Meeting of September 8, 9 And 10 2001 - Public Record of Meeting

Committee Reports

Executive Committee
Championing Committee
Monitoring and Evaluation Committee (M & E)
Communications Committee - AIDS
Special Working Group on Aboriginal Issues (SWGAI)
Ad Hoc Committe on Community-Based Research
Business Arising
Additional Items
Health Canada Report
Additional Items - Presentations

Executive Committee

It was reported that the Executive Committee had three teleconferences since the last MC meeting in June. It was noted that administrative issues such as the Council's budget, orientation of new members, and coordination of agenda were discussed.

 Championing Committee

i) National Reference Group on Women and HIV/AIDS

It was mentioned that there are five priority areas in the report, with goals for each, as well as one or more objectives under each.

(1) Societal barriers faced by women
(2) Gender/Cultural sensitive programs
(3) Heterosexual men
(4) Determinants of risk for marginalized women
(5) Access to information and services

ii) Determinants of Health Paper - Joint Project with FPT

As a result of an RFP process, Spigelman and Associates were selected to develop a Determinants of Health Paper for Council and FPT AIDS.

iii) Vaccines

It was reported that Championing has had 2 presentations on this issue - one from Craig McClure and the other from David Thompson, both of whom are involved in the International AIDS Vaccine Initiative (IAVI) and that the details of these presentations were reported at the June MC meeting.

It was reported that Championing has not been able to meet with Kelly MacDonald yet, but once they do, they will report final recommendations to Council.

iv) UNGASS

There was a brief update on the UN Declaration of Commitment endorsed at The United Nations General Assembly Special Session on HIV/AIDS (UNGASS) in June 2001.

It was mentioned that federal government departments may be considering setting targets for Canada, but that funding levels need to be confirmed for each. A Council member indicated that Canada announced it will contribute $150 million toward the Global Fund in Genoa, but the contribution fell well short of what was expected, particularly since billions of dollars are needed and were requested.

For more information on UNGASS declaration www.UNAIDS.org.

v) Gay Men's Reference Group

A brief update on the Gay Men's Reference Group was provided, as well as the BC Community-Based Research (CBR) report that recommends strategies for making prevention work. It was noted that the report will be circulated to any Council member who wishes to see it.

vi) Taking Stock - Adequacy of Funding of CSHA

It was reported that the document has been translated and will be posted on the web site. It was mentioned that it has been very well received in the community and is being used as an advocacy and education tool.

vii) Mother to Child Surveillance Registry

The members were advised that a registry is required in Canada for this discrete population because:

• it is usually excluded from clinical trials and therefore there's very limited data available
• there is potential for increased toxicity or unique toxicity for example: ddI/d4T deaths from lactic acidosis
• people taking the drugs are often doing so not for themselves
• babies born to HIV positive women are exposed to any medications taken by the mother during pregnancy
• often (1/3) come off drugs after delivery

viii) Bill C-217: Blood Samples Act

It was noted that this Bill was previously C-244 and has re-emerged as Bill C-217. The members were told that it had its first reading in February and that subsequent to that, Council had urged that government not allow it to pass to Second reading. The Bill is in debate prior to second reading and will probably be sent to committee after which it will come back for second reading. It was stated that Council may have a role at that point.

ix) RFP on Inter-ministerial Collaboration

The members were advised that the Minister has received Council's advice on interdepartmental collaboration. An aide-memoire is being developed for Cabinet and should be completed by December. The Minister has directed Health Canada officials to undertake research and planning on this issue. In addition, departmental officials are reviewing intra-departmental coordination and collaboration mechanisms. This work will inform the Minister's discussion of this issue with his Cabinet colleagues late this Fall.

x) Health Canada Response to Legal Network on IDU and HIV/AIDS

It was mentioned that the Legal Network released its report in November 1999. It was stated that it contains 66 recommendations on this subject under a number of areas. The Minister's office promised to respond during his December 1, 1999 press conference. On August 31, 2001 Health Canada finally released its response to the report.

xi) Immigration

A letter was sent to the Minister offering Council's assistance to Immigration representatives in policy development of its mandatory testing policy.

xii) Canadian Institutes of Health Research (CIHR) Presentation

Alan Bernstein, President of CIHR did a presentation on the second day of the meeting.

Monitoring and Evaluation Committee - (M & E)

The Monitoring and Evaluation committee presented the revised Council objectives. Council provided further feedback and approved the objectives with the changes suggested. The Monitoring and Evaluation committee agreed to finalize the objectives using the suggestions provided by the Council and present the final version at the next meeting.

Communications Committee - Aids

The Council was informed that the Committee had been asked to start the implementation of the communication plan. It was mentioned that the Communications Committee will immediately deal with the World AIDS Day issues identified by Council at this meeting.

World AIDS Day 2001

It was noted that this year's WAD report is intended to report on the progress of HC and its partners, as well as acknowledge the 20th anniversary of the first case of AIDS in North America.

Members felt that the draft communication plan prepared by the HIV/AIDS Division focuses too much on the successes, rather than the Canadian and global realities of the epidemic. Focusing predominantly on successes could have an adverse effect, undermining public recognition and appreciation of the fact that many people are still at risk of infection.

It was noted that there should be a balance of success stories, tempered with current realities, concentrating on the nature, extent and anticipated progression of the epidemic in Canada.

Special Working Group On Aboriginal Issues (SWGAI)

A summary of SWGAI's activities was provided. The members were advised that the group has not met since the June 2001 meeting. It was also indicated that the FNIHB regional work plans have not been received at the moment.

Ad Hoc Committee on Community-Based Research

The Council was reminded that the Ad Hoc Committee on CBR was set up at December 2000 MC meeting. Shortly thereafter, Council requested an ex-officio seat on the Health Canada CBR Steering Committee.

It was stated that at the last meeting, Council expressed concern with changing time lines and the long process in hiring a consultant to review the program, make recommendations for creating an accessible program and housing it outside Health Canada.

The Council agreed to:

1. Disband the Ad Hoc Committee on CBR given the added confidence that a process is in place for re-developing and relocating the CBR program , and
2. Charge the Championing Committee with ongoing monitoring of the CBR program.

Business Arising

Next Meeting: November 25-26, 2001, Toronto

Additional Items

Ron Clarke, HC - HIV/AIDS Prevention & Community Action Program (PCAP), co-chair of NRG on Gay Men and Tony Caines, co-chair of NRG presented to Council.

Dr. Bernstein provided Council with background information (including a detailed presentation deck circulated at the meeting) on the CIHR.

Health Canada Report

Canadian Youth, Sexual Health and HIV/AIDS Study

Health Canada (HC) advised that, in collaboration with the Council of Ministers of Education Canada (CMEC) is supporting a study to investigate the determinants of sexual health in youth, in relation to HIV prevention. It was mentioned that the Canadian Youth, Sexual Health and HIV/AIDS Study, conducted by a consortium of researchers from the University of Alberta, Queen's University, Université Laval and Acadia University, will go beyond an investigation of the individual behaviours associated with sexual health to an exploration of interpersonal and social determinants of sexual health. It was also noted that a project advisory committee has been formed to provide input on design and implementation of the study, and dissemination of the study findings.

Community-Based Research (CBR)

It was noted that in April 2001, the HIV/AIDS Division established the CBR Transition Team to administer all of the CBR related activities under the Strategy, including the CBR Program, the Aboriginal Research Program, the CBR Capacity-Building Program and the Aboriginal Capacity-Building Program for Community-Based Research.

Some of the activities that had taken place since the last update in June 2001 were outlined. Under the Community-Based and Aboriginal-Based Research (ABR) Programs, he mentioned that the Review Committees for each program met to review proposals received for the NHRDP March 2001 Call. The Committees have conditionally recommended three proposals (1 CBR and 2 ABR) for funding. The CBR Review Committee has requested revisions to 2 additional proposals which will be reviewed by teleconference in early October. With addition of these five proposals, the total number of currently funded research projects will be thirteen (9 CBR and 4 ABR).

Continuously emerging Anti-Retroviral Drug resistant HIV

The Council was advised that Health Canada has put in place a surveillance system to track the emergence of new HIV strains and HIV ART resistance as they appear and spread in Canada.

It was noted that this is an extremely important issue and that the Bureau of HIV/AIDS, STDs and TB is very much involved in the valuable work underway. There have been recently, some reports of multidrug resistant HIV being transmitted among persons under study in Vancouver. The transmission of drug resistant strains of HIV is becoming more widespread in most countries where HAART is used. Persons infected with drug resistant variants of HIV may be at increased risk of drug failure despite being therapy-naïve. However, the prevalence of primary drug resistance and the variation of this prevalence over time, geographic area and population risk group is not yet well enough understood.

Health Canada's Canadian HIV Strain and Drug Resistance Surveillance Program aims to address these questions and the resulting information will be used to develop guidelines for initial therapeutic regimens and to develop more effective HIV prevention strategies, including the prevention of vertical transmission.

HIV among ethnic populations in Canada

Members were advised that available AIDS surveillance data show that in recent years there has been an increasing proportion of cases among people of colour and persons from HIV-endemic countries. The possible reasons for this trend include late diagnosis of HIV, reduced access to treatment, and/or increasing infections in these groups. National HIV data are less clear due to incomplete data on ethnicity, but that the proportion of HIV diagnoses that is reported among People of colour and persons from HIV-endemic countries also appears to be increasing in recent years.

There is a clear need to obtain more complete ethnicity data transmitted from the provinces and territories into the national HIV/AIDS surveillance system to allow for better monitoring of these trends. It was mentioned that Health Canada is committed to continuing to work with provincial, territorial and community partners to improve the ability to monitor HIV/AIDS trends in Canada's ethnic communities. In fact the Bureau of HIV/AIDS STD and TB has field surveillance officers assigned to each province and territory to strengthen the completeness and timeliness of the HIV (and AIDS) data.

CSHA Direction-Setting and Work-Planning Process

In response to recommendations from the multi-stakeholder CSHA Direction-Setting and work planning Task Group, the Council was advised that Health Canada is currently engaged in key activities to help reinvigorate Gray Rocks participants and to reach a broader range of stakeholders.

The HIV/AIDS Division is currently working on a communications strategy which will include a participative web site and an informational brochure that will be widely disseminated. Both of these pieces will be ready in September. It is hoped that these pieces will help spark a renewed interest in a collaborative approach to implementing the ten directions and the planning of Gray Rocks II which is currently scheduled for May, 2002.

The members were told that in order to facilitate collaborative work planning under the Strategy, Martin Spigelman Research Associates have recently been awarded a contract to: (a) gather information on the existing work planning processes of major stakeholders; (b) gather input on what stakeholders' expectations are regarding collaborative work planning under the CSHA; c) design options for collaborative work planning under the CSHA; and, (d) collect their opinions on the most feasible approach for collaborative work planning in 2002-2003 that respects existing individual internal work planning processes.

The Council will be kept informed on a regular basis of the progress leading up to the next Gray Rocks Meeting. He also solicited advice from members as a means of moving forward on any or all of the ten directions. The Council was asked to consider whether or not community will have adequate time to prepare for Gray Rocks II.

HIV/AIDS and Injection Drug Users (IDU)

It was indicated that following up on commitments made in "Health Canada's Response to the Report of the Canadian HIV/AIDS Legal Network," two Requests for Proposals (RFPs) will shortly be disseminated for the purpose of obtaining expert in-depth analyses on two HIV/AIDS and injection drug use issues. The first proposal will examine the implications and feasibility of enabling the provision of illegal drugs to drug users while they are in HIV/AIDS care. The second proposal will examine the practical implications and feasibility of conducting clinical trials to determine how illicit drugs interact with HIV/AIDS drugs and the effect of illicit drugs on the progression of HIV disease. Barriers to the inclusion of injection drug users in clinical trials will also be examined.

Health Canada's focus is on three key areas, including:

• reducing the harm associated with injection drug use;
• providing care, treatment and support; and
• involving injection drug users in policy making.

CSHA Year Three Evaluation

The Council was advised that a draft evaluation report and the draft technical reports are complete and have been submitted to Health Canada's Departmental Program Evaluation Division (DPED), which is leading the evaluation process. In order to ensure a standard of excellence and high quality, the reports will be reviewed by an evaluation peer review panel. The review will focus on the soundness of the evaluation study's methodology, findings, conclusions and recommendations. The peer review panel recommendations will be used by DPED to determine the next steps to complete the evaluation study.

It was confirmed that the final draft report is expected to be ready for circulation to the Ministerial Council and other stakeholders in the Fall.

It was noted that the evaluation is an important tool to ensure that the CSHA remains relevant and responsive to the changing dynamics of the HIV/AIDS epidemic in Canada.

Additional Items - Presentations

Ron Clarke, HC - HIV/AIDS Prevention & Community Action Program (PCAP), co-chair of NRG on Gay Men and Tony Caines, co-chair of NRG presented to Council.

Ron Clarke provided Council with an overview of the NRG, its background, its mandate, some key developments, as well as its current status. He noted that in December 1998, PCAP gathered 35 men to discuss where to take HIV prevention for MSM. That group of men recommended that PCAP begin to address HIV prevention with a larger discussion of health and wellness. He added that a working group was formed from those 35 men to:

• identify the skills and experience necessary to guide a process to advise PCAP; and
• to identify potential members of a reference group.

He pointed out that in June 1999, the NRG on Gay Men was formed. He added that the group met 6 times and had its final meeting in Winnipeg, June 2001, but that final NRG report had been submitted to the HIV/AIDS Division in May.

Ron indicated that the NRG was mandated to advise PCAP on policy and programming issues on HIV prevention for gay men through three main activities:

• completing an extensive literature review favouring Canadian sources
• analyzing the relationship between gay men's health and wellness issues and population health theory and, therefore, the determinants of health; and recommending a strategy for HIV prevention for gay men.

He described the process used for preparing the document as follows:

• The NRG worked with a writer/researcher
• PCAP hired a meeting facilitator so that all NRG members could participate fully at each meeting;
• all NRG members identified resources from their local areas which were sent to the writer/researcher.
• each meeting built on the results of the last and therefore, by mid point, an analysis of the relationship between the health and wellness issues of gay men and the determinants of health was formed and the first NRG document was completed: "Framing Gay Men's Health in a Population Health Discourse"

He stated that six focus groups were conducted:

• professionals who work with gay men, both positive and negative
• HIV positive gay men - national
• HIV negative gay men - national
• Atlantic Canada
• Prairies
• French-speaking gay men

Ron advised members that the final NRG report was presented at the June meeting of FPT/AIDS. He went on to say that:

• The Division committed to craft a response to the recommendations in Valuing Gay Men's Lives by early Fall.
• A Matrix team was formed in May to complete a review of the recommendations.
• The proposed divisional response will be presented to the Divisional Management Team in mid-September 2001 and once the Division has approved the response, it will be made public.

He stated that the report recommends a three stage approach - short, medium and long-term goals - to allow the Division to act on the recommendations. It is the plan of the Matrix team to have developed a Framework for policy and programming for HIV prevention for gay men by March, 2002. This will be done in cooperation with gay men representing established CSHA partners and the FPT - HIV Prevention Coordinators.

Tony Caines spoke about the "Determinants of Health" that are recognized by HC under its Population Health Framework. He mentioned that the determinants are factors and conditions which have an influence on the health of the individuals and communities. He noted that critical to this definition is understanding that the determinants of health do not act in isolation from each other. Rather it is the complex interaction of these determinants that has an impact on the health of individuals and communities.

He outlined and briefly touched on the following determinants:

• Income and Social Status
• Social Support Networks
• Education
• Employment and Working Conditions
• Social Environment
• Physical Environments
• Personal Health Practices and Coping Skills
• Biology and Genetic Endowment
• Healthy Child Development
• Health Services
• Gender
• Culture

Presentation #2

Dr. Bernstein provided Council with background information (including a detailed presentation deck circulated at the meeting) on the CIHR.

He noted the CIHR Objective :

"To excel, according to internationally accepted standards of scientific excellence in the creation of new knowledge and its translation into improved health for Canadians, more effective health services and products and a strengthened Canadian health care system..."

He noted the 4 research streams as :
Biomedical; Clinical; Health services and health systems; Health of populations, societal and cultural dimensions of health, and environmental influences on health

Dr. Bernstein added that the CIHR has 13 Institutes and 6 of them have an HIV/AIDS component (as denoted by the asterisks *)

• Aboriginal Peoples' Health*
• Cancer Research
• Circulatory and Respiratory Health
• Gender and Health*
• Genetics*
• Health Services and Policy Research*
• Healthy Aging
• Human Development and Child and Youth Health
• Infection and Immunity*
• Musculoskeletal Health and Arthritis
• Neurosciences, Mental Health and Addiction
• Nutrition, Metabolism and Diabetes
• Population and Public Health*

He advised Council that the CIHR has Institute Advisory Boards

• Membership made up of researchers, voluntary sector organizations, patient groups, individual citizens, public/private sectors
• Provides advice to Scientific Director on strategic directions for the institute
• Key link between institute and community
• Helps represent the institute in the community

He touched on Ethical Review of Research Proposals at CIHR, indicating that

• All research that involves human subjects requires review and approval by a Research Ethics Board (REB) in accordance with the Tri-Council Policy Statement
• Institutions or organizations that are eligible to hold a grant from CIHR must have their own REBs or may share a REB

Dr. Bernstein went on to say that CIHR supports:

• Investigator-initiated research proposals
• Any area of health research
• Open competition
• Strategic Research Initiatives
• Priority areas chosen by Institutes
• Requests for application

He spoke about Competitions at CIHR - HIV/AIDS, discussed the Operating Grants & Peer Review process, and more specifically addressed the HIV/AIDS Peer Review at CIHR.

He talked about Funding Decisions and stated that:

• HIV applications have their own ranking list
• Funding cut-off based on funding envelope available for a particular competition (pool of CSHA and CIHR funds)
• Until recently, HIV/AIDS applications have had an advantage in having a lower cut-off than regular applications
• The HIV/AIDS research community developed to the point that the special envelope was constraining its potential
• CIHR, by committing extra funds, currently ensures that at least all HIV/AIDS applications above the regular cut-off are funded

Dr. Bernstein touched on the HIV/AIDS Research Personnel Awards 2001-2002, and listed the HIV/AIDS Research Grants 2001-2002:

• Approved 15 Operating Grants, 2 Groups and 2 Clinical Trials
• Total, including ongoing grants
• 74 Operating Grants
• 3 Groups
• 3 Clinical Trials

Dr. Bernstein touched on HIV/AIDS Research, noting the following:

• Canadian Strategy on HIV/AIDS (CSHA) began in May 1998 and included, on an annual basis $4.6 M for biomedical/clinical research administered by the Medical Research Council (MRC )
• NHRDP administered the following: $3.2 M in infrastructure support for the Canadian HIV Trials Network (CTN); $2.425 M for epidemiological and public health research; 1 M for community-based research; $0.8M for aboriginal community-based research
• Solid working relationship between Health Canada and CIHR resulted in a new letter of agreement effective July 1, 2001 transferring the administration of the Canadian HIV Trials Network and epidemiological and public health research to CIHR
• CIHR remains accountable to the CSHA for the use of CSHA funds
• Health Canada and CIHR are working on an official announcement of the new agreement

He advised Council of CIHR's Investment in HIV/AIDS:

• In 1998, MRC had committed to an average of $2 M per year for 5 years
• Under new 2001 agreement, CIHR's commitment is at least $3.5 M per year for 5 years
• In 2001-2002, CIHR's actual spending on HIV/AIDS is $4.6 M

He also mentioned the Canadian HIV Trials Network (CTN)

• National, non-profit organization created to facilitate the conduct of scientifically sound and ethical HIV/AIDS clinical trials in Canada
• $3.2 M per year until March 31, 2003
• Evaluation to be carried out in 2002, prior to renewal

Dr. Bernstein talked about OPTIMA study which the CIHR is funding, noting that it is

• Designed to evaluate the best treatment strategies for HIV-infected patients for whom highly active antiretroviral therapy has failed
• First study supported by a Trinational Clinical Trials Research Initiative involving CIHR, the US Department of Veterans Affairs and the MRC-UK
• 1700 patients, US$15.3 M
• Coordinated in Canada by the Canadian HIV Trials Network
• 22 centres in Canada, 400 patients

He discussed HIV/AIDS Research Priority Setting, indicating that

• CIHR (led by the Institute of Infection and Immunity) and Health Canada will develop a research priority setting mechanism that is inclusive of CIHR, Health Canada, HIV researchers and other stakeholders
• As research priorities are determined, CSHA funds will be used for more strategic approaches while opening the overall CIHR budget to HIV/AIDS research in general

Dr. Bhagi Singh, Scientific Director of Institute of Infection and Immunity (III) within CIHR, provided Council with an overview of his institute.

He mentioned that the Priority Areas for Strategic Initiatives are:

• Food and Water Safety
• HIV/AIDS*
• Hepatitis C/Blood Borne Infections
• Innovative Vaccine Development and Delivery
• Asthma
• Antimicrobial Resistance
• Transplantation
• Autoimmune diseases with focus on Type 1 Diabetes

He touched on the Institute of Infection and Immunity (III), with an emphasis on HIV/AIDS research objectives which are to.

• Explore national AIDS advisory partnership
• Facilitate translation of novel interventions for prevention and treatment of HIV infection
• Evaluate HIV therapeutic regimes and assess their effect on disease transmission
• Investigate adverse effects to HIV therapies; evaluate impact on health and quality of life of HIV-infected persons
• Support HIV vaccine preparedness studies and vaccine clinical trials

He spoke briefly on HIV/AIDS Research, indicating that

• HIV/AIDS falls under the purview of the Institute of Infection and Immunity (III)
• III will take the lead in determining HIV/AIDS research priorities for CSHA funds using a mechanism that is inclusive of CIHR, Health Canada, HIV researchers and other stakeholders
• III will develop partnerships with agencies and groups to augment research funding in HIV/AIDS
• Global Health and Rural Health Initiatives have HIV/AIDS foci and III input

Dr. Singh talked about the Institute of Infection and Immunity (III) HIV/AIDS Strategic Planning, noting that

• Consultation with national HIV/AIDS researchers and Health Canada is underway
• Other stakeholders will also be invited to provide input
• Comment and advice from the Ministerial Council is also invited
• Develop and launch Request for Applications (RFA)

He also touched on AIDS Research Needs

• Social impacts
• Clinical outcomes
• Vaccine development
• Evaluating prevention and intervention programs

Dr. Singh told Council of the HIV/AIDS Clinical Trials

• Jonathan Angel, U. Ottawa: The impact of therapeutic HIV vaccination followed by a scheduled interruption of antiretroviral therapy on HIV-specific immune function by a scheduled virologic rebound in patients with prolonged viral suppression
• Stephen Moses, U. du Manitoba: A randomized, controlled trial of male circumcision to reduce HIV incidence in Kisumu, Kenya, Sharon Walmsley, University Health Network, Toronto: A prospective randomized trial of structured treatment interruption (STI) versus immediate switching in HIV-infected patients experiencing virologic failure on HAART