The ATHENA human papillomavirus study: design, methods, and baseline results

Am J Obstet Gynecol. 2012 Jan;206(1):46.e1-46.e11. doi: 10.1016/j.ajog.2011.07.024. Epub 2011 Jul 22.

Abstract

Objective: The objective of the study was to describe baseline data from Addressing the Need for Advanced HPV Diagnostics, a prospective, multicenter US cervical cancer screening trial.

Study design: A total of 47,208 women aged 21 years or older undergoing routine screening were enrolled; liquid-based cytology and human papillomavirus (HPV) testing were performed. Women with abnormal cytology underwent colposcopy, as did high-risk HPV (hrHPV)-positive women and a random subset of women negative by both tests aged 25 years or older. Verification bias adjustment was applied; 95% confidence intervals were computed by the bootstrap method.

Results: The prevalence of cytologic abnormalities was 7.1%. hrHPV, HPV 16, and HPV 18 were detected using the cobas HPV Test in 12.6%, 2.8%, and 1.0% of women, respectively. Both cytologic abnormalities and hrHPV positivity declined with increasing age. The adjusted prevalence of cervical intraepithelial neoplasia grade 2 (CIN2) or greater in women aged 25-34 years was 2.3%, decreasing to 1.5% among older women.

Conclusion: The Addressing the Need for Advanced HPV Diagnostics study provides important estimates of the prevalence of cytologic abnormalities, hrHPV positivity, and CIN2 or greater in a US screening population.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Cervical Intraepithelial Neoplasia / diagnosis
  • Cervical Intraepithelial Neoplasia / epidemiology*
  • Cervical Intraepithelial Neoplasia / virology
  • Colposcopy / methods
  • Cross-Sectional Studies
  • Early Detection of Cancer / statistics & numerical data*
  • Female
  • Human papillomavirus 16 / isolation & purification
  • Human papillomavirus 18 / isolation & purification
  • Humans
  • Middle Aged
  • Papillomavirus Infections / diagnosis
  • Papillomavirus Infections / virology
  • Prevalence
  • Prospective Studies
  • Severity of Illness Index
  • United States / epidemiology
  • Uterine Cervical Neoplasms / diagnosis
  • Uterine Cervical Neoplasms / epidemiology*
  • Uterine Cervical Neoplasms / virology
  • Vaginal Smears / methods
  • Young Adult