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Kathleen M. MacQueen, PhD, MPH Social & Behavioral Health Sciences AIDS 2014 Melbourne, Australia

Stakeholder Engagement and Good Participatory Practices for Global Clinical Trials: Developing Tools and Models for the 21st Century. Kathleen M. MacQueen, PhD, MPH Social & Behavioral Health Sciences AIDS 2014 Melbourne, Australia. The PrEP controversies.

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Kathleen M. MacQueen, PhD, MPH Social & Behavioral Health Sciences AIDS 2014 Melbourne, Australia

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  1. Stakeholder Engagement and Good Participatory Practices for Global Clinical Trials: Developing Tools and Models for the 21st Century Kathleen M. MacQueen, PhD, MPH Social & Behavioral Health Sciences AIDS 2014 Melbourne, Australia

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. GPP Examples of stakeholders

  8. Prevention Research Stakeholders Research Context Host Community Context Social, Political, and Economic Context Civil Society Community Clinical Trialists Product Users/Clients Providers MacQueen & Cates, Am J Prev Med 2005;28(5):491–495 Photo credits: K. McLoughlin, 2006 (Kampala, Uganda)

  9. 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

  10. 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

  11. 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

  12. 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

  13. GPP can help bridge from research to roll-out • Co-learning • Dialog • Advocacy • Debate

  14. Summary • Science that is not participatory is • Hard to access • Subject to misunderstanding and misinterpretation • Lacking a foundation for credibility and trust • 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

  15. Thank you!

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