November 4, 2026: Study Snapshots and Updated Ethics Documentation Available for LungSMART and STEP-2 Trials

New study snapshots and updated ethics and regulatory documentation are now available for the LungSMART and STEP-2 trials. One year into the studies, and after receiving approval to transition to the implementation phase, the research teams reviewed and updated the minutes of their initial consultations with the Ethics and Regulatory Core.

LungSMART and STEP-2 are the first NIH Collaboratory Trials to be supported by grant awards from the National Cancer Institute.

LungSMART

Headshots of LungSMART investigators David Wetter, Guilherme Del Fiol, and Ken Kawamoto
Left to right: LungSMART investigators Drs. David Wetter, Guilherme Del Fiol, and Ken Kawamoto

New resources for LungSMART:

LungSMART, led by Dave Wetter, Guilherme Del Fiol, and Ken Kawamoto of the University of Utah, is testing a combination of text messages, an interactive chatbot, and educational videos delivered by text message to address barriers to completing lung cancer screening among patients receiving care in safety net community health centers. Learn more about LungSMART.

STEP-2

Headshots of Drs. Rachel Winer, Amanda Petrik, and Jasmin Tiro
Left to right: STEP-2 investigators Drs. Rachel Winer, Amanda Petrik, and Jasmin Tiro

New resources for STEP-2:

STEP-2, led by Rachel Winer of the University of Washington, Amanda Petrik of the Kaiser Permanente Center for Health Research, and Jasmin Tiro of the University of Chicago, is evaluating the comparative effectiveness and cost-effectiveness of in-clinic vs mailed distribution of human papillomavirus (HPV) self-collect kits to improve cervical cancer screening rates among patients receiving care in community health centers. Learn more about STEP-2.

 

August 20, 2026: LungSMART Team Proposes Framework for Assessing Fit of Large Language Models in Public Health Interventions

Headshots of LungSMART investigators David Wetter, Guilherme Del Fiol, and Ken Kawamoto
Left to right: LungSMART investigators Dr. David Wetter, Dr. Guilherme Del Fiol, and Dr. Ken Kawamoto

Using the interactive text messaging intervention from the LungSMART trial as a case study, researchers demonstrated the application of a proposed framework for assessing the fit of custom large language models (LLMs) in public health interventions.

The report was published online in the Journal of Medical Internet Research.

Integration of custom LLMs into health chatbots and other clinical and public health workflows is increasingly common. However, these novel tools can produce errors and unpredictable results and can be difficult to evaluate, raising ethical and practical challenges for teams seeking to use them.

Researchers from LungSMART, an NIH Collaboratory Trial, developed an “acceptance criteria framework” to guide assessments of an LLM’s performance before its deployment in real-world practice. They demonstrated the framework by applying it to an LLM being developed for the interactive chatbot component of the LungSMART intervention.

Read the full article.

Headshot of Dr. Andy King
Dr. Andy King, lead author of the report

LungSMART, led by Dave Wetter, Guilherme Del Fiol, and Ken Kawamoto of the University of Utah, is testing a combination of text messages, an interactive chatbot, and educational videos delivered by text message to address barriers to completing lung cancer screening among patients receiving care in safety net community health centers.

LungSMART is supported within the NIH Pragmatic Trials Collaboratory by a grant from the National Cancer Institute. Learn more about LungSMART.

June 23, 2026: Updates From LungSMART: An Interview With Guilherme Del Fiol

LungSMART is an NIH Collaboratory Trial testing telehealth interventions designed to address barriers to completing lung cancer screening among patients receiving care in safety net community health centers in Utah. The US Preventive Services Task Force recommends annual lung cancer screening for adults aged 50 to 80 years who are current smokers or who have quit within the past 15 years.

The first phase of LungSMART will test a combination of text messages, an interactive chatbot, and educational videos delivered by text message to increase patients’ participation in an eligibility assessment for lung cancer screening. In the second phase of the trial, the study team will use text messages, an interactive chatbot, and patient navigation by community health workers to increase completion of lung cancer screening by eligible patients who receive a referral.

Learn more about LungSMART, including the research team’s recently published bilingual formative evaluation of the study’s digital health tools. The study is supported within the NIH Collaboratory by a grant from the National Cancer Institute.

At the NIH Collaboratory’s 2026 Annual Steering Committee Meeting, we spoke with co–principal investigator Guilherme Del Fiol to learn more about LungSMART. Del Fiol is a professor of bioinformatics at the University of Utah’s Spencer Fox Eccles School of Medicine. His co–principal investigators are Dave Wetter and Ken Kawamoto, also of the University of Utah.

“If we can show that [the intervention] works and it’s feasible, it could demonstrate a way to deliver lung cancer screening and shared decision-making in a very scalable way in a statewide implementation that could be generalizable to other community health centers across the county,” Del Fiol explained. “And it could suggest a type of care delivery that can be used for other problems as well, not just lung cancer.”

Go to the full video.

In the coming weeks, we will share more highlights from the 2026 Annual Steering Committee Meeting. Access the complete meeting materials.

Video still from an interview with Dr. Guilherme del Fiol
Dr. Guilherme Del Fiol, co–principal investigator for LungSMART

June 16, 2026: LungSMART Team Uses Bilingual Formative Evaluation to Hone Study’s Digital Health Content

Headshots of LungSMART investigators David Wetter, Guilherme Del Fiol, and Ken Kawamoto
Left to right: Drs. David Wetter, Guilherme Del Fiol, and Ken Kawamoto, co–principal investigators for LungSMART

The LungSMART research team conducted a bilingual messaging study and usability assessment to evaluate and adapt the study’s digital health content for patients in community health centers in Utah. The evaluation led to improvements in content and delivery strategies in preparation for the launch of a full pragmatic clinical trial to promote lung cancer screening in low-resource healthcare settings.

The report was published online in Cancer Control.

LungSMART, an NIH Collaboratory Trial led by Dave Wetter, Guilherme Del Fiol, and Ken Kawamoto of the University of Utah, will test telehealth interventions designed to address logistical barriers and hesitancy around completing lung cancer screening among patients receiving care in community health centers in Utah.

In the first phase of the trial, patients identified in the electronic health record through an automated algorithm as being potentially eligible for lung cancer screening will be randomly assigned to engage with low-barrier digital health tools, such as text messages, health education videos, and a rules-based chatbot. This phase of the trial will direct interested and eligible patients to shared decision-making for referral to lung cancer screening.

Both the messaging study and the usability assessment found that participants were interested in the content and were able to navigate the digital health elements of the intervention. The feedback led to improvements in the clarity of terminology, especially for Spanish-speaking participants, and changes to address anxiety about cancer screening, risk, and cost.

Headshot of Dr. Andy King
Dr. Andy King, lead author of the report

“These insights would have been challenging to identify within traditional translation contexts, suggesting the need for thoughtful cultural adaptation in projects aimed at reducing health disparities,” wrote the report’s coauthors, led by Andy King of the University of Utah.

Read the full article.

LungSMART is supported within the NIH Pragmatic Trials Collaboratory by a grant from the National Cancer Institute. Learn more about LungSMART.

December 22, 2025: Rural Health Symposium Opens Registration, Announces Call for Abstracts

The Duke University School of Nursing will convene healthcare professionals, educators, researchers, community leaders, and policymakers for a 1-day symposium dedicated to reducing rural health disparities across North Carolina through collaboration and innovation.

On April 20, 2026, from 9:00 am to 3:00 pm at Duke University in Durham, North Carolina (and virtually via livestream), participants will come together for dynamic presentations, panels, poster sessions, and discussions with guests, including leaders from ECU Health, Sanford Health, UT-Arlington, and the NC Department of Health and Human Services. A reception will follow the program.

The deadline for abstract submission is February 9, 2026. See more information about the program below.

Did you know the NIH Pragmatic Trials Collaboratory supports several innovative pragmatic clinical trials to improve healthcare for rural and remote populations? Learn more about:

  • AIM-CP: Adapting and Implementing a Nurse Care Management Model to Care for Rural Patients with Chronic Pain
  • APA-SM: Personalized Auricular Point Acupressure for Chronic Pain Self-Management in Rural Populations
  • ARBOR-Telehealth: Advancing Rural Back Pain Outcomes Through Rehabilitation Telehealth
  • BeatPain Utah: Nonpharmacologic Pain Management in Federally Qualified Health Centers Primary Care Clinics
  • LungSMART: Population Health Management Approaches to Increase Lung Cancer Screening in Community Health Centers
  • RAMP: Reaching Rural Veterans: Applying Mind-Body Skills for Pain Using a Whole Health Telehealth Intervention

1st Annual Duke University School of Nursing Rural Health Symposium: Innovative Solutions to Addressing Rural Health Disparities

1st Annual Duke University School of Nursing Rural Health Symposium: Innovative Solutions to Addressing Rural Health Disparities

Monday, April 20, 9am-3pm, with Reception to Follow

Duke University Campus and Livestream Webinar

Register Now and Submit Abstracts by February 9

You are warmly invited to participate in the 1st Annual Duke University School of Nursing Rural Health Symposium, a one-day event that will convene healthcare professionals, educators, researchers, community leaders, and policymakers to address rural health disparities across North Carolina through collaboration and innovation.

Date: April 20, 2025
Time: 9:00 AM – 3:00 PM
Location: Duke University (with virtual livestream option)

The symposium will feature dynamic presentations, panel discussions, poster sessions, and networking opportunities, including a closing reception. Distinguished speakers will include:

  • Trisha Baise, ECU Health
  • Erica DeBoer, Sanford Health
  • Elizabeth Merwin, University of Texas at Arlington
  • Maggie Sauer, North Carolina Department of Health and Human Services

We invite you to submit abstracts by February 9 to share your research, innovations, and best practices that advance rural health.

Register today: https://duke.is/ruralhealth

Your participation will help foster meaningful dialogue and actionable strategies to improve health outcomes in rural communities. We look forward to your contributions and engagement in this important event.

July 14, 2025: Researchers Share Tips for Building Relationships With Communities in Pragmatic Research

Engaging with community partners can enrich and inform research through the lifespan of a trial. In a session at the NIH Pragmatic Trials Collaboratory’s 2025 Annual Steering Committee Meeting, Cherise Harrington, cochair of the program’s Community Health Improvement Core, led a discussion about building relationships with communities in pragmatic research.

The panelists included Jennifer Kawi, principal investigator (PI) for APA-SM; Kathleen Sluka, PI for FM-TIPS; Sebastian Tong, PI for AIM-CP; and David Wetter, PI for LungSMART. They shared examples of how community relationships have enriched their trials, along with impediments to meaningful community engagement and successful methods for building relationships with communities.

Key Strategies for Engaging With Communities

  • Build long-standing relationships with community partners, develop shared goals, and practice shared decision-making.
  • Design for sustainability. Design research projects with minimal disruption to the clinical workflow; utilize existing community health workers and programs; and integrate behavioral economics principles (nudges) into study design.
  • Budget for community engagement and include community members in study planning from the beginning.
  • Engage in the preferred language of the community. Ensure there are research staff who are fluent in the community’s preferred language and embedded in the community so they can provide key perspectives and help build trust.
  • Provide community health workers and research staff with training on community engagement.
  • Connect with community members where they spend time, such as community events and fairs, and visit local clinics to share information for referrals.

About the Trials

  • AIM-CP, supported by the National Institute of Nursing Research, is testing the implementation of a care management program to address disparate access to nonpharmacological treatments for chronic pain in rural populations.
  • APA-SM, supported by the National Center for Complementary and Integrative Health and the National Institute of Neurological Disorders and Stroke, is testing a 4-week auricular point acupressure intervention for self-management of chronic pain in rural communities in South Carolina and Texas.
  • FM-TIPS, supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases, is examining whether the addition of transcutaneous electrical nerve stimulation to routine physical therapy improves movement-evoked pain compared with physical therapy alone among patients with fibromyalgia.
  • LungSMART, supported by the National Cancer Institute, is testing telehealth interventions designed to address logistical barriers and hesitancy around completing lung cancer screening among patients receiving care in community health centers in Utah.

This summer, we are sharing highlights from the 2025 Annual Steering Committee Meeting. Access the complete collection of meeting materials.

June 16, 2025: NIH Pragmatic Trials Collaboratory Holds Annual Steering Committee Meeting

The NIH Pragmatic Trials Collaboratory held its 2025 Annual Steering Committee Meeting in Bethesda, Maryland, on May 28 and 29. The program’s leadership discussed evolving approaches to pragmatic clinical trials and considered the latest developments in the landscape of pragmatic research.

All materials from the meeting are now available online.

The NIH Pragmatic Trials Collaboratory added 3 new trials in the past year. The Annual Steering Committee Meeting was a time for new and experienced NIH Collaboratory Trial investigators and program leaders to share challenges and lessons learned in conducting their pragmatic trials.

“The addition of trials to the NIH Collaboratory portfolio is always a highlight of our annual meeting, and this year we were thrilled to welcome 3 new trials,” said Lesley Curtis, chair of the Steering Committee and chair and professor of population health sciences at Duke University.

The LungSMART trial will test telehealth interventions to address barriers to lung cancer screening. The STEP-2 trial will assess the effectiveness of self-testing for cervical cancer. The APA-SM trial will evaluate the effectiveness of self-management of pain using auricular point acupressure.

“These new trials address important public health questions and do so in rural communities and other priority populations,” Curtis noted. Learn more about the NIH Collaboratory Trials.

At the meeting, investigators shared methods for building relationships with communities in pragmatic research, designing and conducting pragmatic trials to support broad implementation, and monitoring and navigating changes in usual care. Investigators and program leaders also considered posttrial obligations, selection of data repositories, and optimal use of digital tools in research.

In the coming weeks, we will share more highlights from the 2025 Annual Steering Committee Meeting. Access the complete meeting materials.

April 21, 2025: Ethics Consultation Documentation Now Available for LungSMART and STEP-2 Trials

Headshots of LungSMART investigators David Wetter, Guilherme Del Fiol, and Ken Kawamoto
Left to right: LungSMART investigators Drs. David Wetter, Guilherme Del Fiol, and Ken Kawamoto

Ethics and regulatory onboarding documentation for 2 of the NIH Pragmatic Trials Collaboratory’s newest studies is now available. The documents include meeting minutes and supplementary materials summarizing recent discussions of ethics and regulatory issues associated with the LungSMART trial and the STEP-2 trial.

The consultations took place by video conference and included representation from the study teams, members of the NIH Collaboratory’s Ethics and Regulatory Core, NIH staff, and NIH Collaboratory Coordinating Center personnel.

LungSMART will test telehealth interventions designed to address logistical barriers and hesitancy around completing lung cancer screening among patients receiving care in community health centers in Utah.

Headshots of Drs. Rachel Winer, Amanda Petrik, and Jasmin Tiro
Left to right: STEP-2 investigators Drs. Rachel Winer, Amanda Petrik, and Jasmin Tiro

The STEP-2 trial will evaluate the comparative effectiveness and cost-effectiveness of in-clinic vs mailed distribution of human papillomavirus (HPV) self-sampling kits to improve cervical cancer screening rates among patients receiving care in community health centers in Oregon and Washington.

LungSMART and STEP-2 are the first NIH Collaboratory Trials to be supported by grant awards from the National Cancer Institute.

Ethics and regulatory documentation for all of the NIH Collaboratory Trials is available on our Data and Resource Sharing page.

December 2, 2024: NCI-Supported LungSMART Trial Joins the NIH Pragmatic Trials Collaboratory

Headshots of LungSMART investigators David Wetter, Guilherme Del Fiol, and Ken Kawamoto
From left to right: Drs. David Wetter, Guilherme Del Fiol, and Ken Kawamoto, principal investigators for LungSMART

The NIH Pragmatic Trials Collaboratory is pleased to welcome LungSMART (Population Health Management Approaches to Increase Lung Cancer Screening in Community Health Centers) to its portfolio of innovative NIH Collaboratory Trials.

Lung cancer is the leading cause of cancer-related deaths in the United States, but only 6.5% of eligible individuals were screened for lung cancer in 2020. Moreover, there are significant disparities in lung cancer screening related to race/ethnicity and socioeconomic status.

The LungSMART team will conduct a sequential multiple-assignment randomized trial (SMART) in community health centers in Utah to test telehealth interventions designed to address logistical barriers and hesitancy around completing lung cancer screening. The new project is supported by a grant award from the National Cancer Institute, a first for the NIH Pragmatic Trials Collaboratory.

David Wetter, Guilherme Del Fiol, and Ken Kawamoto will serve as the principal investigators for LungSMART. Wetter is the Jon M. and Karen Huntsman Presidential Professor, director of the Center for Health Outcomes and Population Equity, senior director for cancer health equity science at the Huntsman Cancer Institute, and director of community and stakeholder engagement at the Clinical and Translational Sciences Institute; Del Fiol is professor and vice chair of biomedical informatics; and Kawamoto is professor and vice chair of clinical informatics—all at the University of Utah.

Learn more about the LungSMART trial.

November 20, 2024 Virtual Onboarding Meeting: LungSMART

NIH Pragmatic Trials Collaboratory Onboarding Meeting

November 20, 2024
Virtual

Purpose

Welcome and hear from our new NIH Collaboratory Trial; provide introductions and an overview of the NIH Pragmatic Trials Collaboratory; hear from the Core Working Groups; and engage in discussion.

Welcome and Opening Remarks
Lesley Curtis
Beda Jean-Francois

Overview of the NIH Pragmatic Trials Collaboratory and a Cooperative Agreement
Beda Jean-Francois

Working With the NIH Collaboratory Coordinating Center
Lesley Curtis

Brief Introduction to the Core Working Groups

New UG3 NIH Collaboratory Trial Overview
Population Health Management Approaches to Increase Lung Cancer Screening in Community Health Centers (LungSMART)
David Wetter
Guilherme Del Fiol
Kensaku Kawamoto

Open Discussion
Lesley Curtis

Closing Remarks
Lesley Curtis
Beda Jean-Francois