Human papillomavirus (HPV) infections and HPV-related cancers are a growing problem among HIV-infected populations, particularly in low-resource countries. Traditional cytology-based screening programs for cervical cancer prevention have failed everywhere other than resource-abundant settings. In resource-constrained settings, tests such as visual inspection with acetic acid (VIA) can provide a suitable platform for clinical evaluation and are very cheap, however they are highly rater-dependent and suffer from substantial false positivity. Carcinogenic HPV DNA detection (e.g., HPV DNA testing by Hybrid Capture-2 assay) is less specific than cytology and cannot differentiate between the great majority of benign infections and the few persistent infections linked to cervical pre-cancer. A reliable and robust test that improves both the sensitivity and specificity of screening may provide better alternatives for HIV-infected women than conventional cytology screening or VIA.
This study, funded through the NIH Office of AIDS Research ‘Intramural-to-India’ initiative, is being conducted in collaboration with the National AIDS Research Institute, a permanent institute of the Indian Council of Medical Research in Pune, India. A cohort of 1,000 HIV-infected women are undergoing evaluation using two novel and potentially sustainable, lower-cost tests for accurate screening for cervical cancer. These tests include HPV mRNA testing and immunocytochemical staining using p16INK4a/Ki-67 (a biomarker correlated with the oncogenic transformation of cervical cells following persistent carcinogenic HPV infection). The study involves simultaneous and independent evaluation of these novel biomarkers along with confirmation by colposcopy/histopathology for all participants. This observational study is enabling investigators to describe the sensitivity and specificity of any of the tests or combinations with reasonable precision in HIV-infected women. It is allowing evaluation of the field adoption and efficacy of these newer assays and is permitting validation of collection, transport, storage, and evaluation protocols.