The existence of cervical neoplasia among HIV-infected women represents a formidable challenge in the clinical care of immunosuppressed patients due to the expanding global prevalence of HIV infection in women. Increasing access to antiretroviral therapy in resource limited settings and the consequent increasing life-span of HIV-infected persons has necessitated the development of new guidelines for improving their routine preventive healthcare. Preventing the development of human papillomavirus (HPV)-induced high-grade cervical squamous intraepithelial lesions (HSIL) among HIV-infected women needs accurate, reliable and cost-efficient screening tools/methods. Given the limited usefulness of cytology-based screening programs, Visual Inspection with 5% Acetic Acid (VIA) and HPV testing (through self-administered swabs or clinician-collected samples) have been envisioned as cost-effective alternatives for resource-limited settings. Though large scale studies (including community randomized trials) are being conducted to evaluate the effectiveness of these tests, published estimates are devoid of the measures of test performance of these newer tools among HIV-infected women in resource limited settings. This test-of-concept preliminary study is a joint proposal of the University of Alabama at Birmingham (UAB), the National ADDS Research Institute (NARI), Pune, India and Johns Hopkins University (JHU). The study aims 1. To estimate the relative measures of test performance of VIA and HPV-testing in comparison with conventional cytology to detect screen-positive or colposcopy-suggestive, histologically-confirmed HSIL among HIV+ women in Pune, India and 2. To conduct a sub-study to examine the feasibility and acceptability of using self-administered vaginal swabs for HPV-testing and to estimate their accuracy compared to clinician-collected samples among HIV+ women in Pune. 300 HIV-infected women attending women's health clinics in Pune, India using VIA, HPV-testing and Cytology as screening tests and colposcopy as the reference investigation in the same clinic visit. This study will gather preliminary data for the design of a definitive clinical trial that may create a new paradigm for cost-effective cervical cancer screening and treatment strategies for HIV-infected women in resource limited settings as like India.
