<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/NCT03304015</url>
  </required_header>
  <id_info>
    <org_study_id>PR-16036</org_study_id>
    <nct_id>NCT03304015</nct_id>
  </id_info>
  <brief_title>HERrespect Evaluation</brief_title>
  <acronym>HERrespect</acronym>
  <official_title>Measuring the Effect of HERrespect: An Intervention Addressing Violence Against Female Garment Workers in Four Factories of Bangladesh</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>International Centre for Diarrhoeal Disease Research, Bangladesh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medical Research Council, South Africa</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>BSR</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Change Associates Limited</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>International Centre for Diarrhoeal Disease Research, Bangladesh</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>
      This study evaluates whether a factory wide intervention, HERrespect, can reduce female&#xD;
      garment workers' experiences of intimate partner violence, and experience and/or witnessing&#xD;
      of violence in the workplace. This is a quasi-experimental study involving four intervention&#xD;
      and four control factories.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background Violence against women (VAW) is an important public health, human rights and&#xD;
      development issue worldwide. Intimate partner violence (IPV) is the most common type of VAW&#xD;
      ranging between 15% and 71% worldwide. IPV in South Asian countries is as high as 42%.&#xD;
      Adverse consequences of spousal violence on women's health and well-being are well&#xD;
      documented. This violence is also known to affect women's work and productivity. IPV affects&#xD;
      not only the women, but also their children, families and the nation.&#xD;
&#xD;
      In Bangladesh, 53% of the ever-married reproductive aged women reported lifetime physical&#xD;
      and/or sexual abuse and about a quarter of the currently married women reported exposure to&#xD;
      this violence during the last 12 months. Common correlates of IPV in Bangladesh include young&#xD;
      age, poverty, low education, history of wife abuse in the family, childhood experience of&#xD;
      violence, dowry, and low spousal communication. The literature on correlates of IPV shows&#xD;
      that, particularly in patriarchal contexts, working women are more vulnerable to IPV.&#xD;
      Although research on IPV has gained great momentum over the last few decades, literature on&#xD;
      IPV against working women in low income settings is still scanty. Unpublished data from&#xD;
      icddr,b show that 70% of the garment workers aged 15 to 29 were physically and/or sexually&#xD;
      abused by their spouses during the last 12 months, while according to the Bangladesh&#xD;
      component of the WHO multi-country study on Women's Health and Domestic Violence against 53%&#xD;
      of urban and 62% of rural peers of them reported such violence. Studies show economic IPV&#xD;
      against female garment workers in Bangladesh. Thus, young female garment workers are highly&#xD;
      vulnerable to violence demanding attention of the researchers, programme implementers and&#xD;
      policy makers.&#xD;
&#xD;
      Approximately 80% of the workforce in the garment manufacturing industry in Bangladesh is&#xD;
      female. According to a report, about 60% of female workers experience harassment at work.&#xD;
      Qualitative research suggests that severe emotional and economic violence is universal in&#xD;
      this sector, while physical and sexual violence is not uncommon. Most common perpetrators of&#xD;
      violence are mid-and low-level factory management staff.&#xD;
&#xD;
      In general, evidence on what works in addressing IPV and workplace violence against women is&#xD;
      thin worldwide. A few sporadic interventions implemented for addressing workplace violence&#xD;
      against female garment workers over the last few years in Bangladesh have not been rigorously&#xD;
      studied. Although there is evidence that a combination of economic empowerment and gender&#xD;
      interventions reduces IPV effectively there has been no attempt at measuring effect of gender&#xD;
      interventions among female garment workers, who are relatively much more economically&#xD;
      empowered compared to their peers. The current research proposes to evaluate HERrespect, a&#xD;
      pilot intervention for preventing and responding to spousal and workplace violence against&#xD;
      female garment workers by providing interactive sessions to the management and the workers on&#xD;
      gender and violence against women and girls (VAWG).&#xD;
&#xD;
      Objectives of the study The primary objective of this study is to measure whether HERrespect&#xD;
      intervention reduces female garment workers' experiences of: (1) Spousal physical and sexual&#xD;
      violence and (2) Workplace violence over a period of 24 months between baseline and end-line&#xD;
      during which the intervention is delivered in the factories.&#xD;
&#xD;
      The secondary objectives are to assess whether HERrespect:&#xD;
&#xD;
        1. Increases gender equitable attitudes among female garment workers&#xD;
&#xD;
        2. Reduces acceptance of VAWG among female garment workers&#xD;
&#xD;
        3. Increases self-esteem of the female garment workers&#xD;
&#xD;
        4. Reduces rate of depression among female garment workers&#xD;
&#xD;
        5. Increases knowledge and uptake of service for addressing spousal violence&#xD;
&#xD;
        6. Increases gender equitable attitudes among garment management staff&#xD;
&#xD;
        7. Improves management skills of management staff&#xD;
&#xD;
        8. Increases knowledge of policies addressing gender discrimination and violence among&#xD;
           management staff&#xD;
&#xD;
      The intervention HERrespect is a workplace programme developed by Business for Socail&#xD;
      Responsibilities (BSR) and South African Medical Research Council (SAMRC), with inputs from&#xD;
      Change Associates Limited. Design of HERrespect is guided by the Theory of Change (TOC) and&#xD;
      the formative research conducted by icddr,b.&#xD;
&#xD;
      Theory of Change The base of the TOC begins with a core problem that female workers in the&#xD;
      RMG industry in Bangladesh experience high levels of violence, both in the workplace and&#xD;
      their intimate relationships. Such violence is not only a violation to their rights, but at&#xD;
      the same time constrain them from contributing to their personal growth, household, community&#xD;
      and the economy at large.&#xD;
&#xD;
      The barriers are based on BSR's experiences in implementing HERproject, a women empowerment&#xD;
      initiative in the supply chain, in Bangladesh, as well as the formative research conducted by&#xD;
      icddr,b. At an individual level, there is a lack of critical awareness about gender and&#xD;
      rights among workers, both male and female, and VAW is normalized and generally accepted in&#xD;
      the workplace. Outside the workplace, workers also do not have sufficient information on&#xD;
      available resources and initiatives in the community targeting IPV victims. Management does&#xD;
      not possess essential skills to manage the workforce, and perceives violence as the most&#xD;
      accessible and effective way to achieve production targets. The dominant social norms of&#xD;
      femininity and masculinity in Bangladesh and the disciplinary nature of operating a factory&#xD;
      reinforce the submissive identity of female workers and the unequal relationship between&#xD;
      managers and workers. Moreover, there are institutional barriers in the workplaces,&#xD;
      particularly on the gender-blind policies and organizational structure to prevent and address&#xD;
      violence; the lack or misuse of such may even incentivize VAW in workplace.&#xD;
&#xD;
      To overcome the barriers, a combination of intervention strategies will be adopted to: (1)&#xD;
      raise awareness on gender, rights and VAW among workers and management; (2) enhance the&#xD;
      skills of workers to prevent and address sexual harassment and IPV; (3) build capacity of&#xD;
      management to promote gender equitable environment; (4) create an enabling environment&#xD;
      through development of gender-sensitive policy and organizational structure, and (5) bridge&#xD;
      the information gap on community services and initiatives on IPV.&#xD;
&#xD;
      Together, the interventions will lead to five outputs. First of all, female workers will have&#xD;
      enhanced awareness and knowledge on gender, rights and VAW; their skills will also be&#xD;
      enhanced to respond to violence in workplace and family. In case they suffer from IPV, they&#xD;
      would have more knowledge on the services available in the community and know where to avail&#xD;
      them. For management and male workers, their awareness and skills will be enhanced to&#xD;
      motivate and support colleagues in preventing and addressing VAW at workplace.&#xD;
      Institutionally, the policies and structures of factory will be improved to address grievance&#xD;
      in more equitable and effective manner, and management will be supported to design and&#xD;
      implement policies to promote positive gender relations.&#xD;
&#xD;
      The outputs will lead to certain empowerment outcomes. Female workers will be empowered from&#xD;
      within through improved self-esteem, confidence and assertiveness; communications and&#xD;
      negotiations around IPV are also expected to improve through the training. The quality of&#xD;
      interactions between management and workers would improve, contributing to a more supportive&#xD;
      social network within the workplace. That will be further augmented by the improved&#xD;
      implementation of policies and mechanism on VAW. Finally, with heightened awareness of&#xD;
      community resources, it is expected that more women in need would avail services for VAW in&#xD;
      the community.&#xD;
&#xD;
      The goal (or impact) of HERrespect is to cultivate more gender equitable attitudes and&#xD;
      relationships among women and men in RMG industry in Bangladesh, which ultimately will&#xD;
      contribute to preventing VAW at workplace and family.&#xD;
&#xD;
      Intervention components&#xD;
&#xD;
      The main intervention components in the workplace, will be implemented by Change Associates,&#xD;
      are:&#xD;
&#xD;
        1. Separate gender transformative training for workers (single sex groups for female and&#xD;
           male workers) and management staff of 18 hours (six 3-hour modules), held over 9 months&#xD;
           and delivered to groups of 25. The session topics include communication skills (e.g.&#xD;
           listening, body language, etc.); assertive responses; reflection and discussion of&#xD;
           gender roles and norms, and relationships; power; violence in relationships (causes,&#xD;
           consequences and support system); stress and conflict management; factory policy; and&#xD;
           goal setting and being a change Maker. The curriculum is participatory, taking reference&#xD;
           from Stepping Stones and Freirean reflective pedagogy.&#xD;
&#xD;
        2. Joint session between workers (15 female and male) and middle-management staff (10),&#xD;
           held after third, fifth and sixth group sessions.&#xD;
&#xD;
        3. Factory-wide activities/campaigns using factories public address systems, skit play and&#xD;
           other behaviour change communication materials&#xD;
&#xD;
        4. Awareness raising among top management (e.g., general manager, HR&amp;A director, etc.; 2&#xD;
           hours)&#xD;
&#xD;
        5. Factory policy review and development. Its activities include at least one meeting in&#xD;
           every two months with the Factory Well-being Committee. The topics include review&#xD;
           existing and develop new gender policies and mechanisms to prevent and address sexual&#xD;
           harassment; design and implement factory-wide promotional activities/campaigns; report&#xD;
           progress and challenges to top management on a regular basis; and design and implement&#xD;
           sustainability plan (initially support, and subsequently run, the joint sessions between&#xD;
           managers and workers).&#xD;
&#xD;
      In addition to the workplace interventions, HERrespect will have an community engagement&#xD;
      component, working with Awaj Foundation in their workers' café to develop a training module&#xD;
      on IPV based on their existing programmatic framework, build capacity of cafés' staff to&#xD;
      facilitate gender transformative curriculum, and develop training materials for use in the&#xD;
      workers' café's network.&#xD;
&#xD;
      Research Design and Methods This is a quasi-experimental study involving four intervention&#xD;
      and four matched control factories recruited by the buyers purposively. Factory matching&#xD;
      criteria include size, location, and type of product. Care will be taken to select control&#xD;
      factories at a distance from the intervention factories to prevent potential contamination.&#xD;
      In the intervention factories a randomly selected cohort of married female workers and all&#xD;
      management staff will receive group sessions. In addition, factory-wide campaigns will also&#xD;
      be carried out. The control factories will be waitlisted for intervention once the evaluation&#xD;
      is over.&#xD;
&#xD;
      All the workers receiving group intervention (n=400) and a cohort of randomly selected&#xD;
      married female workers from the control factories (n=400) will be included in the baseline&#xD;
      and endline worker surveys. The management survey will include 50 randomly selected&#xD;
      management staff from each factory. The endline surveys will be conducted 24 months&#xD;
      post-baseline.&#xD;
&#xD;
      Sample Size Calculation and Outcome The sample size for the worker survey was calculated&#xD;
      considering the primary outcome, physical and/or sexual IPV against female garment workers.&#xD;
      Considering 56% baseline prevalence, 20% effect size, 80% power, 5% level of significance and&#xD;
      20% lost to follow up the required sample size was 330 workers for both intervention and&#xD;
      control groups. Accounting for a 20% lost to follow up and rounding up the sample size became&#xD;
      800 workers (400 in intervention and 400 in control), making 100 workers per factory.&#xD;
&#xD;
      Sample size for the management survey was calculated based on high or moderate gender&#xD;
      inequitable attitudes of the management staff. Considering 50% baseline prevalence, 30%&#xD;
      effect size, 80% power and 5% level of significance a sample size of 183 was derived both for&#xD;
      intervention and control factories. Accounting for a 10% loss to follow up the final sample&#xD;
      size for each group of factories was 200, giving a total of 400 (50 per factory).&#xD;
&#xD;
      Translation of data collection tools The worker and management survey questionnaires will be&#xD;
      developed in English. Once the English version is finalized the questionnaire will be&#xD;
      translated into Bengali. The Bengali questionnaire will be finalized based on feedback from&#xD;
      pre-testing and piloting. Blinded back translation will be carried out by a third party once&#xD;
      the Bengali questionnaire is finalized. Where needed, revisions will be made in the Bengali&#xD;
      version based after comparison between the Bengali version and the back translation.&#xD;
&#xD;
      Recruitment of survey participants&#xD;
&#xD;
      In order to achieve the required sample size of 100 per factory, assuming that 40% of the&#xD;
      female workers will be married and that 80% of them will finally join the groups a list of&#xD;
      315 workers containing information on ID and name will be obtained from each factory. An&#xD;
      enumeration of these selected 315 workers will be carried out within the factory to collect&#xD;
      some socio-demographic information mainly for the purpose of screening eligibility and&#xD;
      obtaining residential addresses and other contact information for conducting the interviews&#xD;
      and for tracking the cohort. The eligibility criteria include:&#xD;
&#xD;
        -  Minimum one year of work experience in the current factory&#xD;
&#xD;
        -  Currently married and living with husband. We will randomly select 100 female garment&#xD;
           workers from the list of eligible workers. The selected workers from the intervention&#xD;
           factories will be assigned for group sessions and will be interviewed both at baseline&#xD;
           and endline. The selected workers from the control factories will be interviewed both at&#xD;
           baseline and endline. If more than one worker belongs to the same household, one will be&#xD;
           chosen randomly for participating in the study.&#xD;
&#xD;
      The management staff from mid-level factory management will be eligible for participating in&#xD;
      the study. A list of 50 management staff will be obtained from the factories for inclusion in&#xD;
      the study.&#xD;
&#xD;
      Pre-testing and piloting The Bengali version of the worker and management survey&#xD;
      questionnaires will be pre-tested on 20 female workers and 10 management staff respectively&#xD;
      using paper questionnaire. Cognitive pre-testing will be carried for sections that have not&#xD;
      been previously used in Bangladesh. The pre-test will help us identify sections and questions&#xD;
      that women find difficult to understand and answer and the cognitive pre-testing will help us&#xD;
      find solutions. Training will be conducted using the revised questionnaire. About 50&#xD;
      interviews will be conducted by the worker and 30 by the management survey team members&#xD;
      during piloting. The questionnaire will be finalized based on feedback from pre-testing and&#xD;
      piloting.&#xD;
&#xD;
      Cohort tracking This will be a closed cohort study. Therefore, it is important to carefully&#xD;
      track the study participants for successfully interviewing them both at baseline and endline.&#xD;
      In case of loss to follow up such tracking will help us understand the reasons for dropout.&#xD;
      One staff will be assigned to follow up the study participants over phone every two months&#xD;
      for ensuring retention. The tracking form will include the following information (the last&#xD;
      three are applicable only after the baseline): allocated ID, name; name of factory; name and&#xD;
      cell phone number of husband; name and cell phone number of a guardian other than the&#xD;
      husband; residential address and cell phone number, name, relationship, address and phone&#xD;
      numbers of other relatives or friends or co-workers or neighbours in close to her; whether&#xD;
      she is still working at the same factory; if not, what is the reason for leaving the factory;&#xD;
      current employment; current residential address&#xD;
&#xD;
      Tracking loss to follow up If a woman is unavailable or untraceable for follow up interview&#xD;
      we need to find out the reason. If she is traced and refuses to be interviewed the reason&#xD;
      will be recorded. If she cannot be found in her previous address, we will try to track her&#xD;
      through additional contact information.&#xD;
&#xD;
      Data collection and management Three teams, each will consisting of four female data&#xD;
      collectors, one female supervisor, and one male field assistant will be employed for the&#xD;
      worker survey. One quality control officer (QCO) will be responsible for rechecking all&#xD;
      questionnaires and providing feedback to the interviewers and the supervisors. A survey&#xD;
      coordinator will be responsible for coordinating survey implementation in the field. In order&#xD;
      to recruit the necessary number of survey team members we will train a greater number of the&#xD;
      candidates shortlisted based on written and verbal tests. The team will receive a 15-day&#xD;
      participatory training on gender, violence against women, ethics, survey methods, the&#xD;
      questionnaire, and use of tablets. Final selection of the survey team members will be based&#xD;
      on performance during the training and pilot. The data will be collected using Personalized&#xD;
      Digital Assistants (PDAs) to address ethical (privacy) issues and to maximize disclosure. An&#xD;
      offline-based survey software will be developed. The interviews of the workers will be&#xD;
      conducted in private in a location convenient for the participants outside the factory.&#xD;
      During working days most interviews are likely to take place in the evening after work.&#xD;
      Female workers are likely to give interviews at home commonly located in slums. If the study&#xD;
      participant is unavailable a maximum of three attempts will be made to complete the&#xD;
      interview. We anticipate two months of fieldwork for workers survey per round of interviews.&#xD;
&#xD;
      Two teams, each consisting of four male data collectors and one male supervisor will conduct&#xD;
      the management survey. The QCO will be responsible for rechecking questionnaires and&#xD;
      providing feedback. In order to recruit the required number of management survey team members&#xD;
      we will invite a greater number of shortlisted candidates to a 8-day training on gender,&#xD;
      violence against women, ethics in research VAWG and questionnaire modules. The final&#xD;
      selection will be done in the way similar to the workers survey. The interviews will be&#xD;
      conducted in private within the factory. An offline-based software will be developed for&#xD;
      collecting data using PDA.&#xD;
&#xD;
      One programmer will be available during the survey period for necessary trouble shooting and&#xD;
      data uploading. Confidentiality will be maintained by keeping the identification information&#xD;
      in separate files.&#xD;
&#xD;
      Data quality monitoring Worker survey Fieldwork for the worker survey will be distributed in&#xD;
      such a way that each interviewer is accompanied to the interview venue either by a supervisor&#xD;
      or by a field assistant. Before moving ahead with the next assignment the supervisor and the&#xD;
      field assistant will make sure the interview can be started in private. Once all the&#xD;
      interviews are started the supervisor and the field assistant will make rounds to check&#xD;
      whether the interview is going on uninterrupted. They will help, if intervention is needed,&#xD;
      to handle gatekeepers. The supervisor will also observe the quality of the interviews, keep&#xD;
      notes and discuss problems at review sessions. The survey coordinator will randomly choose&#xD;
      survey teams for spot checks.&#xD;
&#xD;
      The QCO will recheck all the questionnaires and will provide feedback. The data will be&#xD;
      uploaded to the server every day after the data collection has been completed for that day,&#xD;
      and uploaded data will be checked by the Research Officer using a computer -based data&#xD;
      checking routine. Due to the efficiency of this system, inconsistencies in the data can be&#xD;
      identified within a short period of time. Problems identified in the data will be&#xD;
      communicated to the survey team. The supervisor will resolve the problems through discussion&#xD;
      with the interviewer if possible. If necessary, the interviewer would revisit the respondent&#xD;
      and solve the issues consulting her. If the problems cannot be resolved using this strategy&#xD;
      the researchers will be informed. They will suggest ways of resolving the issue depending on&#xD;
      the nature of the problems. Five percent of the study participants will be revisited by the&#xD;
      supervisors and the coordinator for administering a short questionnaire mainly focused on&#xD;
      identifying problems in adhering to ethical guidelines and administering questions on&#xD;
      particular topics.&#xD;
&#xD;
      Management survey Supervisors will assign interviews to the team members, observe the quality&#xD;
      of the interviews, keep notes and discuss problems at review sessions. Supervisors both in&#xD;
      worker and management survey will report to the coordinator and will communicate directly to&#xD;
      the researchers if needed. The role of the QCO will be in line with the worker survey.&#xD;
&#xD;
      Data Analysis Intention to treat (ITT) analysis will be used for assessing the impact of&#xD;
      HERrespect. Thus, all the workers selected for the study will be included in the analysis.&#xD;
      The primary analysis will be a comparison between intervention and control factories will&#xD;
      enable us to determine the impact of full HERrespect intervention (group sessions and&#xD;
      factory-wide mobilization over control). Chi-square (for categorical variables) and t-tests&#xD;
      (for continuous variables) will be performed to test whether there are differences in&#xD;
      background characteristics between intervention and control groups. If differences between&#xD;
      intervention and control factories are evident, the pre-existing differences will be&#xD;
      controlled in subsequent analyses. The impact of HERrespect intervention on main outcomes of&#xD;
      interest will be assessed using risk ratios derived from binary regression analyses adjusting&#xD;
      for baseline rates. All analyses will be adjusted for the baseline prevalence and age. The&#xD;
      same approach will be followed for assessing the secondary outcomes.&#xD;
&#xD;
      Ethical considerations This study will be guided by the WHO recommendations for ethical&#xD;
      considerations in researching violence against women. The participation of the intervention&#xD;
      and control factories will be based on the factories' consent to be a part of the study.&#xD;
      Attention will be paid when designing the questionnaire to carefully and sensitively&#xD;
      introduce and enquire about workers' experiences of violence and to ensure that questions are&#xD;
      framed in a manner that is non-judgmental. There is evidence in the literature that the&#xD;
      factory management is opposed to disclosure of workplace violence and workers disclosing it&#xD;
      or attempting to address it are victimized. They may be harassed, threatened and dismissed.&#xD;
      The questions on workplace violence will be included in a style which was as far as possible&#xD;
      non-threatening to the factory management. Individual verbal consent will be sought prior to&#xD;
      the interview with each female garment workers and management staff. The participants will be&#xD;
      informed orally of the purpose and nature of the study, its expected benefits, and voluntary&#xD;
      nature of participation. As part of the consent procedure, the participant will be informed&#xD;
      that the data collected will be held in strict confidence. To ensure that the participant is&#xD;
      aware that the survey includes questions on highly personal and sensitive topics, the&#xD;
      interviewer will forewarn the participant that some of the topics are difficult to talk&#xD;
      about. The respondent will be free to terminate the interview at any point, and to skip any&#xD;
      questions that she does not wish to respond to. Because of the low levels of literacy and&#xD;
      concerns regarding confidentiality the interviewer will request verbal consent of the&#xD;
      participant to conduct the interview.&#xD;
&#xD;
      Participation in the study will be entirely voluntary. Interviews will only be conducted in a&#xD;
      private setting outside the factory. The participant will be free to reschedule (or relocate)&#xD;
      the interview to a time (or place) that may be more safe or convenient for her. The physical&#xD;
      safety of interviewees and interviewers from potential retaliatory violence by the&#xD;
      perpetrator will be of prime importance. If the focus of the research becomes widely known&#xD;
      either within the factory or household or among the wider community it may risk the safety&#xD;
      and security of both. Thus, at the factory level the intervention and the study will be thus&#xD;
      introduced as activities focused on addressing IPV and improving management and in the family&#xD;
      and community it will be framed as a survey of factory work management and female workers&#xD;
      life experiences. Even where a researcher or field worker has not herself experienced&#xD;
      violence, listening to stories of violence and abuse may be draining and even overwhelming&#xD;
      for her. During the research regular debriefing meetings will be scheduled to enable the&#xD;
      research team to discuss what they are hearing, their feelings about the situation, and how&#xD;
      it is affecting them. These meetings will aim to reduce the stress of the field work, and&#xD;
      avert any negative consequences. This strategy proved effective in the Bangladesh component&#xD;
      of the WHO multi-country study conducted by icddr,b. Despite these measures, some field&#xD;
      workers may need to be given less emotionally taxing tasks, be given a break from the study&#xD;
      or to withdraw from the research altogether. To account for these possibilities, sufficient&#xD;
      numbers of field workers will be recruited to allow for a 10% attrition rate of interviewers&#xD;
      over the study. All the study participants will be given a unique a code and all the&#xD;
      identifying information will be kept in a separate file exclusively accessed by the research&#xD;
      team and will be used for tracking the individuals over the intervention period and to&#xD;
      contact them during the endline survey. Care will be taken to present the research findings&#xD;
      in sufficiently aggregated form to ensure that no participating factories and workers can be&#xD;
      identified.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 3, 2016</start_date>
  <completion_date type="Actual">October 31, 2019</completion_date>
  <primary_completion_date type="Actual">October 31, 2019</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Physical IPV experience</measure>
    <time_frame>24 months post baseline</time_frame>
    <description>Physical intimate partner violence is assessed using five items based on the WHO VAW scale. A positive response to any item leads to a person being classified as experiencing in the past year.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sexual IPV experience</measure>
    <time_frame>24 months post-baseline</time_frame>
    <description>Sexual intimate partner violence is assessed using five items based on the WHO violence against women (VAW) scale. A positive response to any item leads to a person being classified as experiencing in the past year</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Physical and/or sexual IPV experience</measure>
    <time_frame>24 months post-baseline</time_frame>
    <description>Physical and/or sexual IPV is assessed using 10 items (5 physical and 5 sexual) based on the WHO VAW scale. A positive response to any item leads to a person being classified as experiencing in the past year</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Witnessing and/or experiencing workplace violence</measure>
    <time_frame>24 months post-baseline</time_frame>
    <description>Eight items adapted from the peer victimization scale assess whether a participant had witnessed or experienced workplace violence in the past four weeks. A mean score is derived.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Acceptance of VAWG</measure>
    <time_frame>24 months post-baseline</time_frame>
    <description>Six items adapted from GEM scale and WHO multi-country study on women's health and domestic violence against women assesses acceptance of VAWG among female garment workers. A mean score is derived.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gender equitable attitudes</measure>
    <time_frame>24 months post-baseline</time_frame>
    <description>Thirteen items adapted from GEM scale, WHO multi-country study on women's health and domestic violence against women, and the South African Study on Men, masculinities, Violence and HIV assess gender equitable attitudes among management staff. A mean score is derived.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response to IPV</measure>
    <time_frame>24 months post-baseline</time_frame>
    <description>A single item explores women's help seeking in response to IPV. This question will only be asked to those who experienced physical and/or sexual IPV during last 12 months. A positive response to the item leads to a person being classified as seeking help in response to IPV in the past year.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knowledge of services in response to IPV</measure>
    <time_frame>24 months post-baseline</time_frame>
    <description>One question assesses the knowledge of the workers about where to seek help after experiencing IPV. A positive response to this classifies a person as knowing where to seek help.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-esteem</measure>
    <time_frame>24 months post-baseline</time_frame>
    <description>The 10-item Rosenberg Self-Esteem scale will be used to measure self-esteem. It measures global self-worth by measuring both positive and negative feelings about self. A mean score is derived.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression symptomology</measure>
    <time_frame>24 months post-baseline</time_frame>
    <description>Thirteen items adapted from the CES-D scale assess the depression symptomology among female garment workers in the past week. Each question is a statement and asked the respondent to answer how many days she has had particular feelings or ideas. A mean score is derived.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Management style</measure>
    <time_frame>24 months post-baseline</time_frame>
    <description>Fourteen items adapted from the social power scale developed by French and Raven and revised by Swasy will be asked to the female garment workers for measuring management styles of the managers. A mean score is derived.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correct knowledge regarding laws and policies</measure>
    <time_frame>24 months post-baseline</time_frame>
    <description>The management staff will be asked five questions assessing knowledge on women's rights and protection of women against IPV and workplace violence guaranteed in laws and policies of Bangladesh. Correct answer to all five items will be considered as the management staff having correct knowledge. % correct knowledge will be compared to % incorrect.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Attitudes regarding laws and policies</measure>
    <time_frame>24 months post-baseline</time_frame>
    <description>The management staff will be asked five questions to measure their attitudes regarding the existing laws and policies about protection of women against spousal violence and workplace violence. A mean score is derived.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Burn out</measure>
    <time_frame>24 months post-baseline</time_frame>
    <description>A 16-item scale adapted from the Maslach Burnout Inventory-Human Service Survey (MBI-HSS) assesses the burnout of the management staff. A mean score is derived.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1195</enrollment>
  <condition>IPV</condition>
  <condition>Workplace Violence</condition>
  <arm_group>
    <arm_group_label>Intervention: Behavioral Change Communications</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Control: No intervention</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Behavioral Change Communications</intervention_name>
    <description>HERrespect is developed by Business for Social Responsibility (BSR) and Change Associates. HERproject is one of BSR's numerous initiatives for improving women's lives through enhancement of access and knowledge (BSR, 2015). The factory-based component of HERrespect will be implemented by Change Associates. The intervention group will receive training (group session), research and consultancy services to the corporate and development sectors. HERrespect proposes to use the workplace as an incubator of dialogue among men and women to tackle underlying issues which allow violence against women and girls. Workplace offers a unique platform and environment to engage women who are gaining financial independence to reduce intimate partner violence and workplace violence.</description>
    <arm_group_label>Intervention: Behavioral Change Communications</arm_group_label>
    <other_name>Factory-wide activity/campaign</other_name>
    <other_name>Awareness raising of top management</other_name>
    <other_name>Factory policy review and development</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Currently married woman&#xD;
&#xD;
          -  Working in the factory for at least one year&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not currently married woman&#xD;
&#xD;
          -  Working in the factory for less than one year&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
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  <verification_date>December 2018</verification_date>
  <study_first_submitted>August 22, 2017</study_first_submitted>
  <study_first_submitted_qc>October 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 6, 2017</study_first_posted>
  <last_update_submitted>December 18, 2019</last_update_submitted>
  <last_update_submitted_qc>December 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 20, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Intervention</keyword>
  <keyword>Violence against Women</keyword>
  <keyword>Female Garment Workers</keyword>
  <keyword>Bangladesh</keyword>
  <!-- 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/NCT03304015
org study id: PR-16036
nct id: NCT03304015
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study evaluates whether a factory wide intervention, HERrespect, can reduce female
      garment workers' experiences of intimate partner violence, and experience and/or witnessing
      of violence in the workplace. This is a quasi-experimental study involving four intervention
      and four control factories.
Background Violence against women (VAW) is an important public health, human rights and
      development issue worldwide. Intimate partner violence (IPV) is the most common type of VAW
      ranging between 15% and 71% worldwide. IPV in South Asian countries is as high as 42%.
      Adverse consequences of spousal violence on women's health and well-being are well
      documented. This violence is also known to affect women's work and productivity. IPV affects
      not only the women, but also their children, families and the nation.

      In Bangladesh, 53% of the ever-married reproductive aged women reported lifetime physical
      and/or sexual abuse and about a quarter of the currently married women reported exposure to
      this violence during the last 12 months. Common correlates of IPV in Bangladesh include young
      age, poverty, low education, history of wife abuse in the family, childhood experience of
      violence, dowry, and low spousal communication. The literature on correlates of IPV shows
      that, particularly in patriarchal contexts, working women are more vulnerable to IPV.
      Although research on IPV has gained great momentum over the last few decades, literature on
      IPV against working women in low income settings is still scanty. Unpublished data from
      icddr,b show that 70% of the garment workers aged 15 to 29 were physically and/or sexually
      abused by their spouses during the last 12 months, while according to the Bangladesh
      component of the WHO multi-country study on Women's Health and Domestic Violence against 53%
      of urban and 62% of rural peers of them reported such violence. Studies show economic IPV
      against female garment workers in Bangladesh. Thus, young female garment workers are highly
      vulnerable to violence demanding attention of the researchers, programme implementers and
      policy makers.

      Approximately 80% of the workforce in the garment manufacturing industry in Bangladesh is
      female. According to a report, about 60% of female workers experience harassment at work.
      Qualitative research suggests that severe emotional and economic violence is universal in
      this sector, while physical and sexual violence is not uncommon. Most common perpetrators of
      violence are mid-and low-level factory management staff.

      In general, evidence on what works in addressing IPV and workplace violence against women is
      thin worldwide. A few sporadic interventions implemented for addressing workplace violence
      against female garment workers over the last few years in Bangladesh have not been rigorously
      studied. Although there is evidence that a combination of economic empowerment and gender
      interventions reduces IPV effectively there has been no attempt at measuring effect of gender
      interventions among female garment workers, who are relatively much more economically
      empowered compared to their peers. The current research proposes to evaluate HERrespect, a
      pilot intervention for preventing and responding to spousal and workplace violence against
      female garment workers by providing interactive sessions to the management and the workers on
      gender and violence against women and girls (VAWG).

      Objectives of the study The primary objective of this study is to measure whether HERrespect
      intervention reduces female garment workers' experiences of: (1) Spousal physical and sexual
      violence and (2) Workplace violence over a period of 24 months between baseline and end-line
      during which the intervention is delivered in the factories.

      The secondary objectives are to assess whether HERrespect:

        1. Increases gender equitable attitudes among female garment workers

        2. Reduces acceptance of VAWG among female garment workers

        3. Increases self-esteem of the female garment workers

        4. Reduces rate of depression among female garment workers

        5. Increases knowledge and uptake of service for addressing spousal violence

        6. Increases gender equitable attitudes among garment management staff

        7. Improves management skills of management staff

        8. Increases knowledge of policies addressing gender discrimination and violence among
           management staff

      The intervention HERrespect is a workplace programme developed by Business for Socail
      Responsibilities (BSR) and South African Medical Research Council (SAMRC), with inputs from
      Change Associates Limited. Design of HERrespect is guided by the Theory of Change (TOC) and
      the formative research conducted by icddr,b.

      Theory of Change The base of the TOC begins with a core problem that female workers in the
      RMG industry in Bangladesh experience high levels of violence, both in the workplace and
      their intimate relationships. Such violence is not only a violation to their rights, but at
      the same time constrain them from contributing to their personal growth, household, community
      and the economy at large.

      The barriers are based on BSR's experiences in implementing HERproject, a women empowerment
      initiative in the supply chain, in Bangladesh, as well as the formative research conducted by
      icddr,b. At an individual level, there is a lack of critical awareness about gender and
      rights among workers, both male and female, and VAW is normalized and generally accepted in
      the workplace. Outside the workplace, workers also do not have sufficient information on
      available resources and initiatives in the community targeting IPV victims. Management does
      not possess essential skills to manage the workforce, and perceives violence as the most
      accessible and effective way to achieve production targets. The dominant social norms of
      femininity and masculinity in Bangladesh and the disciplinary nature of operating a factory
      reinforce the submissive identity of female workers and the unequal relationship between
      managers and workers. Moreover, there are institutional barriers in the workplaces,
      particularly on the gender-blind policies and organizational structure to prevent and address
      violence; the lack or misuse of such may even incentivize VAW in workplace.

      To overcome the barriers, a combination of intervention strategies will be adopted to: (1)
      raise awareness on gender, rights and VAW among workers and management; (2) enhance the
      skills of workers to prevent and address sexual harassment and IPV; (3) build capacity of
      management to promote gender equitable environment; (4) create an enabling environment
      through development of gender-sensitive policy and organizational structure, and (5) bridge
      the information gap on community services and initiatives on IPV.

      Together, the interventions will lead to five outputs. First of all, female workers will have
      enhanced awareness and knowledge on gender, rights and VAW; their skills will also be
      enhanced to respond to violence in workplace and family. In case they suffer from IPV, they
      would have more knowledge on the services available in the community and know where to avail
      them. For management and male workers, their awareness and skills will be enhanced to
      motivate and support colleagues in preventing and addressing VAW at workplace.
      Institutionally, the policies and structures of factory will be improved to address grievance
      in more equitable and effective manner, and management will be supported to design and
      implement policies to promote positive gender relations.

      The outputs will lead to certain empowerment outcomes. Female workers will be empowered from
      within through improved self-esteem, confidence and assertiveness; communications and
      negotiations around IPV are also expected to improve through the training. The quality of
      interactions between management and workers would improve, contributing to a more supportive
      social network within the workplace. That will be further augmented by the improved
      implementation of policies and mechanism on VAW. Finally, with heightened awareness of
      community resources, it is expected that more women in need would avail services for VAW in
      the community.

      The goal (or impact) of HERrespect is to cultivate more gender equitable attitudes and
      relationships among women and men in RMG industry in Bangladesh, which ultimately will
      contribute to preventing VAW at workplace and family.

      Intervention components

      The main intervention components in the workplace, will be implemented by Change Associates,
      are:

        1. Separate gender transformative training for workers (single sex groups for female and
           male workers) and management staff of 18 hours (six 3-hour modules), held over 9 months
           and delivered to groups of 25. The session topics include communication skills (e.g.
           listening, body language, etc.); assertive responses; reflection and discussion of
           gender roles and norms, and relationships; power; violence in relationships (causes,
           consequences and support system); stress and conflict management; factory policy; and
           goal setting and being a change Maker. The curriculum is participatory, taking reference
           from Stepping Stones and Freirean reflective pedagogy.

        2. Joint session between workers (15 female and male) and middle-management staff (10),
           held after third, fifth and sixth group sessions.

        3. Factory-wide activities/campaigns using factories public address systems, skit play and
           other behaviour change communication materials

        4. Awareness raising among top management (e.g., general manager, HR&A director, etc.; 2
           hours)

        5. Factory policy review and development. Its activities include at least one meeting in
           every two months with the Factory Well-being Committee. The topics include review
           existing and develop new gender policies and mechanisms to prevent and address sexual
           harassment; design and implement factory-wide promotional activities/campaigns; report
           progress and challenges to top management on a regular basis; and design and implement
           sustainability plan (initially support, and subsequently run, the joint sessions between
           managers and workers).

      In addition to the workplace interventions, HERrespect will have an community engagement
      component, working with Awaj Foundation in their workers' café to develop a training module
      on IPV based on their existing programmatic framework, build capacity of cafés' staff to
      facilitate gender transformative curriculum, and develop training materials for use in the
      workers' café's network.

      Research Design and Methods This is a quasi-experimental study involving four intervention
      and four matched control factories recruited by the buyers purposively. Factory matching
      criteria include size, location, and type of product. Care will be taken to select control
      factories at a distance from the intervention factories to prevent potential contamination.
      In the intervention factories a randomly selected cohort of married female workers and all
      management staff will receive group sessions. In addition, factory-wide campaigns will also
      be carried out. The control factories will be waitlisted for intervention once the evaluation
      is over.

      All the workers receiving group intervention (n=400) and a cohort of randomly selected
      married female workers from the control factories (n=400) will be included in the baseline
      and endline worker surveys. The management survey will include 50 randomly selected
      management staff from each factory. The endline surveys will be conducted 24 months
      post-baseline.

      Sample Size Calculation and Outcome The sample size for the worker survey was calculated
      considering the primary outcome, physical and/or sexual IPV against female garment workers.
      Considering 56% baseline prevalence, 20% effect size, 80% power, 5% level of significance and
      20% lost to follow up the required sample size was 330 workers for both intervention and
      control groups. Accounting for a 20% lost to follow up and rounding up the sample size became
      800 workers (400 in intervention and 400 in control), making 100 workers per factory.

      Sample size for the management survey was calculated based on high or moderate gender
      inequitable attitudes of the management staff. Considering 50% baseline prevalence, 30%
      effect size, 80% power and 5% level of significance a sample size of 183 was derived both for
      intervention and control factories. Accounting for a 10% loss to follow up the final sample
      size for each group of factories was 200, giving a total of 400 (50 per factory).

      Translation of data collection tools The worker and management survey questionnaires will be
      developed in English. Once the English version is finalized the questionnaire will be
      translated into Bengali. The Bengali questionnaire will be finalized based on feedback from
      pre-testing and piloting. Blinded back translation will be carried out by a third party once
      the Bengali questionnaire is finalized. Where needed, revisions will be made in the Bengali
      version based after comparison between the Bengali version and the back translation.

      Recruitment of survey participants

      In order to achieve the required sample size of 100 per factory, assuming that 40% of the
      female workers will be married and that 80% of them will finally join the groups a list of
      315 workers containing information on ID and name will be obtained from each factory. An
      enumeration of these selected 315 workers will be carried out within the factory to collect
      some socio-demographic information mainly for the purpose of screening eligibility and
      obtaining residential addresses and other contact information for conducting the interviews
      and for tracking the cohort. The eligibility criteria include:

        -  Minimum one year of work experience in the current factory

        -  Currently married and living with husband. We will randomly select 100 female garment
           workers from the list of eligible workers. The selected workers from the intervention
           factories will be assigned for group sessions and will be interviewed both at baseline
           and endline. The selected workers from the control factories will be interviewed both at
           baseline and endline. If more than one worker belongs to the same household, one will be
           chosen randomly for participating in the study.

      The management staff from mid-level factory management will be eligible for participating in
      the study. A list of 50 management staff will be obtained from the factories for inclusion in
      the study.

      Pre-testing and piloting The Bengali version of the worker and management survey
      questionnaires will be pre-tested on 20 female workers and 10 management staff respectively
      using paper questionnaire. Cognitive pre-testing will be carried for sections that have not
      been previously used in Bangladesh. The pre-test will help us identify sections and questions
      that women find difficult to understand and answer and the cognitive pre-testing will help us
      find solutions. Training will be conducted using the revised questionnaire. About 50
      interviews will be conducted by the worker and 30 by the management survey team members
      during piloting. The questionnaire will be finalized based on feedback from pre-testing and
      piloting.

      Cohort tracking This will be a closed cohort study. Therefore, it is important to carefully
      track the study participants for successfully interviewing them both at baseline and endline.
      In case of loss to follow up such tracking will help us understand the reasons for dropout.
      One staff will be assigned to follow up the study participants over phone every two months
      for ensuring retention. The tracking form will include the following information (the last
      three are applicable only after the baseline): allocated ID, name; name of factory; name and
      cell phone number of husband; name and cell phone number of a guardian other than the
      husband; residential address and cell phone number, name, relationship, address and phone
      numbers of other relatives or friends or co-workers or neighbours in close to her; whether
      she is still working at the same factory; if not, what is the reason for leaving the factory;
      current employment; current residential address

      Tracking loss to follow up If a woman is unavailable or untraceable for follow up interview
      we need to find out the reason. If she is traced and refuses to be interviewed the reason
      will be recorded. If she cannot be found in her previous address, we will try to track her
      through additional contact information.

      Data collection and management Three teams, each will consisting of four female data
      collectors, one female supervisor, and one male field assistant will be employed for the
      worker survey. One quality control officer (QCO) will be responsible for rechecking all
      questionnaires and providing feedback to the interviewers and the supervisors. A survey
      coordinator will be responsible for coordinating survey implementation in the field. In order
      to recruit the necessary number of survey team members we will train a greater number of the
      candidates shortlisted based on written and verbal tests. The team will receive a 15-day
      participatory training on gender, violence against women, ethics, survey methods, the
      questionnaire, and use of tablets. Final selection of the survey team members will be based
      on performance during the training and pilot. The data will be collected using Personalized
      Digital Assistants (PDAs) to address ethical (privacy) issues and to maximize disclosure. An
      offline-based survey software will be developed. The interviews of the workers will be
      conducted in private in a location convenient for the participants outside the factory.
      During working days most interviews are likely to take place in the evening after work.
      Female workers are likely to give interviews at home commonly located in slums. If the study
      participant is unavailable a maximum of three attempts will be made to complete the
      interview. We anticipate two months of fieldwork for workers survey per round of interviews.

      Two teams, each consisting of four male data collectors and one male supervisor will conduct
      the management survey. The QCO will be responsible for rechecking questionnaires and
      providing feedback. In order to recruit the required number of management survey team members
      we will invite a greater number of shortlisted candidates to a 8-day training on gender,
      violence against women, ethics in research VAWG and questionnaire modules. The final
      selection will be done in the way similar to the workers survey. The interviews will be
      conducted in private within the factory. An offline-based software will be developed for
      collecting data using PDA.

      One programmer will be available during the survey period for necessary trouble shooting and
      data uploading. Confidentiality will be maintained by keeping the identification information
      in separate files.

      Data quality monitoring Worker survey Fieldwork for the worker survey will be distributed in
      such a way that each interviewer is accompanied to the interview venue either by a supervisor
      or by a field assistant. Before moving ahead with the next assignment the supervisor and the
      field assistant will make sure the interview can be started in private. Once all the
      interviews are started the supervisor and the field assistant will make rounds to check
      whether the interview is going on uninterrupted. They will help, if intervention is needed,
      to handle gatekeepers. The supervisor will also observe the quality of the interviews, keep
      notes and discuss problems at review sessions. The survey coordinator will randomly choose
      survey teams for spot checks.

      The QCO will recheck all the questionnaires and will provide feedback. The data will be
      uploaded to the server every day after the data collection has been completed for that day,
      and uploaded data will be checked by the Research Officer using a computer -based data
      checking routine. Due to the efficiency of this system, inconsistencies in the data can be
      identified within a short period of time. Problems identified in the data will be
      communicated to the survey team. The supervisor will resolve the problems through discussion
      with the interviewer if possible. If necessary, the interviewer would revisit the respondent
      and solve the issues consulting her. If the problems cannot be resolved using this strategy
      the researchers will be informed. They will suggest ways of resolving the issue depending on
      the nature of the problems. Five percent of the study participants will be revisited by the
      supervisors and the coordinator for administering a short questionnaire mainly focused on
      identifying problems in adhering to ethical guidelines and administering questions on
      particular topics.

      Management survey Supervisors will assign interviews to the team members, observe the quality
      of the interviews, keep notes and discuss problems at review sessions. Supervisors both in
      worker and management survey will report to the coordinator and will communicate directly to
      the researchers if needed. The role of the QCO will be in line with the worker survey.

      Data Analysis Intention to treat (ITT) analysis will be used for assessing the impact of
      HERrespect. Thus, all the workers selected for the study will be included in the analysis.
      The primary analysis will be a comparison between intervention and control factories will
      enable us to determine the impact of full HERrespect intervention (group sessions and
      factory-wide mobilization over control). Chi-square (for categorical variables) and t-tests
      (for continuous variables) will be performed to test whether there are differences in
      background characteristics between intervention and control groups. If differences between
      intervention and control factories are evident, the pre-existing differences will be
      controlled in subsequent analyses. The impact of HERrespect intervention on main outcomes of
      interest will be assessed using risk ratios derived from binary regression analyses adjusting
      for baseline rates. All analyses will be adjusted for the baseline prevalence and age. The
      same approach will be followed for assessing the secondary outcomes.

      Ethical considerations This study will be guided by the WHO recommendations for ethical
      considerations in researching violence against women. The participation of the intervention
      and control factories will be based on the factories' consent to be a part of the study.
      Attention will be paid when designing the questionnaire to carefully and sensitively
      introduce and enquire about workers' experiences of violence and to ensure that questions are
      framed in a manner that is non-judgmental. There is evidence in the literature that the
      factory management is opposed to disclosure of workplace violence and workers disclosing it
      or attempting to address it are victimized. They may be harassed, threatened and dismissed.
      The questions on workplace violence will be included in a style which was as far as possible
      non-threatening to the factory management. Individual verbal consent will be sought prior to
      the interview with each female garment workers and management staff. The participants will be
      informed orally of the purpose and nature of the study, its expected benefits, and voluntary
      nature of participation. As part of the consent procedure, the participant will be informed
      that the data collected will be held in strict confidence. To ensure that the participant is
      aware that the survey includes questions on highly personal and sensitive topics, the
      interviewer will forewarn the participant that some of the topics are difficult to talk
      about. The respondent will be free to terminate the interview at any point, and to skip any
      questions that she does not wish to respond to. Because of the low levels of literacy and
      concerns regarding confidentiality the interviewer will request verbal consent of the
      participant to conduct the interview.

      Participation in the study will be entirely voluntary. Interviews will only be conducted in a
      private setting outside the factory. The participant will be free to reschedule (or relocate)
      the interview to a time (or place) that may be more safe or convenient for her. The physical
      safety of interviewees and interviewers from potential retaliatory violence by the
      perpetrator will be of prime importance. If the focus of the research becomes widely known
      either within the factory or household or among the wider community it may risk the safety
      and security of both. Thus, at the factory level the intervention and the study will be thus
      introduced as activities focused on addressing IPV and improving management and in the family
      and community it will be framed as a survey of factory work management and female workers
      life experiences. Even where a researcher or field worker has not herself experienced
      violence, listening to stories of violence and abuse may be draining and even overwhelming
      for her. During the research regular debriefing meetings will be scheduled to enable the
      research team to discuss what they are hearing, their feelings about the situation, and how
      it is affecting them. These meetings will aim to reduce the stress of the field work, and
      avert any negative consequences. This strategy proved effective in the Bangladesh component
      of the WHO multi-country study conducted by icddr,b. Despite these measures, some field
      workers may need to be given less emotionally taxing tasks, be given a break from the study
      or to withdraw from the research altogether. To account for these possibilities, sufficient
      numbers of field workers will be recruited to allow for a 10% attrition rate of interviewers
      over the study. All the study participants will be given a unique a code and all the
      identifying information will be kept in a separate file exclusively accessed by the research
      team and will be used for tracking the individuals over the intervention period and to
      contact them during the endline survey. Care will be taken to present the research findings
      in sufficiently aggregated form to ensure that no participating factories and workers can be
      identified.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Physical IPV experience
time frame: 24 months post baseline
description: Physical intimate partner violence is assessed using five items based on the WHO VAW scale. A positive response to any item leads to a person being classified as experiencing in the past year.
measure: Sexual IPV experience
time frame: 24 months post-baseline
description: Sexual intimate partner violence is assessed using five items based on the WHO violence against women (VAW) scale. A positive response to any item leads to a person being classified as experiencing in the past year
measure: Physical and/or sexual IPV experience
time frame: 24 months post-baseline
description: Physical and/or sexual IPV is assessed using 10 items (5 physical and 5 sexual) based on the WHO VAW scale. A positive response to any item leads to a person being classified as experiencing in the past year
measure: Witnessing and/or experiencing workplace violence
time frame: 24 months post-baseline
description: Eight items adapted from the peer victimization scale assess whether a participant had witnessed or experienced workplace violence in the past four weeks. A mean score is derived.
measure: Acceptance of VAWG
time frame: 24 months post-baseline
description: Six items adapted from GEM scale and WHO multi-country study on women's health and domestic violence against women assesses acceptance of VAWG among female garment workers. A mean score is derived.
measure: Gender equitable attitudes
time frame: 24 months post-baseline
description: Thirteen items adapted from GEM scale, WHO multi-country study on women's health and domestic violence against women, and the South African Study on Men, masculinities, Violence and HIV assess gender equitable attitudes among management staff. A mean score is derived.
measure: Response to IPV
time frame: 24 months post-baseline
description: A single item explores women's help seeking in response to IPV. This question will only be asked to those who experienced physical and/or sexual IPV during last 12 months. A positive response to the item leads to a person being classified as seeking help in response to IPV in the past year.
measure: Knowledge of services in response to IPV
time frame: 24 months post-baseline
description: One question assesses the knowledge of the workers about where to seek help after experiencing IPV. A positive response to this classifies a person as knowing where to seek help.
measure: Self-esteem
time frame: 24 months post-baseline
description: The 10-item Rosenberg Self-Esteem scale will be used to measure self-esteem. It measures global self-worth by measuring both positive and negative feelings about self. A mean score is derived.
measure: Depression symptomology
time frame: 24 months post-baseline
description: Thirteen items adapted from the CES-D scale assess the depression symptomology among female garment workers in the past week. Each question is a statement and asked the respondent to answer how many days she has had particular feelings or ideas. A mean score is derived.
measure: Management style
time frame: 24 months post-baseline
description: Fourteen items adapted from the social power scale developed by French and Raven and revised by Swasy will be asked to the female garment workers for measuring management styles of the managers. A mean score is derived.
measure: Correct knowledge regarding laws and policies
time frame: 24 months post-baseline
description: The management staff will be asked five questions assessing knowledge on women's rights and protection of women against IPV and workplace violence guaranteed in laws and policies of Bangladesh. Correct answer to all five items will be considered as the management staff having correct knowledge. % correct knowledge will be compared to % incorrect.
measure: Attitudes regarding laws and policies
time frame: 24 months post-baseline
description: The management staff will be asked five questions to measure their attitudes regarding the existing laws and policies about protection of women against spousal violence and workplace violence. A mean score is derived.
measure: Burn out
time frame: 24 months post-baseline
description: A 16-item scale adapted from the Maslach Burnout Inventory-Human Service Survey (MBI-HSS) assesses the burnout of the management staff. A mean score is derived.
arm group label: Intervention: Behavioral Change Communications
arm group type: Experimental
arm group label: Control: No intervention
arm group type: No Intervention
intervention type: Behavioral
intervention name: Behavioral Change Communications
description: HERrespect is developed by Business for Social Responsibility (BSR) and Change Associates. HERproject is one of BSR's numerous initiatives for improving women's lives through enhancement of access and knowledge (BSR, 2015). The factory-based component of HERrespect will be implemented by Change Associates. The intervention group will receive training (group session), research and consultancy services to the corporate and development sectors. HERrespect proposes to use the workplace as an incubator of dialogue among men and women to tackle underlying issues which allow violence against women and girls. Workplace offers a unique platform and environment to engage women who are gaining financial independence to reduce intimate partner violence and workplace violence.
arm group label: Intervention: Behavioral Change Communications
other name: Factory-wide activity/campaign
other name: Awareness raising of top management
other name: Factory policy review and development
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
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