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 publications@fhi360.org)

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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