SUMMARY It is estimated that less than one-third of clinical trials recruit their target sample size within the originally predicted time frame and that research participants who complete a clinical trial are more likely to be male, younger, have higher incomes, and be more educated. For clinical trials working with underserved and Black, Indigenous, and People of Color (BIPOC) communities, there are additional challenges tied to maintaining contact with participants whose lives may include more transience and practical barriers such as transportation barriers, lack of childcare, competing priorities, etc. Further no study known has specifically examined mechanisms for improving recruitment and retention, let alone a process that further assures diversity in the patient sample, for clinical trials of CIH. Enhancement to the current funded UH3 include the development and utilization of a diversity in recruitment and retention (DRR) advisory board that includes patients with previous integrative medicine clinical trial experience, clinicians with integrative medicine experience, and clinicians who have minimal integrative medicine experience. In addition this supplement adds a recruitment and retention specialist who will coordinate this advisory board and implement the activities to meet its three aims. Through the utilization of both a recruitment and retention specialist and a patient and caregiver Diversity, Recruitment, and Retention (DRR) Advisory Board, our proposed study design will provide both evidence-based recruitment tools and important information about the risk factors associated with loss to follow-up. We will also implement a model that addresses these issues in real-time to ensure the larger study's success. We will engage in structured interviews with patients who select to not engage in the primary study and those who fall at risk of dropping out. In addition, we propose to conduct secondary data analyses of the socio-economic and health care utilization factors that contribute to patients selecting and completing a clinical integrative medicine trial. Primary outcomes of this supplement study include the development of model recruitment and retention tools and an empirical understanding of the barriers and factors contributing to recruitment, loss to follow up and successful completion of a clinical trial such as primary HEAL study. This study will be among the first to carefully examine the nature of CIH clinical trial participants. These findings will be germane to the conceptualization and implementation of future integrative medicine trials and will have a broader utility for future clinical research seeking to recruit and retain more diverse participants.

NARRATIVE This proposal for a supplementary diversity and inclusion study will run ancillary to our currently funded BackinAction/AcuOA study focusing on the IFH study site. The findings generated for the supplementary study will be used to enhance those already being collected by the primary study particularly related to its RE-AIM model assessing: Reach, Effectiveness, Adoption, Implementation, and Maintenance.