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.
Key words
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Article Info
Publication History
Published online: July 25, 2011
Accepted:
July 13,
2011
Received in revised form:
June 14,
2011
Received:
April 12,
2011
Footnotes
T.C.W. has been a consultant and speaker for Merck, GlaxoSmithKline, and Roche Molecular Systems and a consultant for Gen-Probe and Becton Dickenson. M.H.S. has been a consultant in clinical trial and HPV DNA test development for QIAGEN, Roche Molecular Systems, BD, Gen-Probe, Ventana, and Merck. C.M.B., R.A., T.D., and T.L.W. are employed by Roche Molecular Systems, the sponsor of the study. Victoria Tomlinson, Health Interactions, London, England, UK, provided editorial assistance in formatting and proofing of the final draft manuscript, funded by Roche Molecular Systems.
This study was supported in part by Roche Molecular Systems, Inc, Pleasanton, CA.
Cite this article as: Wright TC, Stoler MH, Behrens CM, et al. The ATHENA human papillomavirus study: design, methods, and baseline results. Am J Obstet Gynecol 2012;206:46.e1-11.
Identification
Copyright
© 2012 Mosby, Inc. Published by Elsevier Inc. All rights reserved.
