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Brief title: BCC3

Official title: BC CARMA-CHIWOS Collaboration

Study leads:

• Dr. Melanie Murray, MD, PhD, Clinical Associate Professor, Infectious Diseases, Medicine, University of British Columbia
• Dr. Hélène Côté, PhD, Professor, Pathology & Lab Medicine, University of British Columbia
• Dr. Angela Kaida, PhD, Health Sciences, Simon Fraser University,
• Dr. Katherine Plewes, MD, DPhil, Clinical Assistant Professor, Infectious Diseases, University of British Columbia
• Dr. Elizabeth King, MD, Assistant Professor, Health Sciences, Simon Fraser University

Summary: HIV can cause chronic activation of the immune system, which leads to inflammation and oxidative stress. Social stresses such as stigma, violence, and food insecurity can contribute to stress and inflammation as well. These can both lead to hormonal dysregulation in women, as well as DNA damage and early aging of the body's cells. As a result, people living with HIV often experience greater prevalence of other diseases and a decrease in lifespan.

The purpose of this study is to better understand the impact of viral infections, medications, hormones, chronic diseases, and personal life experiences on cellular aging in women living with HIV.

What does this study involve?

This study is composed of two parts: a clinic visit and a community visit. The 2-3 hour clinic visit includes a brief physical exam, bloodwork, urine pregnancy test, hair sample, and optional rectal and vaginal swabs. It also includes a clinical survey about demographics, medical history, substance use, and reproductive health, to be completed with a trained interviewer. The second portion of the study involves a 1-2 hour survey completed with an interviewer at a community or clinical site. For this survey, participants are asked for further information about demographics, lifestyle, mental health, sexual health, healthcare service utilization, wellbeing and resilience, and experiences with stress, stigma and trauma.

Study sites:

• Oak Tree Clinic, Women's Health Centre, Vancouver, BC
• St. Paul's Hospital, Vancouver, BC
• Fraser Health, Surrey site, BC

Study dates: April 2021 - Present

Target enrolment number: 700 (350 women living with HIV, 350 women without HIV)

Open or closed recruitment: Open for recruitment

Contact information: Dr. Hélène Côté, Co-principal Investigator, 778-288-5125

Brief title: CPHSP

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

Study Leads: Dr. Laura Sauvé, MD, Clinical Assistant Professor, Department of Pediatrics, University of British Columbia

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.

You may visit Surveillance • CPHSP - CPARG.ca for more information.

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: Arezou Azampanah, Research Coordinator, aazampanah@cw.bc.ca, +1(604)875-2424 ext. 5681

‎Brief title: CTN222: Canadian Co-Infection Cohort

Official title: Canadian Co-Infection Cohort: A prospective clinical cohort of HIV and Hepatitis C Co-Infected Patients

Overall Lead: Dr. Marina Klein, MD, M.Sc., FRCPC, Professor, Department of Medicine, Faculty of Medicine and Health Sciences, McGill University

Local Study Lead: Dr. Katherine Plewes, MD, DPhil, Clinical Assistant Professor, Infectious Diseases, University of British Columbia

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.

You may visit Cocostudy for more information.

Study dates: 2008 – 2026

Target enrolment number: 95 for the Oak Tree site, 1050 in total

Recruitment is open for patients with both HIV and HCV.

Brief title: FIND+

Official Title: Assessing Fertility in Youth Living with HIV Since Childhood

Study Leads:

Principal Investigator: Dr. Melanie Murray, MD, PhD, Clinical Associate Professor, Infectious Diseases, Medicine, University of British Columbia

Local Co-Investigator Team:

• Dr. Hélène Côté, PhD, Pathology & Lab Medicine, University of British Columbia
• Dr. Angela Kaida, PhD, Health Sciences, Simon Fraser University,
• Dr. Elizabeth King, MD, Assistant Professor, Health Sciences, Simon Fraser University
• Dr. Laura Sauvé, MD, Clinical Assistant Professor, Department of Pediatrics, University of British Columbia
• Dr. Tatiana Sotindjo, MD, Clinical Instructor, Department of Pediatrics, University of British Columbia

Summary: People living with HIV are living longer and healthier lives due to the benefits of antiretroviral therapy. However, problems related to inflammation from poorly controlled HIV, or damage due to previous or current medications, are some the main barriers to the health and well-being of people living with HIV. Young people living with HIV from an early age are at risk of these effects, given their lifelong or near lifelong infection and medication exposure, as well as the impact of the virus, medications, and inflammation during important developmental stages - including puberty. One aspect of their health that could be affected is their fertility, but this hasn't been studied very much.

This study will guide future research and test the appropriateness of doing a larger study of fertility among youth living with HIV since childhood in the future.

Study sites:

This study is being conducted at three Canadian sites (Toronto, Ottawa, Vancouver).

Study dates: August 2023- Present

Target enrolment number: The plan is to enroll 50 male youth and 50 female youth living with HIV since childhood.

Open or closed recruitment: Open for recruitment

Contact information: Dr. Melanie Murray, Principal Investigator, 604-875-2212

Brief title: NOVA-HIV

Official title: NOVA-HIV Study: A Study of Reduced Dosing of the Nonavalent HPV Vaccine in Women Living with HIV

Study Lead: Dr. Deborah Money, MD, FRCSC, Professor, Department of Obstetrics & Gynecology, Medicine, SPPH, Clinician Scientist, Women's Health Research Institute

Summary: The goal of this study is to explore reduced dosing of the nonavalent HPV vaccine in women living with HIV (WLWH). This multi-site phase IV clinical trial will carry on from our previous HPV in HIV studies. It is now known that the vast majority of cervical cancers are caused by HPV infection. Therefore, cervical cancer can be prevented through HPV vaccination. In young women without HIV, this vaccine has been shown to prevent HPV infection in those not previously infected with the 9 types of HPV that the vaccine protects against. However, there are very little data on nonavalent HPV vaccination among the 18 million women living with HIV globally, who constitute a population most vulnerable to HPV and cervical cancer. This study will determine whether two doses of 9vHPV vaccine can be used in women living with HIV instead of three, and will examine additional aspects of HPV vaccination in WLWH including the immune response to three doses, vaccine safety and efficacy, and attitudes towards self-collected HPV samples in this population. These data will inform global public health policy and programming as well as informing the global strategy for cervical cancer elimination.

What does this study involve?

Participants in this study will have 6 or 7 study visits over 2 years, and each visit will take about 30-45 minutes more than your routine clinic visits. Participants will receive 3 does of the nonavalent HPV vaccine. Over the 2 years of the study, participants will have blood drawn 4 or 5 times. Vaginal swabs will be self-collected at 4 of the study visits. The swab will be tested for HPV DNA as well as for other organisms that live in the vagina (the microbiome). Participants will also complete a short questionnaire on how you feel about collecting a vaginal swab from yourself for the purpose of HPV screening for cervical cancer.

You may visit NOVA-HIV Study or CTN 339: The NOVA-HIV Study for more information.

Study sites: Oak Tree Clinic at BC Women's Hospital and Health Centre in Vancouver, BC is the coordinating site, with additional sites in British Columbia, Saskatchewan, Manitoba, Ontario and Quebec.

Study dates: Recruitment for the study began in late 2023 at the Oak Tree Clinic site and is currently ongoing until 2025, with study visits wrapping up in January 2027.

Target enrollment: 150 in BC, 450 across Canada.

Contact information: Research Manager, Emma Karlsen: emma.karlsen@cw.bc.ca

Brief title: PMIHS

Official Title: Provincial Maternal Infant HIV/Infection Surveillance Program (also called the Perinatal Database)

Study lead: Dr. Deborah Money, MD, FRCSC, Professor, Department of Obstetrics & Gynecology, Medicine, SPPH, Clinician Scientist, Women's Health Research Institute

Summary: 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 at BC Women's Hospital and Health Centre in Vancouver, BC.

Study dates: This study has collected 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. The study has expanded in recent years, along with Oak Tree Clinic, to now collect data on pregnancies impacted by various infectious diseases and congenital infections.

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

Brief title: REDOSE

Official Title: ReEvaluating antiretroviral Drug cOncentrations and Side Effects in individuals living with HIV

Study Leads:

• Dr. Elizabeth King, MD, Assistant Professor, Health Sciences, Simon Fraser University
• Dr. Melanie Murray, MD, PhD, Clinical Associate Professor, Infectious Diseases, Medicine, University of British Columbia

Summary: HIV is a chronic condition managed with lifelong daily medication called antiretroviral therapy (ARVs). As people with HIV live longer, older adults (especially women) experience increased side effects from ARVs. There is limited knowledge about how age and sex affect the body's processing of ARVs. Studies for the development of these medications typically focused on young men, leading to dosing recommendations that may be inappropriate for other groups.

The REDOSE study aims to better understand ARV concentrations and side effects in people living with HIV as they age. Researchers are investigating whether these concentrations differ based on age and sex.

What does this study involve?

This study is composed of two parts: a clinic visit and a take-home survey. The clinic visit is expected to take 1-2 hours, and includes a brief physical exam, bloodwork, a urine test, and optional mouth and rectal swabs. During this visit, participants are also asked to complete a preliminary clinical survey about medical history with a trained interviewer. The second portion of the study includes a survey that participants complete outside of the clinic, either independently online or over the phone with a research assistant. This 90-minute survey includes questions pertaining to demographics, ARV usage and side effects, substance use, stigma, chronic pain, and social support.

Study sites:

• Oak Tree Clinic, Women's Health Centre, Vancouver, BC
• St. Paul's Hospital, Vancouver, BC

Study dates: April 2024 - Present

Target enrolment number: 260 participants

Open or closed recruitment: Open for recruitment

Contact information: Dr. Elizabeth King, Principal Investigator, 604-875-2212, elizabeth_king@sfu.ca