Bridging the Gap: Culturally Responsive Strategies for NIH Trial Recruitment

Abstract

Objective

To enhance recruitment and participation rates of Non-Hispanic Black (NHB) and Hispanic adult patients in a NIH-funded clinical trial studying an emerging health technology.

Data Sources and Study Setting: This study includes primary data collected in Los Angeles, California from November 2020 through November 2023

Study Design

In response to the underrepresentation of NHB and Hispanic patients in a NIH-funded trial on virtual reality for chronic lower back pain, we conducted a study utilizing a mixed-method approach. We conducted focus groups and based upon the feedback, study materials were culturally adapted concordantly. Additionally, a natural language processing program was used to micro target recruitment. Quantitative analysis was performed to assess the efficacy of the modified recruitment strategies by comparing the number of recruited and randomized NHB and Hispanic patients pre and post intervention.

Data Collection/Extraction Methods

Semi-structured focus groups were conducted with NHB and Hispanic patients and community members (age 18 and older). Thematic analysis of focus groups identified four key themes: mistrust, interest, culture, and communication. Adaptations, including revised language, multimedia instructions, targeted outreach, and micro-target recruitment were implemented in the second half of the study.

Principal Findings

Themes guided modifications, resulting in statistically significant increases in the overall proportion of Hispanic individuals approached for the study from 16.6% to 40.6% (p<0.001) and randomized from 16.7% to 34.4% (p<0.001). The randomization rate increased from 32.2% to 44.8% (p=0.045) for Hispanic participants and from 28.2% to 45.9% (p=0.011) for NH Black participants.

Conclusion

This study introduces culturally sensitive recruitment strategies addressing mistrust among NHB and Hispanic populations and microtargeting techniques harnessing technological advancements, yielding a notable increase in the randomization rate of underrepresented groups and enhancing clinical trial diversity.