# Identifying and addressing barriers to clinical trial participation of Urban American Indians by creating a community research worker role

> **NIH FDA U01** · CIRCLE CLINICAL, LLC · 2024 · $249,550

## Abstract

Project Summary
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 resear...

## Key facts

- **NIH application ID:** 11045142
- **Project number:** 1U01FD008274-01
- **Recipient organization:** CIRCLE CLINICAL, LLC
- **Principal Investigator:** Lynn Bartholow
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** FDA
- **Fiscal year:** 2024
- **Award amount:** $249,550
- **Award type:** 1
- **Project period:** 2024-08-01 → 2025-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11045142

## Citation

> US National Institutes of Health, RePORTER application 11045142, Identifying and addressing barriers to clinical trial participation of Urban American Indians by creating a community research worker role (1U01FD008274-01). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/11045142. Licensed CC0.

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