Maternal Microbiome Legacy Project

Principal Investigator: Dr. Deborah Money

Primary Contact: Zahra Pakzad, Research Coordinator, 604-875-2424 ext. 6379, zahra.pakzad@cw.bc.ca

About the study: The role of bacterial communities throughout the body in health and disease is being widely studied. Preliminary research shows a possible link between delivery type (vaginal or caesarean delivery) and the bacterial communities found in the gut in early infancy. In Canada 1 in 4 women have a caesarean delivery and there is some evidence of increased risk of conditions such as asthma, celiac disease, and allergies in caesarean-born infants. To date no cause for this increased risk has been identified. Some researchers have proposed that this potential transfer of maternal vaginal bacteria may be prevented by a caesarean delivery. This may result in altering the establishment of the infant’s own bacterial community. However a clear link between delivery type and the infant’s bacterial community has not been established.

This study will use advanced gene-based methods to profile the bacterial communities present in women who deliver vaginally or via caesarean section and connect these to the infant gut bacterial community in the first 3 months of life. This research will lead to a deeper understanding of the potential role of the maternal bacterial community on the infant gut bacterial community

Why is this research important? The practice of “vaginal seeding” has emerged, where a newborn delivered via caesarean section is swabbed with the mother’s vaginal secretions to transfer the mother’s vaginal bacteria to the infant, mimicking what the infant would have been exposed to during vaginal birth. However the benefits of “vaginal seeding” have not been evaluated and the safety of this practice has not been proven despite it coming into clinical use. The goal of our study will be to determine if the maternal bacterial community is actually transferred to the infant during delivery and if the different types of deliveries alter this transfer.

Interested in ParticipatingFollow the link to the survey, to have us contact you.

Study status: Launching March 5, 2018.

Co-Investigators: Dr. Janet Hill (University of Saskatchewan), Dr. K.S. Joseph (University of British Columbia), Dr. Julie van Schalkwyk (University of British Columbia), Dr. Arianne Albert (B.C. Women’s Hospital, Vancouver), Dr. Chelsea Elwood (University of British Columbia), Dr. Soren Grantt (University  of British Columbia), Dr. Kirsten Grabowska (University of British Columbia), Dr. Jennifer Hutcheon (University of British Columbia), Dr. Matthew Links (University of Saskatchewan), Dr. Amee Manges (University of British Columbia), Dr. Sheona Mitchell (University of British Columbia), Dr. Tim Dumonceaux (Agriculture and Agri-Food Canada, Saskatchewan), Dr. Zoe Hodgson (B.C. Women’s Hospital), Dr. Janet Lyons (University of British Columbia).

Funded by: Canadian Institutes of Health Research (CIHR)

News: 

New $1.4 M CIHR Project Grant brings together three sites across the department to define the maternal legacy

Recruitment Materials:

  1. Recruitment Survey
  2. Recruitment Poster
  3. Recruitment Postcard

Vaginal Microbiome Group Initiative

vogue

Principal Investigator: Dr. Deborah Money

Primary Contact: Zahra Pakzad, Research Coordinator, 604-875-2424 ext. 6379, zahra.pakzad@cw.bc.ca

About the study: The VOGUE study team is comprised of a diverse group of scientists and clinicians from across Canada who are using genomic methods to study the microbial ecosystem (microbiome) of the vagina in varying states of health and disease. The VOGUE research program comprises 5 sub-studies, each examining the vaginal microbiome of distinct clinical populations: healthy non-pregnant women, women living with HIV, women with recurrent vulvovaginitis, pregnant women at low risk for preterm birth, and pregnant women at high risk for preterm birth. The team is united in their goal of capitalizing on advances in genomic sequencing technology to analyze the composition, distribution, and function of vaginal microbes, and probe the links between these microbes and disease to guide the development of novel diagnostic tools and interventions to improve women’s health in Canada and around the world.

Why is this research important? The healthy vagina is host to millions of microorganisms, including many types of “good” bacteria that protect against invading pathogens, and help to promote healthy pregnancy. Until now, clinicians and scientists have had relatively unsophisticated tools at their disposal for studying this critically important ecosystem. It has only been with recent advances in genomic sequencing technology that researchers have been able to uncover and truly understand the sheer number and diversity of organisms that inhabit the vagina (the vaginal microbiome). From a single swab taken from the vagina, we are now able to sequence a section of the DNA from each type of bacteria present, and use this unique DNA “fingerprint” to identify them. As we move toward more sophisticated ways to diagnose and treat imbalances in the vaginal microbiome, this will allow us to develop more personalized and targeted interventions, in order to restore a microbiome that optimizes reproductive health in individual women. Ultimately, we hope our work will lead to significant breakthroughs in the health and well-being of women in Canada and around the world.

Study status: Recruitment is limited to the VOGUE 1B2 sub-study (women with recurrent vulvovaginitis). Recruitment for all other sub-studies is complete. Data analysis, manuscript development, and knowledge translation are ongoing.

Study results/publication:

Albert AY, Chaban B, Wagner EC, Schellenberg JJ, Links MG, van Schalkwyk J, Reid G, Hemmingsen SM, Hill JE, Money D, and the VOGUE Research Group. A study of the vaginal microbiome in healthy Canadian women utilizing cpn60-based molecular profiling reveals distinct Gardnerella subgroup community state types. PLoS One. 2015;10(8):e0135620.

Co-Investigators: Dr. Alan Bocking (University of Toronto), Dr. Sean Hemmingsen (National Research Council’s Plant Biotechnology Institute, Saskatchewan), Dr. Janet Hill (University of Saskatchewan), Dr. Gregor Reid (University of Western Ontario), Dr. Tim Dumonceaux (Agriculture and Agri-Food Canada, Saskatoon), Dr. Gregory Gloor (University  of Western Ontario), Dr. Matthew Links (Agriculture and Agri-Food Canada, Saskatoon), Dr. Kieran O’Doherty (University of Guelph), Dr. Patrick Tang (Sidra Medical and Research Center), Dr. Julie van Schalkwyk (University of British Columbia), Dr. Mark Yudin (University of Toronto).

Funded by: Canadian Institutes of Health Research (CIHR) and Genome BC

Advances in Screening and Prevention in Reproductive Cancers (ASPIRE)

ASPIRE is a women’s health initiative using innovative models and technologies to improve access to reproductive health in low income settings.

Principal Investigator: Dr. Gina Ogilvie

Primary Contact: Visit https://www.globalhpvcontrol.org/ for more information.

About the study: ASPIRE is a women’s health initiative using innovative models and technologies to improve access to reproductive health in low income settings. Since 2007, ASPIRE has conducted various community-based cervical cancer screening initiatives in Kampala, Uganda using self collection-based HPV testing. The project takes an integrated health services approach to address cervical cancer along other reproductive health issues including sexually transmitted infections and HIV.

Why is this research important? Cervical cancer, despite being almost entirely preventable, remains a leading cause of death among women in low and middle income countries largely due to the absence of screening programs in these regions. Cost-effective and acceptable tools are needed to improve access in low income settings. By integrating cervical cancer and reproductive health screening with routine HIV services, the health of vulnerable women can be protected while most effectively utilizing resources.

Study Status: 1) Randomized controlled trial comparing HPV self collection vs VIA in Kampala: complete; 2) Integration of cervical cancer screening with HIV services: under development; 3) Reproductive health & pregnancy outcomes in adolescents: under development.

Study results/publications:

Moses E, Pedersen HN, Mitchell SM, Sekikubo M, Mwesigwa D, Singer J, Biryabarema C, Byamugisha JK, Money DM, Ogilvie GS. Uptake of community-based, self-collected HPV testing vs. visual inspection with acetic acid for cervical cancer screening in Kampala, Uganda: Preliminary results of a randomized controlled trial. Trop Med Int Health. 2015; 20(10):1355-67.

Teng FF, Mitchell SM, Sekikubo M, Biryabarema C, Byamugisha JK, Steinberg M, Money DM, Ogilvie GS. Understanding the role of embarrassment in gynaecological screening: a qualitative study from the ASPIRE cervical cancer screening project in Uganda. BMJ Open 2014;4:4 e004783.

Mitchell SM, Sekikubo M, Biryabarema C, Byamugisha JJ, Steinberg M, Jeronimo J, Money DM, Christilaw J, Ogilvie GS. Factors associated with high-risk HPV positivity in a low-resource setting in sub-Saharan Africa. Am J Obstet Gynecol 2014 Jan;210(1):81.e1-7.

Ogilvie G S, Mitchell S, Sekikubo M, Biryabarema C, Byamugisha J, Jeronimo J, Miller D, Steinberg M, Money D M. Results of a community-based cervical cancer screening pilot project using human papillomavirus self-sampling in Kampala, Uganda. Int J Gynaecol Obstet 2013; 122 (2): 118–123.

Mitchell S, Ogilvie G, Steinberg M, Sekikubo M, Biryabarema C, Money D. Assessing women’s willingness to collect their own cervical samples for HPV testing as part of the ASPIRE cervical cancer screening project in Uganda. Int J Gynaecol Obstet 2011;114(2):111-115.

Co-Investigators: Deborah Money, Jan Christilaw, Josaphat Byamugisha, Sheona Mitchell, Angela Kaida, Ashley Roberts, Curren Warf, Patricia Spittal

Funded by: CIHR, CFRI, BCCDC Foundation, UBC, BC Women’s Foundation

Partners: University of British Columbia, Makerere University, BCCDC

Websites:

http://www.aspireafrica.ca/aspire/

Determining Dietary Phenylalanine Requirements during Different Stages of Gestation in Healthy Pregnant Women

PHENYLALANINE-REQ-PREGNANCY is trying to determine the amount of dietary phenylalanine required by women during pregnancy to ensure healthy development of their baby.

Principal Investigator: Dr. Rajavel Elango

Primary Contact: Madeleine Ennis, Graduate Student 604-875-2000 x 4607, mennis@bcchr.ca

About the study: PHENYLALANINE-REQ-PREGNANCY is trying to determine the amount of dietary phenylalanine required by women during pregnancy to ensure healthy development of their baby.  Pregnancy is a critical time that necessitates sufficient nutrition to ensure healthy development of both the mother and the baby.  Amino acids such as phenylalanine are the building blocks of protein, which are used to create body tissue and support the immune system.  Phenylalanine must be obtained through the diet, and the requirements during pregnancy are not currently determined. Inadequate protein and amino acid consumption during pregnancy has been linked to future risk of high blood pressure, heart disease, and other metabolic problems in the baby.  Therefore, it is important to determine how much phenylalanine should be consumed during pregnancy.

Study status: Recruiting

Who can participate:

Women who are:

  • 20-40 years of age
  • pregnant with a single child
  • between 13-19 weeks of gestation or 33-39 weeks of gestation
  • free of chronic diseases/acute diseases, and have a full range of physical mobility

Co-Investigator: Dr. Ken Lim

Funded by: Canadian Institutes of Health Research

Consent Form: consent-form-for-participant

Immunization of Women with Diphtheria and Tetanus Toxoids Combined with Acellular Pertussis (Tdap) During the Mid Third Trimester of Pregnancy: An Evaluation of the Potential for Immunological Protection for the Neonate

The purpose of this study is to see if the pertussis (also known as “whooping cough”) vaccine antibodies (protection) are transferred from mother to baby through the placenta and breast milk in high enough levels to provide protection to the newborn baby if the mother receives the pertussis vaccine during the mid third trimester of pregnancy. 

Principal Investigator: Dr. Scott Halperin (Global PI), Dr. Deborah Money (Local PI).

Primary Contact: Nancy Lipsky, Research Manager, nlipsky@cw.bc.ca, 604-875-2424 Ext. 4877

About the study: This study involves vaccinating pregnant women with the pertussis (also known as “whooping cough”) vaccine.  Pertussis is a highly transmissible bacterial respiratory infection caused by the bacteria Bordetella pertussis, the classical symptom of which is a serious cough that can last many weeks. The purpose of this study is to see if the vaccine antibodies (protection) are transferred from mother to baby through the placenta and breast milk in high enough levels to provide protection to the newborn baby if the mother receives the pertussis vaccine during the mid third trimester of pregnancy.  We are also looking to see if vaccinating the mother will affect the baby’s protection levels once the baby starts receiving his/her routine infant vaccine.

Why is this research important?  In Canada, there are 1–3 deaths each year from whooping cough; all have been in infants too young to have begun their immunization series.  We are investigating maternal vaccination during the third trimester of pregnancy in an effort to better understand how we can protect young infants from pertussis and prevent related infant harm and deaths.

Study Status: Data analysis

Co-Investigators: Beth Halperin, Victoria Allen, Joanne Langley, Shelly McNeil, Bruce Tapiero, Marc Boucher, Nicole LeSaux, Andree Gruslin, Dat Tran, Mark Yudin, Otto Vanderkooi, Doug Wilson, Wendy Vaudry, Sue Chandra, Simon Dobson, Deborah Money.

HPV FOCAL 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.

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 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

Quadrivalent vaccine evaluation study (QUEST)

QUEST (Quadrivalent HPV Vaccine Evaluation Study) is a Canada-wide study designed to evaluate whether 2 doses of the HPV vaccine are just as effective as 3 doses at preventing Human Papillomavirus (HPV) infection and cervical cancer.

Principal Investigators: Drs. Gina Ogilvie, Simon Dobson

Primary Contact: QUESTION Coordinating Centre, 604.875.2636 (Toll Free: 1-866-502-2424), questhpvstudy@cfri.ca

About the Study: QUEST (Quadrivalent HPV Vaccine Evaluation Study) is a Canada-wide study designed to evaluate whether 2 doses of the HPV vaccine are just as effective as 3 doses at preventing Human Papillomavirus (HPV) infection and cervical cancer. The QUEST study will seek to recruit 8,666 females from across between the ages of 14 to 18.  Study sites are in British Columbia, Alberta, Quebec, Nova Scotia, and PEI.

Why is the study important? A 2 dose schedule instead of 3 doses of the HPV vaccine means girls would  have to endure fewer shots and the program could be extended to more people including boys.  Fewer doses means that middle and lower income countries are more likely to be able to afford the HPV vaccine program.

Who can participate? Females 14-18 years old who received either 2 or 3 doses of the HPV vaccine on the provincial schedule who are located in BC, Alberta, Quebec, PIE or Nova Scotia.

What does participation involve? Participating is quick and simple and can be done from anywhere.  Participants are enrolled in the study for 5 years and involves completing an online survey  once a year and providing self collected swabs twice a year

Study Results/Publication: 

Ogilvie GS, Naus M, Money DM, Dobson SR, Miller D, Krajden M, van Niekerk DJ, Coldman AJ. Reduction in cervical intraepithelial neoplasia in young women in British Columbia after introduction of the HPV vaccine: An ecological analysis. Int J Cancer. 2015;137(8):1931-7.

Krajden M, Cook D, Yu A, Chow R, Su Q, Mei W, McNeil S, Money D, Dionne M, Palefsky J, Karunakaran K, Kollmann T, Ogilvie G, Petric M, Dobson S. Assessment of HPV 16 and HPV 18 antibody responses by pseudovirus neutralization, Merck cLIA and Merck total IgG LIA immunoassays in a reduced dosage quadrivalent HPV vaccine trial. Vaccine. 2014;32(5):624-30.

Dobson SR, McNeil S, Dionne M, Dawar M, Ogilvie G, Krajden M, Sauvageau C, Scheifele DW, Kollmann TR, Halperin SA, Langley JM, Bettinger JA, Singer J, Money D, Miller D, Naus M, Marra F, Young E. Immunogenicity of 2 doses of HPV vaccine in younger adolescents vs 3 doses in young women: a randomized clinical trial. JAMA. 2013;309(17):1793-802.

Co-Investigators: Mel Krajden, Joel Singer, Marie Helene Mayrand, Shelly McNeil, Chantal Sauvageau, Vladmir Gilca, James Kellner, Deborah Money

Funded by: MSFHR, CIHR

Partners: UBC, CFRI, Dalhousie University, University of Calgary, Centre Hospitalier Universitaire de Quebec

Websites:

http://questhpvstudy.ca/contact-us/

http://questhpvstudy.ca/

Long Term Follow-up Study of CTN 236 – A Study of an HPV VLP Vaccine in a Cohort of HIV Positive Girls and Women

This study aims to better understand how the HPV vaccine works in HIV positive girls and women over the long term and to clarify how care can be provided to best protect this population from HPV infection and associated cervical cancer and genital warts.

Principal Investigator: Dr. Deborah Money

Primary Contact: Nancy Lipsky, WHRI Research Manager, 604 875 2000 x4877, NLipsky@cw.bc.ca

About the study: Infection with human papillomavirus (HPV) is the leading cause of cervical cancer and genital warts.  This study extends follow-up of girls and women who received a least one human papillomavirus (HPV) vaccine through the first phase of this research.  353 girls and women from across Canada are therefore eligible and are asked to participate in 3 approximately annual study visits.  At each visit, participant health status is reviewed and blood samples and vaginal swabs are taken to assess response to the HPV vaccine and efficacy of the vaccine in preventing HPV infection and associated diseases over time.

Why is this research important? This research is important because, while the HPV vaccine has been studied extensively in women and girls without HIV, this is one of the first projects to investigate response to the HPV vaccine in girls and women living with HIV.  Generally, persons living with HIV do not respond as well to standard vaccines compared to persons without HIV. Further, Women with HIV have four times higher rates of HPV infection and are much more likely to progress from infection to cervical cancer.  Cervical cancer is responsible for approximately 266,000 deaths globally per year.  This research can help us better understand how the vaccine works in HIV positive girls and women over the long term and can clarify how care can be provided to best protect this population from HPV infection and associated cervical cancer and genital warts.

Study status: Recruitment is limited to girls and women who participated in the first phase of this research.  Eligible women will be recruited throughout the study duration.

Who can participate: Those who 1) received at least one HPV vaccine through CTN 236, phase 1 and 2) who are able to give fully informed consent or assent.

News:

  • Canadian HIV Trials Network (CTN) article on adult participants’ response to the vaccine (2016)
  • Interview by Suzanne MacCarthy. The Positive Side Magazine. Will the HPV Vaccine Guard You? Spring/Summer 2009, PAGES 13-14

Study results/publication: Enrollment and data collection for this follow-up study are ongoing and results are pending.  However, in the first phase of this research, the HPV vaccine was well tolerated, with no safety concerns identified.  Girls and women showed a solid immune response to the vaccine- this suggests ability of the vaccine to protect HIV positive girls and women from HPV infection.  Observed low rates of new HPV infection, genital warts and precancerous changes to the cervix in the 2 years following vaccination further reflect short-term efficacy of the HPV vaccine in this group.  Girls ages 9-14 did not produce as strong an immune response to the vaccine as did comparable girls without HIV; longer term follow up is important to better understand the level of protection provided by the HPV vaccine to girls and women who are a living with HIV.

Co-Investigators & Collaborators: Dr. Neora Pick (University of British Columbia), Dr. Mel Krajden (University of British Columbia), Dr. Gina Ogilvie (University of British Columbia), Dr. Simon R.M. Dobson (University of British Columbia), Dr. Marianne Harris (University of British Columbia), Dr. Fiona Smaill (McMaster University), Dr. Lindy Samson (Children’s Hospital of Eastern Ontario), Dr. Sean Ari Bitnun (University of Toronto), Dr. Mona Loutfy (Women’s College Research Institute), Dr. Fatima Kakkar (Universite de Montreal), Dr. Mark Yudin (University of Toronto), Dr. Sharon Walmsley (University of Toronto), Dr. Marina Klein (McGill University), Dr. Francois Coutlee (Universite de Montreal), Dr. Janet Hill (University of Saskatchewan), Dr. Janet Raboud (University of Toronto), Dr. Wendy Wobeser (Queen’s University), Dr. Sylvie Trottier (Universite Laval), Dr. Catherine Hankins (University of Amsterdam), Dr. Normand Lapointe (Hopital Sainte Justine), Dr. Darrell Tan (University of Toronto), Dr. Jason Brophy (University of Ottawa), Dr. Andrew Coldman (BC Cancer Agency), Dr. Angela Kaida (Simon Fraser University), Dr. Arianne Alimenti (University of British Columbia), Dr. Christos Karatzios (University of Montreal), Dr. Dirk van Niekirk (BC Cancer Agency), Dr. Jan Christilaw (BC Women’s Hospital and Health Centre), Dr. Jeff Cohen (HIV Care Program, Ontario), Dr. Joel Singer (Canadian HIV Trials Network), Dr. Julie van Schalkwyk (University of British Columbia), Ms. Laurie Edmiston (CATIE), Ms. Marcie Summers (Positive Women’s Network).

Funded by: Canadian Institutes of Health Research and further supported by the Canadian HIV Trials Network.

Clinical sites include: Oak Tree Clinic, BC Women’s Hospital and Health Centre, Vancouver, BC; St. Paul’s Infectious Disease Clinic, Vancouver, BC; Toronto General Hospital, Toronto, ON; Maple Leaf Medical Clinic, Toronto, ON; St. Michaels Hospital, Toronto, ON; Hospital for Sick Children, Toronto, ON; McMaster University Hospital, Hamilton, ON; Kingston General, Kingston, ON; Children’s Hospital of Eastern Ontario, Ottawa, ON; HIV Care Program, Windsor, ON; McGill University Health Centre, Montreal, QB; Montreal Children’s Hospital, Montreal, QB; CHU Sainte Justine, Montréal, QB; Centre Hospitalier de l’Université Laval, Québec City, QB;

Statistical Analyses: Dr. Janet Raboud, University Health Network

Data Management: Canadian HIV Trials Network

Lab Analyses: Dr. Francois Coutlee, University of Montreal; Dr. Janet Hill, University of Saskatchewan; British Columbia Centre for Disease Control; Merck (pharmaceuticals).