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 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 Overview of PrEP controversies as an expression of civil engagement in science Separation of treatment and prevention research domains 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

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 Guidelines for 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 Community Stakeholders, in general, refers to both individuals and groups that are ultimately representing the interests of people who would be recruited to or participate in a trial, as well as other local groups and individuals affected by a trial. In general, this includes stakeholders in the locale of a trial/trial site/trial participant (refer to examples in community stakeholders ring). Broader, national, global stakeholders represent groups who may not be in the given locale of the trial/participant, but could have significant influence on a trial or the broader research process/agenda. It is important to note that GPP includes all levels of stakeholders. Community engagement efforts often focus on inner-most layer of stakeholders, but engagement must be broader, hence preference for the term stakeholder engagement. Trial funders, sponsors, and implementers, as well as government bodies and representatives of high-level authority structures, are explicitly excluded from the definition of “community stakeholders” but are clearly considered “trial stakeholders." The diagram here provides examples of stakeholders and how they might be related to one another. This diagram is meant to be illustrative and is not meant to provide exact definitions or categories.

Prevention Research Stakeholders Civil Society Social, Political, and Economic Context Host Community Research 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)

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

Communities of stakeholders 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 Dialog and co-learning that resulted, beyond the confrontations Emergence of Good Participatory Practices model Communities of stakeholders inclusive of advocacy/policy, research enterprise, research participants, and service providers in addition to geographic communities 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

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 Bridging from research to roll-out PrEP highlights importance of continuity of engagement with full range of stakeholders from concept to program implementation Co-learning, dialog, advocacy, debate

Science that is not participatory is 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 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

Thank you!