Identifying and addressing barriers to clinical trial participation of urban american indians by creating a community research worker role

This Cooperative Agreement award from the U.S. Food and Drug Administration (FDA), under the FDA Research program (CFDA 93.103), provides $499,550 to Circle Clinical, LLC to advance equity in clinical trials by identifying and addressing barriers to clinical trial participation experienced by urban American Indians.

The project will create a specialized Community Research Worker (CRW) role, similar to a Community Health Worker, to serve as a liaison between the clinical research site and the urban American Indian community. The CRW will build trusting relationships, assess social determinants of health, and work to improve the willingness of urban American Indians to consider enrolling in clinical trials. The project involves developing a survey to identify barriers, providing CRW training, and evaluating the impact of the CRW model on clinical trial participation.

Abstract

This project seeks to advance equity in clinical trials by identifying and addressing barriers to clinical trial participation experienced by urban american indians at a clinical research site embedded within an urban indian health clinic. Although there are ongoing efforts to make clinical trials more representative of the population, american indians have the lowest representation of race/ethnic groups in the united states. Innovative, novel approaches are needed to address the barriers to participating in clinical research. The project will engage urban american indians and will be influenced by indigenous cultural values of respect, relationship, responsibility, reciprocity and redistribution. The goal of this exploratory research project will be to identify barriers to participation in clinical trials of urban american indians and to identify solutions to address those barriers through a trusted relationship with a community research worker. The project will first involve creating a survey to explore barriers to clinical trial participation. Patients who self- identify as american indian will be asked if they are willing to participate in the study, provide informed consent and take the survey. Results from the survey will be analyzed to determine themes and solutions to these barriers. A main component of this program is the creation of a community research worker (CRW) role, similar to a community health worker (CHW) or community health representative (CHR). A CHW is a frontline public health worker who is a trusted member and has an unusually close understanding of the community served. This trusting relationship enables the worker to serve as a liaison between health/social services and the community to facilitate access to services and improve the quality and cultural competence of service delivery. The difference with a CRW is they would serve as a liaison between clinical trial services and the community to address barriers to clinical trial participation. A specialized training curriculum for the CRW will be created including, but not limited to topics such as: american indian cultural competency, cultural intelligence, unconscious bias, and how to find resources to address social determinants of health (sdoh). Once the training program has been created, the CRW will go through this training. Then the CRW will approach patients who self-identify as american indian, ask them to be part of the research study, obtain informed consent, and have them take the barrier to clinical trial participation survey. The CRW will build a trusting relationship with patients by having a discussion to help determine what sdoh the patient is facing. Patients will then be asked to complete a post survey to determine if they are more likely to consider enrolling in a clinical trial. The impact of CRW engagement on improving willingness to consider clinical trial participation will be evaluated with the intent to determine if further research on the benefits of a CRW is warranted.