The Ministerial Council On HIV/AIDS

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Annual Report April 1, 2004 - March 31, 2005

6.4 All streams of HIV/AIDS-related research, including epidemiological, basic science, clinical science, psycho-social and community-based research

Overview

Research is a major component of the federal approach to HIV/AIDS, with close to 40% of the funding under the Federal Initiative to Address HIV/AIDS in Canada ($31.9 million per year by 2008-2009) dedicated to knowledge development. The Canadian Institutes of Health Research (CIHR) is the lead partner for research; CIHR will set priorities for and administer the Federal Initiative's extramural research program in partnership with the Public Health Agency of Canada.

The focus of research under the Federal Initiative will be on: improving population-specific surveillance; epidemiological, socio-behavioural, ethnographic and community-based research; and clinical trials. Legal, ethical, human rights and other social justice research analysis will be conducted and new knowledge transfer opportunities will be established. Capacity building will focus on training the next generation of HIV/AIDS scientists and programs will be developed to enhance research on new prevention technologies such as vaccines and microbicides. Monitoring of strains of HIV and emerging drug resistance will be enhanced and a national research plan will be developed that includes all domains of research. In collaboration with global partners, technical and policy advice and training will be provided to developing countries.

Other federal programs support HIV/AIDS research, such as Genome Canada, which supports research into the role of genetics in immune-based diseases such as HIV/AIDS. Some laboratory research is done by the Public Health Agency of Canada. The Canadian Foundation for Innovation supports HIV/AIDS research infrastructures in universities and not-for-profit institutions across Canada .

As a signatory to the Declaration of Commitment of the United Nations Special Assembly Session on HIV/AIDS (see section 6.5.2), Canada is committed to increasing and accelerating research on HIV vaccines and increasing research to improve prevention, care, treatment, women-controlled methods of prevention, microbicides, and the means to prevent mother-to-child transmission.

In addition to the ongoing need for more research, an issue for all types of research is the transfer of research findings to those working on the front line.

6.4.1 Canadian Institutes of Health Research

The issue

The Canadian Institutes of Health Research (CIHR) is the lead agency for research under the Federal Initiative to Address HIV/AIDS in Canada . CIHR reports to Parliament through the Minister of Health. Under the Federal Initiative to Address HIV/AIDS in Canada, CIHR will receive $22.6 million annually by 2008-2009 which is close to two-thirds of the funding allocated to knowledge development by the Federal Initiative. Under a Memorandum of Understanding that expires in 2006, CIHR is committed to spending from its own budget an additional $3.5 million annually on HIV/AIDS-related research.

CIHR's Institute of Infection and Immunity and the Institute of Aboriginal People's Health have identified HIV/AIDS as priorities, although other CIHR Institutes may become engaged in aspects of HIV/AIDS research. CIHR funds biomedical and psychosocial research in HIV/AIDS and awards fellowships and training support in order to build HIV/AIDS research capacity. The Canadian HIV Trials Network (CTN) receives funding through CIHR under the Federal Initiative to support clinical trials, in addition to funds that CTN receives from the private and public sectors. CIHR also funds community-based research (see section 6.4.2). In 2003, CIHR established a new HIV/AIDS Research Advisory Committee whose role is to identify priorities for HIV/AIDS research. The Committee membership includes CIHR, Health Canada, the Ministerial Council on HIV/AIDS, HIV researchers and community organizations. The Advisory Committee is active in developing requests for proposals and advising on the allocation of funding.

The Ministerial Council monitors CIHR spending, allocations, review processes, transparency and efficiency in order to advise the Minister. The Council also provides its expertise to CIHR on emerging research issues. The Ministerial Council has been instrumental in advising the Minister on HIV/AIDS research, including the transfer of research responsibility from Health Canada to CIHR in 2003. The Council continues to play an active role in working with CIHR and the Public Health Agency of Canada on process and policy issues.

Work done during 2004-2005

• The Ministerial Council monitored CIHR activity related to HIV/AIDS research.
• The Ministerial Council has a representative on the CIHR HIV/AIDS Research Advisory Committee and dialogued with CIHR about the Council's concerns over:
  • the lack of regular Committee meetings
  • the lack of representation on the Committee of those doing community-based research
  • the need to ensure that persons living with HIV/AIDS are represented on the Committee
  • the need to develop terms of reference for the Committee
  • lack of clarity about the funds available for HIV/AIDS research.
• The Ministerial Council had a special presentation from the President of CIHR, the Chair of the CIHR HIV/AIDS Research Advisory Committee and other CIHR officials at its January 2005 meeting. In its presentation to the Ministerial Council, CIHR reported that:
  • its estimated combined additional direct and indirect investment in HIV/AIDS research from its own budget was more than $16 million in fiscal year 2004-2005
  • it funds both strategic initiatives and investigator-driven research. The priority areas for HIV/AIDS research are: prevention interventions; new therapies; co-infections and co-morbidity; drug resistance, end-organ injury such as liver disease; paediatric pathogenesis; and research associated with vulnerable and at-risk populations.
  • health services and population health are two of the four pillars that guide CIHR's work; the others are clinical and biomedical research
  • it is working to make the Community-Based Research Program more effective
  • the CIHR HIV/AIDS Research Advisory Committee advises on research priorities through the Institute of Infection and Immunity; representation is being sought from persons living with HIV/AIDS and those with experience in community-based research.

In its follow-up letters to the President of CIHR and other CIHR officials, the Ministerial Council raised a number of concerns about community-based research (see section 6.4.2) and recommended that CIHR increase its contribution from its own budget in proportion to the increase it will receive from the Federal Initiative. The Ministerial Council recommended that the CIHR HIV/AIDS Research Advisory Committee include representatives from the community and a person living with HIV/AIDS. The Council stated its concern that co-infection research should not draw entirely on HIV/AIDS funds and its desire to engage in ongoing dialogue with CIHR.

Future activities

The Ministerial Council will continue to monitor these issues and provide advice to the Minister.

6.4.2 Community-based research

The issue

The Federal Initiative to Address HIV/AIDS in Canada supports community-based research as part of its commitment to research. The budget for community-based research will be increased to $3.3 million per year by 2008-2009 from its 2003-2004 level of $1.8 million.

Community-based research is research driven by the community; it is undertaken by community-based researchers and organizations, sometimes in partnership with academic researchers and institutions. The primary focus of the community-based research program is to have the community define the research agenda, involve community organizations in research and transfer the knowledge obtained to the community. The Community-based Research Program under the Federal Initiative has two streams: general and Aboriginal. The Institute for Infection and Immunity and the Institute for Aboriginal People's Health of the Canadian Institutes of Health Research have lead responsibility for the general community-based and the Aboriginal community-based research streams respectively.

Both the general Community-Based Research stream and the Aboriginal Community-Based Research stream have a capacity-building component to enhance the ability of communities to engage in research, including fellowships and training grants. The general Community-Based Research stream provides funding for research technical assistants within four regional HIV/AIDS coalitions who work with non-Aboriginal community organizations in their regions to identify, plan and deliver initiatives that build capacity for community-based research. A similar service exists in the Aboriginal Community-Based Research stream. In 2004 the Community-Based Research Program was transferred from Health Canada to the Canadian Institutes of Health Research (CIHR).

As a result of lessons learned in previous years, the program will support organizations without strong financial and administrative capacity to enhance these capacities and will require that research and academic institutions demonstrate a clear understanding of the principles of community-based research.

The relocation of the Aboriginal Community-Based Research stream to CIHR resulted from consultation involving the National Aboriginal Council on HIV/AIDS (NACHA), Health Canada and CIHR. The Ministerial Council maintained communication with NACHA on this issue.

The Federal Initiative to Address HIV/AIDS in Canada provides support for the HIV Community-Based Research Network which serves as a repository of community-based research models, tools, reports and information.

Community stakeholders have voiced concerns over the amount of paperwork required when applying for community-based research grants, as well as the lack of access to ethics review boards and liability insurance for community-based research projects. CIHR requires that all research proposal applications undergo an ethical review to ensure that they conform to CIHR policy for ethical research.

Work done during 2004-2005

• The Ministerial Council met with the Minister of State (Public Health) and stressed the need for community involvement in research. The Minister suggested holding a roundtable on the issue of ensuring that research is patient-and community-driven.
• The Ministerial Council monitored the transfer of community-based research to CIHR and engaged in dialogue about the process with CIHR and Health Canada . The Council had a particular concern about the lack of ethics review boards for researchers who are not affiliated with an institution that has an ethics review board.
• The Ministerial Council had a special presentation at its January 2005 meeting by the President and other officials of the Canadian Institutes of Health Research. With respect to community-based research, CIHR said that there has been a tripling of the number of applications over previous years, which may indicate that the community is comfortable in approaching CIHR. Various approaches to establishing ethical review boards for community-based research were discussed, with no firm recommendation emerging.

In its follow-up letters to CIHR, the Ministerial Council highlighted the need to address the issue of ensuring that community-based researchers have access to ethics reviews. The Council also asked for confirmation of the increased budget for community-based research under the Federal Initiative to Address HIV/AIDS in Canada . The Council expressed its desire to continue the dialogue with CIHR and offered its assistance on research issues.

Future activities

The Ministerial Council will continue to monitor these issues and provide advice to the Minister.

6.4.3 Microbicides

The issue

The Federal Initiative to Address HIV/AIDS in Canada has designated microbicide development as one of its action areas for knowledge development. Microbicides are substances such as gels or creams that can substantially reduce the transmission of sexually transmitted infections when applied either in the vagina or rectum. Microbicides can be used by women whose partners are reluctant to use condoms. For this reason, microbicides are seen to be an important means of decreasing HIV transmission by empowering women to protect themselves against infection, particularly in developing countries. In situations where saying "No" to unsafe sex may not be an option, a prevention method under the control of women could save millions of lives.

There is increasing interest and investment in microbicide research and development although the pharmaceutical industry has been slow to become involved, aside from a few small biotech firms and not-for-profit researchers. Some promising university-based research is being done in Canada. International coalitions of stakeholders are advocating for public funding for the development of microbicides. The Public Health Agency of Canada, the Canadian International Development Agency, the Canadian Institutes of Health Research and a number of stakeholder organizations are actively working to promote the development of microbicides. This year the Canadian International Development Agency made a $15 million contribution to the International Partnership for Microbicides.

Work done during 2004-2005

• In its World AIDS Day message, the Ministerial Council called on Canada to accelerate the development of microbicides in keeping with the World AIDS Day focus on young women and girls.
• The Ministerial Council studied developments in microbicide initiatives, including the possible establishment of a Canadian microbicide steering committee that would steer an action plan to be launched at the International AIDS Conference in Toronto in 2006. This builds on the momentum created by a microbicide symposium held in Canada in 2003.
• The Ministerial Council suggested to the Canadian Institutes of Health Research (CIHR) that it include information on microbicides research in its annual presentation to the Council. In his presentation to the Ministerial Council at its January 2005 meeting, the President of CIHR reported on progress in microbicide research in Canada, including clinical trials and the development of partnerships within Canada and internationally.
• The Ministerial Council wrote to the Minister of International Cooperation thanking her for her interest in microbicides and congratulating her on the $15 million contribution to the International Partnership for Microbicides made by the Canadian International Development Agency. The Council asked to be kept informed about how the funding would be spent and the outcomes of this investment; the Council offered its support on this issue.
• The Research Committee of the Ministerial Council studied the issue of microbicides and had a special presentation from the International Partnership on Microbicides at its March 2005 meeting.

Future activities

The Ministerial Council will continue to monitor these issues and provide advice to the Minister.

6.4.4 Vaccines

The issue

The hope for a cure for HIV/AIDS has been present since early in the epidemic. Research is ongoing to find both a curative and a preventive vaccine. A preventive vaccine is currently in clinical trials but results so far have not been promising. The Federal Initiative to Address HIV/AIDS in Canada has designated vaccine development as one of its action areas for knowledge development.

Canada is part of the international effort to develop vaccines. The Canadian International Development Agency supports HIV vaccine research through its commitment to the International AIDS Vaccine Initiative and the African AIDS Vaccine Programme; Canada is the largest government donor to the International AIDS Vaccine Initiative. The Canadian Institutes of Health Research have received a grant of US$17 million from the Bill and Melinda Gates Foundation to support HIV vaccine research. The Canadian research community has called for a greater federal investment in Canadian-based vaccine research.

The pharmaceutical industry has given little support to the development of a vaccine. The perception of most stakeholders is that this is because the industry is oriented toward drugs and treatment rather than prevention or cure. This results in the need for publicly-funded research in the absence of industry effort.

Work done during 2004-2005

• At its January 2005 meeting, the Ministerial Council had a special presentation from the President and other officials of the Canadian Institutes of Health Research (CIHR). The report included details of CIHR's support for the Canadian Network for Vaccines and Immunotherapeutics and other vaccine projects, including the first Canadian-led clinical trial of a therapeutic HIV vaccine.
• The Ministerial Council maintained a watching brief on HIV vaccine issues.

Future activities

The Ministerial Council will continue to monitor these issues and provide advice to the Minister.

6.4.5 Injection drug use (research)

The issue

Injection drug users are among the fastest growing populations of newly infected Canadians. Research into injection drug use is needed in order to make prevention, care, treatment and support approaches more effective. Both biomedical (e.g. interaction of street drugs with HIV therapies or the existence of co-infections) and psychosocial research is needed using a determinants of health and social justice framework. A research project is currently underway in Vancouver involving a safer injection site.

A pilot study by Health Canada and other stakeholders began in several Canadian cities in late 2003 to establish a surveillance system tracking HIV and Hepatitis C-associated risk behaviour by injection drug users. The preliminary findings suggest that HIV prevalence rates among injection drug users remain high in Canada. This sentinel surveillance system will continue to yield data that can be used to increase the effectiveness of prevention efforts and policies at the provincial/territorial and national levels.

The policy aspects of injection drug use are discussed in section 6.2.5 of this report.

Work done during 2004-2005

• The Ministerial Council kept a watching brief on injection drug use research.
• The Ministerial Council had a special presentation at its June 2004 meeting on the safer injection site project in Vancouver (see section 6.2.5).

Future activities

The Ministerial Council will continue to monitor these issues and provide advice to the Minister.

6.4.6 Medical use of marihuana (research)

The issue

Marihuana has been recognized as a useful therapy for some persons living with HIV/AIDS, although formal research data are scarce. There are few international clinical research studies on smoked marihuana. Canadian research initiatives include:

• Medical Marihuana Research Program (2001-2006) with $7.5 million funding over five years in partnership with the Canadian Institutes of Health Research (CIHR); this program supports research on safety, efficacy and pharmacokinetics
• Marihuana Open Label Safety Initiative in partnership with CIHR; this initiative supports research on dosages and the safety of the medical use of marihuana
• Community Research Initiative of Toronto : research into the effect of marihuana and appetite stimulation, safety and impact on HIV-related symptoms (ended in 2003)
• Contract Research Initiative funded by the federal government to support randomized control trials. Clinical trials to assess the medical effectiveness of marihuana are taking place with the support of Health Canada.

Research-grade marihuana is supplied by Health Canada through a contracted grower. The policy aspects of the medical use of marihuana are discussed in section 6.2.7 of this report.

Work done during 2004-2005

• The Ministerial Council kept a watching brief on this issue and monitored developments at Health Canada and the Canadian Institutes of Health Research to determine if progress was being made on a research strategy for medical marihuana.

Future activities

The Ministerial Council will continue to monitor these issues and provide advice to the Minister.

6.4.7 Epidemiological surveillance

The issue

Effective surveillance of the HIV/AIDS epidemic provides information that is essential for developing effective approaches to prevention, care, treatment and support; it provides essential information for getting ahead of the epidemic as emerging trends become apparent. Surveillance indicates that 56,000 Canadians were living with HIV at the end of 2002, of whom an estimated 17,000 are unaware of their HIV infection. The Federal Initiative to Address HIV/AIDS in Canada will provide $6.3 million annually for surveillance by 2008-2009; sentinel surveillance for vulnerable populations is a designated action area for knowledge development under the Federal Initiative. The Centre for Infectious Disease Prevention and Control of the Public Health Agency of Canada has the lead responsibility for HIV/AIDS surveillance. The Public Health Agency of Canada has a strong focus on surveillance and will be increasing the number of federal surveillance officers placed in provincial offices; some of this increased effort will be devoted to HIV/AIDS surveillance.

Surveillance involves extensive partnerships at the inter-governmental level. The Federal/Provincial/Territorial HIV/AIDS Working Group on Surveillance works to enhance the role of surveillance and targeted epidemiological studies. In addition to the semi-annual reports HIV and AIDS in Canada, special reports have been released in the past year on the epidemic among Aboriginal peoples and among communities from countries where HIV is endemic.

The Joint United Nations Programme on HIV/AIDS (UNAIDS), the World Health Organization and other organizations have recently developed a "second generation HIV surveillance" framework that emphasizes the need for countries to centre their surveillance resources on populations where HIV infection is most likely to be concentrated. Canada has adopted this framework and is piloting several surveillance systems at sentinel centres across Canada to track infection transmission and risk behaviours for vulnerable populations: men who have sex with men; injection drug users; and street youth.

The continuing emergence of antiretroviral-resistant strains of HIV and the need to find new therapies to counteract resistance are ongoing issues. Canada is seen as a world leader in drug resistance surveillance. Health Canada monitors drug-resistant HIV through the Canadian HIV Strain and Resistance Surveillance Program.

Work done during 2004-2005

The Ministerial Council followed developments in surveillance and in the data produced in order to inform its work.

Future activities

The Ministerial Council will continue to monitor these issues and provide advice to the Minister.

6.4.8 Co-infections (research)

The issue

There is a need for research into co-infection because of the complexity of care, treatment and support involving HIV and other infections or diseases such as tuberculosis, Hepatitis C, syphilis and a variety of other sexually transmitted infections, and the co-morbidities of addictions or mental illness. At the end of 1999, more than 11,000 persons living with HIV/AIDS in Canada were also infected with Hepatitis C. Prevention is influenced by co-infections because those living with other conditions may be at increased risk for HIV infection. Epidemiological, clinical and biomedical research into HIV and Hepatitis C co-infection receives support from the Canadian Institutes of Health Research; CIHR has identified issues of co-infection and co-morbidity as a priority area for HIV/AIDS research. Stakeholders have expressed support for increased research on co-infections and have also stated that this research must not be supported solely by HIV/AIDS funding. The policy aspects of co-infections are discussed in section 6.2.8 of this report.

Work done during 2004-2005

• The Ministerial Council kept a watching brief on research and surveillance with respect to co-infections.
• At its January 2005 meeting, the Ministerial Council had a special presentation from the President and other officials of the Canadian Institutes of Health Research. CIHR reported on its support for HIV and co-infections research as a priority area. Most co-infection research to date has been social and behavioural research involving HIV/AIDS and Hepatitis C. In its follow-up letter to CIHR after the meeting, the Ministerial Council underlined its support for co-infection research and its concern that funding for this research not be drawn only from HIV/AIDS research budgets.

Future activities

The Ministerial Council will continue to monitor these issues and provide advice to the Minister.

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