Abstract IA10: The Prevent Anal Cancer Study: the assessment of novel opportunities for anal cancer screening during COVID-19

Abstract

Abstract Cervical cancer screening began 70 years ago in high-resource settings and it has substantially lowered cervical cancer incidence in those settings; even so, incidence remains very high in many low and middle-income settings. As screening for other human papillomavirus-associated cancers is considered, self-screening approaches may lower some barriers to screening including cost, reluctance to access clinics, and examination embarrassment. The Prevent Anal Cancer (PAC) Study is recruiting men who have sex with men (MSM) and transgender people who have sex with men, aged ≥25 years in three cities in the United States (Chicago, Houston, and Milwaukee) to test anal self-exams and compliance with home-based self-swabbing. The PAC Study is comprised of two randomized clinical trials: NCT03489707 and NCT04090060. It is recruiting 1200 HIV+ and HIV- persons through 2023: 400 in Milwaukee to test home-based self-swabbing and 400 each in Chicago and Houston to test anal self-exams (ASEs). The Milwaukee cohort will evaluate compliance with annual home-based self-swabbing vs clinic-based HPV DNA specimen collection and determine factors associated with annual screening compliance; estimate the influence that home-based vs clinic-based screening has on the uptake of high-resolution anoscopy; estimate the association between high-risk HPV persistence and anal high-grade squamous intraepithelial lesions (HSIL); and estimate the association between HPV-16/host DNA methylation and anal HSIL. The Chicago/Houston cohort will be taught about anal anatomy, pathology, and the procedure for an ASE. The primary objective is to compare the participant’s ASE result with the clinician’s gold-standard Digital Anal Rectal Exam (DARE) to determine concordance, sensitivity and specificity. A secondary objective uses mathematical modeling to estimate the cost-effectiveness, impact on survival and health-related quality-of-life of ASE and DARE. Enrollment in both studies was suspended due to COVID-19. Due to concerns about potential COVID-19-related confounding of key associations, a 437-person online cohort of the same target populations was enrolled to assess COVID-19 impact over 5 longitudinal surveys. This presentation will provide an overview of anal cancer incidence, the PAC Study protocols, how COVID-19 may impact the studies’ results, and data collected to date to assess that impact. This study is supported by grants from the National Cancer Institute, National Institutes of Health (US). Citation Format: Alan G. Nyitray. The Prevent Anal Cancer Study: the assessment of novel opportunities for anal cancer screening during COVID-19 [abstract]. In: Proceedings of the AACR Virtual Conference: Thirteenth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2020 Oct 2-4. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2020;29(12 Suppl):Abstract nr IA10.