A hybrid type III effectiveness-implementation, pragmatic intervention trial for cervical cancer screen and treat in Mozambique

PROJECT SUMMARY AND ABSTRACT Every year approximately 300,000 women die from cervical cancer, with over 90% of those deaths occurring in low-and middle-income countries (LMICs).1 The majority of cervical cancers are preventable through vaccination against high-risk types of human papillomavirus (HPV), the virus that causes nearly all cervical cancers, or by screening for and treatment of precancerous lesions among women already infected with HPV. In 2021, the WHO recommended HPV testing among women aged 25-49 years for all cervical cancer screening programs worldwide.3 Despite this recommendation, access to affordable HPV testing remains a barrier, and to date, there is limited field experience with HPV testing across sub-Saharan Africa (SSA). HPV self-sampling holds great promise in improving access to screening and promoting equity by increasing control over where, when, and how women are screened. Preliminary data from two recent studies conducted by MD Anderson in Mozambique have shown that cervical cancer screening with HPV DNA testing is feasible in Mozambique and that participants in the study preferred self-collection approaches.11,12 Guided by the Knowledge-to-Action conceptual framework, which was designed to enhance uptake of evidence-based practice into clinical care, we propose a hybrid type III effectiveness – implementation trial to test implementation best practices of deploying the Screen & Treat approach to cervical cancer screening utilizing self-collected HPV DNA testing within HIV care and treatment of select health facilities. This proposal directly addresses the ability to safely scale-up a Screen & Treat approach to cervical cancer screening. We propose to capitalize on a pool of screen-eligible women accessing routine care within targeted HIV care and treatment services. The primary outcome of interest is the number of women screened and the number of screen-positive women undergoing treatment. Secondary outcomes will focus on other implementation outcomes, and if successful, will be utilized to inform future research to take this approach to scale across Mozambique.