STEP-2

August 11, 2025: New Living Textbook Chapter Explores Implementation in Pragmatic Clinical Trials

Posted on by Karen Staman

The NIH Pragmatic Trials Collaboratory Implementation Science Core, led by Devon Check and Hayden Bosworth, has developed a new chapter on implementation to assist study teams with the complex process of using and studying implementation strategies to help implement research findings into clinical care. The chapter includes sections on:

Case studies are used to illustrate how pragmatic clinical trials embedded in healthcare systems use implementation frameworks, including examples from RAMP, BEST-ICU, STOP CRC, TSOS, ABATE, STEP-2, and GRACE.

For more, see our collection of chapters on Dissemination and Implementation, which includes chapters on Dissemination to Different Stakeholders, Data Sharing and Embedded Research, and End-of-Trial Decision-Making.

July 31, 2025: Pragmatic Trialists Share Strategies for Monitoring Changes in Usual Care

Posted on by Karen Staman

Pragmatic clinical trials are conducted as part of routine healthcare delivery and often compare an intervention to usual care. To do this, researchers must understand, monitor, and document standard care at participating research sites.

At the NIH Pragmatic Trials Collaboratory’s 2025 Annual Steering Committee Meeting, Duke University’s Emily O’Brian asked a panel of trialists about the strategies they used to define and document usual care. The panelists included Rachel Winer, co–principal investigator (PI) of STEP-2;, Richard Platt, co-PI of INSPIRE; and Christine Goertz, co-PI of IMPACt-LBP.

Key Strategies

  • Establish a community of individuals who are interested in and committed to answering the research question
  • Develop relationships: visit each site and have monthly coaching calls
  • Get commitment in advance from sites to hold their practice constant for the duration of the trial
  • Have sites complete readiness surveys or feasibility assessments that include questions about potential upcoming quality improvement initiatives
  • Minimize burden on sites as much as possible

The Navigating the Unknown chapter of the Living Textbook includes  descriptions of unanticipated challenges that may occur during the years-long course of a study that can have profound effects on usual care, including:

These challenges all require close collaboration with research partners to develop solutions.

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

Posted on by Damon Seils

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

Posted on by Damon Seils
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.

January 13, 2024: STEP-2 Trial of Cervical Cancer Screening Interventions Joins the NIH Collaboratory

Posted on by Damon Seils
Headshots of Drs. Rachel Winer, Amanda Petrik, and Jasmin Tiro
From left to right: Dr. Rachel Winer, Dr. Amanda Petrik, and Dr. Jasmin Tiro, principal investigators of the STEP-2 trial

The NIH Pragmatic Trials Collaboratory is pleased to welcome the STEP-2 trial (Self-Testing for Cervical Cancer in Priority Populations) to its portfolio of innovative NIH Collaboratory Trials.

Only half of eligible patients in US federally qualified health centers were screened for cervical cancer in 2021. The COVID-19 pandemic exacerbated these disparities. Distribution of human papillomavirus (HPV) self-sampling kits to patients is a widely adopted strategy in other countries but is nascent in the United States.

The STEP-2 study team will conduct a cluster randomized trial in federally qualified health centers in Oregon and Washington to evaluate the comparative effectiveness and cost-effectiveness of in-clinic distribution of self-sampling kits, in-clinic plus mailed distribution, and usual care. The project is supported by a grant award from the National Cancer Institute.

Rachel Winer, Amanda Petrik, and Jasmin Tiro are the principal investigators for the STEP-2 trial. Winer is a professor of epidemiology at the University of Washington. Petrik is an investigator at the Kaiser Permanente Center for Health Research. Tiro is a professor of public health sciences at the University of Chicago.

Learn more about the STEP-2 trial.

January 8, 2025 Virtual Onboarding Meeting: STEP-2

NIH Pragmatic Trials Collaboratory Onboarding Meeting

January 8, 2025
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
Wendy Weber
Adrian Hernandez

Overview of the NIH Pragmatic Trials Collaboratory and a Cooperative Agreement
Wendy Weber

Working With the NIH Collaboratory Coordinating Center
Adrian Hernandez

Brief Introduction to the Core Working Groups

New UG3 NIH Collaboratory Trial Overview
Self-Testing for Cervical Cancer in Priority Populations (STEP-2)
Rachel Winer
Amanda Petrik
Jasmin Tiro

Open Discussion
Adrian Hernandez

Closing Remarks
Wendy Weber
Adrian Hernandez