Mailed self-sample HPV testing kits to improve cervical cancer screening in a safety net health system: protocol for a h

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Mailed self-sample HPV testing kits to improve cervical cancer screening in a safety net health system: protocol for a hybrid effectiveness-implementation randomized controlled trial Jane R. Montealegre1,2* , Matthew L. Anderson3, Susan G. Hilsenbeck2,4, Elizabeth Y. Chiao5,6, Scott B. Cantor7, Susan L. Parker2, Maria Daheri6, Shaun Bulsara2, Betsy Escobar2, Ashish A. Deshmukh8, Maria L. Jibaja-Weiss2,9, Mohammed Zare6,10 and Michael E. Scheurer1,2

Abstract Background: Almost 20% of U.S. women remain at risk for cervical cancer due to their inability or unwillingness to participate in periodic clinic-based screening. Self-sampling has been shown to be an effective strategy for screening women for high-risk human papillomavirus (HR-HPV) infection in specific contexts. However, its effectiveness among medically underserved women in safety net health systems has not been evaluated. Furthermore, it is also unclear whether implementation strategies such as patient navigation can be used to improve the success of self-sample screening programs by addressing patient-level barriers to participation. (Continued on next page)

* Correspondence: [email protected] 1 Center for Epidemiology and Population Health, Department of Pediatrics, Baylor College of Medicine, One Baylor Plaza, MS: 305, Houston, TX 77030, USA 2 Dan L Duncan Comprehensive Cancer Center, Baylor College of Medicine, Houston, TX, USA Full list of author information is available at the end of the article © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

Montealegre et al. Trials

(2020) 21:872

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Methods/design: The Prospective Evaluation of Self-Testing to Increase Screening (PRESTIS) trial is a hybrid type 2 effectiveness-implementation pragmatic randomized controlled trial of mailed self-sample HPV testing. The aim is to assess the effectiveness of mailed self-sample HPV testing kits to improve cervical cancer screening participation among patients in a safety net healt