The CTN organizes a National network of researchers around thematic research Cores designed to support scientists in the generation of new concepts and study protocols. Co-led by Dr. Mona Loutfy (Toronto) and Dr. Catherine Worthington (Victoria), the Prevention and Vulnerable Population (PVP) Core research agenda is geared towards working collectively with communities and researchers to understand gaps in health services and to look for and evaluate interventions for decreasing HIV transmissions and mitigating disparity and vulnerabilities. 

“Meaningful HIV health interventions can take many forms beyond randomised drug trials and we want to encourage and support prevention and intervention research for populations that are vulnerable to HIV,” say Dr. Loutfy. Community-based research and cross disciplinary collaboration within the PVP Core provide an excellent opening for meaningful engagement and a solid basis for finding inclusive solutions grounded in community needs. “Our goal,” says Worthington, “is to ensure that the studies that come out of the PVP Core address research questions that communities’ support. We are working hard to forge partnerships beyond basic and clinical sciences to work successfully with vulnerable populations.” 

From the time the PVP was established it was decided to focus CTN resources on Aboriginal Peoples, but not to the exclusion of other vulnerable populations. Aboriginal populations are overly represented within HIV statistics in Canada and also overly represented within statistics highlighting other risk factors, including substance use issues within communities, social inequities resulting from the colonization process and stigma and discrimination. Physicians in some of Canada’s most affected provinces, including Manitoba and Saskatchewan, have argued that there is a huge clinical need in Aboriginal communities across the Prairies. Many of the patients they are diagnosing are presenting with late stage HIV, which results in major challenges for effective health management. In September 2010, the CTN formalized a partnership with the Canadian Aboriginal AIDS Network (CAAN) and this past year the PVP Aboriginal-CTN Working Group was established. The CTN also supported the development of an accredited online course for doctors and health care practitioners focused on community-based and culturally appropriate HIV treatment and care for Aboriginal Peoples. The course is open online at: https://www.mdcme.ca/ 

For the next five years the Core has prioritised research in three main areas. Two of them are within specific vulnerable populations; the first being research with and among Aboriginal peoples, and the second being men who have sex with men. The third priority topic is related to engagement and retention in care for people living with HIV. Retention and engagement is a broad research focus that’s relevant across CTN research Core interests, and encompasses and affects all key HIV populations in Canada.   

As part of a new initiative and in partnership with the University of Saskatchewan, the PVP Core is co-hosting a Rural Engagement and Retention in HIV Care Working Group meeting, taking place in Saskatoon in March 2013. The purpose of this meeting, which is funded by a Canadian Institutes of Health Research Planning Grant, is to bring together as many stakeholders as possible to identify the barriers, challenges and successes in HIV testing strategies, and to discuss how to link HIV patients from rural communities to care, with a focus on the unique issues faced by specific populations. “When we involve service providers, policymakers, communities and advocates in the research process, there is broader investment made in the research, and outcomes and results are hopefully acted upon by all parties involved,” says Worthington.  The goal of the meeting is to form a team to develop a grant proposal for research that would support targeted interventions. 

An inclusive approach to research requires a deep commitment from all parties and when it works well the rewards are significant and meaningful. Both Worthington and Loutfy emphasize that working together in collaboration across disciplines provides a platform for relevant and socially engaged research and an opportunity for deeper levels of understanding and respect. 

Dr Mona Loutfy, MD FRCPC MPH is the CTN Prevention and Vulnerable Populations Core co-Leader. She is currently an Associate Professor in the Department of Medicine at the Women’s College Hospital and heads the Women and HIV Research Program at the Women’s College Research Institute in Canada. She is also the President and Director at Maple Leaf Research adjoined to the Maple Leaf Medical Clinic, Canada’s largest private HIV practice. Focused on the clinical management of HIV infection in women, Loutfy’s work has brought forward innovations such as the Canadian HIV Pregnancy Planning Guidelines. 

Dr Catherine Worthington, PhD is the CTN Prevention and Vulnerable Populations Core co-Leader.

Currently, she is a professor at the School of Public Health and Social Policy at the University of Victoria in British Columbia. Her research focuses on HIV prevention, care and support services development. She has served on the CIHR HIV/AIDS Research Advisory Committee (CHARAC), and also acted as Social Sciences Track co-chair for the Canadian Association for HIV Research (CAHR). Worthington is a principal investigator with the CIHR Social Research Centre in HIV Prevention (SRC), and chairs the Education Committee of the Centre for REACH (Research Evidence in Action for Community Health) in HIV/AIDS.

Clinicians, researchers and representatives from Montreal’s gay community are joining forces to launch a major study, the IPERGAY trial (CTN 268), to evaluate the effectiveness of the drug Truvada in preventing HIV acquisition among individuals who are uninfected but at high risk. If it proves effective, this approach could contribute to eliminating the transmission of the virus that causes AIDS.

In a context in which gay and bisexual men are disproportionately affected by the epidemic (in Montreal, HIV prevalence within this population is estimated to be 13%), community members are mobilizing to assess how new prevention strategies can be added to existing approaches such as condom use.

The IPERGAY study involves comparing the drug Truvada to a placebo (a pill with no active ingredients). Participants will also receive prevention counselling, condoms, and other support, and their well-being will be closely monitored throughout the study. In addition, all participants will be tested for HIV at regular intervals and comprehensive medical care will be provided if an infection is detected.  Part of an international study, the trial aims to include approximately 500 men who have sex with men in Quebec, who will be enrolled for 4 years.  The Montreal study site will be based at CHUM-Hotel-Dieu in collaboration with clinics specializing in HIV treatment and community groups who do outreach to men who are potential candidates for the study.

The concept of daily pre-exposure prophylaxis (taking the medication every day on an ongoing basis) has shown some efficacy in previous studies. However, the success of this approach is dependent on the drug being taken very consistently each day, which can be difficult to maintain over a long period especially among individuals who are not sick. Daily pre-exposure prophylaxis is already starting to be used, but only on a very limited basis. For this reason, we want to rigorously evaluate a different concept, “on-demand” prophylaxis (taken when needed based on the frequency of sexual relations) that has not yet been scientifically validated. Our goal is to learn whether this approach is effective in preventing HIV infection, how easy it is to maintain over the long-term, and how it can be integrated into overall HIV prevention efforts in Montreal.

In the fight against HIV/AIDS, we are living in a period of renewal that has given new hope that an AIDS-free generation may one day be possible. Since the beginning of the epidemic, concerted efforts within the communities hardest hit by the virus as well as by clinicians and researchers have succeeded in transforming a fatal disease into a manageable chronic illness and have inspired belief in the possibility of its eventual eradication.  We are now, once again, gathering our forces to advance the fight one step further.

For more information about the IPERGAY study, please contact:  Ms. Pascale Arlotto, 514-890-8000 ext 15195; This email address is being protected from spambots. You need JavaScript enabled to view it.  

Cécile Tremblay, MD, FRCPC, Principal Investigator, IPERGAY Study – Quebec; Centre Hospitalier de l'Université de Montréal (CHUM); Institut National de Santé Publique du Québec

Mark Wainberg, PhD, Professor, Lady Davis Institute, McGill University

Robert Rousseau, Executive Director, REZO – Santé et mieux-être des hommes gais et bisexuels

Ken Monteith, Executive Director, COCQ-SIDA

Joanne Otis, Canada Research Chair in Health Education (CReCES), UQAM

Thomas Haig PhD, Coordinator, SPOT Project, CReCES, UQAM

Pascale Arlotto, Research Coordinator, CHUM

Gabriel Girard, PhD, Concordia University

Benoit Trottier, MD, Clinique L’Actuel, CHUM

Jean-Guy Baril, MD, Clinique Quartier latin, CHUM

David Thompson, President, Board of Directors, RÉZO

CTN researcher, Dr. Cécile Tremblay is an infectious disease specialist based at the University of Montreal's Faculty of Medicine. Dr. Tremblay is also the Director of Quebec's public health laboratory and she is the Canadian principal investigator for the CTN 268 ANRS IPERGAY trial

As a Communications and Information Officer at the CTN, one of my key tasks is to take scientific writing on CTN trials and new developments in HIV and make these accessible to a larger audience. In this role, I am often confronted with challenging reports and trial protocols that take time to unpack and understand.

Amidst all the complicated science underpinning clinical research, every now and again a paper is published that is abundantly clear and seemingly requires little interpretation. One such paper was published this summer by some of Canada’s leading HIV and hepatitis C researchers. In the paper, the researchers suggest that after having observed over a thousand Canadians living with HIV and hep C for a number of years, over 50 per cent of the deaths recorded might have been preventable. This is a devastating statistic, one that is hard to truly comprehend. 

To learn more about what these findings signal, I spoke to Dr. Marina Klein. She is a clinician and researcher based at McGill University at the Montreal Chest Institute and she is the lead author of the study for the group that was observed to have such high rates of preventable deaths. For the last several years, she has also been the co-leader of the Co-Infections and Concurrent Diseases Core at the CTN and the Principal Investigator for the Canadian Co-infection Cohort (CTN 222).

Health Canada suggests there are 250,000 Canadians living with hep C. Dr. Klein says that up to 30 per cent of Canadians living with HIV also contend with hep C. “We started the cohort study,” she says, “with the aim of understanding how the two viruses, HIV and hep C interact to affect health outcomes and their treatments. It is clear to us that people with co-infections are often not included in key studies evaluating HIV and hepatitis C medications. As a result, there is limited or no information to base treatment recommendations on except expert opinion. The end result is that co-infected patients are often not included in treatment recommendations or the medication are not advised until additional data becomes available.”

The cohort began recruiting participants in Quebec in 2003 with infrastructure funding from the Fonds de la recherche en santé du Québec (FRSQ). With additional CIHR funding awarded in 2006, Dr. Klein with the support of the CTN expanded the study across Canada. It is now one of the largest observational cohorts of its kind, recruiting participants from 16 centres from coast to coast, and following over 1,100 co-infected people. Within the cohort there are extremely high rates of social instability, poverty, mental illness, and alcohol and drug use. Most of the participants live below the poverty line and only 13 per cent have achieved more than a high school education. Aboriginal peoples are disproportionately represented in the cohort and more than 75 per cent of the participants reported a history of injection drug use. Forty per cent report that they continue to inject drugs and over half of the cohort has been previously incarcerated. 

The cohort study has been instrumental in giving researchers a sense of what is going right and what is going wrong with HIV/hepatitis C treatment in Canada. “We have spent a lot of time describing the situation and understanding it,” Dr. Klein says, “ and now we are looking to move to action and intervention. Building on our research we are developing a community-focused health initiative targeted at interventions geared to improving treatment, access to care, and overall health outcomes.”

In terms of addressing what the researchers indicated as preventable deaths, Dr. Klein says “we really need to start targeting interventions aimed at minimizing vulnerabilities and improve social circumstances, reduce the harms from drug and alcohol use and increase the delivery of hepatitis C treatment.” 

With the many new developments in hepatitis C treatments, the management of HIV/hepatitis C co-infection has become more complex. However, as Klein notes, “Because medication-funding criteria is often based on guidelines, co-infected patients end up being denied medications. This is currently being seen with the new hepatitis C protease inhibitors, which are not funded for people living with HIV- hepatitis C co-infection in many Canadian provinces.” 

Working with key partners, Dr. Klein is part of a collaborative CTN initiative led by Dr. Mark Hull (BC Centre for Excellence in HIV/AIDS) to release the first Canadian consensus statement on HIV/hepatitis C co-infection treatment early next year. The new initiative will consist of a set of state of the art guidelines for selecting treatments, treatment timing, and information on drug-drug interactions and will become influential in terms of clinical practice as well as Canadian health policy.  Thankfully, in addition to these guidelines there are many new hepatitis C treatments currently being tested and the future looks very promising for increasing success, reducing the duration of treatment and improving the safety and tolerability of hepatitis C medications. Ultimately we hope, saving lives.

For more information on the guidelines you can email us at: This email address is being protected from spambots. You need JavaScript enabled to view it. .

Research needs you! That’s the tag line of a poster we put about enrolling CTN clinical trials in Canada. It really is the truth. Clinical trials have been a critical part of advancing HIV treatments, but these advances would not amount to much if it were not for the thousands of people who have given significantly of themselves to participate in clinical research in Canada.

In the early to mid 1990s the CTN worked closely with pharmaceutical companies in drug development. Testing new drugs was the primary role of clinical trials in Canada at the time. Finding qualified volunteers for trials was not difficult as people were often eager to get early access to potentially life saving treatments.

The situation in Canada has changed significantly. As access to treatment has improved, the research agenda has shifted. Clinical trials at the CTN still test the safety and effectiveness of new drugs and medical interventions; however increasingly researchers have also turned to look at more subtle refinements of existing treatments, new prevention technologies, managing complex health issues such as co-infections, and learning how to work with and care for vulnerable populations and an aging population of people living with HIV.

Trials at the CTN are now typically public interest studies funded through research grants from agencies such as the Canadian Institutes of Health Research. They are led by individual researchers and connected to other clinics and investigators across the country through our Network. There are currently 35 clinical sites and over 80 signed CTN investigators across Canada. The CTN provides independent researchers with the resources they need to conduct meaningful trials at an appropriate scale.

A unique aspect of CTN endorsed trials is that all the investigations require a community stamp of approval provided by the CTN’s Community Advisory Committee. The nine-member committee brings together people from across Canada who are living with HIV or representing organizations dealing with HIV/AIDS. Members review clinical trial proposals and informed consent forms and make recommendations to the principal investigators conducting the research as well as CTN’s scientific oversight body, the Scientific Steering Committee. This process is key to improving communication between researchers and community representatives, and ensures that the proposed research is relevant and of interest to the community.

CTN clinical trials answer many different research questions. A trial is essentially a carefully designed experiment that allows researchers to assess whether the benefits of a particular treatment or intervention outweigh its risks, and if it will improve the lives of people living with HIV.

In partnership with the Canadian AIDS Society, we put out a handbook called Clinical Trials: What you need to know.  The aim of the handbook is to explain how and why trials are conducted, how people can join a trial, and what they can expect if they decide to participate. The handbook was written in plain language and provides a wealth of basic information for understanding trials. Chapters cover the different types of trials, decision-making, responsibilities and participant rights, benefits and risks, as well as the stages of trial participation. One of the primary themes of this handbook is that people living with HIV play key roles in research, as advisors to the CTN and as volunteers in trials.

In terms of safety it is important to know that all clinical trials are regulated by Health Canada. Health Canada follows Good Clinical Practice (GCP) guidelines developed by the International Committee of harmonization. The CTN Scientific and Community advisory boards also review CTN studies for safety and trial investigators are also required to have their proposals reviewed by various independent and institutional Research Ethics Boards depending on the enrolment sites of the study.

If you are living with HIV and interested in clinical trials, talk to your health care providers or local AIDS organizations about possible alternative treatments. We collaborate with CATIE to publish currently enrolling trials on both organizations websites. 

About the author: Heiko Decosas is a Communications and Information Officer with the CIHR Canadian HIV Trials Network. He has experience in health policy research, knowledge transfer and exchange, broadcast media, and new media production. He currently lives in Vancouver BC.