Design of a pragmatic trial integrating human papillomavirus (HPV) self-sampling into primary care to reduce cervical cancer screening disparities in Somali American individuals: The Isbaar project

John Lin; Rachel L Winer; Christina Bliss Barsness; Jay Desai; Kristi Fordyce; Rahel Ghebre; Anisa M Ibrahim; Sharif Mohamed; Timothy Ramer; Adam A Szpiro; Bryan J Weiner; Sophia Yohe; Rebekah Pratt

doi:10.1016/j.cct.2024.107754

Design of a pragmatic trial integrating human papillomavirus (HPV) self-sampling into primary care to reduce cervical cancer screening disparities in Somali American individuals: The Isbaar project

Contemp Clin Trials. 2025 Jan:148:107754. doi: 10.1016/j.cct.2024.107754. Epub 2024 Nov 17.

Authors

John Lin¹, Rachel L Winer², Christina Bliss Barsness³, Jay Desai⁴, Kristi Fordyce⁵, Rahel Ghebre⁶, Anisa M Ibrahim⁷, Sharif Mohamed⁸, Timothy Ramer⁹, Adam A Szpiro¹⁰, Bryan J Weiner¹¹, Sophia Yohe¹², Rebekah Pratt¹³

Affiliations

¹ Department of Epidemiology, University of Washington, Box 351619, 3980 15th Ave NE, Seattle, WA 98195, USA. Electronic address: indigo@uw.edu.
² Department of Epidemiology, University of Washington, Box 351619, 3980 15th Ave NE, Seattle, WA 98195, USA. Electronic address: rlw@uw.edu.
³ Department of Family Medicine and Community Health, University of Minnesota, 717 Delaware Street, Minneapolis, MN 55414, USA. Electronic address: blis0015@umn.edu.
⁴ Chronic Disease and Environmental Epidemiology, Minnesota Department of Health, 625 Robert St N, Saint Paul, MN 55164, USA. Electronic address: Jay.Desai@state.mn.us.
⁵ Department of Family Medicine and Community Health, University of Minnesota, 717 Delaware Street, Minneapolis, MN 55414, USA. Electronic address: fordy006@umn.edu.
⁶ Division of Gynecologic Oncology, Department of Obstetrics, Gynecology and Women's Health, University of Minnesota, 909 Fulton St SE, Minneapolis, MN 55455, USA. Electronic address: ghebr004@umn.edu.
⁷ Department of Pediatrics, UW Medicine, University of Washington, Box 359850, Seattle, WA, USA. Electronic address: anisai@uw.edu.
⁸ Islamic Civic Society of America, 504 Cedar Avenue South, Minneapolis, MN 55454, USA.
⁹ Department of Family Medicine and Community Health, University of Minnesota, 717 Delaware Street, Minneapolis, MN 55414, USA. Electronic address: ramer001@umn.edu.
¹⁰ Department of Biostatistics, University of Washington, Box 351617, Seattle, WA, USA. Electronic address: aszpiro@uw.edu.
¹¹ Department of Global Health, University of Washington, Box 357965, Seattle, WA, USA. Electronic address: bjweiner@uw.edu.
¹² Division of Molecular Pathology and Genomics and Hematopathology, Department of Lab Medicine and Pathology, University of Minnesota, 420 Delaware St SE, Minneapolis, MN 55455, USA. Electronic address: yohe0001@umn.edu.
¹³ Department of Family Medicine and Community Health, University of Minnesota, 717 Delaware Street, Minneapolis, MN 55414, USA. Electronic address: rjpratt@umn.edu.

PMID: 39561921
DOI: 10.1016/j.cct.2024.107754

Abstract

Background: Somali American individuals have lower cervical cancer screening rates than the U.S. general population. Offering HPV self-sampling in primary care clinics could increase screening rates in Somali American individuals by addressing screening barriers.

Methods: The Isbaar Project is a Hybrid Type 2 effectiveness-implementation study of a patient-centered, culturally tailored HPV self-sampling intervention for Somali American individuals. Guided by the Consolidated Framework for Implementation Research and Social Cognitive Theory, we conducted focus groups with Somali American individuals, and interviews with clinicians and clinic staff to inform refinement and development of implementation strategies. HPV self-sampling was then implemented as a usual care screening option at 3 community-based primary care clinics in Minneapolis, Minnesota in February 2023. The primary objective is to assess the effect of implementing in-clinic HPV self-sampling on screening completion in Somali American individuals. The secondary objective is to assess the effect of implementing HPV self-sampling on screening completion in all patients. Using difference-in-difference methods, we will evaluate changes in screening rates one-year pre and post implementation and compare changes with control clinics followed over the same time period. Using RE-AIM, we will conduct a post-implementation mixed methods analysis of processes and strategies needed to successfully implement HPV self-sampling in primary care.

Conclusions: The study was designed to evaluate a real-world in-clinic HPV self-sampling intervention for Somali American individuals, generating data on both effectiveness and implementation applicable to other community-based clinics in the U.S. The objective of this report is to describe the rationale and design of the study.

Keywords: Cervical cancer; Human papillomavirus; Pragmatic clinical trial; Screening; Self-sampling.

Publication types

Clinical Trial Protocol
Pragmatic Clinical Trial

MeSH terms

Adult
Early Detection of Cancer* / methods
Female
Focus Groups
Healthcare Disparities
Human Papillomavirus Viruses
Humans
Middle Aged
Minnesota
Papillomavirus Infections* / diagnosis
Papillomavirus Infections* / prevention & control
Primary Health Care* / organization & administration
Self Care / methods
Somalia / ethnology
Specimen Handling / methods
Uterine Cervical Neoplasms* / diagnosis
Uterine Cervical Neoplasms* / ethnology
Uterine Cervical Neoplasms* / prevention & control