June 20, 2024: Health Equity Core Leaders Reflect on Supporting NIH Collaboratory Trials

NIH Pragmatic Trials Collaboratory Health Equity Core cochairs Rosa Gonzalez-Guarda and Cherise Harrington recently discussed the Core’s work supporting the NIH Collaboratory Trials to address issues related to health equity.

Gonzalez-Guarda and Harrington sat down together during the NIH Collaboratory’s 2024 Annual Steering Committee Meeting in May and reflected on the past year.

Throughout the last year, the Health Equity Core cochairs have conducted consultations with investigators from new NIH Collaboratory Trials to learn about the trials and provide support and resources for health equity challenges.

“One of the biggest issues the new trials are seeing is the context of the healthcare delivery system they are partnering with and the limitations that has. Healthcare in general is not designed for minoritized populations so the trials are having to retrofit their strategies within a system that is not really designed to engage these populations,” Gonzalez-Guarda said.

The Health Equity Core is providing education and developing resources to help investigators navigate challenges and integrate a health equity lens to their studies.

“A resource we provide is helping the trials assess what health equity means. Across the field we are having issues with the definition. It is a process that must be intentional; it must be embedded across the culture of a project. We are making teams more aware and helping them understand that just assessing demographic data isn’t addressing health equity. Trials need to ask how are we going to address the needs of that particular community? We have been able to provide that resource to the previous and incoming trials,” Harrington said.

In addition to consultations, the Health Equity Core is developing a dashboard to help monitor the areas of diversity in the NIH Collaboratory’s patient population and help identify resources that may be needed. The Core also uses the Duke University School of Nursing’s INFusE checklist to help investigators think through from design to dissemination specific strategies for integrating a health equity lens into their study.

Gonzalez-Guarda is an associate professor of nursing and assistant dean for the PhD program in the Duke University School of Nursing. Harrington is an associate professor of public health education and a senior researcher at North Carolina Central University.

July 17, 2023: NIH Pragmatic Trials Collaboratory Welcomes First Class of Fellows

Headshots of Dr. Stephanie Ibemere and Dr. Kaitlyn McLeod
From left: Dr. Stephanie Ibemere and Dr. Kaitlyn McLeod

The NIH Pragmatic Trials Collaboratory is welcoming its first class of fellows in a new program for early-career investigators with a scholarly interest in pragmatic clinical trials.

"We are very excited to welcome the 2 inaugural fellows to the NIH Pragmatic Trials Collaboratory Fellowship Program and give them the education and tools that they need to launch their careers as pragmatic clinical trials investigators," said Dr. Rosa Gonzalez-Guarda, cochair of the NIH Collaboratory’s Fellowship Program and Health Equity Core.

Dr. Stephanie Ibemere is an assistant professor in the Duke University School of Nursing. Dr. Ibemere will work closely with the Implementation Science Core and the GRACE NIH Collaboratory Trial team during her fellowship year.

Dr. Kaitlyn McLeod is a resident physician in the Internal Medicine Residency Program at the University of Colorado. Dr. McLeod will work closely with the Community Health Improvement Core and the Nudge NIH Collaboratory Trial team during her fellowship year.

"We are delighted that Stephanie and Kaitlyn are joining the NIH Collaboratory as fellows, and we look forward to the insights they will bring to the Cores and NIH Collaboratory Trials," said Dr. Kevin Weinfurt, co–principal investigator of the Coordinating Center and cochair of the new Fellowship Program.

During the 1-year fellowship, which began July 1, 2023, fellows will become members of the NIH Collaboratory program and have access to a wide range of activities and opportunities. Fellows will be active participants in a Core Working Group that aligns with their interests and will also be given education on the fundamentals of designing and conducting successful pragmatic clinical trials.

Working with a NIH Collaboratory Trial investigator mentor and a Core leadership mentor from the NIH Collaboratory, each fellow will complete a project that contributes to the field of pragmatic trials, resulting in a new publishable product or resource. In addition, fellows will participate in the following activities:

  • Regular presentations and discussions with experienced pragmatic trial investigators and leaders in the field
  • Individualized coursework and mentorship
  • Guided research program
  • Professional development training
  • Presentation and publication opportunities
  • Training on health equity as it relates to pragmatic trials

Ibemere and McLeod joined leaders from the NIH Collaboratory and their mentors for a welcome and orientation meeting on July 6 to kick off their fellowship year.

June 29, 2023: Health Equity Core Leaders Share Insights From Annual Steering Committee Meeting

Headshots of Dr. Rosa Gonzalez-Guarda and Dr. Cherise Harrington
Rosa Gonzalez-Guarda and Cherise Harrington

In an interview during the annual Steering Committee meeting, Drs. Rosa Gonzalez-Guarda and Cherise Harrington, cochairs of the Health Equity Core Working Group, shared insights and next steps for health equity in the NIH Pragmatic Trials Collaboratory.

One question discussed at the meeting was how to embed health equity in pragmatic clinical trials. Gonzalez-Guarda said that a key component of addressing health equity is acknowledging the structural and social drivers of that inequity and developing strategies to target them.

“The next phase is to figure out ways that we can encourage embedded pragmatic clinical trials that address the structural causes of health inequities,” said Gonzalez-Guarda, who noted that the National Institutes of Health is supporting more structural interventions.

One way the NIH Pragmatic Trials Collaboratory can lead is by integrating a pragmatic clinical trial lens into structural intervention work, Gonzalez-Guarda said. This work is central to the Health Equity Core, which was launched last fall and began meeting regularly in early 2023.

Health Equity Core members are reviewing a checklist on how to infuse a health equity lens into the research life cycle. As a next step, Harrington and Gonzalez-Guarda would like to ask Core members to think critically about how the checklist can be adapted for pragmatic clinical trials and develop it as a new tool for the research community.

Harrington said another way the Health Equity Core can make an impact is by gathering examples from the NIH Collaboratory Trials of data on underrepresented populations that are not statistically significant but may be clinically significant so that other projects can learn from them.

Drawing from and adding to the NIH Pragmatic Trials Collaboratory’s lessons learned is also a key strategy for the Health Equity Core’s work. Harrington said it is important to share knowledge outside of the research community.

“We need to remember to ask ourselves, 'What am I leaving with this community after the funding is gone that they can still leverage?,’” said Harrington.

Many of the NIH Collaboratory Trials are already implementing health equity plans and engagement strategies to reach diverse patient populations, providers, and community stakeholders.

Gonzalez-Guarda said that it is important to continue this work and to support the careers of junior researchers working on pragmatic clinical trials so they can use engagement practices and be successful. In addition to preparing investigators to engage with diverse communities, part of the engagement work may also be training for communities to better engage with projects in a more meaningful way, Harrington said.

Developing tools and resources is a top priority as the Health Equity Core moves forward, and Gonzalez-Guarda and Harrington look forward to providing guidance for pragmatic clinical trials and continuing the conversation from the Steering Committee meeting.

Learn more about the Health Equity Core and see the complete materials from the 2023 Steering Committee meeting.

January 30, 2023: NIH Pragmatic Trials Collaboratory Begins 2023 With New Cores in Health Equity and Implementation Science

Headshots of Dr. Rosa Gonzalez-Guarda and Dr. Cherise Harrington
Dr. Rosa Gonzalez-Guarda (left) and Dr. Cherise Harrington (right)

The NIH Pragmatic Trials Collaboratory began 2023 with 2 new Core Working Groups focused on health equity and implementation science. The membership of both Cores draws from across the program to support the design and implementation of the NIH Collaboratory Trials.

“By launching these 2 new Core Working Groups, the NIH Pragmatic Trials Collaboratory is reaffirming its commitment to generating knowledge that supports equitable pragmatic research to improve healthcare for all,” said Dr. Adrian Hernandez, co-principal investigator of the NIH Pragmatic Trials Coordinating Center.

The Health Equity Core provides leadership and guidance to help the NIH Collaboratory Trials and investigators be more equitable in research. The Core’s work includes supporting pragmatic trials to address social and structural drivers of inequities, implement patient and community engagement strategies, promote the inclusion and mentorship of historically underrepresented scientists, and develop culturally and contextually aligned research and translation strategies that overcome bias and resonate with patients and communities.

The Health Equity Core is led by Dr. Rosa Gonzalez-Guarda and Dr. Cherise Harrington. Gonzalez-Guarda is an associate professor of nursing at Duke University, faculty lead for the Population Health Research Area of Excellence at Duke’s Center for Nursing Research, and codirector of the Community Engagement Core for Duke Clinical Translational Science Institute. Harrington is a senior researcher and associate professor of public health education at North Carolina Central University. Alex Fist of the Duke Clinical Research Institute serves as the Core’s project manager in the Coordinating Center. The Core’s members include Jessica Lee Barnhill, Sheana Bull, Gaby Castro, Andrea Cheville, Allison Cuthel, Dana Dailey, Juanita Darby, Graham Dore, Julie Fritz, Morgan Fuoco, Christine Goertz, Katharine Lawrence, Vivian Lyons, Keith Marsolo, Alice Pressman, Nina Siman, and Miguel Vazquez.

Headshots of Dr. Devon Check and Dr. Hayden Bosworth
Dr. Devon Check (left) and Dr. Hayden Bosworth (right)

The Implementation Science Core provides technical support and pragmatic trial expertise for NIH Collaboratory Trials with a specific focus on innovative dissemination and implementation science approaches. The Core will study methods and strategies to promote the uptake of interventions that have proven effective in routine practice, with the aim of improving population health.

The Implementation Science Core is co-led by Dr. Devon Check and Dr. Hayden Bosworth. Check is an assistant professor in population health sciences at Duke University. Bosworth is a professor in population health sciences, psychiatry, and nursing at Duke and deputy director for the Center for Health Services Research in Primary Care at the Durham VA Medical Center. Jill George of the Duke Clinical Research Institute serves as the Core’s project manager in the Coordinating Center. The Core’s members include Kristin Archer, Gaby Castro, Allison Cuthel, Ardith Doorenbos, Carol Greco, Crystal Patil, Sarah Redmond, Isabel Jordan Roth, Stacie Salsbury, Stacy Sterling, Anne Thackeray, Cindy Tofthagen, Katy Trinkley, Miguel Vazquez, and Angelo Volandes.

“Through their work in the areas of implementation science and health equity, the new Cores can help uncover how best to implement improved clinical practices so the benefits reach at-risk and traditionally underserved populations,” Hernandez said.