STEP-2, an NIH Collaboratory 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.
This summer, after our 2026 Annual Steering Committee Meeting, we spoke with co–principal investigators Rachel Winer, Amanda Petrik, and Jasmin Tiro to learn more about STEP-2.
"We're assigning clinics to 1 of 3 approaches: usual care, structured in-clinic HPV self-testing implementation, and in-clinic implementation paired with Medicaid-supported outreach with mailed HPV self-testing kits," Winer explained.
The STEP-2 team is partnering closely with federally qualified health centers and Medicaid health plans in the implementation of the self-testing intervention.
"The broader goal is to generate evidence that health systems can use to expand access to and optimize delivery of cervical cancer screening," Winer said.
"One major challenge in pragmatic trials...is that usual care can change over time, which means that the team has to be flexible while preserving the integrity of the study," said Tiro.
Tiro discussed the challenges of working with healthcare systems and health plans that have different structures and workforces and that serve different populations—challenges that influence every area of trial logistics and implementation.
"We're staying closely engaged with our health system and community partners, designing workflows that fit routine practice...and making sure that our evaluation protocols are adapted to closely monitor care delivery changes," Tiro said. "That framing is really consistent with the [NIH Collaboratory's] emphasis on building relationships with communities and designing trials that can support broad implementation as well as sustainability."
"STEP-2 aims to make cervical cancer screening more accessible for people who are under-screened and face barriers to screening," explained Petrik. "We hope this trial is going to help health systems choose the most effective and feasible ways to offer HPV self-testing so that more people complete screening and fewer cases of cervical cancer are missed."
Learn more about the STEP-2 trial.
For more information about the 2026 Annual Steering Committee Meeting, access the complete meeting materials.
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.