Cervical cancer, the main human papillomavirus (HPV)-related cancer, affects almost half a million women and is associated with the deaths of 270,000 women every year; 85% of which occur in developing countries. Even though cervical cancer is preventable, it is still highly prevalent due to the lack of resources for well-organized high-coverage screening programs.

PATH and QIAGEN Inc. (Gaithersburg, MD; formerly Digene Corp.) partnered to develop the careHPV(TM) Test, designed and created for low-resource areas. This HPV DNA test is more affordable, technical requirements are more suitable for health centers with limited infrastructure, and training required for running the test can be completed in approximately one week. PATH is conducting demonstration projects (2008-2012) in three countries (India, Nicaragua, and Uganda) to generate evidence on different available screening options (Pap smear, visual inspection with acetic acid [VIA], and careHPV(TM)).

The demonstration project site in Nicaragua had enrolled 1,300 women as of February 2010. Each woman self-collected a vaginal sample and gave a provider-collected cervical sample for the careHPV(TM) Test; this was followed by Pap smear and VIA. Preliminary results obtained so far (N=827) show a sensitivity of 85.7% for the careHPV(TM) Test at both a 0.5 relative light unit (RLU) cut-off and 1.0 RLU cut-off using a cervical sample. The careHPV(TM) Test's sensitivity for the vaginal self-collected sample was 92.9% and 85.7% for 0.5 and 1.0 RLU cut-offs, respectively. Sensitivity for VIA and Pap smear was 71.4% and 28.6%, respectively.

CareHPV(TM) testing was more sensitive compared to Pap and VIA. These results suggest that careHPV(TM) testing may be a reliable and affordable alternative for cervical cancer screening programs. Results of additional women enrolled in the study will be available at the time of presentation.

*START-UP = Screening Technologies to Advance Rapid Testing for Cervical Cancer Prevention - Utility and Program Planning.