1. Good Participatory Practice (GPP) Guidelines for Biomedical HIV Prevention Trials 2011, Second Edition

2. Why were the GPP guidelines created?  In response to the pre-exposure prophylaxis (PrEP) trial controversies in Cambodia and Cameroon in 2004 and 2005  To help prevent misunderstanding and miscommunication among research stakeholders  Based on the idea that 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

3. GPP guidelines development  Just as other aspects of clinical trial conduct are informed by guidelines, the relationship between research entities and stakeholders should be informed by a set of guidelines.  The GPP guidelines were developed to facilitate the building of effective partnerships among all research stakeholders.

4. GPP guidelines development  The first edition of the guidelines was developed by an international, multidisciplinary working group, with input from stakeholders around the globe.  The second edition incorporates feedback gathered through global consultations and piloting.

5. GPP guidelines development  The guidelines are meant to serve as a companion to the UNAIDS/WHO publication Ethical Considerations in Biomedical HIV Prevention Trials.  More specifically, they are intended to explain how “Guidance Point 2: Community Participation” can be applied.

6. GPP guidelines, second edition

7. What is the objective of the 2011 GPP guidelines?

8. Objective of the GPP guidelines  To set global standard practices for stakeholder engagement.  To provide trial funders, sponsors, and implementers with systematic guidance on how to effectively engage with stakeholders in the design, conduct, and outcome of biomedical HIV prevention trials.

9. Who should use the GPP guidelines?

10. Intended audience of the GPP guidelines  The GPP guidelines are primarily written for trial funders, sponsors, and implementers.  Stakeholders, such as NGOs, policymakers, and CABs, can use the GPP guidelines to understand the methods of stakeholder engagement and to evaluate the engagement efforts of research teams.

11. How is GPP different from Good Clinical Practice (GCP)?

12. How is GPP different from GCP? Research Investigator Trial participants GCP Research teams (and trial sponsors and funders) Stakeholders GPP GPP is about working with stakeholders.

13. What is in the second edition of the GPP guidelines?

14. Contents of the GPP guidelines, second edition

16. The Topic Areas are divided into subsections: A.Definition B.Relevance to good participatory practice C.Special considerations D.Good participatory practices E.Additional guidance

18. How does GPP define stakeholders ?

19. Definition of stakeholders The GPP guidelines define stakeholders as individuals, groups, organizations, government bodies, or any other individuals or collections of individuals who can influence or are affected by the conduct or outcome of a biomedical HIV prevention trial. In the guidelines, the term “stakeholders” is all- encompassing and includes any individual or collection of individuals who have a stake in a biomedical HIV prevention trial.

20. Examples of stakeholders

21. How do the GPP guidelines define stakeholder engagement?

22. Definition of stakeholder engagement  It is a process through which trial funders, sponsors, and implementers build meaning relationships with stakeholders.  Its goal is to shape the research process by using the expertise of stakeholders.  It is not recruitment!

23. Why is stakeholder engagement necessary in the research process?

24. Why stakeholder engagement? Stakeholder engagement improves research quality:  Stakeholders, especially community stakeholders, have critical knowledge about local cultures and dynamics of the HIV epidemic that trial entities may lack. Their feedback can help ensure that the research and procedures are culturally sensitive and appropriate.  A wide range of stakeholders can give research teams advice about research questions, procedures, and conduct.  Stakeholders’ advice can lead to better recruitment, better retention, better adherence, better data, and greater likelihood of uptake, should HIV prevention interventions prove safe and effective.

25. Why stakeholder engagement? Stakeholder engagement not only makes the research better; it is also ethical. If stakeholders will be affected by the research, even if only in an indirect or a minor way, they have the right to be meaningfully engaged and to help shape the process.

26. How can research teams engage with external stakeholders?

27. Stakeholder advisory mechanisms Engaging with CABs is only one of many, many ways in which research teams can engage with stakeholders.

28. Stakeholder advisory mechanisms Engaging with CABs is often necessary but is seldom sufficient for adequate stakeholder engagement. Many mechanisms exist for effective engagement between researchers and the wide array of research stakeholders.

29. How can the GPP guidelines be used most effectively?

30. They must be adopted and implemented Ethics, principles, expectations Development of guidelines Adoption of guidelines and Establishment of resources and support for participatory practices Implementation of participatory practices MonitoringEvaluation

31. Ensuring GPP uptake Implement:  Trial sponsors and research teams should follow the practices outlined in subsection D for each GPP topic area.  Implementation should be tailored to individual site and research environment. Monitor:  Stakeholders can assess.  Research teams can assess themselves.  Community stakeholders, such as community groups or CABs, can assess research teams.  Trial monitors can conduct assessments.

32. Ensuring GPP uptake Evaluate:  How did the engagement improve the research?  Did stakeholders provide useful feedback during the research lifecycle?  How do various stakeholders feel about the quality of the engagement process and their relationships with the research team?  Can an association be made between engagement and trial outcomes? Note: As with monitoring, all stakeholders can be involved in the evaluation process and share their perspectives.

33. How will the GPP guidelines be adopted?

34. How will GPP be adopted?  Investment in building relationships is a long-term process!  Adoption of the guidelines will be different in every setting. There isn’t one answer or formula. It will depend on the country, institution, sponsor, and trial site.

35. Who can require adherence to GPP guidelines?  Funders and sponsors  National governments  Ethics Committees or IRBs  NGOs/civil society  Research teams  Community stakeholders Or... increased awareness may cause GPP to become standard practice for conducting research.

36. Thank you! www.avac.org/gpp