The eight stakeholders were comprised of three physicians (one nephrologist and two internal medicine physicians), one registered nurse, one patient with kidney disease who received a transplant, one policy decision-maker (Juris Doctor), one Doctor of Philosophy-trained health disparities researcher, and one executive director of a non-profit health organization. Seven out of the 8 stakeholders self-identified as Latinx at least once during the study; information about ethnicity was not available for one participant (Table 1).

Table 1 Participant characteristics, n = 8

We identified five themes: 1) lack of personal relevance, 2) fear and vulnerability, 3) logistical and financial barriers, 4) distrust and asymmetry of power, and 5) stimulating interest and establishing trust in the research process. The first four themes encompassed barriers that stakeholders perceived hindered Latinx participation in kidney-related research, whereas the fifth theme conveyed stakeholder-recommended strategies to overcome barriers. Respective subthemes are described in the following sections and in Fig. 1 with selected supporting quotations provided in Table 2.

Fig. 1Table 2 Selected supporting quotationsLack of personal relevance Unable to relate to research staff and marketing resources

Stakeholders stated that Latinx patients may be reluctant to engage in research because they do not relate to those who appear in study advertisements. They suggested that patients “have to see something to believe it includes [them].” Stakeholders remarked there was a lack of Latino researchers, staff, and advocates who “look like the patient,” and that study communications were not always in the patient’s or family’s preferred language. “Take time to hire diverse staff who can help infuse cultural nuances that will be lost in translation.” Stakeholders believed these issues should be addressed since obtaining study information “from people [who] look like them, speak like them,” could help establish trust, and may thereby “create more receptivity” to participating in trials and other forms of clinical research.

Unclear benefit of research to self, family, and community

Stakeholders believed there were “not enough educational resources on the power of clinical trials.” The need for simple, culture- and language-concordant educational resources about the potential benefits of participation was advocated. One stakeholder (a kidney transplant recipient) remarked, “It wasn't until I got involved with [fundraising organization] that I really started to understand the importance of research and clinical trials.” Stakeholders were concerned that Latinx patients may not perceive a personal or direct benefit of engaging in trials or other forms of clinical research. One stakeholder (medical provider caring for patients with kidney disease) added: “Our patients are very receptive to participating because they can see how much more attention patients get in a clinical trial (this is very evident to the in-center hemodialysis patients who can see their peers participating in trials in the center).” Regarding the structure and processes, of clinical trials, not knowing whether patients would be placed in the intervention arm or control arm of a clinical trial contributes to hesitancy. Moreover, one stakeholder remarked that while investigational products were approved based on trial evidence, undocumented patients would not be able to access approved medications. As such, their participation may not be considered to directly benefit their own family and the larger community. Stakeholders emphasized informing patients of the “disparities and increased burden” of diseases affecting the Latinx community. “The average Latino/a may not know how diversity in clinical trials can improve patient health outcomes for themselves, their families and/or their communities.”

Fear and vulnerabilityConcern about deportation and legal recourses

Stakeholders believed fear of deportation was a major concern. They explained that undocumented patients were often reluctant to seek healthcare as they were terrified of being reported to authorities and that there was a “lack of assurance from clinical trial recruitment staff that immigration status [would be kept confidential].”

Stigma associated with seeking health care

Through previous personal and professional experiences with Latinx family members, friends, and patient individuals, stakeholders recognized a societal and cultural pressure to “always appear healthy,” and believed many Latinx individuals avoided being “diagnosed,” or “sick or weak,” and feared that receiving a diagnosis would threaten their source of income. Stakeholders described how some individuals feared that by seeking care, their health would deteriorate, and they would not be able to afford follow-up. Stakeholders believed the “strong stigma” attached with seeking care was inadvertently transferred to the context of trial participation.

Skepticism about western medicine

Stakeholders suggested that Latinx individuals may be averse to enrolling in trials evaluating pharmacological interventions as patients had a “preference for non-western medicine” and wanted to rely on natural remedies.

Logistical and financial barriersLimited opportunities to enroll in clinical trials

Stakeholders believed that many medical providers serving Latinx communities felt “overwhelmed” having to address social challenges experienced by their patients and were more focused on ensuring appropriate medical care and follow-up over enrolling Latinx patients in research. These logistical barriers hinder Latinx patients’ ability to even enter clinical research studies.

Prohibitive out-of-pocket costs

Participating in a trial was expected to impose a financial burden on Latinx individuals. Stakeholders were concerned that the costs of taking time off work and childcare would be prohibitive for Latinx individuals of low-socioeconomic status who often were uninsured. Stakeholders advocated for compensation to address the financial obstacles of study participation. “Ramping up the financial incentives for low-income potential enrollees may also address part of the obstacle to participating.”

Difficulties with transportation

The cost and challenges of arranging transportation were identified as a major impediment to participating in trials. “It may be too expensive for them to travel to a study visit.” Stakeholders suggested arranging transportation or providing vouchers, scheduling “in-home appointments” and using easily accessible community venues to address transportation-related barriers. One stakeholder commented, “I can't stress enough how important the transportation piece is. The transportation is not as important for [patients receiving in-center hemodialysis] because they're already coming to the dialysis center, but for the non-dialysis, chronic kidney disease patients, sometimes they have to travel 35–40 miles.”

Distrust and asymmetry of powerIntimidation due to limited English proficiency and low health literacy

Stakeholders remarked that Latinx individuals may feel “reluctant to admit when they don’t understand.” When having to fill out forms in clinical settings, for example, bilingual staff members may be able to “translate a bare minimum,” but even in a group setting, patients may feel “intimidated to admit they don't understand.” In the context of clinical care, Latinx individuals may “play down their illness, pain,” which could inadvertently delay referrals to specialists or relevant clinical trials for an underlying disease process.

Provider bias and assumptions of non-adherence

Some stakeholders believed that physicians may not discuss research opportunities with Latinx patients as they assumed that Latinx patients had “poor medical adherence” exacerbated by poor health literacy and low socioeconomic status. This biased perspective may make providers less inclined to enroll Latinx patients in studies.

Stimulating interest and establishing trust in the research processEstablish community partnerships and buy-in

To foster interest in trials, stakeholders suggested that research teams harness community events and settings, and that they deliver information through trusted community members. “You have to lean more into the communities where you want to help most and find people that the community trusts.” They explained that taking action to help the community (e.g. free screening for kidney disease) could pique the interest in research among Latinx patients and families. Prioritizing visibility of community-centeredness was deemed critical to establish trust.

Appeal to cultural priorities and values

“Cultural targeting” of information and education that resonated with Latinx communities was underlined as a vital strategy to promote engagement. This could include the integration of community priorities such as family, food, music, and religion, and sharing information via news and media channels that were familiar and trusted by the target community. Specifically, framing participation in research studies as an opportunity to “help their families and communities” may further resonate with Latinx individuals. Stakeholders also recommended obtaining input early on from community members or “Latino organizations” to help ensure cultural appropriateness in research designs and outreach strategies.

Empower decision-making

Stakeholders suggested that Latinx patients and families should “feel completely comfortable with their decision to consent.” They believed it was important to present information in a clear and engaging manner (e.g. using videos rather than “a stack of papers”), provide sufficient time for decision-making, and opportunities to ask questions using multiple platforms, including by email, phone call, or during face-to-face appointments.

Respect the centrality of family

Stakeholders raised the concept of “familismo” and explained that for many Latinx individuals, “family comes before self” and that the family “took on the burden” of the patient’s illness by providing emotional and social support and participating in decision-making. Latinx patients would “seek advice and encouragement from extended family members.” Family members were recognized to have the “power to influence the perception and behavior of the patient.” Family members also had a role in “bridging” cultural aspects in managing the illness, for example, “younger generations being information brokers for older generations.” Moreover, family support could also encourage adherence to treatment and thereby trial protocols.

Build familiarity and confidence in technology

The increasing use of technology in trial recruitment and follow-up was acknowledged and thus stakeholders suggested providing access to, and training, in the use of technology. For example, they suggested that a mobile training team could conduct home visits to conduct “language-specific training” with patients in the use of health technology and telehealth devices (e.g. blood pressure monitors).