Development and pilot implementation of guidelines for culturally tailored research recruitment materials for African Americans and Latinos.

BACKGROUND: Previous studies support cultural tailoring of recruitment materials as a strategy to promote the enrollment of minoritized groups in clinical trials. However, there is a lack of guidance for research teams to create culturally tailored materials, potentially contributing to low recruitment rates of minoritized groups. We describe the development and pilot testing of recruitment material guidelines used to culturally tailor clinical trial recruitment materials targeting African Americans and Latinos. METHODS: The guideline development team consisted of investigators, research staff, and community leaders and members experienced in the recruitment and community engagement of minoritized groups. The recruitment material guidelines were developed using the literature, focus groups with African Americans and Latinos, the teams' research experience, and guidance from a community advisory board. To assess the effectiveness of the guidelines, a pilot study was conducted comparing advertisement click-through rates and enrollment outcomes between two institutions differing in use of culturally tailored versus non-tailored Facebook banner ads for the "Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-Term Effectiveness" (ADAPTABLE) study. RESULTS: Five themes emerged from focus groups: (1) employ diversity and inclusion in recruitment efforts; (2) access multiple recruitment channels to increase reach and possible participation; (3) increase your "footwork"; (4) personalize outreach and recruitment to specific groups' beliefs and values; (5) align recruitment messaging with language preferences and motivations for study participation; and (6) specify incentives for participation. Guidelines were: 1) be inclusive; 2) use all forms of media; 3) take a personalized approach; 4) align recruitment messaging with motivations for study participation; 5) specify incentives; and 6) get out into the community. Additional guidelines were developed addressing specific considerations for images and language when targeting African American and Latino populations. Pilot study results demonstrated that clicks per impression ratio (0.47 clicks per impression vs. 0.03 clicks per impression) and the percentage of African American enrollment were significantly higher when using tailored compared to non-tailored ads (12.8% vs. 8.3%, respectively). CONCLUSION: The recruitment material guidelines offer practical recommendations to reach diverse populations for clinical trial participation more effectively. Our preliminary data supports use of these guidelines as a strategy to enhance recruitment of minoritized groups into clinical research studies.

Evidence-based recruitment strategies for clinical research: Study personnel's and research participants' perceptions about successful methods of outreach for a U.S. Autism-Research Cohort.

Introduction: Under enrollment of participants in clinical research is costly and delays study completion to impact public health. Given that research personnel make decisions about which strategies to pursue and participants are the recipients of these efforts, we surveyed research staff (n = 52) and participants (n = 4,144) affiliated with SPARK (Simons Foundation Powering Autism for Knowledge) - the largest study of autism in the U.S. - to understand their perceptions of effective recruitment strategies. Methods: In Study 1, research personnel were asked to report recruitment strategies that they tried for SPARK and to indicate which ones they would and would not repeat/recommend. In Study 2, SPARK participants were asked to indicate all the ways they heard about the study prior to enrollment and which one was most influential in their decisions to enroll. Results: Staff rated speaking with a SPARK-study-team member (36.5%), speaking with a medical provider (19.2%), word of mouth (11.5%), and a live TV news story (11.5%) as the most successful strategies. Participants most often heard about SPARK via social media (47.0%), speaking with a medical provider (23.1%), and an online search (20.1%). Research personnel's and participants' views on effective recruitment strategies often differed, with the exception of speaking with a medical provider. Conclusion: Results suggest that a combination of strategies is likely to be most effective in reaching diverse audiences. Findings have implications for the selection of strategies that meet a study's specific needs, as well as recruitment-strategy "combinations" that may enhance the influence of outreach efforts.

Race/ethnicity matching boosts enrollment of black participants in clinical trials.

BACKGROUND: Enrollment of a representative sample of racial or ethnic-minority participants can be challenging for researchers conducting clinical trials. One proposed solution is race/ethnicity matching (i.e., aligning the racial or ethnic identity of the trial recruiter with that of the desired participant), but in practice this idea has yielded mixed results. Nevertheless, the approach seems inherently strong, so we reevaluated this strategy in a secondary analysis. METHODS: Black participant enrollment was tracked during the screening phase of two clinical trials led by the same PI and conducted in the same setting: the NICU of a midwestern academic hospital in a predominantly White locale. In the first trial, the recruiter was a White neonatal nurse practitioner from the NICU. In the second trial, the recruiter was a Black research nurse. In this evaluation of race/ethnicity matching, the number of Black women who enrolled into the screening phase of the two trials was compared. RESULTS: The Black research nurse enrolled twice as many Black participants into the screening phase of a clinical trial compared to the White NICU neonatal nurse practitioner (12.24% & 6.1%, respectively). The 6.14 percentage-point difference in Black participant enrollment is significant using Fisher's exact test (p = 0.035). CONCLUSIONS: The key finding is that the Black recruiter enrolled a significantly greater number of Black participants than the White recruiter, suggesting that race/ethnicity matching is a viable strategy for increasing racial/ethnic minority participation in clinical studies.

Opening doors to clinical trial participation among Hispanics: Lessons learned from the Spanish translation of ResearchMatch.

INTRODUCTION: Clinical trial participation among US Hispanics remains low, despite a significant effort by research institutions nationwide. ResearchMatch, a national online platform, has matched 113,372 individuals interested in participating in research with studies conducted by 8778 researchers. To increase accessibility to Spanish speakers, we translated the ResearchMatch platform into Spanish by implementing tenets of health literacy and respecting linguistic and cultural diversity across the US Hispanic population. We describe this multiphase process, preliminary results, and lessons learned. METHODS: Translation of the ResearchMatch site consisted of several activities including: (1) improving the English language site's reading level, removing jargon, and using plain language; (2) obtaining a professional Spanish translation of the site and incorporating iterative revisions by a panel of bilingual community members from diverse Hispanic backgrounds; (3) technical development and launch; and (4) initial promotion. RESULTS: The Spanish language version was launched in August 2018, after 11 months of development. Community input improved the initial translation, and early registration and use by researchers demonstrate the utility of Spanish ResearchMatch in engaging Hispanics. Over 12,500 volunteers in ResearchMatch self-identify as Hispanic (8.5%). From August 2018 to March 2020, 162 volunteers registered through the Spanish language version of ResearchMatch, and over 500 new and existing volunteers have registered a preference to receive messages about studies in Spanish. CONCLUSION: By applying the principles of health literacy and cultural competence, we developed a Spanish language translation of ResearchMatch. Our multiphase approach to translation included key principles of community engagement that should prove informative to other multilingual web-based platforms.

Managing Chronic Illness.

Models of care coordination can significantly improve health outcomes for older adults with chronic illnesses if they can engage participants. The purpose of this study was to examine the impact of nursing contact on the rate of participants' voluntary disenrollment from a care coordination program. In this retrospective cohort study using administrative data for 1,524 participants in the Health Quality Partners Medicare Care Coordination Demonstration Program, the rate of voluntary disenrollment was approximately 11%. A lower risk of voluntary disenrollment was associated with a greater proportion of in-person (vs. telephonic) nursing contact (Hazard Ratio [HR] 0.137, confidence interval [CI] [0.050, 0.376]). A higher risk of voluntary disenrollment was associated with lower continuity of nurses who provided care (HR 1.964, CI [1.724, 2.238]). Findings suggest that in-person nursing contact and care continuity may enhance enrollment of chronically ill older adults and, ultimately, the overall health and well-being of this population.

Socio-ecological Model as a Framework for Overcoming Barriers and Challenges in Randomized Control Trials in Minority and Underserved Communities.

BACKGROUND: Numerous barriers and challenges can hinder the successful enrollment and retention of study participants in clinical trials targeting minority populations. To conduct quality research, it is important to investigate these challenges, determine appropriate strategies that are evidence-based and continue seeking methods of improvement. METHODS: In this paper, we report such experiences in a registered clinical trial in an underserved minority population in the Southern part of United States. This research study is a randomized double-blind controlled clinical trial that tests the efficacy of higher-strength as compared to low-strength/standard of care folic acid to prevent fetal body and brain size reduction in pregnant women who smoke. A unique approach in this socio-behavioral, genetic-epigenetic clinical trial is that we have adopted the socio-ecological model as a functional platform to effectively achieve and maintain high participant recruitment and retention rates. RESULTS: We highlight the barriers we have encountered in our trial and describe how we have successfully applied the socio-ecological model to overcome these obstacles. CONCLUSIONS AND GLOBAL HEALTH IMPLICATIONS: Our positive experience will be of utility to other researchers globally. Our fi ndings have far-reaching implications as the socio-ecological model approach is adaptable to developed and developing regions and has the potential to increase recruitment and retention of hard-to-reach populations who are typically under-represented in clinical trials.