HPV FOCAL Study

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Primary Contact: Laurie Smith RN BN MPH, Manager, HPV FOCAL Study, BC Cancer Agency, Direct line: 604-877-6000 x 4829, Study Centre: 1-877-707-5955, laurie.smith@bccancer.bc.ca

About the study: A clinical trial conducted within the BC Cervical Cancer Screening Program. HPV FOCAL evaluated the effectiveness and safety of HPV testing compared to the Pap test for cervical cancer prevention. The study recruited over 25,000 BC women, aged 25-65 engaged in cervical cancer screening. Women were randomly assigned to receive the standard of care, cytology (Pap) testing and managed according to provincial guidelines, or they were assigned to primary HPV testing with management determined by the results of HPV testing.

Why is this research important? Research around the world has shown HPV testing has the potential to improve the performance of cervical screening programs, thereby enhancing cervical cancer prevention. However, high quality Canadian research studies were needed for public health policy formulation within Canada. There is general agreement within the public health community that large scale randomised controlled trials (RCTs) are required for this purpose. As a result, HPV FOCAL was conducted within the BC organized screening program.

Study status: All trial procedures are complete and final results are being published in various scientific journals. See “Study results/Publications” section for more information.

News coverage: 

Study results/publications: 

Ogilvie GS, van Niekerk D, Krajden M, et al. Effect of Screening With Primary Cervical HPV Testing vs Cytology Testing on High-grade Cervical Intraepithelial Neoplasia at 48 MonthsThe HPV FOCAL Randomized Clinical Trial. JAMA. 2018;320(1):43–52. doi:10.1001/jama.2018.7464

Ogilvie GS, Smith LW, van Niekerk D, Khurshed F, Pedersen HN, Taylor D, Thomson K, Greene SB, Babich SM, Franco EL, Coldman AJ. Correlates of women’s intentions to be screened for human papillomavirus for cervical cancer screening with an extended interval. BMC Public Health. 2016;16(1):213.

Cook DA, Mei W, Smith LW, van Niekerk DJ, Ceballos K, Franco EL, Coldman AJ, Ogilvie GS, Krajden M. Comparison of the Roche cobas® 4800 and Digene Hybrid Capture® 2 HPV tests for primary cervical cancer screening in the HPV FOCAL trial. BMC Cancer. 2015;15:968.

Coldman AJ, Phillips N, van Niekerk D, Smith L, Krajden M, Cook D, Quinlan DJ, Ehlen T, Miller D, Stuart GC, Peacock S, Elwood Martin R, Franco EL, Ogilvie G. Projected Impact of HPV and LBC Primary Testing on Rates of Referral for Colposcopy in a Canadian Cervical Cancer Screening Program. J Obstet Gynaecol Can. 2015;37(5):412-20.

Smith LW, Khurshed F, van Niekerk DJ, Krajden M, Greene SB, Hobbs S, Coldman AJ, Franco EL, Ogilvie GS. Women’s intentions to self-collect samples for human papillomavirus testing in an organized cervical cancer screening program. BMC Public Health. 2014;14:1060.

Regier DA, van der Hoek K, Ogilvie G, Smith L, Henwood E, Miller DM, McTaggart-Cowan H, Peacock SJ. Exploring colposcopists’ attitudes towards use of HPV testing as a primary screening tool for cervical cancer in British Columbia. J Obstet Gynaecol Can. 2013 Jul;35(7):657-63.

Ogilvie GS, Smith LW, van Niekerk DJ, Khurshed F, Krajden M, Saraiya M, Goel V, Rimer BK, Greene SB, Hobbs S, Coldman AJ, Franco EL. Women’s intentions to receive cervical cancer screening with primary human papillomavirus testing. Int J Cancer. 2013;133(12):2934-43.

Ogilvie GS, Krajden M, van Niekerk DJ, Martin RE, Ehlen TG, Ceballos K, Smith LW, Kan L, Cook DA, Peacock S, Stuart GC, Franco EL, Coldman AJ. Primary cervical cancer screening with HPV testing compared with liquid-based cytology: results of round 1 of a randomised controlled trial — the HPV FOCAL Study. Br J Cancer. 2012;107(12):1917-24.

Ogilvie GS, van Niekerk DJ, Krajden M, Martin RE, Ehlen TG, Ceballos K, Peacock SJ, Smith LW, Kan L, Cook DA, Mei W, Stuart GC, Franco EL, Coldman AJ. A randomized controlled trial of Human Papillomavirus (HPV) testing for cervical cancer screening: trial design and preliminary results (HPV FOCAL Trial). BMC Cancer. 2010;10:111.

Co-Investigators: Dirk van Niekerk, Eduardo Franco, Mel Krajden, Marette Lee, Kathy Ceballos; Gavin Stuart; Ruth Martin; Stuart Peacock.

Funded by: CIHR

Partners: BC Cancer Agency, BC Centre for Disease Control,  BCCDC  BC Public Health & Microbiology Reference Laboratory

Website: http://www.bccancer.bc.ca/our-research/participate/cervical-screening

HPV FOCAL Study

WHRI

HPV FOCAL Study

Principal Investigators: Dr. Gina Ogilvie, Dr. Andrew Coldman

Primary Contact: Laurie Smith RN BN MPH, Manager, HPV FOCAL Study, BC Cancer Agency, Direct line: 604-877-6000 x 4829, Study Centre: 1-877-707-5955, laurie.smith@bccancer.bc.ca

About the study: A clinical trial being conducted within the BC Cervical Cancer Screening Program. HPV FOCAL is evaluating the effectiveness and safety of HPV testing compared to the Pap test for cervical cancer prevention. The study recruited over 25,000 BC women, aged 25-65 engaged in cervical cancer screening. Women were randomly assigned to receive the standard of care, cytology (Pap) testing and managed according to provincial guidelines, or they were assigned to primary HPV testing with management determined by the results of HPV testing.

Why is this research important? Research around the world has shown HPV testing has the potential to improve the performance of cervical screening programs, thereby enhancing cervical cancer prevention. However, high quality Canadian research studies were needed for public health policy formulation within Canada. There is general agreement within the public health community that large scale randomised controlled trials (RCTs) are required for this purpose. As a result, HPV FOCAL was conducted within the BC organized screening program.

Study status: Remaining study participants are completing trial procedures; several manuscripts have been published and are currently in progress; data analysis continues.

Study results/publications: 

Ogilvie GS, Smith LW, van Niekerk D, Khurshed F, Pedersen HN, Taylor D, Thomson K, Greene SB, Babich SM, Franco EL, Coldman AJ. Correlates of women’s intentions to be screened for human papillomavirus for cervical cancer screening with an extended interval. BMC Public Health. 2016;16(1):213.

Cook DA, Mei W, Smith LW, van Niekerk DJ, Ceballos K, Franco EL, Coldman AJ, Ogilvie GS, Krajden M. Comparison of the Roche cobas® 4800 and Digene Hybrid Capture® 2 HPV tests for primary cervical cancer screening in the HPV FOCAL trial. BMC Cancer. 2015;15:968.

Coldman AJ, Phillips N, van Niekerk D, Smith L, Krajden M, Cook D, Quinlan DJ, Ehlen T, Miller D, Stuart GC, Peacock S, Elwood Martin R, Franco EL, Ogilvie G. Projected Impact of HPV and LBC Primary Testing on Rates of Referral for Colposcopy in a Canadian Cervical Cancer Screening Program. J Obstet Gynaecol Can. 2015;37(5):412-20.

Smith LW, Khurshed F, van Niekerk DJ, Krajden M, Greene SB, Hobbs S, Coldman AJ, Franco EL, Ogilvie GS. Women’s intentions to self-collect samples for human papillomavirus testing in an organized cervical cancer screening program. BMC Public Health. 2014;14:1060.

Regier DA, van der Hoek K, Ogilvie G, Smith L, Henwood E, Miller DM, McTaggart-Cowan H, Peacock SJ. Exploring colposcopists’ attitudes towards use of HPV testing as a primary screening tool for cervical cancer in British Columbia. J Obstet Gynaecol Can. 2013 Jul;35(7):657-63.

Ogilvie GS, Smith LW, van Niekerk DJ, Khurshed F, Krajden M, Saraiya M, Goel V, Rimer BK, Greene SB, Hobbs S, Coldman AJ, Franco EL. Women’s intentions to receive cervical cancer screening with primary human papillomavirus testing. Int J Cancer. 2013;133(12):2934-43.

Ogilvie GS, Krajden M, van Niekerk DJ, Martin RE, Ehlen TG, Ceballos K, Smith LW, Kan L, Cook DA, Peacock S, Stuart GC, Franco EL, Coldman AJ. Primary cervical cancer screening with HPV testing compared with liquid-based cytology: results of round 1 of a randomised controlled trial — the HPV FOCAL Study. Br J Cancer. 2012;107(12):1917-24.

Ogilvie GS, van Niekerk DJ, Krajden M, Martin RE, Ehlen TG, Ceballos K, Peacock SJ, Smith LW, Kan L, Cook DA, Mei W, Stuart GC, Franco EL, Coldman AJ. A randomized controlled trial of Human Papillomavirus (HPV) testing for cervical cancer screening: trial design and preliminary results (HPV FOCAL Trial). BMC Cancer. 2010;10:111.

Co-Investigators: Dirk van Niekerk, Eduardo Franco, Mel Krajden, Marette Lee, Kathy Ceballos; Gavin Stuart; Ruth Martin; Stuart Peacock.

Funded by: CIHR

Partners: BC Cancer Agency, BC Centre for Disease Control,  BCCDC  BC Public Health & Microbiology Reference Laboratory

Website: http://www.bccancer.bc.ca/our-research/participate/cervical-screening

The Women’s Health Research Institute would like to acknowledge that we are uninvited guests on the unceded ancestral territories of the xʷməθkwəy̓əm (Musqueam), Skwxwú7mesh (Squamish), Stó:lo, and sel̓íl̓witulh (Tsleil-waututh) Nations.

As a provincial research institute committed to improving the health outcomes of women, including those across the 2SLGBTQIA+ spectrum, we recognize our responsibility in the collective effort towards establishing culturally safe health care systems and services that address health inequities among Indigenous peoples, especially Indigenous women, girls, and Two-spirit peoples.

We encourage all people involved in research to read both the Truth and Reconciliation Commission of Canada: Calls to Action and the In Plain Sight Report, and reflect on ways we can incorporate the recommendations into our work. As we gather in spaces together, we encourage you to reflect on your positionality on these lands and your personal commitments to reconciliation.

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