HPV Testing for Cervical Cancer Screening Study

NCT00461760CompletedNAINTERVENTIONAL

Summary

Key Facts

Lead Sponsor

University of British Columbia

Enrollment

25223

Start Date

2007-03-01

Completion Date

2017-04-30

Study Type

INTERVENTIONAL

Official Title

A Randomized Controlled Evaluation of HPV Testing for Cervical Cancer Screening

Interventions

Cervical cancer screening undertaken by HPV testing as a single primary screening test with cytology triage of women who are HPV positiveCervical cancer screening undertaken by HPV testing as a single primary screening test with cytology triage of women who are HPV positive

Conditions

Cervical Cancer Screening

Eligibility

Age Range

25 Years – 65 Years

Sex

FEMALE

Inclusion Criteria:

Women from 25 to 65 years of age, registered with the Medical Services Plain in BC attending a collaborating healthcare provider for routine cervical screening in Metro Vancouver or Greater Victoria.

Exclusion Criteria:

1. pregnant
2. history of invasive cervical cancer
3. no cervix
4. HIV positive or on immunosuppressive treatments
5. unable or unwilling to give informed consent
6. Treatment of moderate or greater dysplasia within last 5 years

Outcome Measures

Primary Outcomes

Histologically confirmed greater than or equal to CIN2 detected at 2 years in both the control and the safety-check arms.

Time frame: 2 years

Histologically confirmed greater than or equal to CIN3 detected over the 4 years post recruitment in the control and intervention arms will be evaluated and compared as a surrogate marker for estimating reductions in the incidence of cervical cancer.

Time frame: 4 years

Detection of histologically confirmed greater than or equal to CIN3 in the participants allocated to 6-month retesting.

The total estimated cost per woman screened and the total estimated cost per quality-adjusted life-year gained for each technology.

Secondary Outcomes

Clearance of HPV infection in women who are HPV positive at recruitment

HPV type specific prevalence in the screening population

Locations

Laurie Smith, Vancouver, Canada

BC Cancer, Vancouver, Canada

BC Center for Disease Control, Vancouver, Canada

Vancouver General Hospital, Vancouver, Canada

Linked Papers

2021-10-07

Women’s acceptability of and experience with primary human papillomavirus testing for cervix screening: HPV FOCAL trial cross-sectional online survey results

Objective To study participant’s acceptability of and attitudes towards human papillomavirus (HPV) testing compared with cytology for cervical cancer screening and what impact having an HPV positive result may have in future acceptability of screening. Design Cross-sectional online survey of clinical trial participants. Setting Primary care, population-based Cervix Screening Program, British Columbia, Canada. Participants A total of 5532 participants from the HPV FOCAL trial, in which women received HPV and cytology testing at study exit, were included in the analysis. Median age was 54 years. The median time of survey completion was 3 years after trial exit. Outcome measures Acceptability of HPV testing for primary cervical cancer screening (primary); attitudes and patient perceptions towards HPV testing and receipt of HPV positive screen results (secondary). Results Most respondents (63%) were accepting of HPV testing, with the majority (69%) accepting screening to begin at age 30 years with HPV testing. Only half of participants (54%) were accepting of an extended screening interval of 4–5 years. In multivariable logistic regression, women who received an HPV positive screen test result during the trial (OR=1.41 95% CI 1.11 to 1.80) or were older (OR=1.01, 95% CI 1.00 to 1.02) were more likely to report HPV testing as acceptable. Conclusions In this evaluation of acceptability and attitudes regarding HPV testing for cervix screening, most are accepting of HPV testing for screening; however, findings indicate heterogeneity in concerns and experiences surrounding HPV testing and receipt of HPV positive results. These findings provide insights for the development of education, information and communication strategies during implementation of HPV-based cervical cancer screening. Trial registration numbers ISRCTN79347302 and NCT00461760.

Linked Investigators

Eduardo L. Franco

Professor Eduardo Franco is a Distinguished James McGill Professor in the Departments of Oncology and Epidemiology & Biostatistics at McGill University. He served as Director of the Division of Cancer Epidemiology (1995–2024) and Chair of the Department of Oncology (2011–23). Earlier, he was on the faculty of Université du Québec and Head of the Epidemiology Unit at the Ludwig Institute for Cancer Research in São Paulo, Brazil. He holds biology degrees from the Universidade de Campinas and MPH and DrPH degrees from the University of North Carolina at Chapel Hill. His early training included fellowships at the U.S. Centers for Disease Control, the International Agency for Research on Cancer, the U.S. National Cancer Institute, and Louisiana State University. Since 1985, his research has contributed to understanding and preventing cervical cancer and HPV‑related diseases, and to studies of upper aerodigestive tract, prostate, endometrial, and childhood cancers. His work spans cancer screening evaluation, measurement error, and factors influencing cancer survival. He has led international collaborations in the Americas, Europe, Africa, and through IARC. His research has been funded by CIHR, NIH, the National Cancer Institute of Canada, the Canadian Cancer Society, FRSQ, and the Cancer Research Society. As of March 2026, he had published more than 600 scientific papers (Google Scholar link: https://scholar.google.com/citations?user=9GDejd4AAAAJ&hl=en). His work has appeared in The Lancet, JAMA, NEJM, JNCI, BMJ, and PLOS Medicine. He is Editor‑in‑Chief of the Journal of the National Cancer Institute and JNCI Monographs, and Editor‑in‑Chief Emeritus of Preventive Medicine and Preventive Medicine Reports. He has served on more than a dozen major editorial boards, on scientific and grant‑review panels internationally, and twice advised the U.S. President’s Cancer Panel. Professor Franco has mentored 101 graduate students, 36 postdoctoral fellows, and 41 undergraduate trainees, and has taught widely in North America, Latin America, Europe, Asia, and the Middle East. He has held leadership roles in 68 conference committees, chaired the 16th World Congress of Epidemiology, and served as Vice-President and President of the Canadian Society for Epidemiology and Biostatistics. He is President‑Elect of the International Epidemiological Association (2024–27). His honours include major lifetime achievement awards from McGill and international organizations, and national distinctions such as Officer of the Order of Canada, Fellow of the Royal Society of Canada, the Canadian Academy of Health Sciences, and Foreign Fellow of the Brazilian Academy of Sciences.

Gina S. Ogilvie

Gina Ogilvie is a Senior Scientist at BCCDC. She is also a Senior Advisor at BC Women's Hospital Health Centre, Assistant Director of the Women's Health Research Institute, and a professor in the UBC School of Population & Public Health. Research Dr. Ogilvie’s clinical and research focuses on both the public health and clinical aspects of reproductive health, human papillomavirus infection and vaccines, HIV in women and care for marginalized populations, and other sexually transmitted infections. She has been awarded with several recognitions and awards, including UBC’s Killam Faculty Research Prizes 2020, ASTDA Annual Legacy Awards 2021, American Sexually Transmitted Diseases Association (ASTDA) Achievement Award 2020, President’s Award, and Medical Staff Association of Children’s and Women’s Health Centre. Dr. Ogilvie is also a Tier 1 Canada Research Chair at Global Control of HPV Related Disease and Cancer. She is principal investigator on over 10 million dollars in research grants and has received funding from PHAC, CIHR, Michael Smith Foundation for Health Research, Canadian Foundation for Innovation and private foundations. Bio Dr. Ogilvie obtained her medical degree and family practice certification at McMaster University, and then did a fellowship in population health at McMaster University. She completed her Masters of Science (MSc) in clinical epidemiology at UBC, focusing on the care of HIV-positive women, and her Doctor of Public Health (DrPH) in HPV primary screening at the University of North Carolina at the Gillings School of Global Public Health. She has published over 150 peer reviewed manuscripts and provides advice and consultation to national and international institutions, including the Canadian Partnership Against Cancer, Public Health Agency of Canada, the World Health Organization (WHO), and Ministries of Health on STI, HIV and HPV vaccine policy and programming

HPV Testing for Cervical Cancer Screening Study