LAUSR

OBJECTIVE HIV-infected women (WLHIV) have >10-fold higher risk for squamous cell cancer of the anus (SCCA). Experts suggest cytology-based strategies developed for cervical cancer screening may prevent anal cancer by detecting anal histological High-Grade Squamous Intraepithelial Lesion (hHSIL) for treatment. Currently, there is no consensus on anal-hHSIL screening strategies for WLHIV. DESIGN Between 2014 and 2016, 276 WLHIV were recruited at 12 U.S. AIDS Malignancy Consortium (AMC) clinical-trials sites to evaluate hHSIL prevalence and (test) screening strategies. METHODS Participants completed detailed questionnaire, underwent anal assessments including high-risk human papillomavirus (hrHPV) testing using hrHPV-HC2™ and hrHPV-APTIMA™, anal cytology, and concurrent high-resolution anoscopy. Screening test characteristics for predicting hHSIL validated by central pathology, were estimated: sensitivity (SN), specificity (SP), positive predictive value (PPV) and false-omission rate. Paired analyses compared SN and SP for hrHPV single tests to anal cytology alone. RESULTS 83% (229/276) of enrolled WLHIV had complete anal assessment data and were included in this analysis. Mean age was 50, 62% black and 60 (26%) had hHSIL. Anal cyotology (>ASC-US), hrHPV-HC2, and -APTIMA SN estimates were similarly high, (83%, 77%, and 75%, respectively, p-values>0·2). SP was higher for both hrHPV-APTIMA, and -HC2 compared with anal cytology (67% vs. 50%, p < 0.001), and (61% vs. 50%, p = 0·020), respectively. CONCLUSION Anal hrHPV testing demonstrated similar SN for anal cytology (>ASC-US) to predict anal hHSIL. Among tests with similar SN, the SP was significantly higher for hrHPV-APTIMA and -HC2. Thus, anal hrHPV testing may be an important alternative strategy to anal cytology for anal hHSIL screening among WLHIV.