<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/NCT03808883</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-2018-2194</org_study_id>
    <nct_id>NCT03808883</nct_id>
  </id_info>
  <brief_title>TRANSLATE: Transgender and Gender Nonconforming Individuals' Access to Healthcare</brief_title>
  <official_title>Understanding and Reducing Health Disparities Faced by Transgender and Gender Non-conforming (TGNC) Individuals in Cleveland Through TGNC-Directed Advocacy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Case Western Reserve University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>LGBT Community Center of Greater Cleveland</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>MetroHealth Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Case Western Reserve University</source>
  <oversight_info>
    <has_dmc>No</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>
      Transgender and gender nonconforming (TGNC) individuals face a number of health disparities,&#xD;
      many of which can be tied to a lack of access to or use of primary care. Stigma and&#xD;
      misunderstanding make simple doctor's visits into ordeals only worth enduring for the most&#xD;
      serious of problems. This project addresses those issues by enlisting TGNC people as experts&#xD;
      on their own experience. TGNC individuals will form a year-long cohort that will form the&#xD;
      basis for this research. Collectively, they will define the scope of challenges faced when&#xD;
      seeking healthcare, what medical advocacy training they desire, and how to address groups of&#xD;
      healthcare providers and staff. Healthcare providers, including MDs, nurses, and PAs, will&#xD;
      attend two facilitated sessions with the TGNC cohort to meet as peers with knowledge&#xD;
      exchanged in both directions. Similar meetings will occur with clinic staff, as TGNC&#xD;
      individuals have expressed how stigma begins from the moment they call a medical office. Our&#xD;
      hypothesis is that when TGNC individuals are given the tools to navigate the healthcare&#xD;
      system and the ability to speak with medical professionals as peers, rather than patients,&#xD;
      through a participatory action research design they will be better able to access appropriate&#xD;
      care through increased confidence and mutual support. The complementary hypothesis for&#xD;
      medical providers is that direct interaction with a variety of TGNC individuals who&#xD;
      articulate their needs will decrease stigma and increase comfort when treating TGNC people as&#xD;
      patients. As a partnership between academic, medical, and community institutions, this&#xD;
      project has the potential to directly impact the lives of TGNC individuals who participate&#xD;
      and indirectly impact others served by the LGBT Center. This proposal works on three levels:&#xD;
      1) at the academic level - an assessment of participatory action research as an intervention&#xD;
      to decrease health disparities, 2) at the individual level - the potential for individuals to&#xD;
      increase personal knowledge and skills, and 3) at the institutional level - as actors within&#xD;
      the TGNC community develop relationships with individual healthcare providers, medical&#xD;
      clinics and activist groups and community partners and educational institutions are&#xD;
      concurrently forming networks that will have positive, although probably more diffuse, impact&#xD;
      on TGNC individuals as these institutions come together to support TGNC health care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      RESEARCH QUESTION: Do interactive dialogues between trans and gender nonconforming (TGNC) -&#xD;
      trained in health literacy and advocacy - and healthcare providers and staff seeking cultural&#xD;
      competency around TGNC primary care result in 1) more confidence on the part of TGNC in&#xD;
      navigating the healthcare system, 2) more confidence on the part of providers in responding&#xD;
      to the needs of TGNC patients, (sub question - is there a measurable difference between types&#xD;
      of providers' responses to trainings, i.e., medical doctors compared to nurse practitioners)&#xD;
      3) person-to-person networks between the two populations resulting in ongoing, sustainable&#xD;
      dialogue, 4) TGNC individuals prepared to train other TGNC in a peer-to-peer role to act as&#xD;
      advocates on behalf of the TGNC population within the healthcare system, all of which&#xD;
      ultimately result in increased access to and use of primary care services and reduce the&#xD;
      health disparities faced by TGNC individuals? SIGNIFICANCE: The LGBTQ+ community has&#xD;
      historically acted on its own behalf out of necessity, including for the push to remove&#xD;
      homosexuality as a mental disorder from the DSM and reframing the HIV/AIDS conversation and&#xD;
      demanding research. Our project, driven by TGNC people's interests and advocacy, falls within&#xD;
      this tradition of advocacy from inside the community. Our project aims to improve quality of&#xD;
      life by addressing health disparities faced by TGNC individuals and by developing a&#xD;
      self-sustained space to teach self-advocacy skills to navigate the healthcare system. The&#xD;
      LGBT Community Center of Greater Cleveland (The LGBT Center) is in the process of hiring a&#xD;
      new Youth Program Coordinator who will be responsible for the project management of this&#xD;
      program. The ideal candidate will bring both professional and personal experience of working&#xD;
      within the TGNC community and an interest in research. &quot;TRANS in the CLE Conference,&quot;&#xD;
      convened in October of 2017, had more than 130 attendees, 26 presenters, and 15 workshops.&#xD;
      The LGBT Center regularly hosts the Queer Youth Initiative, serving an average of 100 people&#xD;
      a month between the ages of 11 and 20. A majority of those individuals identify as&#xD;
      transgender, non-binary, or gender nonconforming. This demonstrates both the significant&#xD;
      presence of TGNC individuals in Cleveland and the LGBT Center's ability to reach this&#xD;
      population.&#xD;
&#xD;
      INNOVATION: This project places TGNC community members and The LGBT Center in position to&#xD;
      lead the direction of the research project, to gain research and health advocacy skills&#xD;
      themselves, and the ability to form a cohort that will continue to operate beyond this pilot&#xD;
      project. In Cleveland, TGNC affirming services are available at the Pride Network at&#xD;
      MetroHealth, Cleveland Clinic's Center for LGBT Care, and University Hospital's navigator&#xD;
      program. ECHO community partners receive technical assistance from experts in the field, but&#xD;
      these are not necessarily informed by TGNC community input. Almost no other academic program&#xD;
      is asking TGNC people what issues to prioritize, and no other program in the Cleveland area,&#xD;
      to our knowledge. TGNC individuals are often research subjects and not recognized as experts&#xD;
      themselves. Alpert's online survey asks LGBTQ+ individuals what they feel doctors should say&#xD;
      and do, but the interaction is still mediated through an academic expert. The intervention&#xD;
      closest to what is proposed is the Transgender Law's &quot;Organizing for Transgender Healthcare:&#xD;
      A Guide for Community Clinic Organizing and Activism&quot;, which defines transgender health care&#xD;
      as &quot;culturally appropriate primary health care, including access to sex-specific and&#xD;
      transition-related procedures&quot;. In a case study in Los Angeles, a group of trans men formed&#xD;
      an advocacy group (C3) that engaged with two community clinics to improve the clinics'&#xD;
      cultural competency, medical forms, outreach materials, protocols for accessing hormones, and&#xD;
      the referral process. This project is being proposed by cisgender women but is designed to be&#xD;
      driven by TGNC individuals as partners and advocates navigating the healthcare system. In&#xD;
      comparison to the model of C3 in Los Angeles, this project is innovative in that it calls for&#xD;
      a sustained dialogue between the TGNC cohort and the health care providers and reaches a&#xD;
      cross-section of practitioners from clinics that provide primary care.&#xD;
&#xD;
      METHODS: Over the course of the grant year, each step of the project is divided into three&#xD;
      month portions. The first quarter will be dedicated to recruiting and forming a cohort of&#xD;
      TGNC individuals, drawn mostly from the LGBT Center's extensive contact lists and centrality&#xD;
      within the TGNC population. The investigators plan on recruiting 20 individuals to ensure the&#xD;
      study meets the minimum retention of 12 subjects throughout the study needed for qualitative&#xD;
      saturation, and individuals between 14-18 years of age will be able to participate with&#xD;
      guardian permission. Interested individuals will fill out applications to identify their&#xD;
      interests and ability to commit to the project and will allow us to create a cohort that&#xD;
      reflects the diversity of the TGNC community in Cuyahoga County, including gender identity,&#xD;
      types of gender-affirmative care required (including whether or not someone is considering,&#xD;
      in the process of, or completed physical transition), racial and ethnic identity, age (over&#xD;
      14), and socio-economic class. Upon accepting the invitation to participate, each member of&#xD;
      the cohort will complete a pretest that will elicit data on their experiences in the&#xD;
      healthcare system, their knowledge of basic and transgender-specific medical terminology,&#xD;
      their familiarity with healthcare providers in Cuyahoga County, and the likelihood of seeking&#xD;
      care under a number of conditions (acute, chronic, moderate, severe). The investigators&#xD;
      expect this to take one month. The following two months will consist of meeting as a cohort&#xD;
      twice a month. The first two meetings will be dedicated to understanding the group's&#xD;
      collective experiences with health care, what they would like to see change, and what&#xD;
      strategies can be used to accomplish those ends. The investigators recognize that TGNC people&#xD;
      come from a variety of backgrounds and each will bring their own strengths, networks, and&#xD;
      perspectives to the table which will allow us to make full use of the indigenous expertise of&#xD;
      the group. In consultation with the Nursing School of CWRU, the investigators will develop a&#xD;
      health literacy training that meets the expressed needs of the cohort and Jesse Honsky will&#xD;
      present it during the 3rd meeting. The goal here is not to provide all possible health&#xD;
      education but rather to arm the cohort with the skills and language to empower them to act as&#xD;
      advocates on their own behalf when navigating the healthcare system. The final meeting (the&#xD;
      4th) in this first quarter will be with a trained facilitator (Shemariah Arki) who will,&#xD;
      under the direction of the TGNC cohort, plan a series of three interactive dialogues between&#xD;
      the TGNC cohort and the healthcare providers. By meeting with the TGNC cohort first, without&#xD;
      the healthcare providers, the TGNC cohort will have the opportunity to ensure the dialogues&#xD;
      are designed to meet their objectives. Individual healthcare practitioners and medical staff&#xD;
      will be recruited during the first quarter from the aforementioned clinics. The investigators&#xD;
      will recruit at least twelve providers and twelve staff members. In the second quarter, the&#xD;
      investigators will conduct a pretest that will collect data on attitudes towards TGNC&#xD;
      individuals, TGNC-specific healthcare concerns, depth and breadth of referral networks for&#xD;
      TGNC providers. Once the healthcare provider group is solidified, the LGBT Center will host&#xD;
      three evening meetings (once per month) with the trained facilitator wherein TGNC individuals&#xD;
      lead a conversation about what they see as barriers to their care, how they would like to be&#xD;
      treated, and what they want healthcare providers to know about them as people. The first two&#xD;
      meetings will be with healthcare practitioners and the final meeting will be medical staff so&#xD;
      that the meetings can be more specific and without the interference of power dynamics within&#xD;
      the provider groups. During this second quarter, the TGNC cohort will continue to meet on its&#xD;
      own once a month to debrief from meetings, respond to what they have learned so far, and&#xD;
      possibly refine the strategies for future meetings with healthcare providers as the series&#xD;
      goes forward. At the end of the three months of dialogue, each participant, from both the&#xD;
      TGNC cohort and healthcare provider, will be given a post-test to measure changes in&#xD;
      attitude, practice, and knowledge. Participants will also have the opportunity to engage in a&#xD;
      reflective interview.&#xD;
&#xD;
      The third quarter will diverge onto two different paths: the LGBT Center project coordinator&#xD;
      will continue to engage with the cohort as they shift into the role of peer educators and&#xD;
      advocates with other members of the TGNC community that interact at the LGBT Center. Luminais&#xD;
      will conduct follow-up interviews with any TGNC cohort member that notifies the researchers&#xD;
      that they have sought medical care and with any healthcare provider that notifies the&#xD;
      researchers that they have had a clinical interaction with a TGNC individual. The&#xD;
      investigators will not be seeking any protected medical information or the identity of&#xD;
      patients, in the case of healthcare providers, but rather a discussion of the ease or&#xD;
      difficulty in communication, levels of comfort, and comparison with other interactions in&#xD;
      general.&#xD;
&#xD;
      Throughout the process, both Luminais and the LGBT Center coordinator will be engaged in&#xD;
      participant observation and keep detailed field notes on all the meetings. All interviews&#xD;
      will be transcribed; interviews and field notes will be coded with a priori codes derived&#xD;
      from the literature on reducing health disparities and TGNC-specific health care by a&#xD;
      research assistant. Pre- and post-tests will be analyzed to determine the success of&#xD;
      facilitated dialogue in improving confidence and knowledge by both the TGNC cohort and the&#xD;
      healthcare providers, and depending on sample size, the investigators will determine if there&#xD;
      are any statistically significant changes. This analysis and write up will encompass the last&#xD;
      quarter of the project.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">February 2019</start_date>
  <completion_date type="Anticipated">January 2020</completion_date>
  <primary_completion_date type="Anticipated">November 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>All participants will be assigned to the intervention</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in knowledge of TGNC individuals of total number of locations to receive medical care in Cleveland known</measure>
    <time_frame>9 months - 1 year</time_frame>
    <description>Pre/post test free list of all places medical care can be accessed - change measured in total number of answers given</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in knowledge of medical providers of total number of medical and social issues faced by TGNC individuals</measure>
    <time_frame>3 months - 6 months</time_frame>
    <description>Pre/post test free list of all issues TGNC individuals face - change measured in total number of answers given</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in attitude of TGNC individuals towards healthcare providers' sensitivity to transgender issues as measured by 10 Likert scale questions developed for this project</measure>
    <time_frame>9 months - 1 year</time_frame>
    <description>pre/post test survey of 10 Likert scale measures on a scale of 1-5</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in attitude of medical providers towards transgender issues as measured by 10 Likert scale questions developed for this project</measure>
    <time_frame>3 months - 6 months</time_frame>
    <description>pre/post test survey of 10 Likert scale measures on a scale of 1-5</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Qualitative shift in confidence of TGNC individuals in seeking medical care after the intervention based on semi-structured interviews created for this project</measure>
    <time_frame>1 year</time_frame>
    <description>post-intervention semi-structured interview conducted by trained anthropologist with tool developed for this project and analyzed with qualitative data analysis software for emergent themes and repetition of a priori codes</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Qualitative shift in confidence of medical provider in providing culturally competent medical care to TGNC individuals after the intervention based on semi-structured interviews created for this project</measure>
    <time_frame>6 months</time_frame>
    <description>post-intervention semi-structured interview conducted by trained anthropologist with tool developed for this project and analyzed with qualitative data analysis software for emergent themes and repetition of a priori codes</description>
  </primary_outcome>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Gender Identity</condition>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>TGNC Directed Advocacy Meetings</intervention_name>
    <description>Series of community meetings with TGNC individuals to include meeting with health professionals to articulate barriers to access and to enter into dialogue with medical providers and staff</description>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  self-identify as transgender or gender nonconforming&#xD;
&#xD;
          -  fluent English speaker&#xD;
&#xD;
          -  above the age of 14 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  non-fluent English speaker&#xD;
&#xD;
          -  below the age of 14 years old&#xD;
&#xD;
          -  does not identify as transgender or gender nonconforming&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <gender_description>TGNC cohort must self-identify as transgender or gender nonconforming</gender_description>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Misty Luminais, PhD</last_name>
    <phone>216-368-1329</phone>
    <email>misty.luminais@case.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Wendy Boerger</last_name>
    <phone>216-368-5235</phone>
    <email>wendy.boerger@case.edu</email>
  </overall_contact_backup>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 9, 2019</study_first_submitted>
  <study_first_submitted_qc>January 15, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <last_update_submitted>January 15, 2019</last_update_submitted>
  <last_update_submitted_qc>January 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Case Western Reserve University</investigator_affiliation>
    <investigator_full_name>Misty Luminais</investigator_full_name>
    <investigator_title>Senior Research Associate</investigator_title>
  </responsible_party>
  <keyword>Barriers to Healthcare Access</keyword>
  <keyword>Participatory Action Research</keyword>
  <keyword>Cultural Competency</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>December 13, 2021</submitted>
    <returned>March 3, 2022</returned>
    <submitted>March 13, 2022</submitted>
    <returned>June 14, 2022</returned>
    <submitted>September 8, 2022</submitted>
    <submission_canceled>September 8, 2022</submission_canceled>
    <submitted>September 9, 2022</submitted>
    <returned>July 28, 2023</returned>
    <submitted>September 14, 2023</submitted>
  </pending_results>
  <!-- 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/NCT03808883
org study id: IRB-2018-2194
nct id: NCT03808883
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Transgender and gender nonconforming (TGNC) individuals face a number of health disparities,
      many of which can be tied to a lack of access to or use of primary care. Stigma and
      misunderstanding make simple doctor's visits into ordeals only worth enduring for the most
      serious of problems. This project addresses those issues by enlisting TGNC people as experts
      on their own experience. TGNC individuals will form a year-long cohort that will form the
      basis for this research. Collectively, they will define the scope of challenges faced when
      seeking healthcare, what medical advocacy training they desire, and how to address groups of
      healthcare providers and staff. Healthcare providers, including MDs, nurses, and PAs, will
      attend two facilitated sessions with the TGNC cohort to meet as peers with knowledge
      exchanged in both directions. Similar meetings will occur with clinic staff, as TGNC
      individuals have expressed how stigma begins from the moment they call a medical office. Our
      hypothesis is that when TGNC individuals are given the tools to navigate the healthcare
      system and the ability to speak with medical professionals as peers, rather than patients,
      through a participatory action research design they will be better able to access appropriate
      care through increased confidence and mutual support. The complementary hypothesis for
      medical providers is that direct interaction with a variety of TGNC individuals who
      articulate their needs will decrease stigma and increase comfort when treating TGNC people as
      patients. As a partnership between academic, medical, and community institutions, this
      project has the potential to directly impact the lives of TGNC individuals who participate
      and indirectly impact others served by the LGBT Center. This proposal works on three levels:
      1) at the academic level - an assessment of participatory action research as an intervention
      to decrease health disparities, 2) at the individual level - the potential for individuals to
      increase personal knowledge and skills, and 3) at the institutional level - as actors within
      the TGNC community develop relationships with individual healthcare providers, medical
      clinics and activist groups and community partners and educational institutions are
      concurrently forming networks that will have positive, although probably more diffuse, impact
      on TGNC individuals as these institutions come together to support TGNC health care.
RESEARCH QUESTION: Do interactive dialogues between trans and gender nonconforming (TGNC) -
      trained in health literacy and advocacy - and healthcare providers and staff seeking cultural
      competency around TGNC primary care result in 1) more confidence on the part of TGNC in
      navigating the healthcare system, 2) more confidence on the part of providers in responding
      to the needs of TGNC patients, (sub question - is there a measurable difference between types
      of providers' responses to trainings, i.e., medical doctors compared to nurse practitioners)
      3) person-to-person networks between the two populations resulting in ongoing, sustainable
      dialogue, 4) TGNC individuals prepared to train other TGNC in a peer-to-peer role to act as
      advocates on behalf of the TGNC population within the healthcare system, all of which
      ultimately result in increased access to and use of primary care services and reduce the
      health disparities faced by TGNC individuals? SIGNIFICANCE: The LGBTQ+ community has
      historically acted on its own behalf out of necessity, including for the push to remove
      homosexuality as a mental disorder from the DSM and reframing the HIV/AIDS conversation and
      demanding research. Our project, driven by TGNC people's interests and advocacy, falls within
      this tradition of advocacy from inside the community. Our project aims to improve quality of
      life by addressing health disparities faced by TGNC individuals and by developing a
      self-sustained space to teach self-advocacy skills to navigate the healthcare system. The
      LGBT Community Center of Greater Cleveland (The LGBT Center) is in the process of hiring a
      new Youth Program Coordinator who will be responsible for the project management of this
      program. The ideal candidate will bring both professional and personal experience of working
      within the TGNC community and an interest in research. "TRANS in the CLE Conference,"
      convened in October of 2017, had more than 130 attendees, 26 presenters, and 15 workshops.
      The LGBT Center regularly hosts the Queer Youth Initiative, serving an average of 100 people
      a month between the ages of 11 and 20. A majority of those individuals identify as
      transgender, non-binary, or gender nonconforming. This demonstrates both the significant
      presence of TGNC individuals in Cleveland and the LGBT Center's ability to reach this
      population.

      INNOVATION: This project places TGNC community members and The LGBT Center in position to
      lead the direction of the research project, to gain research and health advocacy skills
      themselves, and the ability to form a cohort that will continue to operate beyond this pilot
      project. In Cleveland, TGNC affirming services are available at the Pride Network at
      MetroHealth, Cleveland Clinic's Center for LGBT Care, and University Hospital's navigator
      program. ECHO community partners receive technical assistance from experts in the field, but
      these are not necessarily informed by TGNC community input. Almost no other academic program
      is asking TGNC people what issues to prioritize, and no other program in the Cleveland area,
      to our knowledge. TGNC individuals are often research subjects and not recognized as experts
      themselves. Alpert's online survey asks LGBTQ+ individuals what they feel doctors should say
      and do, but the interaction is still mediated through an academic expert. The intervention
      closest to what is proposed is the Transgender Law's "Organizing for Transgender Healthcare:
      A Guide for Community Clinic Organizing and Activism", which defines transgender health care
      as "culturally appropriate primary health care, including access to sex-specific and
      transition-related procedures". In a case study in Los Angeles, a group of trans men formed
      an advocacy group (C3) that engaged with two community clinics to improve the clinics'
      cultural competency, medical forms, outreach materials, protocols for accessing hormones, and
      the referral process. This project is being proposed by cisgender women but is designed to be
      driven by TGNC individuals as partners and advocates navigating the healthcare system. In
      comparison to the model of C3 in Los Angeles, this project is innovative in that it calls for
      a sustained dialogue between the TGNC cohort and the health care providers and reaches a
      cross-section of practitioners from clinics that provide primary care.

      METHODS: Over the course of the grant year, each step of the project is divided into three
      month portions. The first quarter will be dedicated to recruiting and forming a cohort of
      TGNC individuals, drawn mostly from the LGBT Center's extensive contact lists and centrality
      within the TGNC population. The investigators plan on recruiting 20 individuals to ensure the
      study meets the minimum retention of 12 subjects throughout the study needed for qualitative
      saturation, and individuals between 14-18 years of age will be able to participate with
      guardian permission. Interested individuals will fill out applications to identify their
      interests and ability to commit to the project and will allow us to create a cohort that
      reflects the diversity of the TGNC community in Cuyahoga County, including gender identity,
      types of gender-affirmative care required (including whether or not someone is considering,
      in the process of, or completed physical transition), racial and ethnic identity, age (over
      14), and socio-economic class. Upon accepting the invitation to participate, each member of
      the cohort will complete a pretest that will elicit data on their experiences in the
      healthcare system, their knowledge of basic and transgender-specific medical terminology,
      their familiarity with healthcare providers in Cuyahoga County, and the likelihood of seeking
      care under a number of conditions (acute, chronic, moderate, severe). The investigators
      expect this to take one month. The following two months will consist of meeting as a cohort
      twice a month. The first two meetings will be dedicated to understanding the group's
      collective experiences with health care, what they would like to see change, and what
      strategies can be used to accomplish those ends. The investigators recognize that TGNC people
      come from a variety of backgrounds and each will bring their own strengths, networks, and
      perspectives to the table which will allow us to make full use of the indigenous expertise of
      the group. In consultation with the Nursing School of CWRU, the investigators will develop a
      health literacy training that meets the expressed needs of the cohort and Jesse Honsky will
      present it during the 3rd meeting. The goal here is not to provide all possible health
      education but rather to arm the cohort with the skills and language to empower them to act as
      advocates on their own behalf when navigating the healthcare system. The final meeting (the
      4th) in this first quarter will be with a trained facilitator (Shemariah Arki) who will,
      under the direction of the TGNC cohort, plan a series of three interactive dialogues between
      the TGNC cohort and the healthcare providers. By meeting with the TGNC cohort first, without
      the healthcare providers, the TGNC cohort will have the opportunity to ensure the dialogues
      are designed to meet their objectives. Individual healthcare practitioners and medical staff
      will be recruited during the first quarter from the aforementioned clinics. The investigators
      will recruit at least twelve providers and twelve staff members. In the second quarter, the
      investigators will conduct a pretest that will collect data on attitudes towards TGNC
      individuals, TGNC-specific healthcare concerns, depth and breadth of referral networks for
      TGNC providers. Once the healthcare provider group is solidified, the LGBT Center will host
      three evening meetings (once per month) with the trained facilitator wherein TGNC individuals
      lead a conversation about what they see as barriers to their care, how they would like to be
      treated, and what they want healthcare providers to know about them as people. The first two
      meetings will be with healthcare practitioners and the final meeting will be medical staff so
      that the meetings can be more specific and without the interference of power dynamics within
      the provider groups. During this second quarter, the TGNC cohort will continue to meet on its
      own once a month to debrief from meetings, respond to what they have learned so far, and
      possibly refine the strategies for future meetings with healthcare providers as the series
      goes forward. At the end of the three months of dialogue, each participant, from both the
      TGNC cohort and healthcare provider, will be given a post-test to measure changes in
      attitude, practice, and knowledge. Participants will also have the opportunity to engage in a
      reflective interview.

      The third quarter will diverge onto two different paths: the LGBT Center project coordinator
      will continue to engage with the cohort as they shift into the role of peer educators and
      advocates with other members of the TGNC community that interact at the LGBT Center. Luminais
      will conduct follow-up interviews with any TGNC cohort member that notifies the researchers
      that they have sought medical care and with any healthcare provider that notifies the
      researchers that they have had a clinical interaction with a TGNC individual. The
      investigators will not be seeking any protected medical information or the identity of
      patients, in the case of healthcare providers, but rather a discussion of the ease or
      difficulty in communication, levels of comfort, and comparison with other interactions in
      general.

      Throughout the process, both Luminais and the LGBT Center coordinator will be engaged in
      participant observation and keep detailed field notes on all the meetings. All interviews
      will be transcribed; interviews and field notes will be coded with a priori codes derived
      from the literature on reducing health disparities and TGNC-specific health care by a
      research assistant. Pre- and post-tests will be analyzed to determine the success of
      facilitated dialogue in improving confidence and knowledge by both the TGNC cohort and the
      healthcare providers, and depending on sample size, the investigators will determine if there
      are any statistically significant changes. This analysis and write up will encompass the last
      quarter of the project.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: All participants will be assigned to the intervention
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change in knowledge of TGNC individuals of total number of locations to receive medical care in Cleveland known
time frame: 9 months - 1 year
description: Pre/post test free list of all places medical care can be accessed - change measured in total number of answers given
measure: Change in knowledge of medical providers of total number of medical and social issues faced by TGNC individuals
time frame: 3 months - 6 months
description: Pre/post test free list of all issues TGNC individuals face - change measured in total number of answers given
measure: Change in attitude of TGNC individuals towards healthcare providers' sensitivity to transgender issues as measured by 10 Likert scale questions developed for this project
time frame: 9 months - 1 year
description: pre/post test survey of 10 Likert scale measures on a scale of 1-5
measure: Change in attitude of medical providers towards transgender issues as measured by 10 Likert scale questions developed for this project
time frame: 3 months - 6 months
description: pre/post test survey of 10 Likert scale measures on a scale of 1-5
measure: Qualitative shift in confidence of TGNC individuals in seeking medical care after the intervention based on semi-structured interviews created for this project
time frame: 1 year
description: post-intervention semi-structured interview conducted by trained anthropologist with tool developed for this project and analyzed with qualitative data analysis software for emergent themes and repetition of a priori codes
measure: Qualitative shift in confidence of medical provider in providing culturally competent medical care to TGNC individuals after the intervention based on semi-structured interviews created for this project
time frame: 6 months
description: post-intervention semi-structured interview conducted by trained anthropologist with tool developed for this project and analyzed with qualitative data analysis software for emergent themes and repetition of a priori codes
intervention type: Behavioral
intervention name: TGNC Directed Advocacy Meetings
description: Series of community meetings with TGNC individuals to include meeting with health professionals to articulate barriers to access and to enter into dialogue with medical providers and staff
criteria: 
gender: All
gender based: Yes
gender description: TGNC cohort must self-identify as transgender or gender nonconforming
minimum age: 14 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Misty Luminais, PhD
phone: 216-368-1329
email: misty.luminais@case.edu
last name: Wendy Boerger
phone: 216-368-5235
email: wendy.boerger@case.edu
responsible party type: Principal Investigator
investigator affiliation: Case Western Reserve University
investigator full name: Misty Luminais
investigator title: Senior Research Associate
sharing ipd: No
submitted: December 13, 2021
returned: March 3, 2022
submitted: March 13, 2022
returned: June 14, 2022
submitted: September 8, 2022
submission canceled: September 8, 2022
submitted: September 9, 2022
returned: July 28, 2023
submitted: September 14, 2023