Patient-centered practices for engaging transgender and gender diverse patients in clinical research studies

Transgender and gender diverse (TGD) people are individuals whose gender identity differs from their assigned sex at birth. TGD people are disproportionately burdened by adverse outcomes across a range of physical and mental health conditions, such as in HIV infection, mental health, and substance use, and have unmet healthcare needs compared to their cisgender (non-transgender) peers [1‐6]. Social marginalization and experiences of gender minority stress and stigma [7, 8] have been shown to fuel health disparities for TGD people. There is a need to identify health-promoting factors to leverage for interventions to improve TGD population health. Research has found that medical gender affirmation (hormonal therapies, surgical interventions) is associated with improved psychological functioning and health-related quality of life for TGD people [9‐16], yet to our knowledge no studies have demonstrated a causal relationship between gender affirming medical care and improved HIV-related outcomes [17]. Studies are needed to evaluate the impact of medical gender affirmation on HIV prevention and care, known areas of health disparity for TGD people, particularly longitudinal research to assess improved outcomes over time to inform clinical care and models of healthcare delivery.

Despite the growing evidence-base that TGD individuals suffer profound health disparities, transgender individuals may be reticent to participate in research. TGD people face many barriers to access and receipt of healthcare generally, such as lack of knowledgeable providers, experiences of violence and harassment in health settings, and financial costs [4, 18, 19]. TGD individuals may experience apprehensions and/or similar barriers regarding participating in medical research about their health, such as lacking trust in cisgender researchers and providers due to concerns about damaging, exploitative encounters [20, 21]. Conversely, factors may facilitate the participation of TGD in research, such as access to needed medical care, community engagement and participation, and wanting to contribute to trans health research [21, 22].

Historically, TGD people have engaged with research in the context of HIV programs and funding resources. Some prior research has been conducted to assess barriers and facilitators to TGD people participating in HIV-specific research [21, 23, 24]. Aside from HIV clinical trials, there has been little insight into the barriers and facilitators of other health outcomes research in TGD populations [25, 26].

Research into barriers and facilitators to participating in research has been conducted in other marginalized populations, such as people living with HIV [27‐29], men who have sex with men (MSM) [30‐35] racial and ethnic minorities [32, 36, 37] and people who use drugs [32, 37]. Common barriers to participating in research for these groups have included: 1. Mistrust of researchers [38‐41], 2. Feeling exploited/ having fears of being exploited [28, 41], 3. Aversion to research [42], 4. Time [32, 37, 40, 41, 43], 5. Study design concerns [44], 6. Not wanting to feel like a guinea pig [29, 37, 38, 40, 44], and 7. Confidentiality concerns [40]. Facilitators to research participation have included: 1. Finding meaning in the study content [38], 2. Believing the research could benefit participants and/or society/ altruism [31, 32, 37, 39, 42, 43, 45], 3. Financial incentive [31, 32, 34, 37, 39, 46], 4. Opportunity to build and/or be part of a community [32], 5. Familiarity with the organization conducting the research [31], 6. Having a trusted person, such as a primary care provider, think it is a good idea to participate [41], and 7. Having past positive experiences with the research staff [41].

One study examined barriers and facilitators to research participation in LGBT women living with HIV in Toronto, Canada, but it was not focused specifically on the trans community. This study found that “meaningful engagement” in research, especially for marginalized communities, required listening to the voices of the research participants. Participants spoke of facilitators to participating, such as feeling the research would come back to the community or benefit them, as well as barriers, such as feeling exploited or dehumanized when participating in research [28]. It is important to ascertain barriers and facilitators that exist for TGD people in research participation, especially any barriers and facilitators that uniquely necessitate consideration for the TGD population.

Additionally, the importance of study methods and procedures beyond surveys, such as collection of biospecimens for clinical research has been documented in prior research [47]. Certain health outcomes, such as STIs and viral load, cannot always be determined by self-report, and TGD specific biobanking efforts may provide scientific breakthroughs in understanding the relationships between medical gender affirmation and health outcomes [47].

The purpose of this study was to generally assess barriers and facilitators to participation of TGD patients in clinical research, and 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. Prior research conducted by TGD researchers has advocated for this community input in the research process [48‐50].

In discussing both facilitators and barriers to TGD health research participation, a consistent theme that emerged from this study was a strong desire from FG participants to feel connected to and engaged in the research, and certainty that the work would have an impact on TGD communities. Since the impact of research is often dependent on study findings, there is no guarantee as to what benefit findings can and will have on TGD communities. Therefore, there may be a need to provide education to research participants and TGD communities on research processes. This transparency is important for study participants having clear expectations and equipping them with better agency to decide whether or not to participate. Additionally, it is vital that researchers include TGD communities in conversations of how to best utilize research findings.

Participants highlighted that having TGD investigators and research staff leading the research would foster participant engagement and community comfort. A “participatory population perspective” has been described by Reisner et al. [53] as vital to public health efforts with TGD populations. This approach entails working “with” not “on” communities in public health research, practice, and advocacy. It is a methodology grounded in the philosophical perspective that any TGD public health endeavor will only be a true success if there is meaningful input and partnership with TGD communities. Findings from the current study support the use of a participatory population perspective to conduct clinical research with TGD people, including partnering with paid staff, researchers, and community members in all aspects of the work—research methodology, recruitment and retention, data collection, analysis and interpretation, and dissemination and sharing of results—to inform and advocate for TGD health justice.

Trust was a critical theme that emerged across focus groups. In the context of social stigma, many people who are members of a marginalized group, such as TGD populations, may feel most trusting of and comfortable interacting with people from within the same group. A barrier identified to research participation was the historical absence of TGD people on research teams. Participants felt that involvement of TGD staff would help to ensure a study is properly vetted and prioritizes participant safety, comfort, privacy, and trust. Lack of TGD research staff contributed to participant skepticism about whether and how the research is valued by the researchers or how findings will be utilized. Rather than feel like collaborators, participants may feel like they are being taken advantage of or exploited [41, 45]. While FG participants expressed concern over their experiences being commodified by research scientists seeking to advance their own agenda and cisgender lens, TGD-centered research is in actuality grossly underfunded and under-published. Additional TGD research is greatly needed, especially from funding streams beyond those focusing exclusively on HIV outcomes. Addressing these barriers is essential for making research careers accessible to more TGD individuals, which study participants expressed was essential in their comfort to participating in research. In addressing concerns of feeling exploited, it also important to consider and utilize multiple research methodologies. Depending on the research question and current level of trust with the community, it is imperative that research methods are employed thoughtfully and intentionally, and that researchers consider having a collaborative discussion (e.g. pilot acceptability and feasibility study, CAB) with community members before immediately recruiting TGD individuals to participate in a clinical study.

Building upon this theme, participants expected to be fairly compensated for their time, or to otherwise have participation be low-barrier and low-effort [31, 32, 34, 37, 39, 46]. For a cohort that is recruited from a clinical patient population, participants identified one way to make participation low-effort is to integrate survey measures into existing healthcare models and delivery. One example would be to not require additional visits to the clinic, if not necessary; however, there was a strong preference for compensation among participants, regardless of low-effort or streamlined survey implementation.

In addition, participants emphasized a desire for research methods that are non-pathologizing of TGD identities. Specifically, participants requested questions that could be asked of both TGD and cisgender TGD people, so as not to pathologize learning about TGD health and medicine. Further, they highlighted that some TGD people do not identify with the label “TGD” and therefore wanted to feel as though the questions being asked of them could apply to all people, irrespective of TGD status. Additionally, results underscore how some TGD people may still be questioning, unsure of their gender identity, not “out’ as TGD, or not using the identifier “TGD” to describe their lived experience. As a result, they may not understand that a study is inclusive of them, or may not participate due to internal stigma, even if the inclusion criteria are broad enough to encompass their gender identity. Participants expressed concern that individuals who do not perceive their own experience as “trans enough” may not participate—which could lead to survey bias and exclude information from an important segment of TGD people receiving clinical care.

Several themes that arose in the focus group discussions have important implications for recruitment and retention methods. Many revolve around the value of connection and building trusted relationships and rapport into recruitment and retention strategies. Participants spoke of wanting to be connected to research by their medical providers, a trusted party. They wanted researchers to similarly make a connection with them, either through one-on-one methods, such as telephone calls and texts, going into and showing up in TGD community spaces, or using social media networking platforms to reach out to them. This finding is important as we know that mistrust of researchers is also a common barrier to research participation among other minority populations [39‐41, 54]. Methods that help build rapport between the community and researchers, therefore, are critical for TGD health researchers. Similarly, participants wanted to feel a connection to the study, explaining that the research content would likely keep them retained and engaged in research. Feeling they were a part of something that would make an impact was described as necessary to enhance research participation, a finding that has been observed in other minority populations [54]. Therefore, recruitment strategies—such as flyers and other recruitment materials—may benefit from highlighting the expected impact of a study for TGD people. In order to reach patients of all TGD experiences and identities, a multi-faceted approach is needed. Trust, skilled community engagement, inclusive eligibility criteria, inclusive recruitment language, and focused efforts to engage TGD subgroups are all methods of ensuring a strong sampling methodology.

Practicality emerged as another key theme for recruitment and retention of TGD people. Participants wanted researchers to reach out to potential study participants via multiple modalities. This was perceived as especially important to reach participants of different identities and create a diverse and inclusive sample. Multiple modalities of communication (e.g., flyers, email, text, telephone) were also mentioned as accessible ways of reaching TGD participants. Ease of participation was highlighted as important for recruitment as well as retention. Methods like providing postage and reminders via telephone calls, emails, and mail-out letters were identified as ways to make ongoing participation more realistic. Thus, TGD health researchers should prioritize methods to make participation in research as convenient as possible for participants, especially given many participants may have competing needs (e.g., work, family, housing). Ensuring ease of participation was also felt to be essential to building trust with participants. Methods that communicate and show participants that researchers value their time, a barrier to research participation documented in other marginalized communities [32, 37, 40, 41, 43], were highly endorsed. The themes of connection, rapport, and trust in TGD health research also emerged in discussing best practices for research methodology. Participants wanted qualitative research methods (e.g., focus groups, interviews) to feel candid, informal, and transparent. They also emphasized the import of disseminating research findings back into the community and prioritizing report-backs (e.g., newsletters with research results) as a means to show value and respect for research participation, which can be implemented most successfully when trust and rapport have already been established between researchers and participants. While many of these recruitment methods are applicable to other marginalized groups, it is still important for researchers working with TGD populations to utilize them, as they were confirmed by TGD focus group participants as priorities.

Participants were concerned that current research methodologies could be misrepresenting TGD people’s experiences and identities. They spoke of survey bias and measures often focusing exclusively on negative issues, such as depression, and missing the resilience of participants, such as learning and growing through hard times. The participant who described the focus on gender dysphoria at the expense of gender euphoria offered a powerful example. Findings highlight that research surveys which capture a full spectrum of participants’ experiences and feelings may maximize acceptability of research to TGD people. Further, researchers should consider adding resiliency scales to their surveys. Participants also expressed that researchers take care to ensure TGD research participants are not homogenous in identity, underscoring the importance of enrolling samples diverse in race, ethnicity, geographic locales, and sexual and gender identities.

Participants also emphasized building options into research methodology, such as biospecimen collection being optional with consent required for each specific usage. Participants wanted to be explicitly told how their biospecimen would be used. Research ethics guidelines dictated by the governing IRB do require informed consent for biospecimen [55]; however, participants expressed the desire for this consent to be more detailed and encompassing. They wanted to provide consent for each specific usage of their biospecimen and for researchers to ask their permission. In addition, participants wanted to have the option to opt out of biospecimen collection entirely while still having an opportunity to participate in other aspects of the study. Researchers should consider ways to offer participants more autonomy and control in decision-making about participating in research, including opting not to participate in some components. This further serves to communicate respect for TGD people in clinical research procedures and re-enforces trust-building with the community.

Amongst barriers and facilitators to participating in research, participants discussed financial incentive. It is important for participants to be compensated fairly for their time as they may need to take time off work and pay for transportation or childcare to participate. However, researchers also need to consider what is a reasonable amount so individuals with financial hardship do not feel obligated to participate.

Our findings with TGD patients corroborate findings from prior research on research participation in other marginalized populations. There are common facilitators (e.g., financial incentive/ compensation, altruism/ helping their community, positive experiences with research staff) and barriers (e.g., study design concerns, feeling exploited, confidentiality concerns) to research participation amongst other marginalized communities. However, this study also found that there are barriers and facilitators unique to TGD populations. The unique facilitators included research led by TGD researchers and being relatable to TGD and cisgender people. The unique barriers were not identifying with being labeled as TGD, overlooking individuals who are not “trans enough” or missing those who are questioning, and research from a “cisgender lens.” Unique research methods were also identified, such as survey bias in measures. Therefore, it is important for TGD voices to be involved in all aspects of research, including the planning, study design, recruitment, data collection, analysis and interpretation, and dissemination. It is important to identify research priorities for TGD people, including where these priorities do and do not overlap with other stigmatized groups. However, identifying best practices for research with TGD people ultimately requires data from TGD research, rather than applying research from non-TGD groups. Many of these themes are in alignment with research led by other TGD researchers advocating for community input in research, sharing research findings back to the community, having a diverse sample of TGD identities, using TGD affirming language, and empowering TGD individuals to lead and provide input on TGD research [48‐50].

Although the list of barriers and facilitators identified to research participation for TGD people in this study is not exhaustive, it is a promising starting point for future researchers to consider when developing projects that engage TGD communities. More time should be spent to continue learning about and overcoming the barriers and facilitators TGD people face to participating in research, as well as how research methodologies, recruitment, and retention efforts can best engage and reach TGD individuals. Results suggest that gender-affirming practices grounded in community engagement and participation, transparency, and trust are vital to TGD research. Working collaboratively in researcher-community partnerships to move TGD health research ahead should be prioritized as a strategy moving forward in TGD clinical research.