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Oak Tree Clinic Research

Oak Tree Clinic contributes to clinically-oriented research, and improving access to clinical trials and other research for women and children.
Our Publications

Menopause in women living with and without HIV in two studies: Children and Women: AntiRetrovirals and Markers of Aging (CARMA) and the British Columbia CARMA-CHIWOS Collaboration (BCC3)

Authors: Shayda A Swann,1,2 Elizabeth M King,2,3 Amber Campbell,2,4 Shelly Tognazzini,7 Hélène CF Côté,2,5,6 Angela Kaida,2,7 Sofia A Levy,2,4 Valerie Nicholson,7,8 Neora Pick,2,4 Tetiana Povshedna,5,6 Melanie CM Murray,2,4,9 on behalf of the CARMA (CIHR, CTN 277) and BCC3 (CIHR, CTN 335) Study Teams


Our Studies

Oak Tree Clinic is part of BC Women’s Hospital + Health Centre and is an academic health sciences clinic. As a result trainees and researchers are embedded in the clinic at all times. We have many research studies going on at any one time which are designed to better understand HIV disease for women and children at multiple levels - from the effect of HIV and HIV drugs on cells, to the best way to delivery HIV care, to how to prevent future infections in others, and ultimately to improve life for persons living with HIV.

The CARMA Studies: The effect of HIV and HIV drugs on aging in women and children.

Overall project led by Dr. Hélène Côté.

Examples of current studies in our clinic are:

 
CARMA-1-PREG

Brief Title: CARMA-1-PREG

Official Title: Mitochondrial and Telomere Studies in Pregnancy AND Placental Mitochondrial Toxicity in HIV Therapy during Pregnancy AND Measuring Mitochondrial Aging, Application to HIV Infection and Therapy AND Cellular Aging and HIV Comorbidities in Women and Children 


Study Lead: Dr. Deborah Money

Summary: CARMA-1-PREG is studying pregnancy outcomes for HIV positive women, including in particular factors related to early delivery. Anti-HIV medication has dramatically reduced the risk of childrem of HIV positive mothers getting HIV infection from 25% to less than 1%. However, research has shown that HIV+ pregnant women are twice as likely to deliver their babies early (more than 3 weeks before their due dates), compared to women without HIV. The purpose of CARMA-1-PREG is to study the effect of taking particular anti-HIV drugs on women during pregnancy and on their infants by examining two markers of cell function: the length of DNA at the ends of chromosomes and the energy producing parts of the cell. 

CARMA-1-PREG is also investigating how HIV, the anti-HIV medications and other factors (e.g. the bacteria that inhabit a pregnant woman’s vagina) may affect early delivery 

What does this study involve? CARMA-1-PREG would like to see women up to 3 times during their pregnancy, once close to their delivery date, and once 1 to 2 months following delivery. Study visits involve 20-25 minutes of questions about factors known to affect early delivery, a research blood sample, and two self-collected vaginal swabs. CARMA-1-PREG would also like to collect two earlobe swabs and a small blood sample from participants’ newborns, and a small piece of cord and placental tissue at delivery 

Study sites: Oak Tree Clinic, Women’s Health Centre, Vancouver, BC; expected to launch at Centre Hospitalier Universitaire Sainte-Justice, Montreal, QC in 2014
Study dates: The first phase of this study took place between 2008 and 2012. The study recently received funding to continue enrolling participants and follow up with existing participants until 2017

Target enrolment number: 160 participants

Open or closed recruitment: CARMA-1-PREG is currently recruiting women (≥ 19 years old) living with HIV who are currently pregnant and who are taking or planning to take anti-HIV medications during their pregnancy 

Contact information: For more information about this study, please contact Ariel Nesbitt, Oak Tree Research Assistant at 604-875-2000 ext. 6706

 
CARMA-2-CORE
 
Brief Title: CARMA-2-CORE

Official Title: Mitochondrial and Telomere Studies in a Prospective Cohort AND Measuring Mitochondrial Aging, Application to HIV Infection and Therapy AND Cellular Aging and HIV Comorbidities in Women and Children


Study Lead: Dr. Deborah Money

Summary: CARMA-CORE is studying the effects of HIV and anti-HIV medications on cellular aging among children and adults living with or exposed to HIV. As people with HIV are living longer, there is increasing evidence that HIV may cause a type of “early aging”. CARMA-2-CORE is trying to better understand the impact of HIV and the anti-HIV medications on aging by looking at two markers of cellular aging: the length of DNA at the ends of chromosomes and the energy producing parts of the cell. Additionally, CARMA-2-CORE is examining the relationship between cellular aging and hormone problems (endocrine) dysfunction and bone loss among HIV+ women and girls 
What does this study involve? CARMA-2-CORE study visits involve 10-15 minutes of general health questions and a research blood sample (max 20mL). Additional blood samples (15mL) and questionnaires (endocrine sub study: 30-40 minutes of questions related to endocrine health, bone health sub- study: 45-90 minutes of questions related to bone health) are required for the optional endocrine and hormone health components of the study.

Study sites: Oak Tree Clinic, Women’s Health Centre, Vancouver, BC; Children’s Hospital of Eastern Ontario, Ottawa, ON; The Hospital for Sick Children, Toronto, ON; Centre Hospitalier Universitaire Sainte-Justice, Montreal, QC

Study dates: The first phase of this study took place between 2008 and 2012. The study recently received funding to continually enrolling participants and following up with existing participants until 2017

Target enrolment number: ~500 participants. Of these, we are hoping to recruit 200 participants into the endocrine sub study and 150 participants into the bone health sub study 
Open or closed recruitment: CARMA-2-C0RE is currently actively recruited women and children living with or exposed to HIV. The endocrine sub study is currently recruiting women and girls (≥12 years of age) living with HIV or exposed to HIV who have reached puberty. The bone health study is currently recruiting women (≥ 19 years of age) living with or exposed to HIV who are undergoing a bone density scan as part of their routine clinical care. CARMA-2-CORE is also recruiting HIV uninfected, unexposed women and children to act as a comparison group

Contact information: For more information about this study, please contact Ariel Nesbitt, Oak Tree Research Assistant, at 604-875-2000 ext.6706
 

 
CARMA 7

Brief Title: CARMA 7

Official Title: Bone and Renal Outcomes in HIV-Exposed, Uninfected Infants with Perinatal Exposure to Tenofovir 


Study Lead: Dr. Ariane Alimenti

Summary: Anti-HIV medication has reduced the risk of HIV transmission from mother to child from 25% to less than 1%. The effects of some of these medications on the developing fetus, however, have not been thoroughly studied. One medication, in particular, is becoming far more common because it is so well tolerated, and an increasing number of women are getting pregnant while taking this medication (almost 25% of HIV+ pregnancies in BC in 2011). This medication can cause some bone and kidney problems for among HIV+ adults with existing bone and kidney diseases; its effects on developing fetuses are not well understood. The purpose of CARMA 7 is to investigate how fetal exposure to this particular medication affects infants’ bone and kidney health and development among HIV exposed, uninfected children 
What does this study involve? CARMA 7 would like to see participants and their families up to 3 times before 18 months of age, when they are coming to the clinic for their regular clinical care. Study visits involve 10-15 minutes of questions about the mother’s health prior to and during pregnancy (1st visit only) and the infant’s health following birth, a urine sample, a bone density scan, and x-rays of the knees and wrists to look for abnormal bone growth. Some additional bone and kidney health blood tests will also be added to the infants’ clinical lab work 

Study sites: Oak Tree Clinic, Children’s and Women’s Hospital and Health Centre, Vancouver, BC; Children’s Hospital of Eastern Ontario, Ottawa, ON; The Hospital for Sick Children, Toronto, ON; Centre Hospitalier Universitaire Sainte-Justice, Montreal, QC

Study dates: CARMA 7 started enrolling participants at the Children’s Hospital of Eastern Ontario in 2012. Recruitment at the Oak Tree Clinic began in June 2013 and will continue until January 2015 

Target enrolment number: 20 participants

Open or closed recruitment: CARMA 7 is currently actively recruiting infants and their families, who are between the ages of 0 and 18 months, and whose mothers took two commonly used anti-HIV medications during their pregnancy 

Contact information: For more information about this study, please contact Ariel Nesbitt, Oak Tree Research Assistant, at 604-875-2000 ext.6706
 

 
CTN 222: HIV-HCV study

Brief Title: CTN 222: HIV-HCV study
Overall Lead: Dr. Marina Klein
Local Study Lead: Dr. Neora Pick, Medical Director, Oak Tree Clinic

Official Title: A Prospective Clinical Cohort of HIV and Hepatitis C Virus Co infected Patients – expansion to a cross-Canada study entitled: “If HCV is an OI Why Has HAART Not Improved Liver Disease?” (CTN 222); Prospective Investigation of the Relationship Between Food Insecurity and Health and Behavioural Outcomes in HIV-HCV Co-Infection: Clues for Prevention Interventions (CTN 264)


Sub-Studies: 
1. Food Security – CTN 264
Prospective Investigation of the Relationship Between Food Insecurity and Health and Behavioural Outcomes in HIV-HCV Co-Infection: Clues for Prevention Interventions
2. FibroScan
Novel Approaches to Studying Liver Fibrosis – Transient Elastography (FibroScan)

Summary: Many people who have HIV infection are also infected with hepatitis C virus (HCV). In these people liver disease is becoming an increasing cause of illness and death. Furthermore treatment of HIV is complicated by the presence of liver disease, and treatment of HCV is complicated by HIV. The purpose of this study is to examine a group of patients infected with both HIV and the Hepatitis C Virus, to understand how these two infections interact and to measure the impact of treatment on the course of their disease and on quality of life. 
The Food Security sub-study looks at the relationship between 1) levels of food security, 2) behavioural and clinical factors related to HIV-HCV co-infection, and 3) health-related quality of life and health and treatment outcomes among co-infected patients participating in HIV care in Canada.
The purpose of the FibroScan sub-study is to see whether FibroScans, rapid and relatively painless procedure, can be used to help measure liver fibrosis resulting from HIV-HCV co-infection. 

What does this study involve? 
Participation in this study involves a structured questionnaire every six months over a period of five years. A sample of blood will be collected for study with each questionnaire. Participants enrolled in the Food Security sub-study will be asked to fill out a second questionnaire at the same time as their main study visit for a period of up to two years. 
Participants in the FibroScan sub-study will be asked to undergo a FibroScan every six months for a period of up to five years. The FibroScan is a non-invasive procedure that uses sound waves to examine the liver, similar to an ultrasound.

Study dates: March 2008 – July 2014
Target enrolment number: 95 for the Oak Tree site, 1050 in total 

Open or closed recruitment: 
 Recruitment in the main study is closed except for patients at Oak Tree Clinic who will be starting Hepatitis C therapy
 Recruitment in the Food Security study is open to existing participants in the main study
 Recruitment in the FibroScan study is only open to existing participants in the main study who are starting HIV treatment for the first time, are starting Hepatitis C treatment, or who have had a liver biopsy in the past year or are scheduled for a liver biopsy in the next year

Contact information: Sara O’Shaughnessy, Research Coordinator, 604-875-2000 ext. 6861, SOShaughnessy@cw.bc.ca

 
HPV in HIV 

Brief Title: HPV Vaccine in HIV

Official Title: A study of an HPV VLP Vaccine in a Cohort of HIV Positive Girls and Women

Study Lead: Deborah Money, MD, FRCSC, 
Professor, Department of Obstetrics & Gynecology University of British Columbia 

Summary:

Virtually all cervical cancers are caused by Human PapillomaVirus infections, with just two HPV types, 16 and 18, responsible for about 70 percent of all cases. HPV types 6 and 11 cause an estimated 90% of genital warts cases.
It is known that HPV and cervical cancer are more common in women with HIV. Pre-existing HPV infection is associated with a 2-fold increase in the risk of HIV acquisition in women.
The purpose of this study is to determine the safety and effectiveness of giving 3 doses of vaccine against the HPV to girls and women who are living with HIV.

What does this study involve?
There are seven to eight visits for this study, spaced out over 2 years and 3 months. Each visit may require a brief physical exam, clinical and study blood work, urine pregnancy test, a routine pap test (Girls who are not menstruating yet and are not sexually active will not have any genital examinations or sampling until they become sexually active and have their first period.) Gardasil, HPV quadrivalent vaccine in preventing infection and disease due to HPV 6, 11, 16 and/or 18, is given as 3 injections over 6 months (first dose, 2 months, 6 months).

Study sites: 21 sites across Canada

Study dates: July 2008- ongoing (follow ups)

Target enrolment number: Reached at N=407

Open or closed recruitment: Recruitment closed (Dec 2012); Follow up visits ongoing and vital to complete to permit full information from all study participants.

Contact information: Arezou Azampanah, Research Assistant, 604-875-2000 x 5681 aazampanah@cw.bc.ca
 

 
Validate – CTN 240

Brief Title: Validate – CTN 240

Official Title: VALacyclovir In Delaying Antiretroviral Treatment Entry


Sub-Studies:
Genetic Predictors of HIV Disease Progression and of the Effects of HSV-2 and Valacyclovir on HIV Disease Progression

Study Lead: Dr. Neora Pick, Adult Physician – Oak Tree Clinic

Summary: Herpes Simplex Virus (HSV)-2 is one of the more common co-infections among people living with HIV. Valacyclovir, a medication used to suppress HSV-2 is known to reduce HIV levels in a person infected by both viruses. This study looks at whether the use of valacyclovir can delay the need to start highly active antiretroviral therapy (HAART). Participants who begin HAART over the course of this study are eligible to participate in a rollover study that looks at the level of inflammatory markers in the blood of people starting HIV treatment for the first time. There is also an optional genetic predictors sub-study that looks at whether the genes in the human body that determine the progression of HIV also influence the effects of HSV-2 and valacyclovir. 

What does this study involve?
Participants in the main Validate study will be randomly given either valacyclovir or a placebo drug to take twice a day. Participants will be asked to fill out a short questionnaire and provide a blood sample every three months for a period of up to five years. Participants who choose to partake in the genetic predictors sub-study will be asked to give an extra tube of blood with each study visit.
Participants who start HIV medication during the study will be invited to participate in the rollover study. This portion of the study only involves a questionnaire and blood sample every three months for one year. No valacyclovir or other study medications will be given out. 

Study sites: In addition to the Oak Tree Clinic, the Validate study includes over twenty sites across British Columbia, Alberta, Ontario, Quebec, Nova Scotia, Brazil, Argentina and the United Kingdom

Study dates: March 2010 – February 2016

Target enrolment number: 230

Open or closed recruitment: Closed

Contact information: Sara O’Shaughnessy, Research Coordinator, SOShaughnessy@cw.bc.ca, 604-875-2000 ext. 6861 
 

 
WelTel

Title: WelTelOAKTREE: Text Messaging to Support Patients with HIV/AIDS in British Columbia


Study Lead: Dr. Melanie Murray, Adult Physician – Oak Tree Clinic

Summary: The WelTelOAKTREE study is one of the first studies in Canada to explore the role that text messaging between healthcare providers and patients can play in improving the health of people living with HIV. The use of mobile phone technology (sometimes referred to as Mobile health, or mHealth), is an emerging tool that can improve patients’ sense of connectedness with their care providers, which is an important factor in health and wellbeing of people living with HIV. Ultimately, the WelTelOAKTREE study is looking to see if the sense of connectedness from text messaging provides benefits to the study participants’ health outcomes.

What does this study involve?
Participation in the WelTelOAKTREE study involves a weekly ‘check-in’ text sent by clinic staff, to which participants are asked to respond. The study also involves a brief survey looking at overall health at the beginning, middle and end of the study.

Study sites: Oak Tree Clinic, Vancouver BC 

Study dates: April 2013 – December 2014

Target enrolment number: 125

Open or closed recruitment: Open
Patients at Oak Tree for one year or more, having had at least one visit in the last year, a detectable HIV viral load, and low CD4 count

Contact information: Sara O’Shaughnessy, Research Coordinator, 604-875-2000 ext. 6861, SOShaughnessy@cw.bc.ca

 
CHIWOS

Brief Title: CHIWOS

Official Title: The Canadian HIV Women’s Sexual and Reproductive Health Cohort Study (CHIWOS), a Canadian Observational Cohort (CANOC) Affiliated Study


Study Lead: Dr. Angela Kaida, Assistant Professor, SFU 

Oak Tree Clinic lead - Dr. Mary Kestler – Adult HIV Specialist, Oak Tree 

Summary: Women represent one of the fastest growing demographics at risk for HIV. However, there remain major gaps in our knowledge about the epidemiology, management and response of HIV-positive women living in different areas of Canada. The aims of this community-based, longitudinal study are to estimate the: 1) proportion, distribution and patterns of uptake of women-centred HIV/AIDS services; 2) effect of women-centred HIV/AIDS services uptake on reproductive and sexual health outcomes; 3) effect of women-centred HIV/AIDS services uptake on women’s health outcomes; and 4) the effect of women- centred HIV/AIDS services uptake on the mental health of HIV-positive women.
What does this study involve? Participants will be asked to complete a survey at baseline and again at an 18-month follow-up visit. The surveys will be administered by a trained Peer Research Associate (PRA) and will take approximately 2 ½ hours to complete

Study sites: Oak Tree Clinic and multiple other sites across BC, Ontario and Quebec

Study dates: May 2013 – May 2016

Target enrolment number: 350 in BC, 1250 for the entire study

Open or closed recruitment: Open to HIV positive women aged 16 years or older

Contact information: Evelyn Maan, Research Manager, 604-875-2000, ext. 2463, emaan@cw.bc.ca
 

 
CPHSP Summary

Brief Title: CPHSP

Official Title: Canadian Perinatal HIV Surveillance Program: Web-Based Database


Study Leads: Drs. Ariane Alimenti and Laura Sauve– Paediatric HIV Specialist, Oak Tree Clinic

Summary: The Canadian Perinatal HIV Surveillance Program is an ongoing study initiated by the Canadian Pediatric AIDS Research Group to collect national data for the active surveillance of infants born to HIV infected women across the country. This program reports its data annually to the Public Health Agency of Canada. 
In Canada, the use of administrative database anti-HIV medications in pregnancy has significantly reduced the rate of vertical transmission of HIV. Despite the fact that antiretroviral therapy given to mothers in their pregnancy can prevent vertical transmission, and these medications are readily available in Canada at no cost to the family, there are still a few cases of HIV transmission every year. The goal of the study is to observe the changing patterns of pregnancies and births to HIV positive women in Canada, understand the Canadian trends, improve access to and uptake of anti-HIV medications as well as positively influence the overall care HIV-infected pregnancies.

What does this study involve?This study collects annual clinical data on the number of infants born to HIV positive women, rates of vertical HIV transmission, the use of antiretroviral therapy in pregnancy, and the health outcomes of the infants. This study does not involve any recruitment of participants or require active participation of patients at Oak Tree Clinic.

Study sites: This study involves sites across BC, Alberta, Saskatchewan, Manitoba, Ontario, Quebec, Nova Scotia, PEI, Newfoundland and the Yukon. 

Study dates: The CPHSP data has been collected at the individual centres since 1991. Since 2007, the data collection has been standardized across all sites and stored in a secure, web-based database housed at the Canadian HIV Trials Network. The coordinating centre for this study is the Oak Tree Clinic at present.

Contact information: 
Evelyn Maan, Research Manager, emaan@cw.bc.ca, 604-875-2000 ext. 2463.
 

 
PMIHS Summary

Brief Title: PMIHS

Official Title: Provincial Mother-Infant HIV Surveillance Program

Study Lead: Dr. Deborah Money, VP of Research, BC Women’s Hospital

Summary: The purpose of this surveillance is to update and maintain an administrative database of all HIV-positive pregnant women and their infants seen or followed through the Oak Tree Clinic for their perinatal HIV care. The data will be used to investigate trends in pregnancy, including HIV treatment and associated outcomes. We are the provincial resource for information on vertical transmission rates. 

What does this study involve? This surveillance program involves the collection of clinical information from the medical charts of HIV-positive pregnant women receiving care or follow-up through the Oak Tree Clinic. This study does not involve any recruitment of participants or require active participation of patients at Oak Tree Clinic. The secondary analysis of this data once de-identified, enables understanding of evolving problems seen in HIV positive pregnant women related to underlying health and/or the use of newer antiretroviral drugs as well as the early infant outcomes.

Study sites: Oak Tree Clinic, Vancouver, BC

Study dates: This study is collecting data on all pregnancies of HIV positive women referred to Oak Tree Clinic since 1995 and holds data back to 1990, when HIV exposed infants were followed at BC Children’s Hospital.

Contact information: Evelyn Maan, Research Manager, emaan@cw.bc.ca, 604-875-2000 ext. 2463. 
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