A new clinical trial was awarded to Rebekah Pratt, PhD, (MPI) and Rachel Winer, PhD (MPI; University of Washington), along with co-investigators Rahel Ghebre, MD, MPH (OBGYN), Timothy Ramer, MD, Sophia Yohe, MD, (Laboratory Medicine), Bryan Weiner, PhD (University of Washington), and Adam Szpiro, PhD (University of Washington). The team received a $2,910,214 award from the National Cancer Institute, National Institutes of Health for their clinical trial "Reducing cervical cancer screening disparities in Somali immigrant women through a primary care based HPV self-sampling intervention."

Somali women living in the U.S. have lower cervical cancer screening rates than the U.S. general female population. This disparity is due to a range of factors, including limited awareness of HPV and cervical cancer, cultural and religious beliefs, mistrust of healthcare providers, and concerns around modesty. HPV self-sampling is an emerging cervical cancer screening modality that may address common screening barriers among Somali women, particularly those related to modesty. HPV self-sampling is accurate for detecting pre-cancerous cervical lesions and effective in reaching under-screened women. While research has focused primarily on home-based HPV self-sampling, there is an untapped opportunity to offer HPV self-sampling in the primary care setting.

Offering HPV self-sampling in primary care could effectively increase cervical cancer screening rates in Somali women by positioning providers to address screening barriers, enabling clinics to opportunistically fit in HPV self-sampling with other appointments and providing an alternative modality for women. The team proposes a Hybrid Type 2 effectiveness-implementation design to assess the effectiveness and implementation of a patient-centered, culturally tailored HPV self-sampling intervention for Somali women. The team will conduct focus groups with Somali patients and interviews with providers to identify patient-, provider-, clinic-, and systems-level factors to inform refinement of intervention materials and development of implementation strategies (Aim 1). After tailoring the intervention, the team will then implement HPV self-sampling in two primary care clinics and evaluate changes in Somali women's cervical cancer screening rates one-year pre- and one-year post-implementation (Aim 2). Changes will be compared with Somali women attending 27 control clinics followed over the same time period using difference-in-difference methods. Finally, using RE-AIM, the team will conduct a post-implementation mixed methods analysis of the processes and strategies needed to successfully implement HPV self-sampling in primary care for Somali patients (Aim 3), including interviews with providers and Somali women.

The team's hypothesis is that implementing HPV self-sampling in primary care will lead to increased uptake of cervical cancer screening in Somali women and that an implementation science-based analysis of the processes needed to successfully implement the intervention will lead to sustainable, novel strategies to support the sustained integration of HPV self-sampling into primary care.