NCT03808883

Brief Summary

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 Physicians Assistants (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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 18, 2019

Completed
14 days until next milestone

Study Start

First participant enrolled

February 1, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2020

Completed
3.7 years until next milestone

Results Posted

Study results publicly available

August 14, 2024

Completed
Last Updated

August 14, 2024

Status Verified

August 1, 2024

Enrollment Period

10 months

First QC Date

January 9, 2019

Results QC Date

December 13, 2021

Last Update Submit

August 13, 2024

Conditions

Keywords

Barriers to Healthcare AccessParticipatory Action ResearchCultural Competency

Outcome Measures

Primary Outcomes (7)

  • Change in Knowledge of TGNC Individuals of Total Number of Locations to Receive Medical Care in Cleveland Known

    TGNC participants were asked pre and post-intervention to name all the hospitals they knew of where they could received medical care. Mean and range are reported. This measure was unreliable as participants, when asked in the post survey to name locations for healthcare, were not given those they had identified in the pre-intervention survey, so some participants actually decreased the number they named. Additionally, growth from this measure is mean growth of the group, not a mean of the sum of individual's growth.

    Baseline and 11 months

  • Change From Baseline in Knowledge of TGNC Cohort About Transgender and Gender Nonconforming Medical Issues

    TGNC Cohort Participants were asked to respond with their agreement with the following statement: "I am knowledgeable about how being transgender or gender non-conforming impacts my health." Response options were 1=Disagree Strongly, 2=Disagree, 3=Neutral, 4=Agree, and 5=Agree Strongly. Change was measured as month 11 minus baseline score, and higher scores represented the better outcome.

    Baseline and 11 months

  • Change From Baseline in Knowledge of Healthcare Participants About Transgender and Gender Nonconforming Medical Issues

    Healthcare Participants were asked to respond with their agreement with the following statement: "I know about medical issues that affect transgender and gender nonconforming patients." Response options were 1=Disagree Strongly, 2=Disagree, 3=Neutral, 4=Agree, and 5=Agree Strongly. Because healthcare providers only participated in one facilitated dialogue, baseline was measured prior to the dialogue, and post measures were administered the day after the dialogue. Change was measured as post score- baseline score, and higher scores represented the better outcome.

    Baseline and 24 hours

  • Change From Baseline in Attitude of TGNC Individuals Towards Navigating Their Interactions With Healthcare Providers.

    TGNC Individuals were asked to respond with their agreement with the following two statements: 1. "I am able to navigate the healthcare system easily", and 2. "I know how to express my concerns about my health and well-being to healthcare providers." Response options were 1=Disagree Strongly, 2-=Disagree, 3=Neutral, 4=Agree and 5=Strongly agree. For these questions, a higher score indicated confident attitude in handling their healthcare needs. Change from Baseline to 11 months was measured.

    Baseline and 11 months

  • Change in Attitude of Medical Providers Towards Transgender Issues.

    Healthcare Participants were asked to respond with their agreement with the following statement: "I am comfortable advocating for transgender and gender non-conforming people's right to access respectful and appropriate health care in the place where I practice." Response Options were 1=Disagree Strongly, 2=Disagree, 3=Neutral, 4=Agree, and 5=Agree Strongly, with a higher score indicating a more positive attitude towards transgender issues. Change was measured by subtracting the providers' responses after participation in a facilitated dialogue with TGNC participants from their scored response prior to participating in the dialogue.

    Baseline and 24 hours.

  • Qualitative Shift in Confidence of TGNC Individuals in Seeking Medical Care After the Intervention.

    Percentage of TGNC individuals expressing key themes related to shift of confidence of TGNC Individuals to seek medical care following the intervention.

    Interview at 11 months.

  • Qualitative Shift in Confidence of Medical Provider in Providing Culturally Competent Medical Care to TGNC Individuals After the Intervention.

    The number of medical providers expressing themes illustrating a shift in confidence with their ability to provide culturally competent medical care in structured interview following the facilitated dialogue with members of the TGNC participant group.

    Interview within one day following the facilitated dialogue

Study Arms (2)

TGNC Cohort

EXPERIMENTAL

The Translate Study developed a cohort of transgender and gender non-conforming individuals (referred to here as TGNC cohort) and held three facilitated dialogue sessions with healthcare providers and staff (referred to here as healthcare participants). The overall goal of the Translate Study was to improve quality of life by reducing health disparities suffered by transgender and gender nonconforming (TGNC) individuals and by increasing their access to and use of primary health care.

Behavioral: TGNC Directed Advocacy MeetingsBehavioral: Facilitated Dialogues between TGNC Cohort and Healthcare Participants

Healthcare Participants

EXPERIMENTAL

The Translate Study held three facilitated dialogue sessions between the TGNC Cohort and a group of healthcare participants, identified as physicians, nurse practitioners, registered nurses, students, physician assistants, and non-provider staff positions. Non-providers included healthcare administrative positions, rehabilitation, and vocational services.

Behavioral: Facilitated Dialogues between TGNC Cohort and Healthcare Participants

Interventions

Series of 18 meetings with TGNC cohort, including 3 facilitated dialogues with the healthcare participants, to articulate barriers to access and to enter into dialogue with medical providers and staff.

TGNC Cohort

Healthcare Participants attend a facilitated dialogue with the TGNC cohort. 3 total facilitated dialogues were held, but each healthcare participant attends only 1 session.

Healthcare ParticipantsTGNC Cohort

Eligibility Criteria

Age14 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsTGNC cohort must self-identify as transgender or gender nonconforming
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • self-identify as transgender or gender nonconforming
  • fluent English speaker
  • above the age of 14 years old

You may not qualify if:

  • non-fluent English speaker
  • below the age of 14 years old
  • does not identify as transgender or gender nonconforming
  • Currently employed as a medical provider or medical staff
  • At least 18 years old
  • fluent English speaker
  • Not currently employed as a medical provider or medical staff
  • non-fluent English speaker
  • below the age of 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LGBT Community Center of Greater Cleveland

Cleveland, Ohio, 44102, United States

Location

Limitations and Caveats

The Translate Study was a pilot study, with a convenience sampling design that limits the findings' generalizability. Sample size and inability to use a validated scale limits the findings' reliability. The surveys were developed before assembling the TGNC cohort so the questions did not always align with their objectives. One healthcare participant complained that the facilitated dialogue with TGNC cohort unnecessarily discussed racism. The Study PI and staff are no longer employed by CWRU.

Results Point of Contact

Title
Sarah Fulton, MA, RA, Begun Center, Jack, Joseph and Morton Mandel School of Applied Social Science
Organization
Case Western Reserve University

Study Officials

  • Daniel J Flannery, PhD

    Director, Begun Center for Violence Prevention Research and Education; Jack, Joseph and Morton Mandel School of Applied Social Sciences

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2019

First Posted

January 18, 2019

Study Start

February 1, 2019

Primary Completion

December 10, 2019

Study Completion

December 10, 2020

Last Updated

August 14, 2024

Results First Posted

August 14, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations