Assessing 10-year safety of a single negative HPV test for cervical cancer screening: Evidence from FOCAL-DECADE Cohort

Anna Gottschlich, Dirk van Niekerk, Laurie W. Smith, Lovedeep Gondara, Joy Melnikow, Darrel A. Cook, Marette Lee, Gavin Stuart, Ruth E. Martin, Stuart Peacock, Eduardo L. Franco, Andrew Coldman, Mel Krajden, Gina Ogilvie

Research output: Contribution to journalArticlepeer-review

2 Scopus citations


Background: Long-term safety of a single negative human papillomavirus (HPV) test for cervical cancer screening is unclear. The HPV FOr cerviCAL Cancer Trial (FOCAL) was a randomized trial comparing HPV testing with cytology. The FOCAL-DECADE cohort tracked women who received one HPV test during FOCAL, and were HPV negative, for up to 10 years to identify cervical intraepithelial neoplasia grade 2 or worse (CIN2+) and grade 3 or worse (CIN3+) detected through a provincial screening program. Methods: FOCAL participants who received one HPV test, were negative, and had at least one post-FOCAL cervix screen were included (N = 5,537). We constructed cumulative incidence curves of CIN2+/CIN3+ detection, analyzed cumulative risk of detection at intervals post-HPV test, calculated average incidence rates for detection, and compared hazard across ages. Results: Ten years after one negative HPV test, the probability of CIN2+ detection was lower than 1%, with most lesions detected 7 years or later. Average incidence rates of CIN2+/CIN3+ lesions over follow-up were 0.50 [95% confidence interval (CI), 0.31-0.78] and 0.18 (95% CI, 0.07-0.36) per 1,000 person-years, respectively. Hazards were higher for younger ages (nonsignificant trend). Conclusions: Among women with a single negative HPV test, long-term risk of CIN2+ detection was low, particularly through 7 years of follow-up; thus, one negative HPV test appears to confer long-term protection from precancerous lesions. Even 10-year risk is sufficiently low to support extended testing intervals in averagerisk populations. Impact: Our findings support the safety of screening policies using HPV testing alone at 5-year or longer intervals.

Original languageEnglish (US)
Pages (from-to)22-29
Number of pages8
JournalCancer Epidemiology Biomarkers and Prevention
Issue number1
StatePublished - Jan 2021

ASJC Scopus subject areas

  • Epidemiology
  • Oncology


Dive into the research topics of 'Assessing 10-year safety of a single negative HPV test for cervical cancer screening: Evidence from FOCAL-DECADE Cohort'. Together they form a unique fingerprint.

Cite this