association, health&#xD;
      professionals, health extension workers, and women lawyers.&#xD;
&#xD;
      Data Collection&#xD;
&#xD;
      Mixed data collection method will be carried out using structured and semi structured&#xD;
      questionnaires, that adapted from various literature. The tool will be pretested, modified to&#xD;
      the local context and suite to the study objectives. The tool will consisted of demographic,&#xD;
      socio-economic characteristics of couples (women self-reported profile), relationship level,&#xD;
      community level and societal level factors of domestic violence. In addition, the tool will&#xD;
      comprise questions about the experience of psychological, physical, sexual violence. In&#xD;
      addition, semi structured questionnaire will be designed for qualitative study. Similarly,&#xD;
      interview guide will be used to assess and dig-out the underlying bottlenecks in the&#xD;
      community that hinder implementation of preventive interventions.&#xD;
&#xD;
      Data Collection Procedure&#xD;
&#xD;
      Data will be collected using sequential explanatory mixed method for baseline, intervention&#xD;
      monitoring/tracking and endline implementation evaluation. Here below is the flow chart of&#xD;
      the mixed data collection process adapted from other study. Two quantitative (1 and 2) and&#xD;
      qualitative (1 and 2) process will be sequentially implemented to gather necessary data .&#xD;
      Face-to-face interview method among married or cohabited women, key informant interview,&#xD;
      in-depth interview, focus group discussion, meeting and training time data capturing will be&#xD;
      carried out to have relevant information. In addition to the domestic violence assessment&#xD;
      tool, the alternative questionnaire will be prepared and provide to data collectors to secure&#xD;
      confidentiality issue if incase of third person might come suddenly during interview time.&#xD;
      Very confidential place for women will be arranged by data collectors as per the training and&#xD;
      WHO VAW research ethics recommendation.&#xD;
&#xD;
      Then qualitative data collection (KII, in-depth interview and FGDs) will be held to explore&#xD;
      community perception, attitudes, norms and beliefs about domestic violence. However, mini&#xD;
      (quick) qualitative data collection for contextualization has been done among officially in&#xD;
      the districts and zone administrative level. On the other hand, it will use to find out&#xD;
      community mobilization strategies, existing legal sanctions, available training guidelines,&#xD;
      collaboration and integration of implementation activity. This will also help to design&#xD;
      appropriate tool for main study, to design correct and culturally compatible intervention&#xD;
      materials to tackle the problem. The KII will be held among women representative, district&#xD;
      council members, women affair office, police officers, lawyers, elders, local&#xD;
      politicians/leaders, health care providers, nongovernmental organization, and religious&#xD;
      leaders.&#xD;
&#xD;
      Gender specific focused group discussion will be held on group of men and women to assess&#xD;
      societal perception about domestic violence against women. Each focus group discussion will&#xD;
      consisted of eight to ten participants. All participants' sociodemographic data will be&#xD;
      captured using anonymously coded structured questionnaire. The FGDs will be facilitated by a&#xD;
      group of three people (moderator, note taker and principal investigator). Voice recorder,&#xD;
      note taking and nonverbal communication (physical gestures) during the discussion will be&#xD;
      recorded as much as possible to capture necessary information. An estimate of 60 to 90&#xD;
      minutes will be taken to conduct one FGD. Moreover, implementation of domestic violence&#xD;
      against women preventive intervention activities will be monitored/tracked using ongoing&#xD;
      qualitative study method. Eventually, intervention implementation endline evaluation will be&#xD;
      carried out using as same structured questionnaire, data collectors and supervisors as of the&#xD;
      formative assessment. Data will be collected by exclusively twelve female health&#xD;
      professionals (Nurse, Midwifery or public health).&#xD;
&#xD;
      Data Quality Assurance&#xD;
&#xD;
      Participants Allocation: Allocation of study participants in the intervention and control&#xD;
      group will be considered geographic proximity to minimize information contamination.&#xD;
      Representative sample will be taken using scientifically sounded procedures.&#xD;
&#xD;
      Appropriate Data Collectors recruitment: Data will be collected by twelve trained Diploma and&#xD;
      above qualification female Nurses, Midwives and or public health officers who are not local&#xD;
      resident in the community for trustworthiness and ethical concerns. Four supervisor who have&#xD;
      Master of Public Health (MPH) with good previous field survey experience will be recruited.&#xD;
&#xD;
      Data Collectors Training: A five days training will be given for research assistants by the&#xD;
      principal investigator. The training will mainly focus on the purpose of the study, data&#xD;
      collection procedure, interview techniques, sampling methods, strict protection of&#xD;
      confidentiality, ethical issues of VAW research and data quality assurance. Ethical&#xD;
      sensitiveness of VAW will be explained to research assistants to maintain confidentiality and&#xD;
      also quality of data. Brief explanation will be provided on biomedical research ethical&#xD;
      principles and WHO (2001) gender based violence research ethical guideline recommendations&#xD;
      called &quot;women's safety first&quot;. Refreshment training and short orientation/debriefing will be&#xD;
      provided regularly to research assistants during the study period.&#xD;
&#xD;
      Pretest: Pretest will be done among 5% of the sample size among married women from nearby&#xD;
      district to check the compatibility of the data collection tool. The pretest will address&#xD;
      sensitive words in the question, time, data collection procedure, interview techniques,&#xD;
      sequence of questions, consent taking from study participants, and FGD facilitation skill and&#xD;
      note taking. Necessary amendment will be taken according to feedback from study participant&#xD;
      (verbal and non-verbal expression during pretest interview) and comment from research&#xD;
      assistants.&#xD;
&#xD;
      Training of Implementers: intensive training and supportive supervision will be given for&#xD;
      implementers. Two implementation facilitators and 6 community health extension workers will&#xD;
      be recruited and hired for one year (12 months) contract employment. Implementers will be&#xD;
      participated on the intervention tool validation to be familiar with the tool. Regular&#xD;
      discussion and close supportive supervision will be given by principal investigator and&#xD;
      facilitators.&#xD;
&#xD;
      Data Processing and Statistical Analysis&#xD;
&#xD;
      Baseline, monitoring and end-line gathered data will be checked and edited for incompleteness&#xD;
      and inconsistency at field as well as at office. Explanatory and outcome variables will be&#xD;
      clearly predefined prior to data entry. During data entry if woman will report at least one&#xD;
      type of experience of either physical, psychological or sexual violence items coded as &quot;Yes =&#xD;
      1&quot; and &quot;No = 0&quot;. On the other hand, women acceptance to violence or gender inequity norm will&#xD;
      be measured using six questions/measurements, and also if women respond at least one&#xD;
      justifies of wife beating. Similarly women autonomy will be measured in four components&#xD;
      autonomy indicators such as women's economic decision-making autonomy, familial health care&#xD;
      and family planning decision-making autonomy, extent of freedom of movement autonomy, and&#xD;
      women's attitudes toward partner's violence. After completing the definition and coding of&#xD;
      raw data. Data entry template will be designed on Epi data window version 3.5.1, and data&#xD;
      entry will be carried out.&#xD;
&#xD;
      Then data will be exported to SPSS window version (23.0) for further analysis. Data cleaning&#xD;
      will be performed computing frequency using box plot to explore outliers and other data&#xD;
      anomalies. Multiple imputation will be done to handle missing data. Different statistical&#xD;
      assumptions will be checked for data distribution and suitability for statistical analysis.&#xD;
      Descriptive statistics will be computed to determine prevalence (proportion), mean, median,&#xD;
      and standard deviation of some independent variables as necessary. Cross tabulation&#xD;
      (chi-square) will be employed. Binary logistic regression will be carried out to confirm the&#xD;
      association of explanatory variable with DVAW. Explanatory variable which will have score of&#xD;
      p-value less than 0.25 in binary logistic regression will be included into the multiple&#xD;
      logistic regression analysis to determine the independent determinants of domestic violence&#xD;
      by controlling the confounding variable. In addition, Intention to Treat Analysis (ITTA) will&#xD;
      be carried out to compute the overall changes on the level of DVAW. Moreover, Difference in&#xD;
      Difference (DID) will be calculated to determine the net intervention effect. The DID will be&#xD;
      computed as subtracting intervention arm outcomes from baseline data to endline minus&#xD;
      difference of control arm outcomes from baseline to endline. Finally, statistical&#xD;
      significance of intervention effect will be measured using adjusted prevalence ratio,&#xD;
      adjusted odd ratio/adjusted risk ratio at 95% CI and p value less than 0.05.&#xD;
&#xD;
      Qualitative data will be transcribed through playing and replaying the voice recorder and&#xD;
      also referring the note taken during interview or FGD. The voice recorder audio will be&#xD;
      listen multiple times as much as possible at very quiet place. It will be transcribed&#xD;
      independently by research assistant and principal investigator according to the verbatim of&#xD;
      participants. Then transcribed qualitative data will be translated from local language&#xD;
      (Amharic) into English. In the meantime, the qualitative data will be read and reread to&#xD;
      understand what they want to say. The quotes will be narrated and cited using participant's&#xD;
      code. All the qualitative data gathered from interview and FGD will be arranged into thematic&#xD;
      areas. Similar ideas will be color coded, and then merged accordingly. Qualitative Data&#xD;
      Analysis (QDA) software like Nvivo will be used to arrange or organize manually coded&#xD;
      qualitative data.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">November 28, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">December 31, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>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.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of the level of domesic violence against women from baseline to endline assessent</measure>
    <time_frame>12 month period from baseline assessment to endline interevntion evalaution</time_frame>
    <description>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.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">1217</enrollment>
  <condition>Domestic Violence Against Women</condition>
  <condition>Community-based Prevention</condition>
  <condition>Interevntion Implementation</condition>
  <arm_group>
    <arm_group_label>Comprehensive (Intervention 1)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention 2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control/Comparator</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>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.&#xD;
-No intervention package but standard service will be maintained</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Intervention 1: Comprehensive preventive intervention</intervention_name>
    <description>aims to implement the existing evidence and policy documents Advocacy workshop to politicians, Community mobilization, Awareness creation on women,training community representative, Husband participation</description>
    <arm_group_label>Comprehensive (Intervention 1)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Intervention 2: Awareness creation and community mobilization</intervention_name>
    <description>Advocacy politicians, Community mobilization, Awareness creation to women, Training community representative</description>
    <arm_group_label>Intervention 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>available standard care</intervention_name>
    <description>The standard care will be maintained but no other additional intevvenion designed by this study</description>
    <arm_group_label>Control/Comparator</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  Both the intervention and control participants will be selected from the general&#xD;
             population&#xD;
&#xD;
          -  All married and or cohabited women (15-49 year)&#xD;
&#xD;
          -  Got married and stayed with partner at least 12 months&#xD;
&#xD;
          -  Registered or recognized as permanent (at least 6 months)&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
        - participants who are unable to respond due to severe physical or mental illness&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>49 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Augustine Ankomah, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>University of Ghana</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kwasi Torpey, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>University of Ghana</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Abubakar Manu, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>University of Ghana</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Awi zone administaration</name>
      <address>
        <city>Injibara</city>
        <state>Amhara Regional State</state>
        <country>Ethiopia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Ethiopia</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>August 26, 2017</study_first_submitted>
  <study_first_submitted_qc>August 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>March 8, 2018</last_update_submitted>
  <last_update_submitted_qc>March 8, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 9, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Haramaya Unversity</investigator_affiliation>
    <investigator_full_name>Agumasie Semahegn</investigator_full_name>
    <investigator_title>PhD Candidate</investigator_title>
  </responsible_party>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03265626
org study id: HaramayaU
nct id: NCT03265626
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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).
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.

      Regarding to qualitative study, purposive sampling method will be used to select study
      participants for in-depth interview, key informant interview (KII) and FGD. The community
      leaders will be consulted and actively involved on the recruitment of the most knowledgeable
      and respected community representatives for in-depth interview, key informant interview (KII)
      and FGD. The purpose of the study will be explained in detail to the community leaders who
      will participate on the recruitment of qualitative study participants. It will be conducted
      to assess individual perception towards DVAW mainly focused on sex negotiation, decision
      making, community gender norm, and wife beating attitudes with in the community. In addition,
      community sanction (response) against DVAW will be assessed qualitatively. It will mainly
      involve by taking from people who are in position (authority) such as local leaders,
      religious fathers, elders, police, women affair office, women association, health
      professionals, health extension workers, and women lawyers.

      Data Collection

      Mixed data collection method will be carried out using structured and semi structured
      questionnaires, that adapted from various literature. The tool will be pretested, modified to
      the local context and suite to the study objectives. The tool will consisted of demographic,
      socio-economic characteristics of couples (women self-reported profile), relationship level,
      community level and societal level factors of domestic violence. In addition, the tool will
      comprise questions about the experience of psychological, physical, sexual violence. In
      addition, semi structured questionnaire will be designed for qualitative study. Similarly,
      interview guide will be used to assess and dig-out the underlying bottlenecks in the
      community that hinder implementation of preventive interventions.

      Data Collection Procedure

      Data will be collected using sequential explanatory mixed method for baseline, intervention
      monitoring/tracking and endline implementation evaluation. Here below is the flow chart of
      the mixed data collection process adapted from other study. Two quantitative (1 and 2) and
      qualitative (1 and 2) process will be sequentially implemented to gather necessary data .
      Face-to-face interview method among married or cohabited women, key informant interview,
      in-depth interview, focus group discussion, meeting and training time data capturing will be
      carried out to have relevant information. In addition to the domestic violence assessment
      tool, the alternative questionnaire will be prepared and provide to data collectors to secure
      confidentiality issue if incase of third person might come suddenly during interview time.
      Very confidential place for women will be arranged by data collectors as per the training and
      WHO VAW research ethics recommendation.

      Then qualitative data collection (KII, in-depth interview and FGDs) will be held to explore
      community perception, attitudes, norms and beliefs about domestic violence. However, mini
      (quick) qualitative data collection for contextualization has been done among officially in
      the districts and zone administrative level. On the other hand, it will use to find out
      community mobilization strategies, existing legal sanctions, available training guidelines,
      collaboration and integration of implementation activity. This will also help to design
      appropriate tool for main study, to design correct and culturally compatible intervention
      materials to tackle the problem. The KII will be held among women representative, district
      council members, women affair office, police officers, lawyers, elders, local
      politicians/leaders, health care providers, nongovernmental organization, and religious
      leaders.

      Gender specific focused group discussion will be held on group of men and women to assess
      societal perception about domestic violence against women. Each focus group discussion will
      consisted of eight to ten participants. All participants' sociodemographic data will be
      captured using anonymously coded structured questionnaire. The FGDs will be facilitated by a
      group of three people (moderator, note taker and principal investigator). Voice recorder,
      note taking and nonverbal communication (physical gestures) during the discussion will be
      recorded as much as possible to capture necessary information. An estimate of 60 to 90
      minutes will be taken to conduct one FGD. Moreover, implementation of domestic violence
      against women preventive intervention activities will be monitored/tracked using ongoing
      qualitative study method. Eventually, intervention implementation endline evaluation will be
      carried out using as same structured questionnaire, data collectors and supervisors as of the
      formative assessment. Data will be collected by exclusively twelve female health
      professionals (Nurse, Midwifery or public health).

      Data Quality Assurance

      Participants Allocation: Allocation of study participants in the intervention and control
      group will be considered geographic proximity to minimize information contamination.
      Representative sample will be taken using scientifically sounded procedures.

      Appropriate Data Collectors recruitment: Data will be collected by twelve trained Diploma and
      above qualification female Nurses, Midwives and or public health officers who are not local
      resident in the community for trustworthiness and ethical concerns. Four supervisor who have
      Master of Public Health (MPH) with good previous field survey experience will be recruited.

      Data Collectors Training: A five days training will be given for research assistants by the
      principal investigator. The training will mainly focus on the purpose of the study, data
      collection procedure, interview techniques, sampling methods, strict protection of
      confidentiality, ethical issues of VAW research and data quality assurance. Ethical
      sensitiveness of VAW will be explained to research assistants to maintain confidentiality and
      also quality of data. Brief explanation will be provided on biomedical research ethical
      principles and WHO (2001) gender based violence research ethical guideline recommendations
      called "women's safety first". Refreshment training and short orientation/debriefing will be
      provided regularly to research assistants during the study period.

      Pretest: Pretest will be done among 5% of the sample size among married women from nearby
      district to check the compatibility of the data collection tool. The pretest will address
      sensitive words in the question, time, data collection procedure, interview techniques,
      sequence of questions, consent taking from study participants, and FGD facilitation skill and
      note taking. Necessary amendment will be taken according to feedback from study participant
      (verbal and non-verbal expression during pretest interview) and comment from research
      assistants.

      Training of Implementers: intensive training and supportive supervision will be given for
      implementers. Two implementation facilitators and 6 community health extension workers will
      be recruited and hired for one year (12 months) contract employment. Implementers will be
      participated on the intervention tool validation to be familiar with the tool. Regular
      discussion and close supportive supervision will be given by principal investigator and
      facilitators.

      Data Processing and Statistical Analysis

      Baseline, monitoring and end-line gathered data will be checked and edited for incompleteness
      and inconsistency at field as well as at office. Explanatory and outcome variables will be
      clearly predefined prior to data entry. During data entry if woman will report at least one
      type of experience of either physical, psychological or sexual violence items coded as "Yes =
      1" and "No = 0". On the other hand, women acceptance to violence or gender inequity norm will
      be measured using six questions/measurements, and also if women respond at least one
      justifies of wife beating. Similarly women autonomy will be measured in four components
      autonomy indicators such as women's economic decision-making autonomy, familial health care
      and family planning decision-making autonomy, extent of freedom of movement autonomy, and
      women's attitudes toward partner's violence. After completing the definition and coding of
      raw data. Data entry template will be designed on Epi data window version 3.5.1, and data
      entry will be carried out.

      Then data will be exported to SPSS window version (23.0) for further analysis. Data cleaning
      will be performed computing frequency using box plot to explore outliers and other data
      anomalies. Multiple imputation will be done to handle missing data. Different statistical
      assumptions will be checked for data distribution and suitability for statistical analysis.
      Descriptive statistics will be computed to determine prevalence (proportion), mean, median,
      and standard deviation of some independent variables as necessary. Cross tabulation
      (chi-square) will be employed. Binary logistic regression will be carried out to confirm the
      association of explanatory variable with DVAW. Explanatory variable which will have score of
      p-value less than 0.25 in binary logistic regression will be included into the multiple
      logistic regression analysis to determine the independent determinants of domestic violence
      by controlling the confounding variable. In addition, Intention to Treat Analysis (ITTA) will
      be carried out to compute the overall changes on the level of DVAW. Moreover, Difference in
      Difference (DID) will be calculated to determine the net intervention effect. The DID will be
      computed as subtracting intervention arm outcomes from baseline data to endline minus
      difference of control arm outcomes from baseline to endline. Finally, statistical
      significance of intervention effect will be measured using adjusted prevalence ratio,
      adjusted odd ratio/adjusted risk ratio at 95% CI and p value less than 0.05.

      Qualitative data will be transcribed through playing and replaying the voice recorder and
      also referring the note taken during interview or FGD. The voice recorder audio will be
      listen multiple times as much as possible at very quiet place. It will be transcribed
      independently by research assistant and principal investigator according to the verbatim of
      participants. Then transcribed qualitative data will be translated from local language
      (Amharic) into English. In the meantime, the qualitative data will be read and reread to
      understand what they want to say. The quotes will be narrated and cited using participant's
      code. All the qualitative data gathered from interview and FGD will be arranged into thematic
      areas. Similar ideas will be color coded, and then merged accordingly. Qualitative Data
      Analysis (QDA) software like Nvivo will be used to arrange or organize manually coded
      qualitative data.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: 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.
primary purpose: Prevention
masking: None (Open Label)
measure: Change of the level of domesic violence against women from baseline to endline assessent
time frame: 12 month period from baseline assessment to endline interevntion evalaution
description: 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.
arm group label: Comprehensive (Intervention 1)
arm group type: Experimental
description: 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.
arm group label: Intervention 2
arm group type: Active Comparator
description: 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.
arm group label: Control/Comparator
arm group type: Other
description: 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
intervention type: Behavioral
intervention name: Intervention 1: Comprehensive preventive intervention
description: aims to implement the existing evidence and policy documents Advocacy workshop to politicians, Community mobilization, Awareness creation on women,training community representative, Husband participation
arm group label: Comprehensive (Intervention 1)
intervention type: Behavioral
intervention name: Intervention 2: Awareness creation and community mobilization
description: Advocacy politicians, Community mobilization, Awareness creation to women, Training community representative
arm group label: Intervention 2
intervention type: Other
intervention name: available standard care
description: The standard care will be maintained but no other additional intevvenion designed by this study
arm group label: Control/Comparator
criteria: 
gender: Female
gender based: Yes
minimum age: 15 Years
maximum age: 49 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Augustine Ankomah, PhD
role: Study Chair
affiliation: University of Ghana
last name: Kwasi Torpey, MD, PhD
role: Study Chair
affiliation: University of Ghana
last name: Abubakar Manu, PhD
role: Study Chair
affiliation: University of Ghana
facility: 
country: Ethiopia
responsible party type: Principal Investigator
investigator affiliation: Haramaya Unversity
investigator full name: Agumasie Semahegn
investigator title: PhD Candidate