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 health care providers, concerns around modesty and circumcision,
and low provider self-efficacy to perform Pap tests on circumcised women. HPV self-sampling is an emerging
cervical cancer screening modality that may address common screening barriers among Somali women,
particularly those related to modesty and circumcision. HPV self-sampling is accurate for detecting pre-
cancerous cervical lesions and effective in reaching underscreened women. In addition, our pilot work has
demonstrated the feasibility and acceptability of HPV self-sampling in Somali 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 circumcised women. We propose 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. Guided by the Consolidated Framework for Implementation Science and Social
Cognitive Theory, we 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, we will then implement HPV
self-sampling in 2 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, we 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. Our 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
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