<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/NCT03249649</url>
  </required_header>
  <id_info>
    <org_study_id>5252</org_study_id>
    <nct_id>NCT03249649</nct_id>
  </id_info>
  <brief_title>Female Genital Cutting in the Arizona Somali Refugee Community</brief_title>
  <acronym>FGC</acronym>
  <official_title>Enhancing Culturally-Informed Health Care Services for Women Affected by Female Genital Cutting in Arizona</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Arizona State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Catholic Charities Phoenix</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Phoenix International Refugee Committee</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Refugee Focus Phoenix</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Refugee Focus Tucson</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Catholic Charities Tucson</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Somali Bantu Community of Greater Phoenix</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Horizons Refugee Families</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Arizona State University</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>
      The focus of this project is to elucidate the gaps in care and enhance the provision of&#xD;
      FGC-related health care and social services for women in Arizona who have experienced FGC;&#xD;
      engaging the Somali and Somali Bantu communities. As of 2012, Arizona ranked 7th in the US&#xD;
      for Somali refugee resettlement. The Refugee Women's Health Clinic (RWHC) is a nationally&#xD;
      recognized best practice model for refugee women's health, providing specialized care for&#xD;
      women with FGC. The project will accomplish four outcomes throughout its three-year duration:&#xD;
      1: Identify specific FGC-related health care needs and available health and social services&#xD;
      for women in Arizona who have experienced FGC to improve services to FGC-affected&#xD;
      communities; 2: Identify gaps, barriers, and/or assets in FGC-related health care and social&#xD;
      services for women in Arizona who have experienced FGC to provide improved services to&#xD;
      FGC-affected communities; 3: Create and implement FGC education efforts so that providers&#xD;
      improve culturally competent care for women who have experienced FGC in health care and&#xD;
      social service settings; and, 4: Create and implement community outreach and educational&#xD;
      programs among communities affected by FGC to increase awareness of FGC-related health&#xD;
      issues, prevention and services available. To inform these initiatives, an established&#xD;
      infrastructure exists through the Refugee Women's Health Community Advisory Coalition&#xD;
      (RWHCAC), a team of more than 60 stakeholders from various local ethnic organizations,&#xD;
      refugee resettlement and voluntary agencies, mental health and social services agencies, and&#xD;
      academic partners and including local voluntary resettlement agencies (VOLAGs) and Ethnic&#xD;
      Community-Based Organizations (ECBOs). RWHCAC will be (a) involved in the planning/design of&#xD;
      the project, (b) encouraged to assume responsibility to identify additional Community&#xD;
      Mobilizers, (c) engaged in aligning educational material content to cultural standards, and&#xD;
      (d) engaged in evaluating the project processes and outcomes.&#xD;
&#xD;
      Project strategies include: (1) identifying specific FGC-related health care needs and&#xD;
      available health and social services for FGC-affected women including identification of gaps,&#xD;
      barriers, and/or assets in FGC-related care (year 1); (2) utilizing results from the&#xD;
      Community Health Needs Assessment (CHNA) to refine existing educational materials and&#xD;
      implement educational outreach efforts across the state to improve culturally competent care&#xD;
      among providers (years 2 and 3); (3) promoting outreach and education among FGC-affected&#xD;
      communities through development of culturally appropriate materials and community education&#xD;
      sessions (years two and three); and, (4) partnering with Arizona Department of Health&#xD;
      Services, the University of Arizona, and African Women's Health Center, Brigham and Women's&#xD;
      Hospital during year 2 to deliver inter-professional training workshops for health and social&#xD;
      service providers on FGC, and with Johns Hopkins University for FGC teleECHO™ video&#xD;
      conferencing clinics to promote sustainability via links to online resources, educational&#xD;
      materials, and webinars (years 2 and 3). Emergent products include online learning&#xD;
      components, community education sessions, FGC teleECHO™ sessions, and capacity building&#xD;
      trainings for all partners.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prevalence of Female Genital Cutting (FGC) in Arizona is uncertain; no available state or&#xD;
      national surveys with either prevalence or risk estimates exist, necessitating estimates&#xD;
      indirectly derived. Acknowledging a diversity of African-born communities where FGC is&#xD;
      prevalent within Arizona, for this proposal our team chose to focus specifically on the&#xD;
      Somali and Somali Bantu communities in Phoenix and Tucson for three reasons: 1) size of the&#xD;
      community and FGC-related health care concerns, 2) Type III FGC (most severe form) is most&#xD;
      common among Somali women, and 3) a long-standing record of robust community partnerships&#xD;
      that exist among our partnering agencies and the Somali community. This Project Community&#xD;
      will establish comprehensive strategies to ensure diverse input from partners in developing&#xD;
      collaborative operating principles. The community partners will be: 1) involved in the&#xD;
      planning and design of the project; 2) given the responsibility to identify Community&#xD;
      Mobilizers; and, 3) evaluate and align the educational content of outreach materials to match&#xD;
      cultural standards.&#xD;
&#xD;
      RWHC Clinical Care, Prior Research, and History of CBPR Engagement/Partnership RWHC: Since&#xD;
      2008, RWHC at Maricopa Integrated Health System (MIHS) has addressed disparities in knowledge&#xD;
      and expertise in care of women with FGC, establishing a patient-centered medical home for&#xD;
      refugee women. The first of its kind in Arizona, it is nationally recognized as a best&#xD;
      practice model for refugee women's health care, addressing reproductive health disparities&#xD;
      among newly-resettled refugee women. The multilingual, bicultural staff, refugee women who&#xD;
      serve as Cultural Health Navigators (CHNs), facilitate an integrated team approach to&#xD;
      comprehensive health care delivery and health care system navigation. RWHC has robust&#xD;
      partnerships with local communities affected by FGC, engaging in Community-Based&#xD;
      Participatory Research (CBPR) to enhance community collaboration in culturally relevant&#xD;
      intervention/program design. Despite these efforts, there remains a critical need for&#xD;
      increased provider cultural competency in caring for FGC-affected populations and in&#xD;
      de-monopolizing care so that providers become skilled in caring for FGC-affected women.&#xD;
&#xD;
      Prior Research: Training among Healthcare Providers: In 2014, RWHC surveyed 508 US healthcare&#xD;
      providers to assess awareness of FGC, prior training exposure, and current approaches to care&#xD;
      for women affected by FGC. Results showed widespread knowledge gaps among providers, with 81%&#xD;
      expressing a desire for further education/training on FGC. Results also showed that exposure&#xD;
      to FGC training and direct clinical care encounters with FGC-affected populations predicted&#xD;
      increased competency in the care of these women.&#xD;
&#xD;
      Prior Research: Gaps between Providers and Somali Women: Our team conducted a mixed-methods&#xD;
      study in Maricopa County, Arizona (July 2011-May 2012) exploring knowledge, perceptions and&#xD;
      experiences in the context of FGC among Somali women (n=73) and obstetrics/gynecology&#xD;
      healthcare providers (n=74). Findings suggested a substantial lack of agreement between&#xD;
      Somali women and health care providers on prenatal care, labor, and delivery in the context&#xD;
      of FGC. Although providers often failed to recognize FGC-related health concerns and&#xD;
      management around childbirth and agreed they lacked formal training on FGC- related care,&#xD;
      they linked all types of FGC to adverse birth outcomes. Stigmatization, alienation, distrust,&#xD;
      lack of cultural knowledge and clinical skills, and fear of surgical interventions led Somali&#xD;
      women to delay prenatal care and arrangements for labor and delivery while they categorically&#xD;
      rejected the imposed construct of &quot;FGC-victimization.&quot; History of Community&#xD;
      Engagement/Partnership: An established infrastructure of community partnership, engagement,&#xD;
      and shared community leadership exists through the Refugee Women's Health Community Advisory&#xD;
      Coalition (RWHCAC). The RWHCAC is an interdisciplinary team of more than 60 stakeholders from&#xD;
      various community organizations representing local ethnic organizations, refugee resettlement&#xD;
      and volunteer agencies, mental health and social services agencies, and academic partners.&#xD;
      Through RWHCAC, we have partnered with the Somali community on numerous collaborative&#xD;
      initiatives to build community capacity on Somali reproductive health issues of importance&#xD;
      Goal and Anticipated Outcome To address health disparities for Somali women, the goal of this&#xD;
      initiative will be to elucidate gaps in care and enhance the provision of FGC-related health&#xD;
      care and social services for women in Arizona who have experienced FGC. Outcome 1: Identify&#xD;
      specific FGC-related health care needs and available health and social services for&#xD;
      FGC-affected women in Arizona. Outcome 2: Identify gaps, barriers, and/or assets in&#xD;
      FGC-related health care and social services for women in Arizona. The Somali community has&#xD;
      expressed their desire for greater engagement of all community stakeholders in providing&#xD;
      community-wide education enhancing community awareness on available health&#xD;
      services/resources, interpreting FGC-related legislation, and educating health care&#xD;
      providers. Outcome 3: Create and implement FGC education efforts to improve culturally&#xD;
      competent care in healthcare and social service settings for FGC-affected women. Outcome 4:&#xD;
      Implement comprehensive community outreach and education about FGC- related health issues,&#xD;
      prevention, and services available.&#xD;
&#xD;
      Year 1 Strategy: Outcomes 1 and 2 will be addressed by identifying specific FGC-related&#xD;
      health care needs and available health and social services for FGC-affected women including&#xD;
      an identification of the gaps, barriers, and/or assets in FGC-related care. Instrument: The&#xD;
      CNHA will assess baseline and interval changes in: knowledge, attitudes, and behavioriii on&#xD;
      FGC-health related issues, as well as gaps, barriers and/or assets in the receipt of health&#xD;
      services (see Work Plan Appendix). This same survey will re-administered in-person or via&#xD;
      telephone by Community Mobilizers in Year 3 to assess changes in knowledge, attitudes and&#xD;
      behavior.&#xD;
&#xD;
      Recruitment: A Respondent-Driven Sampling (RDS) strategy will be used to recruit community&#xD;
      participants in this project. RDS is an effective method for recruiting &quot;hidden&quot; populations,&#xD;
      such as refugee populations and when participant behaviors are stigmatized. The RDS is an&#xD;
      advanced adaptation of the traditional snowball sampling method; a small number of selected&#xD;
      initial recruiters (socially connected community mobilizers and organizations) generate a&#xD;
      list of potential recruits from their social networks, connections and community memberships.&#xD;
      They are given distinctive identifying coded coupons and incentives to create the first wave&#xD;
      of recruits. The first wave of recruits will also be incentivized to recruit a second wave,&#xD;
      and so on; the wave after wave recruitment cycle will continue until equilibrium is attained&#xD;
      and sample size is achieved. We performed a precision analysis to estimate a sample size&#xD;
      based on the prevalence rate of FGC in the population, the margin of error desired, the&#xD;
      confidence interval, the total population size, the expected attrition, and the design effect&#xD;
      from using RDS. We expect 40 percent attrition, with a population size of about 3,300 women,&#xD;
      and a RDS design effect of 2, thus a need to retain 2,040 women in the sample. Data&#xD;
      Management: Each questionnaire will be given a unique identifier code to match coded coupons&#xD;
      of the community mobilizer to identify the specific wave it originated from. Data entry will&#xD;
      occur in the field, completed by surveyors, eliminating the need for further entry processes&#xD;
      so that preliminary analyses will proceed concurrently. CHNA results will inform the&#xD;
      educational training among health and social service providers as well as community&#xD;
      educational outreach for providers and community members.&#xD;
&#xD;
      Barriers and Assets: Potential barriers include low literacy, trust, confidentiality,&#xD;
      ethnic/clan affiliation, and/or discussion of FGC as a sensitive/taboo subject matter. To&#xD;
      address these concerns, the survey will be verbally administered in Somali and/or Maay Maay&#xD;
      by female Community Mobilizers sharing the same ethnic/cultural/linguistic background as the&#xD;
      participant. Community Mobilizers, trained on human subjects protections regarding consent&#xD;
      and confidentiality, will conduct interviews in settings deemed appropriate and safe by the&#xD;
      participant, and in respect for Muslim prayer times.&#xD;
&#xD;
      Year 2 - 3 Strategy: Utilizing CHNA results we will refine and implement educational&#xD;
      outreachefforts across the state to improve provider culturally competent care of&#xD;
      FGC-affected women and to promote community education about the prevention of FGC. Health&#xD;
      care and Provider Education: A detailed description of partnerships for provider education&#xD;
      and training in Year 2 are included in the Work Plan Appendix. Sustainability: Throughout&#xD;
      Years 2 and 3, participants in the workshops will be invited to join FGC ECHO, through&#xD;
      monthly FGC teleECHO™ video conferencing clinics. This educational outreach will build&#xD;
      culturally competent care expertise across a wider net of health and social service providers&#xD;
      to improve health outcomes. Providers will be offered links to online educational resources&#xD;
      and webinars, and ADHS BWCH/RHP will offer continuous support. Bridging Refugee Youth and&#xD;
      Children's Services (BRYCS), a current Office of Refugee Resettlement (ORR)-funded technical&#xD;
      assistance (TA) provider, will enhance efforts through its website, national Clearinghouse&#xD;
      and newsletters across a diverse platform of providers. Data Management: Pre-post surveys&#xD;
      will be conducted at baseline, Year 2, and 15 months after the workshop completion in Year 3.&#xD;
      Analyses will assess changes in provider knowledge, attitudes towards FGC, and clinical care&#xD;
      and management. Barriers and Assets: To address the potential for low provider attendance at&#xD;
      the educational workshops, we will offer Continuing Medical Education/Continuing Education&#xD;
      Unit (CME/CEU) credits to promote provider professional development, and specifically, to&#xD;
      target providers and health care institutions serving FGC-affected communities. Assets that&#xD;
      will ensure strong provider attendance and sustainable access to professional development are&#xD;
      ADHS BWCH/RHP's resources to host live webinars for those who are unable to attend the&#xD;
      workshops in-person.&#xD;
&#xD;
      BRYCS will facilitate statewide and national dissemination of provider educational materials&#xD;
      through its online network of 7,000+ members and strong social media following. Benefits to&#xD;
      other communities: Arizona will be one of 10 states participating in the provider workshops&#xD;
      led by Dr. Nawal Nour. Data gathered from pre-post surveys will inform national efforts to&#xD;
      address gaps in provider and community knowledge. Furthermore, the FGC ECHO initiative&#xD;
      promises far-reaching implications for improving provider competency and skill in regions&#xD;
      where there are no FGC specialists. Specific products/outcomes proposed for development or&#xD;
      modification beyond the OWH final report: Providers will receive a workshop program workbook&#xD;
      on caring for FGC-affected populations, links to online resources, webinars and ongoing&#xD;
      access to FGC, ECHO and BRYCS networks of inter-professional providers. Community Outreach&#xD;
      and Education: Prior collaborations have demonstrated the critical role of men in women's&#xD;
      healthcare decision-making. Moreover, cultural etiquette requires male forums to be held&#xD;
      separately from female forums. Community forums will be convened and led by trained community&#xD;
      leaders and will break into small groups organized by generational status comprising youth,&#xD;
      elders, and the middle-aged to facilitate further discussions to illuminate specific&#xD;
      community needs and educational priorities for providers (see Work Plan for details). During&#xD;
      the FGC Listening Sessions held in 2014, the Somali community voiced a need to hear from&#xD;
      religious leaders who could interpret the significance of FGC through the lens of their&#xD;
      faith. In response to this request, leaders from the Islamic community will be invited to&#xD;
      address the forums on FGC from a religious perspective. In particular, the forums will invite&#xD;
      younger Somali women to address health care needs of women engaging in FGC and attitudes&#xD;
      about prevention. Also, during the women's forums, participants will view the ORR Somali&#xD;
      health educational video on FGC and receive a bilingual educational brochure on FGC to&#xD;
      facilitate the empowerment of women to discuss their FGC-related care and management with&#xD;
      their providers.&#xD;
&#xD;
      In Year 3, a follow-up CHNA will be re-administered. Community Mobilizers will conduct the&#xD;
      surveys either in-person or via telephone. Role of Sub-recipients: One sub-recipient will&#xD;
      provide support for additional time for the Project Lead and a Project Manager (see&#xD;
      subcontract scope of work for details). Data Management: The Work Plan Appendix includes a&#xD;
      detailed description of the tasks, performance measures and expected products from the&#xD;
      community forums. Sustainability: This project will build capacity for Community Mobilizers,&#xD;
      ECBOs and Community Representatives to be closely engaged with ongoing efforts of the VOLAGs,&#xD;
      healthcare institutions, and RWHC/SIRC to promote refugee community health.&#xD;
&#xD;
      Strength and Expertise of the Applicant and Partnerships of Project Community: Project Lead,&#xD;
      Dr. Crista Johnson-Agbakwu, MD, MSc, Founding Director of RWHC, brings nearly two decades of&#xD;
      experience with FGC-affected communities. Her academic research home, the Southwest&#xD;
      Interdisciplinary Research Center (SIRC) at Arizona State University, is anNIH/NIMHD&#xD;
      Exploratory Center of Excellence in CBPR-driven health disparities research to address social&#xD;
      and cultural processes as factors in the reduction and elimination of health disparities&#xD;
      (P20MD002316). SIRC provides research infrastructure support including methods expertise,&#xD;
      data management, statistical, grant development, and evaluation. As part of SIRC, the Project&#xD;
      Lead guided a refugee health literacy demonstration project in partnership with RWHCAC. Thus,&#xD;
      the RWHC/SIRC partnership is well-positioned to co-lead this project. The Project Community,&#xD;
      comprised of members of the RWHCAC including local voluntary resettlement agencies (VOLAGs),&#xD;
      Ethnic Community-Based Organizations (ECBOs), individual Somali/Somali Bantu Community&#xD;
      Representatives, and local health care institutions in Phoenix and Tucson, has been engaged&#xD;
      in planning this proposal and will be immersed in all phases of implementation, reporting,&#xD;
      statewide dissemination and sustainability.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2016</start_date>
  <completion_date type="Actual">June 30, 2019</completion_date>
  <primary_completion_date type="Actual">May 15, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Comprehensive Healthcare Needs Assessment (CHNA)</measure>
    <time_frame>7/1/2016-12/31/2017</time_frame>
    <description>Measure of patient-provider communication, patient healthcare services, and provider treatment of Somali Refugee women.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Gaps, Barriers, and Assets in FGC Related Healthcare</measure>
    <time_frame>1/1/2018-6/30/2018</time_frame>
    <description>Report on gaps, barriers, and/or assets in FGC-related health care and social services for women in Arizona.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Provider Education and Training</measure>
    <time_frame>7/1/2018-6/30/19</time_frame>
    <description>Report on FGC education efforts to improve culturally competent care in healthcare and social service settings for FGC-affected women.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Community Education and Training</measure>
    <time_frame>7/1/2018-6/30/19</time_frame>
    <description>Report on comprehensive community outreach and education about FGC- related health issues, prevention, and services available.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">1736</enrollment>
  <condition>Female Genital Mutilation Type I Status</condition>
  <condition>Female Genital Mutilation Type II Status</condition>
  <condition>Female Genital Mutilation Type III Status</condition>
  <arm_group>
    <arm_group_label>Phoenix Cohort</arm_group_label>
    <description>Somali Refugee women ages 15 and older</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tucson Cohort</arm_group_label>
    <description>Somali Refugee women ages 15 and older</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Comprehensive Healthcare Needs Assessment</intervention_name>
    <description>Questionnaire focused on existing healthcare communication, treatment and services plus community needs in those three areas.</description>
    <arm_group_label>Phoenix Cohort</arm_group_label>
    <arm_group_label>Tucson Cohort</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Somali and Somali Bantu Refugee females ages 15 and older who have been resettled to&#xD;
        Arizona and who have received healthcare, health services, and/or social services from&#xD;
        Arizona providers.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  live and receive healthcare treatment and social services in Arizona&#xD;
&#xD;
          -  meet the age criteria&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  males&#xD;
&#xD;
          -  non-Somali Refugee women&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Somali and Somali Bantu Refugee females ages 15 and older</gender_description>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Crista Johnson-Agbakwu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Arizona State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Southwest Interdisciplinary Research Center</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>August 10, 2017</study_first_submitted>
  <study_first_submitted_qc>August 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 15, 2017</study_first_posted>
  <last_update_submitted>January 8, 2020</last_update_submitted>
  <last_update_submitted_qc>January 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Arizona State University</investigator_affiliation>
    <investigator_full_name>Crista Johnson-Agbakwu</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>defibulation</keyword>
  <keyword>healthcare needs assessment</keyword>
  <keyword>CBPR</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Data will be available for use by qualified individuals within the scientific community after publication. The quantitative data will be made available in SPSS (.sav format), after removing from the file any information personally identifying human subjects. A codebook, produced in SPSS, and a brief summary of the original study, including information on sampling and design, will accompany the dataset. Qualitative data that contain no identifiers will be made available in text files (.txt format). Requests for the data will be made in writing directly to the principal investigator. Requestors must indicate the research question to be addressed. Users will not be permitted to share the requested data with other users unless they have the express permission of the principal investigator. Users' acknowledgement of these requirements will be recorded in a signed Use Agreement, to be kept on file at the principal investigator's offices.</ipd_description>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Data will become available following publication of all manuscripts reporting outcomes of primary and secondary aims. It is anticipated that these data will be available beginning year 7 and for 7 years following.</ipd_time_frame>
    <ipd_access_criteria>Access criteria are identified in the plan to share IPD.</ipd_access_criteria>
  </patient_data>
  <!-- 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/NCT03249649
org study id: 5252
nct id: NCT03249649
lead sponsor: 
collaborator: 
collaborator: 
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has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The focus of this project is to elucidate the gaps in care and enhance the provision of
      FGC-related health care and social services for women in Arizona who have experienced FGC;
      engaging the Somali and Somali Bantu communities. As of 2012, Arizona ranked 7th in the US
      for Somali refugee resettlement. The Refugee Women's Health Clinic (RWHC) is a nationally
      recognized best practice model for refugee women's health, providing specialized care for
      women with FGC. The project will accomplish four outcomes throughout its three-year duration:
      1: Identify specific FGC-related health care needs and available health and social services
      for women in Arizona who have experienced FGC to improve services to FGC-affected
      communities; 2: Identify gaps, barriers, and/or assets in FGC-related health care and social
      services for women in Arizona who have experienced FGC to provide improved services to
      FGC-affected communities; 3: Create and implement FGC education efforts so that providers
      improve culturally competent care for women who have experienced FGC in health care and
      social service settings; and, 4: Create and implement community outreach and educational
      programs among communities affected by FGC to increase awareness of FGC-related health
      issues, prevention and services available. To inform these initiatives, an established
      infrastructure exists through the Refugee Women's Health Community Advisory Coalition
      (RWHCAC), a team of more than 60 stakeholders from various local ethnic organizations,
      refugee resettlement and voluntary agencies, mental health and social services agencies, and
      academic partners and including local voluntary resettlement agencies (VOLAGs) and Ethnic
      Community-Based Organizations (ECBOs). RWHCAC will be (a) involved in the planning/design of
      the project, (b) encouraged to assume responsibility to identify additional Community
      Mobilizers, (c) engaged in aligning educational material content to cultural standards, and
      (d) engaged in evaluating the project processes and outcomes.

      Project strategies include: (1) identifying specific FGC-related health care needs and
      available health and social services for FGC-affected women including identification of gaps,
      barriers, and/or assets in FGC-related care (year 1); (2) utilizing results from the
      Community Health Needs Assessment (CHNA) to refine existing educational materials and
      implement educational outreach efforts across the state to improve culturally competent care
      among providers (years 2 and 3); (3) promoting outreach and education among FGC-affected
      communities through development of culturally appropriate materials and community education
      sessions (years two and three); and, (4) partnering with Arizona Department of Health
      Services, the University of Arizona, and African Women's Health Center, Brigham and Women's
      Hospital during year 2 to deliver inter-professional training workshops for health and social
      service providers on FGC, and with Johns Hopkins University for FGC teleECHO™ video
      conferencing clinics to promote sustainability via links to online resources, educational
      materials, and webinars (years 2 and 3). Emergent products include online learning
      components, community education sessions, FGC teleECHO™ sessions, and capacity building
      trainings for all partners.
Prevalence of Female Genital Cutting (FGC) in Arizona is uncertain; no available state or
      national surveys with either prevalence or risk estimates exist, necessitating estimates
      indirectly derived. Acknowledging a diversity of African-born communities where FGC is
      prevalent within Arizona, for this proposal our team chose to focus specifically on the
      Somali and Somali Bantu communities in Phoenix and Tucson for three reasons: 1) size of the
      community and FGC-related health care concerns, 2) Type III FGC (most severe form) is most
      common among Somali women, and 3) a long-standing record of robust community partnerships
      that exist among our partnering agencies and the Somali community. This Project Community
      will establish comprehensive strategies to ensure diverse input from partners in developing
      collaborative operating principles. The community partners will be: 1) involved in the
      planning and design of the project; 2) given the responsibility to identify Community
      Mobilizers; and, 3) evaluate and align the educational content of outreach materials to match
      cultural standards.

      RWHC Clinical Care, Prior Research, and History of CBPR Engagement/Partnership RWHC: Since
      2008, RWHC at Maricopa Integrated Health System (MIHS) has addressed disparities in knowledge
      and expertise in care of women with FGC, establishing a patient-centered medical home for
      refugee women. The first of its kind in Arizona, it is nationally recognized as a best
      practice model for refugee women's health care, addressing reproductive health disparities
      among newly-resettled refugee women. The multilingual, bicultural staff, refugee women who
      serve as Cultural Health Navigators (CHNs), facilitate an integrated team approach to
      comprehensive health care delivery and health care system navigation. RWHC has robust
      partnerships with local communities affected by FGC, engaging in Community-Based
      Participatory Research (CBPR) to enhance community collaboration in culturally relevant
      intervention/program design. Despite these efforts, there remains a critical need for
      increased provider cultural competency in caring for FGC-affected populations and in
      de-monopolizing care so that providers become skilled in caring for FGC-affected women.

      Prior Research: Training among Healthcare Providers: In 2014, RWHC surveyed 508 US healthcare
      providers to assess awareness of FGC, prior training exposure, and current approaches to care
      for women affected by FGC. Results showed widespread knowledge gaps among providers, with 81%
      expressing a desire for further education/training on FGC. Results also showed that exposure
      to FGC training and direct clinical care encounters with FGC-affected populations predicted
      increased competency in the care of these women.

      Prior Research: Gaps between Providers and Somali Women: Our team conducted a mixed-methods
      study in Maricopa County, Arizona (July 2011-May 2012) exploring knowledge, perceptions and
      experiences in the context of FGC among Somali women (n=73) and obstetrics/gynecology
      healthcare providers (n=74). Findings suggested a substantial lack of agreement between
      Somali women and health care providers on prenatal care, labor, and delivery in the context
      of FGC. Although providers often failed to recognize FGC-related health concerns and
      management around childbirth and agreed they lacked formal training on FGC- related care,
      they linked all types of FGC to adverse birth outcomes. Stigmatization, alienation, distrust,
      lack of cultural knowledge and clinical skills, and fear of surgical interventions led Somali
      women to delay prenatal care and arrangements for labor and delivery while they categorically
      rejected the imposed construct of "FGC-victimization." History of Community
      Engagement/Partnership: An established infrastructure of community partnership, engagement,
      and shared community leadership exists through the Refugee Women's Health Community Advisory
      Coalition (RWHCAC). The RWHCAC is an interdisciplinary team of more than 60 stakeholders from
      various community organizations representing local ethnic organizations, refugee resettlement
      and volunteer agencies, mental health and social services agencies, and academic partners.
      Through RWHCAC, we have partnered with the Somali community on numerous collaborative
      initiatives to build community capacity on Somali reproductive health issues of importance
      Goal and Anticipated Outcome To address health disparities for Somali women, the goal of this
      initiative will be to elucidate gaps in care and enhance the provision of FGC-related health
      care and social services for women in Arizona who have experienced FGC. Outcome 1: Identify
      specific FGC-related health care needs and available health and social services for
      FGC-affected women in Arizona. Outcome 2: Identify gaps, barriers, and/or assets in
      FGC-related health care and social services for women in Arizona. The Somali community has
      expressed their desire for greater engagement of all community stakeholders in providing
      community-wide education enhancing community awareness on available health
      services/resources, interpreting FGC-related legislation, and educating health care
      providers. Outcome 3: Create and implement FGC education efforts to improve culturally
      competent care in healthcare and social service settings for FGC-affected women. Outcome 4:
      Implement comprehensive community outreach and education about FGC- related health issues,
      prevention, and services available.

      Year 1 Strategy: Outcomes 1 and 2 will be addressed by identifying specific FGC-related
      health care needs and available health and social services for FGC-affected women including
      an identification of the gaps, barriers, and/or assets in FGC-related care. Instrument: The
      CNHA will assess baseline and interval changes in: knowledge, attitudes, and behavioriii on
      FGC-health related issues, as well as gaps, barriers and/or assets in the receipt of health
      services (see Work Plan Appendix). This same survey will re-administered in-person or via
      telephone by Community Mobilizers in Year 3 to assess changes in knowledge, attitudes and
      behavior.

      Recruitment: A Respondent-Driven Sampling (RDS) strategy will be used to recruit community
      participants in this project. RDS is an effective method for recruiting "hidden" populations,
      such as refugee populations and when participant behaviors are stigmatized. The RDS is an
      advanced adaptation of the traditional snowball sampling method; a small number of selected
      initial recruiters (socially connected community mobilizers and organizations) generate a
      list of potential recruits from their social networks, connections and community memberships.
      They are given distinctive identifying coded coupons and incentives to create the first wave
      of recruits. The first wave of recruits will also be incentivized to recruit a second wave,
      and so on; the wave after wave recruitment cycle will continue until equilibrium is attained
      and sample size is achieved. We performed a precision analysis to estimate a sample size
      based on the prevalence rate of FGC in the population, the margin of error desired, the
      confidence interval, the total population size, the expected attrition, and the design effect
      from using RDS. We expect 40 percent attrition, with a population size of about 3,300 women,
      and a RDS design effect of 2, thus a need to retain 2,040 women in the sample. Data
      Management: Each questionnaire will be given a unique identifier code to match coded coupons
      of the community mobilizer to identify the specific wave it originated from. Data entry will
      occur in the field, completed by surveyors, eliminating the need for further entry processes
      so that preliminary analyses will proceed concurrently. CHNA results will inform the
      educational training among health and social service providers as well as community
      educational outreach for providers and community members.

      Barriers and Assets: Potential barriers include low literacy, trust, confidentiality,
      ethnic/clan affiliation, and/or discussion of FGC as a sensitive/taboo subject matter. To
      address these concerns, the survey will be verbally administered in Somali and/or Maay Maay
      by female Community Mobilizers sharing the same ethnic/cultural/linguistic background as the
      participant. Community Mobilizers, trained on human subjects protections regarding consent
      and confidentiality, will conduct interviews in settings deemed appropriate and safe by the
      participant, and in respect for Muslim prayer times.

      Year 2 - 3 Strategy: Utilizing CHNA results we will refine and implement educational
      outreachefforts across the state to improve provider culturally competent care of
      FGC-affected women and to promote community education about the prevention of FGC. Health
      care and Provider Education: A detailed description of partnerships for provider education
      and training in Year 2 are included in the Work Plan Appendix. Sustainability: Throughout
      Years 2 and 3, participants in the workshops will be invited to join FGC ECHO, through
      monthly FGC teleECHO™ video conferencing clinics. This educational outreach will build
      culturally competent care expertise across a wider net of health and social service providers
      to improve health outcomes. Providers will be offered links to online educational resources
      and webinars, and ADHS BWCH/RHP will offer continuous support. Bridging Refugee Youth and
      Children's Services (BRYCS), a current Office of Refugee Resettlement (ORR)-funded technical
      assistance (TA) provider, will enhance efforts through its website, national Clearinghouse
      and newsletters across a diverse platform of providers. Data Management: Pre-post surveys
      will be conducted at baseline, Year 2, and 15 months after the workshop completion in Year 3.
      Analyses will assess changes in provider knowledge, attitudes towards FGC, and clinical care
      and management. Barriers and Assets: To address the potential for low provider attendance at
      the educational workshops, we will offer Continuing Medical Education/Continuing Education
      Unit (CME/CEU) credits to promote provider professional development, and specifically, to
      target providers and health care institutions serving FGC-affected communities. Assets that
      will ensure strong provider attendance and sustainable access to professional development are
      ADHS BWCH/RHP's resources to host live webinars for those who are unable to attend the
      workshops in-person.

      BRYCS will facilitate statewide and national dissemination of provider educational materials
      through its online network of 7,000+ members and strong social media following. Benefits to
      other communities: Arizona will be one of 10 states participating in the provider workshops
      led by Dr. Nawal Nour. Data gathered from pre-post surveys will inform national efforts to
      address gaps in provider and community knowledge. Furthermore, the FGC ECHO initiative
      promises far-reaching implications for improving provider competency and skill in regions
      where there are no FGC specialists. Specific products/outcomes proposed for development or
      modification beyond the OWH final report: Providers will receive a workshop program workbook
      on caring for FGC-affected populations, links to online resources, webinars and ongoing
      access to FGC, ECHO and BRYCS networks of inter-professional providers. Community Outreach
      and Education: Prior collaborations have demonstrated the critical role of men in women's
      healthcare decision-making. Moreover, cultural etiquette requires male forums to be held
      separately from female forums. Community forums will be convened and led by trained community
      leaders and will break into small groups organized by generational status comprising youth,
      elders, and the middle-aged to facilitate further discussions to illuminate specific
      community needs and educational priorities for providers (see Work Plan for details). During
      the FGC Listening Sessions held in 2014, the Somali community voiced a need to hear from
      religious leaders who could interpret the significance of FGC through the lens of their
      faith. In response to this request, leaders from the Islamic community will be invited to
      address the forums on FGC from a religious perspective. In particular, the forums will invite
      younger Somali women to address health care needs of women engaging in FGC and attitudes
      about prevention. Also, during the women's forums, participants will view the ORR Somali
      health educational video on FGC and receive a bilingual educational brochure on FGC to
      facilitate the empowerment of women to discuss their FGC-related care and management with
      their providers.

      In Year 3, a follow-up CHNA will be re-administered. Community Mobilizers will conduct the
      surveys either in-person or via telephone. Role of Sub-recipients: One sub-recipient will
      provide support for additional time for the Project Lead and a Project Manager (see
      subcontract scope of work for details). Data Management: The Work Plan Appendix includes a
      detailed description of the tasks, performance measures and expected products from the
      community forums. Sustainability: This project will build capacity for Community Mobilizers,
      ECBOs and Community Representatives to be closely engaged with ongoing efforts of the VOLAGs,
      healthcare institutions, and RWHC/SIRC to promote refugee community health.

      Strength and Expertise of the Applicant and Partnerships of Project Community: Project Lead,
      Dr. Crista Johnson-Agbakwu, MD, MSc, Founding Director of RWHC, brings nearly two decades of
      experience with FGC-affected communities. Her academic research home, the Southwest
      Interdisciplinary Research Center (SIRC) at Arizona State University, is anNIH/NIMHD
      Exploratory Center of Excellence in CBPR-driven health disparities research to address social
      and cultural processes as factors in the reduction and elimination of health disparities
      (P20MD002316). SIRC provides research infrastructure support including methods expertise,
      data management, statistical, grant development, and evaluation. As part of SIRC, the Project
      Lead guided a refugee health literacy demonstration project in partnership with RWHCAC. Thus,
      the RWHC/SIRC partnership is well-positioned to co-lead this project. The Project Community,
      comprised of members of the RWHCAC including local voluntary resettlement agencies (VOLAGs),
      Ethnic Community-Based Organizations (ECBOs), individual Somali/Somali Bantu Community
      Representatives, and local health care institutions in Phoenix and Tucson, has been engaged
      in planning this proposal and will be immersed in all phases of implementation, reporting,
      statewide dissemination and sustainability.
observational model: Ecologic or Community
time perspective: Cross-Sectional
measure: Comprehensive Healthcare Needs Assessment (CHNA)
time frame: 7/1/2016-12/31/2017
description: Measure of patient-provider communication, patient healthcare services, and provider treatment of Somali Refugee women.
measure: Gaps, Barriers, and Assets in FGC Related Healthcare
time frame: 1/1/2018-6/30/2018
description: Report on gaps, barriers, and/or assets in FGC-related health care and social services for women in Arizona.
measure: Provider Education and Training
time frame: 7/1/2018-6/30/19
description: Report on FGC education efforts to improve culturally competent care in healthcare and social service settings for FGC-affected women.
measure: Community Education and Training
time frame: 7/1/2018-6/30/19
description: Report on comprehensive community outreach and education about FGC- related health issues, prevention, and services available.
arm group label: Phoenix Cohort
description: Somali Refugee women ages 15 and older
arm group label: Tucson Cohort
description: Somali Refugee women ages 15 and older
intervention type: Behavioral
intervention name: Comprehensive Healthcare Needs Assessment
description: Questionnaire focused on existing healthcare communication, treatment and services plus community needs in those three areas.
arm group label: Phoenix Cohort
arm group label: Tucson Cohort
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: Somali and Somali Bantu Refugee females ages 15 and older
minimum age: 15 Years
maximum age: N/A
last name: Crista Johnson-Agbakwu, MD
role: Principal Investigator
affiliation: Arizona State University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Arizona State University
investigator full name: Crista Johnson-Agbakwu
investigator title: Principal Investigator
sharing ipd: Yes
ipd description: Data will be available for use by qualified individuals within the scientific community after publication. The quantitative data will be made available in SPSS (.sav format), after removing from the file any information personally identifying human subjects. A codebook, produced in SPSS, and a brief summary of the original study, including information on sampling and design, will accompany the dataset. Qualitative data that contain no identifiers will be made available in text files (.txt format). Requests for the data will be made in writing directly to the principal investigator. Requestors must indicate the research question to be addressed. Users will not be permitted to share the requested data with other users unless they have the express permission of the principal investigator. Users' acknowledgement of these requirements will be recorded in a signed Use Agreement, to be kept on file at the principal investigator's offices.
ipd info type: Analytic Code
ipd time frame: Data will become available following publication of all manuscripts reporting outcomes of primary and secondary aims. It is anticipated that these data will be available beginning year 7 and for 7 years following.
ipd access criteria: Access criteria are identified in the plan to share IPD.