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Cervical Cancer Screening Among HIV-Infected Women in India

Traditional cytology-based screening programs for cervical cancer prevention have failed everywhere other than resource-abundant settings. In resource constrained settings, while tests such as visual inspection with acetic acid (VIA) provide a suitable platform for clinical evaluation and are very cheap, they are highly rater-dependent and suffer from substantial false positivity. Carcinogenic HPV DNA detection (e.g., HPV DNA testing by Hybrid Capture-2 [hc2] 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) will be 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 will undergo evaluation using two novel and potentially sustainable, lower-cost tests for accurate screening for cervical cancer. These tests include detection of HPV E6 oncoprotein (using a low-cost, rapid, strip test that detects HPV E6 oncoprotein and can be performed without complex machinery or a cold chain) and immunocytochemical staining using p16INK4a/Ki-67 (a biomarker correlated with the oncogenic transformation of cervical cells following persistent carcinogenic HPV infection). This study involves simultaneous and independent evaluation of these novel biomarkers along with confirmation by colposcopy/histopathology for all participants. Linear Array HPV polymerase chain reaction assay will measure carcinogenic HPV-DNA for comparison purposes. This observational study will permit investigators to describe the sensitivity and specificity of any of the tests or combinations with reasonable precision for a wide range of prevalence of cervical pre-cancer and cancer. This study will allow evaluation of the field adoption and efficacy of these newer assays as well as permit validation of collection, transport, storage, and evaluation protocols.

For more information, contact Nicolas Wentzensen or Vikrant Sahasrabuddhe.

Hormonal and Reproductive Epidemiology Branch - Research Areas