For this process, within each ward, random numbers were generated in Excel. Households were subsequently organized from highest to lowest based on the randomly generated number. The 20 households with the highest randomly generated numbers were selected for the study.
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Ten possible replacements were similarly identified given the increased likelihood of ineligible couples based on the reliance on informants and other sources during the creation of the sampling frame. Replacement of LDG members will occur if a member decides to discontinue participation or if the LDG moderator in consultation with VDRC, EA, and the study PI deem that further participation places the member or another member at risk of violence or other adverse event. Groups with low attendance will receive an in-person supervisory visit from the field monitor and the LDG moderator will follow-up via telephone or in-person with LDG members who are absent to assess barriers to participation and intention to continue.
Family members of LDG members will be recruited for sex-specific FGDs at baseline and again at 9-months post baseline to understand changes in family-based norms on gender equity and IPV, as well as the impact of any project activities and couple-based activism they may have been exposed to. Interested family members will be identified by recommendations made by LDG members. Leaders will be identified through recommendations made by stakeholders who are consulted within the study communities. As exact matches are not possible, the final matching procedure was done with VDRC representatives familiar with the local communities best to ensure that the matching process benefited from contextual information not available through public census statistics.
Allocation of treatment condition was accomplished by the study Primary Investigator through simple randomization using randomly generated numbers in Excel, with the highest random number per pair being assigned to treatment.
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Baseline community survey recruitment and administration occurred prior to randomizing study sites in order to minimize bias in recruitment. Further, the informed consent forms did not identify which study-related activities would be implemented in their community. These individuals will be interviewed by the data collection firm who has no role in the project, enabling the study to keep community survey participants and outcome assessors blind to site allocation. LDG participants cannot be blinded due to the nature of their engagement. Individual recruiters, outcome assessors and data analysts will be blinded to treatment assignment.
The modelling strategy will adhere to intention-to-treat principles. Characteristics of participants and baseline levels of study outcomes across arms will be compared descriptively at baseline to examine potential confounding and to ensure that randomization was successful. Treatment effects will be estimated with generalized logistic mixed models specified to compare differences in primary outcome from baseline to follow-up, and baseline to months post. A random effect for cluster VDC will be included to account for within-group clustering, and degrees of freedom will be properly calculated.
Time, condition, and time by condition interaction will be fit as fixed effects. To the extent necessary, estimates will be adjusted for socio-demographic characteristics should confounding be detected. Additional quantitative analyses using mixed models will be employed to investigate mediation [ 39 ] and adherence. Missing data will be handled using full information maximum likelihood [ 40 ].
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An analysis team comprised of the PI and select EA staff will analyse the transcripts using a mixture of deductive and inductive coding approaches, analytic memos, and matrix and network displays [ 41 ]. Analysis team members will independently read the transcripts and contribute to a collective draft codebook and series of memos, which are separated into process and analytic components.
Analysis will examine the occurrence, dynamics, and pathways to change with a particular emphasis on differences by location, caste, and socioeconomic status. Qualitative analyses will additionally seek to identify any other characteristic or contextual feature that is revealed to be a potential modifying factor of the intervention impact or explanation for null findings.
Findings from the qualitative data analysis will inform subsequent quantitative subgroup analyses. Qualitative and quantitative findings will be iteratively fed back into the analysis of the other to generate rich, contextualized results and findings from both processes will be jointly presented in manuscripts to the extent possible. The project has an extensive monitoring plan and an accompanying process evaluation.
An independent audit is not anticipated.
The study adheres to international guidelines for the protection of participants and staff involved in research on violence against women [ 42 ] and has a data and safety monitoring plan which details procedures and reporting obligations regarding expected risks and planned protections, confidentiality and data security, and adverse events with oversight provided by an Independent Monitor who is unaffiliated with the study.
This study will be stopped prior to its completion if it is associated with adverse effects that call into question the safety of the participants enrolled. Permission was also received from the District Development Committees representing Nawalparasi, Kapilvastu and Chitwan. Written informed consent will be sought from all participants prior to randomization, except for activities related to LDG participation for which recruitment occurred after treatment allocation.
VDRC field officers who are involved in recruiting will read the statement the because of the significant number of illiterate individuals in Nepal, most of whom are women. Once participants have agreed to participate in the study, the participant and the person obtaining the consent will sign the consent document. VDRC field officers will obtain informed consent during the recruitment visit.
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Informed consent will be reaffirmed by the enumerator by reading a summary of participant rights just prior to administering the survey. Research indicates that social norms campaigns may have perverse effects [ 13 ] including raising awareness of VAWG to the point where it is perceived as being ubiquitous and, thus, more acceptable.
We take several steps to address this including engaging community actors in social norms change, such as addressing injunctive rather than descriptive norms, engaging community stakeholders at all levels and involving diverse genders in the development of programming [ 13 , 43 ]. Additionally, raising awareness of VAWG and available services may encourage women to seek help [ 44 ].
The study entails an extensive safety plan, including partnering with key violence advocate and service-providing organizations to ensure the availability of counselling and immediate response. All study participants will be made aware of other resources for women and couples in their areas.
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Lessons learned from the study will be shared widely throughout Nepal and among global audiences. To further social change, EA will conduct community forums to review the activities conducted and the results of the intervention. EA will make the evaluation tools, including the baseline and endline surveys and qualitative data questions available to the international community via the internet.
EA and the research team will also share the lessons from the impact via local and international media vehicles, such as press releases, social media, and op-eds. The study is registered with clinicaltrials.
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This registration, and all bodies with regulatory oversight will be notified of protocol changes. This study seeks to rigorously evaluate a multi-component social norms intervention involving radio, LDGs, and community outreach to reduce IPV. Findings may contribute to the evidence-base for strategies to reduce IPV and to shift gender norms. Despite the numerous strengths of the study design and approach, the limitations of the study must be discussed.
As with all RCTs, this study aims to have strong internal validity, as opposed to strong external validity. One specific limitation is that only women who have received support and permission from their husbands to participate in the study will be recruited. While this criterion likely restricts the study from including the most vulnerable women, it is meant to protect women in high-risk situations from exacerbated abuse and protect the research team and other participants from potentially dangerous situations.
Another important limitation regarding external validity is that the trial excludes participants with easily detectable physical or cognitive impairments, and growing research has underscored how women with disabilities may be particular to VAWG [ 45 — 48 ]. Thus, the research team is fully aware that those who are restricted from participating may have different profiles than those who are able to join. Another important concern is fidelity of intervention delivery given the number of LDGs and their geographic spread which is bolstered by an extensive monitoring and support plan for LDG facilitators.
The impact of the study may also be difficult to discern due to overlap with programs that have similar content being conducted in the study areas. Intermittent and ongoing disruptions in programmatic activities may possibly occur due to fuel shortages and safety issues pertaining to political tensions.
The research team will closely monitor these potential disruptions. In summary, the Change Starts at Home Change is a multi-component behaviour change communication and community engagement strategy designed to prevent IPV in Nepal.
Vox Pop is short for Vox Populi meaning voice of the people and is a broadcasting term used to describe a range of opinions expressed by the public in the form of informal comments on the same topic or short answers to the same question. World Health Organization. Global and regional estimaets of violence against women: prevalence and health effects of intimate partner violence and non-partner sexual violence.
Geneva: World Health Organization; Nepal Demographic and Health Survey Intimate partner violence against women in Nepal: an analysis through individual, empowerment, family and societal level factors. J Res Health Sci. Agenda setting and framing of gender-based violence in Nepal: how it became a health issue. Health Policy Plan. Nepal TAF. Kathmandu: The Asian Foundation- Nepal; Prevention of violence against women and girls: what does the evidence say? Heise LL.
What Works to Prevent Partner Violence? An Evidence Overview.
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