Canadian HIV Vaccine Initiative

Consultation on CHVI Funding Programs

Policy Development and Community Engagement

Global Context

Presentations were made by two leading experts in the areas of policy and community engagement related to HIV prevention efforts, as follows:

Dr. Robert Hecht - Senior Vice President, International AIDS Vaccine Initiative (IAVI)
AIDS Vaccine Policy Issues

Dr. Hecht highlighted the need for sound policy choices to establish a strong enabling environment for R&D and to ensure future access.  In addition to scientific and political challenges, researchers in HIV vaccine research face policy challenges that include:

• Constrained and unpredictable financing;
• Lack of incentives for bio-medical industry and innovation research;
• Ethical issues and regulatory barriers; and
• Future vaccine delivery/health systems challenges.

By employing a range of push and pull mechanisms, and effective policy analysis, incentives can be created to encourage the desired behaviour from the private sector, academic institutions and governments.   Effective policy can promote innovation in R&D and strengthen community engagement in HIV vaccine trials.  It can also have a positive impact in reducing the disease burden and thereby helping to achieve the MDGs.  One notable policy impact was the development of advance market commitments (AMCs), to entice private sector participation in a field, where market inducements had been traditionally poor.  The key areas for HIV vaccine policy in the next three to five years include promoting scientific innovation; implementing schemes for sustainable financing; expanding developing country R&D capacity; maintaining political support; and forging synergistic collaboration between actors in HIV prevention and other R&D efforts. Advocacy actions could also spur on changes in existing policies. Robert Hecht’s presentation

Mitchell Warren - Executive Director, AIDS Vaccine Advocacy Coalition (AVAC)
An Update on the Development of Good Participatory Practice Guidelines in HIV Prevention Trials

Mitchell Warren updated participants on the HIV products pipeline and elaborated on the AIDS Vaccine Advocacy Coalition (AVAC’s) Good Participatory Practice (GPP) guidelines for biomedical HIV prevention trials.

In comparison with the pipeline in September 2006, there is a dearth of products pipeline in February 2008. This change has a direct impact on participants, investigators, trial sites, funders, communities, developers, and all linkage services related to HIV prevention trials.
The objective of the GPP guidelines is to establish clear, global standards for community participation and input in HIV prevention trials and to provide guidance on sound participatory practice guidelines for biomedical HIV prevention trials. The document outlines 10 core principles; describes essential activities; and illustrates these throughout the research life-cycle.

The GPP document has the potential to be the basis for and/or a tool in community advocacy around HIV prevention research.  Community input is essential to ensure that the principles and minimum elements of good practice are accurate, feasible and appropriate. Mitchell Warren's presentation

Policy Development and Community Engagement Fund Objectives

Gloria Wiseman, Director, International Health Division, International Affairs Directorate, Health Canada made a brief presentation on this funding stream. She stated that the fund is meant to strengthen rights-based approaches for the development of a safe, effective, affordable and globally accessible HIV vaccine and to ensure community engagement.  The key objectives envisaged under this component are as follows:

1. Strengthen vaccine policy approaches that promote global access to HIV vaccines;
2. Collaborate with partners in Canada and in low-and-middle-income countries in advancing legal, ethical and human rights dimensions of HIV vaccines, R&D, delivery; and
3. Strengthen existing mechanisms to support community involvement in vaccine R&D, clinical trials and activities related to public awareness and education.

The funding plan and program will require projects to have both domestic and international components, with the principal recipients being Canadian NGOs. Gloria Wiseman's presentation

Stakeholder Input

Although some items are distinct, the policy development and community engagement components of this funding stream overlap somewhat.  As well, the community engagement component includes a variety of activities related to clinical trials, affected communities, people living with HIV, gay men, women, Aboriginal communities, among others.

Activities in community engagement could be structured to integrate advocacy, training, participation in trial design, recruitment for trials and policy development.  At the same time, the policy development component could include regulatory frameworks and environment, intellectual property, and access, among other issues. Participants recognized the need to develop linkages with the other funding streams, particularly the clinical trials and social research funding stream.

Proposed Funding Structure

Participants stated that timing and sequencing should be taken into account when establishing priority activities to be funded. The funding stream should build on collaborative-learning between Canada and international institutions.

There was a recognition that this work needs to be located in the context of other/broader prevention efforts, including global HIV efforts and development work.

This work should also be integrated into existing global networks/efforts, such as the UNAIDS Programme Coordination Board (PCB), the Global Fund, the African AIDS Vaccine Programme, the Global Campaign for Microbicides, as well as regional networks/mechanisms operating in Africa and Europe.

Funding Mechanisms

Participants agreed that the mechanisms for the policy and community engagement fund should:

• Adopt a call for proposals process that is broad enough to encourage innovation;
• Follow an RFP process, which would be simple and quick, and, if possible, a Letter of Intent process should be considered to make the application process as easy as possible;
• Include multi-year options;
• Encourage groups to build on existing work, and institute funding criteria that require  prospective applicants to have experience in HIV work;
• Clearly define national and international components of projects/activities;
• Include a global dissemination and collaboration component in proposed projects/ activities;
• Encourage multi-sectoral engagement; and
• Clarify eligibility criteria and the definition of “Non-Governmental Organization” for the purpose of the fund.

Summary of Priorities

1. Clarify CHVI’s Secretariat’s Role

Participants stated that the role of the CHVI Secretariat needs to be better defined and communicated to stakeholders and that it should consider supporting parallel activities in each fund, in order to ensure integration of linkages and lessons learned between them.

2. Community Awareness and Preparedness

Community awareness and preparedness was an activity that was strongly recommended for funding to develop adequate resources and tools to support community organizations in HIV vaccine research and clinical trials.  Community engagement is crucial in all three funding streams. As such, it would be useful to build a forum for each stream to come together and collaborate, at least, every 18 months.

3. Policy Mapping

One of the first activities they suggested was an environmental scan of both domestic and international policy and community engagement landscapes, and to use that as a basis for further work in that field. 
Participants recommended that an initial policy mapping be undertaken outside of the RFP to avoid delaying the funding call--the Canadian HIV Vaccines Plan provides a good basis for policy and community engagements issues.  A follow-up consultation with community/policy stakeholders should be held, once the initial mapping is completed.

4. Inclusiveness and Linkages

Participants stated the importance of ensuring inclusiveness by creating linkages with other HIV/AIDS prevention technologies and by clearly defining eligibility criteria and taking care not to exclude potential community groups.  Therefore, linkages need to be created and components of the three funding streams need to be reinforced, and CHVI’s work should be situated within the broader context of HIV prevention efforts.