Community-based Prevention Clinical Trial
Official title:
Community Based Intervention to Prevent Domestic Violence Against Women in Ethiopia; a Protocol for Quasi-Experimental Implementation Research
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.
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