Domestic Violence Clinical Trial
Official title:
Impact Assessment of the Rural Response System to Reduce Violence Against Women in Ghana
AIM: To assess the community level impact of the Gender Centre's Rural Response System (RRS)
in reducing violence against women (VAW) in Ghana.
METHODS:
Design: An unmatched cluster randomised controlled trial with two arms i) Intervention arm-
Receive Gender Centre's RRS /COMBAT package for communities as well as state agencies.
Control arm - No intervention. Qualitative component Setting: Rural and urban communities in
the Central Region of Ghana. i). Rural and urban communities in four (4) Districts located in
the Central Region of Ghana. Two districts are along the Coast (Abura and Komenda) while the
other two (Agona and Upper Denkyira) are inland districts.
ii). State Agencies (DOVVSU/Police, CHRAJ, Social Welfare, and Health Services).
Interventions: Carried out in two Districts - Agona district and Komenda district. Workings
of the intervention arm will be facilitated by the Gender Studies and Human Rights
Documentation Centre in Ghana.
Sample size: A total of 3280 adults (1640 women and 1640 men) from 20 clusters per trial arm
(approximately 82 households per cluster) will be recruited at baseline and again at
post-intervention survey. Sampling format will be a community survey with independent samples
design (i.e. in each community, the people surveyed at baseline may not necessarily be the
same people who are surveyed at post intervention. Clusters refer to the selected localities
and their participating communities in each district.
Evaluation design: Pre-test all study participants with a standardized instrument then
introduce the independent variable (intervention) to the experimental group while withholding
it from the control group. After 24 months of intervention, post-test both groups with the
same instrument and under the same conditions as the pretest (baseline). Compare the amount
of change in dependent variable for both experimental and control groups.
Data analysis: The data will be analysed by intention to treat. The past 12 months prevalence
of IPV will be compared between arms in the study.
The Rural Response System (RRS) was a strategy developed by the Gender Centre over a decade
ago to deal with the major problems related to VAW including poor institutional response to
VAW; high degree of tolerance of VAW in the Ghanaian society which is perpetuated by strong
perceptions that domestic violence is a private matter; the general confusion about what
constitutes violence and ignorance about the causes, consequences and mechanisms that
perpetuate VAW [1]. It is generally acknowledged that to enable victims to take advantage of
laws and policies for their protection, there is the need to have structures in place that
support and enable them assert their rights. The RRS model uses multiple strategies (such as
training, sensitization and awareness-raising, support services, networking and coalition
building, advocacy) targeting multiple stakeholders including women, men, religious and
traditional leaders, policy makers, state agencies etc. to ensure that women are empowered to
become their own agents of change, with communities that support and uphold women's rights
and a state where gender sensitive laws and policies are implemented.
The Rural Response System uses the strategy of trained community members known as
Community-based action team, COMBAT to undertake awareness-raising on gender-based violence
as well as providing support to victims of violence to access justice. The RRS is stressed as
a community initiative facilitated by GC to ensure community ownership. The selection of the
COMBAT, the criteria for their selection and their roles are done by the community members
with the GC serving only as a facilitator in this process. Teams usually work as a group when
undertaking community sensitization and awareness-raising but could also work individually as
they are encouraged to use every opportunity, such as community festivals and meetings,
membership meetings of social associations, religious groupings, meetings of family and
friends to carry out this role. The sensitization will be an ongoing process and not a
one-off activity.
Goal and Objectives: Our project goal is to reduce the prevalence of VAW and promote and
protect the rights of women and girls. We will do this by increasing the visibility of VAW as
a social issue, improving the public's knowledge and understanding of the negative impact of
VAW on the status of women and girls; establish a community based response system for the
support and protection of women and provide counselling services as well as work with state
agencies to ensure effective response to victims; whilst sharing best practice and key
lessons learnt with other stakeholders.
With regard to the RRS model/COMBAT, the specific objectives of the impact assessment will be
as follows: To assess the impact of the RRS model/COMBAT in reducing VAW; To determine
whether RRS model/COMBAT interventions are effective in enabling women in to reduce their
exposure to intimate partner violence (IPV) and men to reduce their perpetration of IPV; To
assess if the RRS model changes discriminatory social norms and gender roles which consider
VAW acceptable; To assess the extent to which RRS has changed individual attitudes about
gender inequality To assess state institutional response to reported cases of VAW ;To assess
whether the RRS model facilitated a shift in power relations between men and women in the
household/community to become more equitable.
Study Setting: This study will be carried out in 4 Districts located in the Central Region of
Ghana. Two districts are along the Coast (Abura and Komenda) while the other two (Agona and
Upper Denkyira) are inland districts.
Study Population: Participating districts from the Central Region of Ghana were selected on
the basis of operational and program considerations. Selection of districts was done using a
census map of the Central Region that showed Inland and Coastal districts [2]. After
excluding some districts on the grounds that previous intervention work on GBV has been
carried out in those districts, two inland and two coastal districts were then purposively
selected as study sites. Designated sites are separated from each other by a geographical
buffer (at least one district wide) to reduce the possibility of intervention diffusing into
control districts.
Sample Size Estimation: Sample size for a cluster randomized control trial in a community was
defined at two levels: The level of randomization - number of clusters randomized, and the
level of data collection - number of individuals surveyed in each household. Using the method
of Hayes and Bennet [3], we estimated sample size (i.e. the number of clusters required in
each arm of treatment) for an unmatched cluster-randomized control trial. The calculation
made the following assumptions: Power: 90%; Ho (Pi_0): Proportion in the population that
experience any form of IPV (emotional, physical, sexual violence, or all three forms). This
estimate is based on national level data from the 2008 Ghana Demographic and Health Survey
which indicates that among ever-married women age 15-49 years, 34.9% have experienced
violence (any form) commuted by their husband/partner in the 12 months preceding the DHS
survey [4]. Alpha (ɑ) = 0.05 (two-sided). K: coefficient of variation = 20%. This refers to
the coefficient of variation between clusters for the outcome measure. We used k = 0.20 on
the basis of district level census within the Central Region of Ghana [2]. We will oversample
by 15% to allow for incomplete questionnaires. A total sample size of 1640 women and 1640 men
will to be sampled from 20 clusters per trial arm. This would imply 90% power to detect a
significant change at the 5% level with a 20% reduction in IPV incidence.
To randomize the districts, the names of the two Inland districts were written on a piece of
paper and put in a bag. One paper was blindly drawn from the bag, the selected district was
assigned as an intervention district, and the other designated as the control district.
Clusters in the Ghana DHS are census listed localities with each locality comprising one or
more enumeration areas. Owing to the nature of intervention design, participants will not be
blind to their study arm. All clusters will be allocated numbers and the randomization done
using a system of numbers. Within each selected district, lists of localities will be
obtained from the Ghana Statistical Service, and a random sample of 10 localities from each
district taken using simple random sampling.
Qualitative Approach: The qualitative approach will be adopted to provide in-depth
understanding of the effects of the CHiPs intervention, if any, at individual, community as
well as institutional levels. Qualitative methods will be used to assess the overall goal of
the project; specifically evaluating the level of visibility for violence against women (VAW)
issues in communities, knowledge and awareness of VAW and its outcomes. In this regard,
various qualitative data collection techniques (Focus Group Discussions (9), In-depth
Interviews (60), Key Informant Interviews (8) and Document Reviews will be used at baseline,
midpoint (9 months) and the endpoint of the intervention (18 months) to collect data in both
intervention and control communities. These will involve community members, COMBAT members,
as well as critical stakeholders to examine community experiences, programmatic perspectives
and outcomes as well as institutional responses.
At the individual level the Community FGDs and IDIs will explore knowledge about VAW,
experiences with the intervention including Gender attitudes, Women's subordination,
Tolerance of VAW, Social stigma for the victims of VAW, Decision making on number of children
and spacing and Decision making on the use of contraceptives. FGDs with COMBAT Members will
also explore themes on attitudes of service providers, Increased knowledge of community
members on the impact of VAW, Perceptions about intervention and Assessment of the
effectiveness of the programme. KIIs will assess Institutional response to VAW, Relevant laws
on VAW, Women & societal responses to VAW, Improved institutional response to cases of VAW
reported to State Agencies, and Institutional assessment of VAW cases.
Ethical Considerations: This research proposal is structured in accordance with the ethical
principles provided by the World Medical Association Declaration of Helsinki (last updated in
2013) [5], and the Belmont report (1979) [6]. These documents emphasize respect for person's
autonomy, justice, beneficence, and non-maleficence (do no harm) in the conduct of research
with human participants. Ethical approval for the study will be sought from the Institutional
Review Board at the Noguchi Memorial Institute for Medical Research, University of Ghana, and
the South African Medical Research Council's Ethics Committee. This trial has been designed
to ensure that the project does not expose participants to more than minimal risk (more than
everyday risk). The study design has measures in place to minimize the potential of harm to
participants and be able to respond to any adverse consequences i.e. emotional or
psychological harm that may result from the questions that will be asked in this study. The
following measures will be put in place to ensure that the study is conducted in an ethical
correct manner. Complete privacy is essential for ensuring the security of the respondent and
the interviewer. Asking about or reporting violence, especially in households where the
perpetrator may be present at the time of interview, carries the risk of further violence.
Accordingly, interviewers will be provided specific training for implementing the domestic
violence module to enable the field staff to collect violence data in a secure, confidential,
and ethical manner.
Informed Consent and Confidentiality: All research participants will be asked to give written
informed consent before participating. Prospective participants will be informed of the
purpose of the trial, procedures involved, risk and benefits of the trial and their rights as
participants. All prospective participants will be informed that participation in the trial
is voluntary, and that they may withdraw at any stage, or skip any question in the research
with no adverse consequences to them. All participants will be assured that the information
they provide in the trial will be handled confidentially and that findings will be reported
with complete anonymity. Participants will be guaranteed that all the information collected
will be kept confidential. The confidentiality of information given by participants will be
ensured using codes on the questionnaires instead of subject names.
The study will be conducted over 36 months with recruitment commencing soon after ethical
approvals have been granted. There will be one baseline survey, followed by 18 months of
intervention, and one impact evaluation survey. This research is funded by the United Kingdom
Government's Department for International development (DFID).
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