Health Canada/UNAIDS ancillary session at 18th Annual Canadian Conference on HIV/AIDS Research

Summary report

Exploring Ethical and Logistical Challenges in Biomedical HIV Prevention Trials: International examples of Standard of Prevention and Principles of Community Engagement

Given the results of past trials and advances in the field, HIV prevention research faces a number of ethical and participatory challenges in the design and conduct of future research and clinical trials. Topics of particular concern include: community consultation in trial protocol development; the informed consent process; establishment of adequate community advisory mechanisms; and setting standards of HIV prevention and levels of care.

Hosted by Health Canada and UNAIDS, this session was led by a panel of international experts who shared evidence-based lessons learned to inform the conduct of future trials in resource-limited settings, and also to enhance awareness of two publications: The Good Participatory Practice Guidelines for Biomedical HIV Prevention Trials (GPP); and The HIV Research Ethics Guidelines for International Settings.¹

The objectives of the session were to:

• To build capacity of Canadian researchers to undertake HIV prevention research that is grounded in a rights-based approach, in line with best practice in research ethics and community engagement;
• To share experiences using evidence-based examples and case studies to learn from previous HIV prevention trials and inform the conduct of future trials in international settings; and
• To enhance awareness of two sets of guidelines the “Good Participatory Practice Guidelines for Biomedical HIV Prevention Trials”  and the “Research Ethics Issues for HIV/AIDS Researchers in International  Settings - Perspectives from Canadian Experience”.

 

The panellists, in order of presentations, were:
Origin of the ethics and GPP documents and what they say about standard of prevention
Catherine Hankins, UNAIDS

GPP Pilots in twelve settings
Lori Miller, AIDS Vaccine Advocacy Coalition

Standard of prevention and standard of care
Saladin Osmanov, WHO

GCM standard of care in trials
Katie West, Global Campaign for Microbicides (GCM)

Positive Synergies in HIV Research Ethics Guidelines for International Settings
Dan Allman, University of Toronto

Standard of prevention in biomedical HIV prevention trials
Catherine Hankins, UNAIDS

Highlights of deliberations:

• The kinds of research activities highlighted by the session, such as standards of good or best practices, can evolve across time, be they standards of care or standards of prevention. It is imperative that we be prepared to shift guidance about how we do our work - and how we guide others to do theirs - accordingly.
• The community consultations on the Good Participatory Practice (GPP) Guidelines, being led by AVAC, were found to be innovative and necessary. They will be useful in revising and adapting the GPP to community "language". It appears thus far that the document is too technical and translation in other languages is also an issue.  
• As a large number of trials for biomedical HIV prevention research continue, and as more late-stage trial results are made public, there is increasing interest among Canadian researchers and advocates to learn more about this area of investigation. We need to create more opportunities and tools to raise awareness and build capacity for Canadian researchers, policy-makers and community representatives to engage meaningfully in international dialogues, community mobilisation and research efforts around biomedical HIV prevention, including microbicides, vaccines, pre-exposure prophylaxis (PEP) and treatment-as-prevention (treating the HIV-positive partner to reduce transmission).

There were approximately 40 participants who attended the session.

 

• Lori Miller presentation
• WHO/AAVP presentation
• Dan Allman presentation
• Katie West presentation

 

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¹ Health Canada provided funding through its CHVI grant programme to support the development of the Good Participatory Practice Guidelines led by UNAIDS.