Cervical Cancer Screening Among HIV-Infected Women in India
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.
For more information, contact Nicolas Wentzensen or Vikrant Sahasrabuddhe.