Design and methods of the evaluation of an HPV-based XXXX screening strategy in Mexico: The Morelos HPV Study.

@entity1 @entity75 @entity5 @entity281 @entity3146
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, self-collected vaginal and clinician-collected cervical, to detect pre-invasive @entity75 and @entity5 . MATERIAL AND METHODS: This study was conducted within the regular population-based framework of the Mexican Institute of Social Security (IMSS) @entity5 screening program in Morelos. A total of 7,868 @entity1 were recruited between May and October 1999 and are representative of the population of @entity1 attending @entity5 screening services at the 23 IMSS clinics in the state of Morelos in 1999. @entity1 were provided with a detailed description of the study before signing an informed consent form. Basic data were obtained from all @entity1 using a standard IMSS registration form. During the initial recruitment visit, a randomly selected subsample of 1,069 @entity1 were interviewed to collect additional information about @entity5 risk factors, acceptability of the HPV and Pap tests, as well as @entity1 costs. Before the pelvic exam, @entity1 were asked to provide a self-collected vaginal specimen for HPV testing. All @entity1 underwent a pelvic examination that involved collecting a cervical sample for the Pap smear and a clinician-collected HPV specimen. Data were evaluated from 7,732 @entity1 with complete information for the three tests. The 1,147 @entity1 who received at least one positive result (Pap, self- and/or clinician-HPV tests) were invited to return for a colposcopic examination. During colposcopy, biopsies were taken as appropriate, to histologically confirm a diagnosis of @entity3146 ( @entity3146 ) 2/3 or invasive @entity5 . A total of 1,015 @entity1 attended colposcopy, and 101 @entity1 received a histologically-confirmed @entity3146 2/3 or @entity5 diagnosis. CONCLUSIONS: The initial enrollment activities of the Morelos HPV study are the basis for a prevalent case-control study and a prospective cohort study that will investigate the natural history of @entity281 and determine if an HPV-based screening strategy is a safe and cost-effective alternative to Pap screening. The English version of this paper is available too at: http://www.insp.mx/salud/index.html.
