Design and methods of the evaluation of an HPV-based cervical cancer screening strategy in Mexico: the Morelos HPV study

Objective. The purpose of this paper is to describe the design and methodology of the Morelos HPV Study. The main objective of this study is to examine the use of two different methods for obtaining HPV DNA specimens, selfcollected vaginal and clinician-collected cervical, to detect pre-invasive cervical lesions and cancer. Material and Methods. This study was conducted within the regular population-based framework of the Mexican Institute of Social Security (IMSS) cervical cancer screening program in Morelos. A total of 7,868 women were recruited between May and October 1999 and are representative of the population of women attending cervical cancer screening services at the 23 IMSS clinics in the state of Morelos in 1999. Women were provided with a detailed description of the study before signing an informed consent form. Basic data were obtained from all participants using a standard