Optimal Strategy for the Management of ASCUS Cytology in Health Care Services of Medellin, Colombia
Condition: Cervical Abnormalities; Cervical Intraepithelial Neoplasia Grade 2/3; Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms; Neoplasms; Uterine Cervical Dysplasia
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): HPV test; COLPOSCOPY; cytology
Intervention type(s): Device; Procedure; Device
Intervention description(s): QIAGEN - The Digene HPV test®; Colposcopy routine health services; Cytology routine health services
Other intervention name(s): Human Papillomavirus test; DNA HPV test; High risk HPV test; Pap smear; Papanicolaou test; cervical cytology
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Human Papillomavirus; cervical cancer; health services research; Colombia; Cervical Intraepithelial Neoplasia