Using Community Feedback to Inform Strategies for Inclusive Participation in Research: Lessons Learned From the Louisiana Community Engagement Alliance (LA-CEAL)

Race and ethnicity remain important predictors of access to critical health care resources in the United States, including clinical trials.^1,2 Ethically sound research and evidence-based clinical practice are grounded in the equitable and inclusive participation of diverse socio-demographic groups in clinical trials.^1,3,4 Yet, minority populations, particularly Blacks, continue to be vastly underrepresented in US trials.^2,3,5,6

Early in the pandemic, stark racial and ethnic disparities in COVID-19 infection, hospitalization, and mortality directed attention toward the role of social determinants in vulnerability to poor health and its consequences⁷ and underscored the need for adequate representation of racial and ethnic minorities in clinical trials to ensure the scientific value, clinical relevance, and public health promise of COVID-19 trials.^3,7 Importantly, clinical trial participation is affected by multiple factors, and some well-established barriers and facilitators may not be common to all minority populations.⁸

Individual-level factors, including limited awareness, fear, and mistrust, are well-recognized barriers to trial participation.^1,5,8 Yet, strategies to promote equitable inclusion of minority communities need to consider the larger social context within which willingness to participate in clinical trials may be shaped, via an intentional focus on provider-level^1,5,9 and system-level¹ influences on participation. Furthermore, efficacy of community-based strategies to encourage inclusive research participation is dependent on identification of distinct, culturally relevant factors that may influence trial participation decisions.⁸ Community-engaged research strategies identify salient community issues and may thus be useful for understanding and addressing participation barriers among specific minority groups to support informed decision-making.^7,10

LA-CEAL’S INTENTIONAL COMMUNITY-ENGAGED RESEARCH STRATEGIES

The Louisiana Community Engagement Alliance (LA-CEAL) against COVID-19 Disparities is a National Institutes of Health (NIH)‒funded community‒academic‒public health‒practice partnership (https://covid19community.nih.gov) that aims to understand community-level preferences regarding COVID-19 and identify barriers to participation in clinical trials to increase inclusive participation in research and support equitable distribution of benefits.

From November 2020 through December 2021, LA-CEAL launched a community needs assessment and mixed-methods study in Southeast Louisiana (Jefferson, Orleans, East Baton Rouge, and nearby rural parishes), integrating 1539 cross-sectional surveys (see “Community Concerns About COVID-19 Survey,” available as a supplement to the online version of this article at https://ajph.org) among federally qualified health center (FQHC) patients and community residents, seven focus group discussions (FGDs; moderator guide available in Craig et al.¹¹) including 40 community attendees, and four listening forums (see Planning Forum for Clinical Trials, available as a supplement to the online version of this article at https://ajph.org) with 20 LA-CEAL stakeholders including community pharmacists, FQHC providers, and faith-based organization and multicultural leaders. Given COVID-19’s disproportionate burden, LA-CEAL’s research and community-engagement efforts predominantly focused on Black community residents.

Among surveyed participants, 1.9% reported ever having signed up for a COVID-19 clinical trial.¹¹ Among those who had never signed up, 45.8% were aware of COVID-19 trials being done, and 57.2% were not at all willing to sign up for a COVID-19 trial.¹¹ Doctors or health care providers (HCPs) and local health care clinics or hospitals were most often reported by surveyed respondents as being trusted “a great deal” for COVID-19 trial information.¹¹ Qualitative approaches echoed findings of limited awareness of clinical trials in general, with FGDs and listening forums providing further elucidation on fears, matters of trust, and other important barriers. FGDs revealed general mistrust, particularly within the Black community, stemming from a history of racism, experiences of discrimination, and prevailing health inequities.¹¹ Listening forums highlighted fears arising from uncertainty, perceived risks, and concerns about being a “guinea pig”; during listening forums, the importance of geography was also stressed, with HCPs noting that rural populations further encounter barriers because of difficulties accessing opportunities (e.g., trial information, trial sites).

Across employed qualitative methodologies, strategies proffered by listening forum and FGD participants to enhance clinical trial participation centered around increasing knowledge of trial processes and potential via engagement with trusted, local voices (e.g., HCPs) and use of decentralized, community-centered approaches that “meet people where they are.” Collectively, these findings signaled the need to equip HCPs and health care institutions with tools to effectively communicate about trials. Considering distinct geographical barriers, creation of rural Louisiana “research hubs” would present an additional opportunity and proximal resource to ensure information sharing, training, and reliable access to groundbreaking research and ongoing trials.

COMMUNITY-ENGAGED ACTION LESSONS LEARNED FROM LA-CEAL

Using findings from quantitative assessment, qualitative inquiry, and ongoing community stakeholder discussions, the LA-CEAL team developed and applied targeted strategies to address identified barriers to minority participation in clinical trials in Louisiana (Table 1). Short video testimonials featuring trial participants, investigators, and health advocates of diverse ages, sexes, and racial/ethnic backgrounds (62.5% Black; 12.5% Hispanic; 50% female) were developed to educate on expectations, experiences, motivations, and the importance of diversity. Animated videos (see https://www.youtube.com/watch?v=5j8Ppc4Ti8w and https://www.youtube.com/watch?v=hXv9NgTRjYw) featuring trusted local physicians and cultural ambassadors (e.g., New Orleans cultural icon Irma Thomas) were created to demystify the process of participating in a research study, via discussion of trial procedures and participation benefits, while addressing the history of racism in medicine and highlighting important changes to ensure safety and oversight. To amplify our reach and commitment to inclusive trial participation, videos were disseminated through LA-CEAL social media and partner networks, including to social media influencers for distribution across their platforms, and to LA-CEAL’s 10 partner FQHCs, to be played in clinic waiting rooms.

TABLE 1—

Using Community-Engaged Research Findings to Target Action: Lessons Learned From the Louisiana Community Engagement Alliance (LA-CEAL): November 2020 through December 2022

Targeted LA-CEAL Action	Community-Identified Barrier
	Limited Knowledge and Awareness	Mistrust and Fear	Physical Access Challenges
Video testimonials to describe personal research experiences and explain the importance of inclusive participation in clinical trials (n = 8)	✓	✓
Animated videos with local leaders and cultural icons to address knowledge gaps on clinical trial processes (n = 2)	✓	✓
Numerous flyers continuously distributed to rural and community partners to provide information about how to access trials	✓		✓
Mobile clinical research unit visits to rural federally qualified health center sites and community events to increase awareness and enable recruitment of diverse Louisiana communities in ongoing clinical studies and trials	✓	✓	✓

Building on this positive momentum, LA-CEAL successfully employed additional collaborative strategies for promoting inclusive participation in its own clinical research. The LA-CEAL team was featured on a Radio Town Hall to share personal COVID-19 stories and generate interest in participating in a LA-CEAL trial testing a health coaching intervention to increase vaccine acceptance among unvaccinated Black Louisianans. In addition, the “Your Voice, Your Choice” multimedia campaign was launched in collaboration with a Black-owned media firm, featuring a trusted New Orleans community physician as spokesperson, leading to a 16-fold increase in LA-CEAL Web site traffic from before to after the campaign and indicating increased study interest. This spokesperson recorded and disseminated videos through his wide social media platform and was featured in a local television news segment explaining the importance of diversity in research and encouraging unvaccinated individuals to participate in the trial. These efforts supported LA-CEAL’s attainment of greater than 50% of its target trial enrollment goal (with 100% of the sample identifying as Black).

LOOKING AHEAD TO IMPROVE DIVERSITY AND INCLUSIVITY

Use of community-engaged strategies was critical to understanding key barriers and developing intentional action reflective of Louisiana community needs. Findings supported the need for local messengers and cultural icons who resonate within the community and can engage community members by sharing information and experiences in simple, clear, and meaningful ways.

In keeping with principles of implementation science,¹² findings further highlighted the importance of scientists, HCPs, program managers, and community leaders working together at all stages of the research process to monitor activities, evaluate outcomes, and accommodate necessary adaptations to ensure success. For example, while the Louisiana Clinical and Translational Science Center–NIH Researching COVID to Enhance Recovery (RECOVER) study site partnership allowed for dissemination of information about trial participation opportunities with referral of at least 68 individuals (58% Black) into ongoing clinical trials, unforeseen logistical and technical challenges (e.g., poor Internet connectivity, need for refrigerated space, staff burnout and turnover) precluded additional screening, enrollment and other activities. Capacity to readily and reliably adapt planned strategies in the face of unexpected challenges (e.g., via establishment of rural hubs) would improve research efficiency. Such opportunities are currently being investigated to inform and support outreach in Louisiana with a goal to include all for the benefit of all.