Optimal Strategy for the Management of ASCUS Cytology in Health Care Services of Medellin, Colombia
Optimal Strategy for the Management of ASCUS Cytology in Health Care Services of Medellin, Colombia
Cervical cancer as well cervical preneoplastic abnormalities (CIN2+) are cause by human
 papillomavirus (HPV) infection. These abnormalities have been historically detected by
 cervical cytology, but recent evidence shows that HPV testing is superior to cytology to
 detect cervical lesions that eventually will progress to cancer. Despite evidence,
 conventional cytology (Pap) remains as a primary screening test in Colombia and HPV test is
 recommended as a triage test for women with atypical squamous cells of undetermined
 significance (ASC-US) in settings around the world. Women with ASC-US have low risk to CIN2+
 but higher than healthy population, and therefore it is important to provide appropriate
 clinical management. However, there is no consensus of how to deal women with ASC-US and
 therefore there are still three strategies for this purpose: 1) immediate colposcopy, 2)
 repeat conventional cytology at 6 and 12 months and 3) HPV testing. The main objective of
 this study is to compare the effectiveness and the efficient among the strategies as well as
 to evaluate the acceptability of the HPV testing in a real-life setting.
The aim of this study is to compare the effectiveness and efficiency of immediate colposcopy
 (IC), repeat conventional cytology at 6 and 12 months (RC) and HPV triage (HPV) (QIAGEN-The
 digene HPV Test®) for the clinical management of women with ASC-US insured in healthcare
 management organizations (HMO) within the Colombian health security system. This study
 randomized 2,661 20-69 years old women with ASC-US, insured in HMOs in Medellin-Colombia to 3
 arms: IC, RC and HPV. All women are scheduled for a visit at 2 years after recruitment that
 includes HPV-test/cytology and colposcopy either if HPV+ (RLU>=1) or abnormal cytology
 (>=ASC-US). This colposcopy is performed by a trained colposcopist and women are followed-up
 according to a well-defined algorithm. The fewer high-grade cervical neoplasia (CIN2+) rate
 at the end of following will determine the most effective arm. The most efficiency arm will
 be which reach the major effective with the minimum resource (cytologies, colposcopies and
 histologies) consumed. The resource consumed is being retrieved from the HMOs. This study
 also pretends to evaluate the acceptability of the HPV testing. This study will allow us to
 know if within the Colombian health security system, the HPV test will remain superior to
 repeating cytology and/or to immediate colposcopy as it has been demonstrated in randomized
 controlled trials carried out in outside settings.
Inclusion Criteria:

 -  ASC-US cytology, living in metropolitan area of Medellin

 Exclusion Criteria:

 -  Previous abnormal cytology