Engaging Hispanic/latinx Community in TBI Rehabilitation Research with Bilingual and Bicultural Navigators

Research Objectives: In 2022 the Hispanic population reached 63.6 million, comprising 19.1 % of the US population.1 Yet, Hispanic/Latinx participation in clinical studies varies from 1-15%.3,4 Furthermore, in NIH-funded Traumatic Brain Injury (TBI) studies, Hispanics represent only 11% of participants.2 We describe the implementation of a bilingual and bicultural TBI multicenter research randomized control trial (RCT) and our effectiveness in recruiting and retaining Hispanic/Latinx participants using inclusive research practices.

Design: Pediatric TBI RCT NCT05261477.

Setting: Multicenter study at 3 Pediatric Hospitals and a Level 1 Trauma Center, recruiting children 3-17 years with mild to severe TBIs and their caregivers in Washington, Oregon, and Texas.

Participants: RCT target enrollment is 150 parent-child dyads. We describe the work of 6 Research PN’s who are native Spanish speakers and identify as Hispanic/Latinx.

Interventions: 3-month bilingual/Bicultural patient navigation (PN) and education. Inclusive research strategies were informed by Latinx families since the trial's inception; including bilingual/bicultural staff, recruitment and study materials culturally and linguistically designed (not adapted) for the population of interest, prioritization of in-person recruitment, telephone intervention, and flexible times for study visits.

Main Outcome Measures: Recruitment and retention rates within the ongoing TBI RCT.

Results: From July 2022-June 2024, 99 parent-child dyads have been approached; 48 dyads were successfully enrolled (49%). Completion of 3-m intervention is 97.6%. Retention ranges from 94.4%-97.6% at various points in the 12-month trial. Communication with families has been entirely in Spanish for 51% of participants. Reasons for no participation are feeling overwhelmed by their child's condition or perceiving a lack of value if randomized to a control group.

Conclusions: Our study has higher enrollment and retention rates compared to other Pediatric TBI studies. These findings support using bilingual and bicultural research staff and inclusive practices to boost recruitment among Hispanic/Latinx participants . Enrollment data from the NIH underscores the urgent need to enhance the participation of Hispanic/Latinx individuals in research studies.

Author(s) Disclosures: Current trial funded by R01HD103700 NICHD-Research Project Grant 1stBIEN.
1.Krogstad JM, et al. Key facts about U.S. Latinos for National Hispanic Heritage month. Pew Research Center. September 22, 2023. Accessed July 15, 2024. https://www.pewresearch.org/short-reads/2023/09/22/key-facts-about-us-latinos-for-national-hispanic-heritage-month/.
2. NIH RCDC Inclusion Statistics Report. National Institutes of Health. Accessed July 15, 2024.https://report.nih.gov/RISR/#/ic?rcdcCategory=Traumatic+Brain+Injury+(TBI)&ic=Total,+NIH.
3. Reopell L, et al. Community engagement and clinical trial diversity: Navigating barriers and co-designing solutions-A report from the "Health Equity through Diversity" seminar series. PLoS One. 2023;18(2):e0281940. Published 2023 Feb 16.
4. Rojo MO, et al. Hispanics’ perceptions of participation in research studies and solutions for improvement in participation. FMCH. 2024;11(1):1-