Patient-Centered Practices for Engaging Transgender and Gender Diverse Patients in Clinical Research Studies

Abstract

Background: The purpose of this formative study was to assess barriers and facilitators to participation of transgender and gender diverse (TGD) patients in clinical research to solicit specific feedback on perceived acceptability and feasibility of research methods to inform creation of a multisite longitudinal cohort of primary care patients engaged in care at two community health centers.Method: Between September-November 2018, four focus groups (FGs) were convened at two community health centers in Boston, MA and New York, NY (N=28 participants across all 4 groups; 11 in Boston and 17 in New York). FG guides asked about patient outreach, acceptability of study methods and measures, and ideas for study retention. FGs were facilitated by TGD study staff, lasted approximately 90 min in duration, were audio recorded, and then transcribed verbatim by a professional transcription service. Thematic analyses were conducted by two independent analysts applying a constant comparison method. Consistency and consensus were achieved across code creation and application aided by Dedoose software.Results: Participants were a mean age of 33.9 years (SD 12.3; Range 18-66). Participants varied in gender identity with 4 (14.3%) being male, 3 (10.7%) female, 8 (28.6%) transgender male, 10 (35.7%) transgender female, and 3 (10.7%) nonbinary. Eight (26.6%) were Latinx, 5 (17.9%) Black, 3 (10.7%) Asian, 3 (10.7%) another race, and 5 (17.9%) multiracial. Motivators and facilitators to participation were: research creating community, research led by TGD staff, compensation, research integrated into healthcare, research applicable to TGD and non-TGD people, and research helping TGD communities. Barriers were: being research/healthcare averse, not identifying as TGD, overlooking questioning individuals, research coming from a ‘cisgender lens”, distrust of how the research will be used, research not being accessible to TGD people, and research being exploitative.Conclusion: Though similarities emerged between the perspectives of TGD people and research citing perspectives of other underserved populations, there are barriers and facilitators to research which are unique to TGD populations. It is important for TGD people to be involved as collaborators in all aspects of research that concerns them.

Incorporating a trauma‐informed perspective in HIV‐related research with transgender and gender diverse individuals

“…It is important that staff avoid stigmatizing language [6] and use gender‐affirming language and materials during interactions with participants. While a research staff that reflects the study participants may increase participant comfort and trust and has been identified as important by TGD individuals [7], having a TGD research staff does not replace the need to incorporate a trauma‐informed perspective by everyone who interacts with study participants. Given that TGD individuals working on the study may themselves have histories of trauma, the research environment needs to support and empower all staff to address trauma and cope with secondary traumatic stress.…”

Inclusion of Transgender and Gender Diverse People in Phase III Trials: Examples from HIV Pharmacologic Prevention Studies

“…Additionally, TGD community members have advocated for their inclusion within study teams. 30,34,[65][66][67] Using Global Community Advisory and Accountability Group feedback, PURPOSE-2 included study investigators and staff who were members of the study's priority population. 52 Diverse study teams can support participant retention efforts while minimizing REVIEW potential harm to the communities participating in the research.…”

“…While PURPOSE‐2 participant data are forthcoming, HPTN 083 exceeded its recruitment goal and illustrated the positive impact of enhanced recruitment efforts for transgender women. Additionally, TGD community members have advocated for their inclusion within study teams 30,34,65–67 . Using Global Community Advisory and Accountability Group feedback, PURPOSE‐2 included study investigators and staff who were members of the study's priority population 52 .…”

Addressing Barriers to Clinical Trial Participation for Transgender People With Cancer to Improve Access and Generate Data

“…17 Qualitative research suggests that transgender people are motivated to participate in trials that (1) are led or staffed by transgender researchers, (2) benefit transgender communities, (3) provide resources that address financial barriers, and (4) are integrated into health care and/or are recommended by trusted clinicians. 18,19 In addition, trials that are designed to minimize the conduct of invasive procedures that can be triggering for patients with higher exposure to physical violence may also further increase interest in clinical trial participation. 19,20 Institution-level barriers may also hinder access to clinical care and clinical research.…”

“…In addition, well-defined institutional practices are needed to engage transgender communities to develop recruitment and retention strategies across the clinical research continuum and develop metrics for advancing inclusive research. [18][19][20] Institutions that employ transgender investigators and/or clinical research staff and utilize community-based participatory research are highly effective at recruiting transgender people, including transgender people of color to participate in clinical trials. Strategies such as these may be useful when incorporated into cancer clinical trials.…”