Testing the Performance and Local Laboratory Capacity for p16 INK4a ELISA for Cervical Cancer Screening Among HIV-Infected Women in Western Kenya

Award amount: 75,000.00

The HIV epidemic has increased cervical cancer morbidity and mortality, especially in developing countries. The increased biologic risk for cervical cancer associated with HIV-infection combined with the strain on already overburdened health care systems work synergistically to increase the disparity in cervical cancer risk for women in these countries. 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 low-resource settings. Novel, resource-appropriate testing and treatment strategies are urgently needed to address cervical cancer in these countries, especially among the vulnerable population of HIV-infected women. To address this, our research team is completing a pilot study to evaluate the feasibility of a biochemical assay for the biomarker p16 INK4a for cervical cancer screening among HIV-infected women in western Kenya. In the currently ongoing study, we will determine the cut-off value for p16 INK4a levels that provides the greatest sensitivity and specificity for cervical intraepithelial neoplasia 2 or 3 (CIN2/3) among HIV-infected women. We anticipate that the data will be available in March. We now seek funding to validate the performance of p16 INK4a at that cut-off level through a cross-sectional study of women undergoing cervical cancer screening, using colposcopy and biopsy as the gold standard. In addition, we propose a second aim to introduce and validate the p16 INK4a assay in the outpatient laboratory of the HIV-care clinic in Kenya. The combination of these two aims will increase our understanding of the relationship between HIV and cervical cancer biomarkers, and advance the field of cervical cancer prevention among HIV-infected women, especially in resource limited settings. Validation of a screening biomarker with improved accuracy for detection of CIN2/3 could exponentially increase options for cervical cancer screening among HIV-infected women and add another choice for screening women in all parts of the world.