Determining the Feasibility and Accuracy of a Novel Biomarker for Cervical Dysplasia Among HIV-Infected Women in Western Kenya
Cervical cancer and HIV are intersecting epidemics that both disproportionately affect low-income women. The impact of the socioeconomic disparity and biologic synergy of these two diseases is seen most dramatically in sub-Saharan Africa, where cervical cancer is the most common cancer killer among women, and new HIV infections are five times more likely to occur in young women than men. HIV-infected women are at increased risk for the development of cervical precancer and cancer, develop more aggressive lesions and are affected at younger ages. The majority of global HIV-infections occur among women in resource-limited countries, which, in addition to being overburdened with the demands of providing care and treatment for HIV, often lack the basic health care infrastructure necessary for primary health care programs such as cervical cancer screening. Cervical cancer prevention efforts that have reduced the incidence of cervical cancer to close to zero in resource-rich countries are costly and not available in most resource-limited countries. Novel testing and treatment strategies that can be carried out in low-resource settings are urgently needed to prevent cervical cancer in these settings, especially among HIV-infected women. Testing for protein biomarkers expressed in the presence of cervical dysplasia has shown the potential to increase accuracy of detection of cervical intraepithelial neoplasia (CIN), a precancerous lesion. Biomarkers identified in cervical lesions can also be identified through a biochemical assay, allowing for the development of a point-of-care screening test, which would be ideal for a resource-limited setting. p16INK4a has been identified as a biomarker with high sensitivity and specificity for CIN. There are no studies looking at its use among HIV-infected women or in resource-limited settings, where it could have greatest impact. We propose to test the feasibility and accuracy of using a p16INK4a biochemical assay to screen for CIN among HIV-infected women attending an HIV-care and treatment clinic in Western Kenya.