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
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

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 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

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
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.

8. 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)

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. 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

11. Stakeholder Engagement Toolkit for HIV Prevention Trials
Printed copies of the Stakeholder Engagement Toolkit for HIV Prevention Trials are available by request
Includes a CD with the 2014 Toolkit Quick Guide and additional resources
Access a web version of the Toolkit Quick Guide at

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
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

14. 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

15. Thank you!