Project 2: Anal self-sampling for human papillomavirus (HPV).

University Of Miami School Of Medicine, Coral Gables FL

Investigators

Abstract

Anal cancer (AC), although rare among the general population, disproportionately affects several specific populations within the catchment areas of the University of Miami Sylvester Comprehensive Cancer Center and the Emory University Winship Comprehensive Cancer Center. AC is caused by human papillomavirus (HPV) and is preceded by anal high-grade squamous intraepithelial lesions (aHSIL), which are screening-detectable precancerous lesions. Recent findings from the Anal Cancer HSIL Outcomes Research (ANCHOR) trial uphold the clinical importance of treating aHSIL to reduce the risk of invasive AC; ensuing screening guidelines, in turn, have stimulated widespread interest in determining how to optimally structure AC prevention programs to maximize routine use of high-resolution anoscopy (HRA) for population groups who shoulder an excess burden of disease incidence and mortality. The availability of HRA is limited however, even in resource-rich settings like the US, due, in part, to the paucity of health providers trained in performing this modality. Access to HRA remains a particular challenge for vulnerable populations who are disenfranchised from the formal healthcare system and are often at increased risk for poor AC outcomes, given untreated aHSIL. There is a need and opportunity to test novel screening methods to identify who can benefit most from HRA to better guide clinical triage and public health interventions. The proposed study aims to fill this gap, examining the acceptability and feasibility of self-sampling for anal HPV among men and women at risk for anal cancer living in Miami and Atlanta, while accounting for potential variability in these outcomes by different demographics, including ancestry (self-reported vs. genomic ancestry testing), and social determinants of health. Self-sampling for cervical high-risk-HPV is an effective strategy for identifying women at increased risk of cervical cancer, circumventing known structural, access, and cultural issues to disease prevention, and was recently approved by the Food and Drug Administration for clinical use. The proposed study investigators contributed significantly to the body of translational research underpinning this approval and have the necessary experience engaging hard-to-reach individuals across the Miami and Atlanta metropolitan areas in studies to similarly advance knowledge in AC prevention and early detection. Leveraging the robust Community Outreach and Engagement infrastructure at Sylvester Comprehensive Cancer Center and Winship Cancer Institute, both NCI-designated Cancer Centers, the proposed study findings can ultimately be successfully translated into different community settings throughout the US for maximal impact on attenuating persistent AC burden in populations disproportionally affected by the disease.