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Stakeholder Engagement and Good Participatory Practices for Global Clinical Trials:
Developing Tools and Models for the 21st CenturyKathleen M. MacQueen, PhD, MPHSocial & Behavioral Health Sciences
AIDS 2014Melbourne, Australia
The PrEP controversies
• Controversies reflected many layers of concern– Distrust surrounding profit motivations of pharmaceutical companies
involved– Experimental use of ARVs for prevention in populations with
limited/no access to ARVs for treatment– Potential for undue inducement and/or inadequate compensation– Appropriate linkage to long-term care for seroconverters – Ancillary care for health issues identified in course of research– Adequacy of informed consent processes
• Concerns centered on exploitation of vulnerable populations in resource-constrained settings
The PrEP controversies
• Separation of treatment and prevention research domains– Dates back to early/mid 1990s
• Knowledge of the science in one domain did not translate easily to the other
• 21st century communication & globalization of social interaction, community-building among stakeholders
• PrEP controversies can be viewed as an expression of civil engagement in science
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Who is “the community”?
21st Century global research includes:
• Multi-site trials• Public-private partnerships• Profit/non-profit sponsors/implementers• Government/foundation/corporate funders• Advocates: population, disease, social causes• Policy: local, national, global
Good Participatory Practice Guidelinesfor Biomedical HIV Prevention Trials
Response to PrEP trial controversies in Cambodia and Cameroon in 2004/2005
Leadership from AVAC and UNAIDS
First edition (2007) developed by international, multidisciplinary working group with input from stakeholders around the globe
The second edition (2011) incorporates feedback gathered through global consultations and piloting
Why were the GPP guidelines created?
To prevent misunderstanding and miscommunication among research stakeholders
Because what happens with one product, in one trial, in one region affects all biomedical HIV prevention stakeholders: trial participants, research teams, funders, sponsors, community
stakeholders, and product developers
GPP Examples of stakeholders
Social, Political, and Economic Context
Host Community Context
Research Context
Photo credits: K. McLoughlin, 2006 (Kampala, Uganda)
Prevention Research Stakeholders
Clinical Trialists
Providers
Civil Society
Product Users/Clients
Community
MacQueen & Cates, Am J Prev Med 2005;28(5):491–495
GPP-TB: extending the model
• Critical Path to TB Drug Regimens (CPTR) initiative
• Stakeholder & Community Engagement Workgroup (SCE-WG)
• 2011 mapping exercise by WG confirmed need for guidance
• In 2012 WG partnered with AVAC to adapt GPP-HIV to TB context
GPP model
Communities of stakeholders Connecting local and extra-local networks of
stakeholders Challenges of inclusiveness: time, human effort,
disparate agendas, divergent principles Tools to support doing GPP Need for evaluation and self-reflection
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Stakeholder Engagement Toolkit for HIV Prevention Trials
Printed copies of the Stakeholder Engagement Toolkit for HIV Prevention Trials are available by request
Email [email protected])
Includes a CD with the 2014 Toolkit Quick Guide and additional resources
Access a web version of the Toolkit Quick Guide at www.fhi360.org
Objectives of the SE Toolkit
• Provide step-by-step guidance to help HIV researchers engage stakeholders efficiently and transparently
• Provide tools to help staff document their plans and experiences as they implement a SE engagement strategy
• Make it easier for research teams in different settings to compare methods and identify best practices
GPP can help bridge from research to roll-out
• Co-learning• Dialog• Advocacy • Debate
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Summary
Science that is not participatory iso Hard to accesso Subject to misunderstanding and misinterpretationo Lacking a foundation for credibility and trusto A closed community
The public engages with the science it can access Credibility and trust are gained through social
interaction Communities are formed and sustained through
social interaction
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THANK YOU!
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