Medicine - Gynecology & Obstetrics
Proof of Principle of a novel, point-of-care E6 HPV oncoprotein screening assay for cervical precancer and cancer in low-resource settings.
Despite the availability of Pap testing, cervical cancer remains the leading cause of cancer incidence in women in Peru. The subjective nature of cytology and insufficient resources for colposcopy are major barriers to successful screening in the Peruvian Amazon and other remote and low-resource settings. Therefore, we propose a proof of principle study to demonstrate feasibility and estimate participation in a cervical cancer screening program that relies on molecular diagnostics. Using a village-randomized design in Iquitos, Peru, we aim to compare two screening algorithms based on either primary screening with HPV self-sampling or in-clinic screening with the new Arbor Vita E6 HPV oncoprotein cervical cancer diagnostic assay. This rapid, low-technology assay detects clinically-relevant high-grade precancerous lesions and has been shown to be more sensitive and specific than cytology. We will enroll 150 women from two villages and track their participation in screening and HPV and E6 test results. Women E6 positive will receive immediate cervical treatment. For safety, all women will be invited for HPV DNA screening one year after the initial screening, and all HPV positive women will undergo a colposcopic examination by the principle investigator. This pilot study will provide sufficient data on participation and test positivity rates and demonstrate feasibility of screening algorithms for a future R01 grant application. In these extremely poor and isolated communities where high rates of cervical cancer persist, alternative triage and diagnostic tests for cervical cancer are needed to increase screening and treatment.
Patti Gravitt, School of Public Health, Epidemiology; Anne Rositch, School of Public Health, Epidemiology; Jean Anderson, School of Medicine, Obstetrics and Gynecology