1. Good Participatory Practice (GPP) Guidelines for Biomedical HIV Prevention Trials 2011, Second Edition
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You may use all or part of this presentation, or adapt as necessary for your given audience, objectives of presentation, time available, and other factors. Discussion points have been written in the notes section for many slides. Complete supporting information/content for the points listed in slides can be found in the GPP Guidelines document. If you have questions about the content of this presentation, or would like other help to prepare your presentation, please contact AVAC at

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?
GPP is about working with stakeholders.
Research Investigator
GCP
Trial participants
Stakeholders
Research teams
(and trial sponsors and funders)
Stakeholders
GCP provides guidance to investigators regarding their responsibilities toward trial participants as well as data integrity.
GPP offers guidance regarding the relationships between research teams (and funders and sponsors) and all other stakeholders in biomedical HIV prevention research. It provides systematic guidance on how to engage with other stakeholders in order to shape the design and conduct of the research collectively.
GPP
Stakeholders
Stakeholders
Stakeholders
Stakeholders

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

14. Contents of the GPP guidelines, second edition
The GPP Guidelines are divided into 3 sections. This slide describes each of the 3 sections.

15. The 3 sections are color coded
The 3 sections are color coded. This slide shows the specific contents of each of the sections.
Section 3 – outlines 16 topic areas in the clinical trial process.

16. The Topic Areas are divided into subsections:
Definition
Relevance to good participatory practice
Special considerations
Good participatory practices
Additional guidance
The “meat” of GPP is in Section 3. Section 3 is divided into 16 topic areas. These topic areas are aspects related to preparation, trial design, conduct, and conclusion which take place over the trial life-cycle.
Each Topic Area is divided into subsections.
Subsection D is the most important subsection, as it provides the optimal practices that are expected to be followed.
Groups or individuals wanting to monitor or evaluate GPP compliance should use the good participatory practices listed in subsection D for each of the topic areas.

17. As an example, this slide shows how the Communications Plan is divided into subsections.
Please note: Subsection D only contains 2 practices in this slide, so that all subsections could be shown. Please refer to the actual GPP guidelines to see the full list of practices in subsection D for the Communications Plan.

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
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.

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
Monitoring
Evaluation
Ethics or principles or expectations in society are often turned into guidelines. Guidelines must then be adopted by relevant bodies and resources must be made available to facilitate their adoption and implementation. The guidelines must then be implemented. Once they are implemented, involved entities can be monitored to determine if they have been followed. Stakeholders can then evaluate the outcome: what was the effect of the guidelines being implemented? In the case of GPP, evaluation would help stakeholders determine how stakeholder engagement improved the research.

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.
Implement = using GPP at various levels. Primarily at trial site level; also by sponsors and funders.
Monitor = determining if practices were followed. GPP users and stakeholders may monitor GPP efforts.

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.
Evaluation = looking at the impact of stakeholder engagement

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.
Requirements for each trial are different. They depend on the sponsor of the research, where the funding is from, the country where the research is conducted, and the local institution where the research is conducted.

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.
All of these entities may require that GPP be followed. It will be a different process for different sponsors, in different locations, at different institutions, in different research networks.
Funders and sponsors – can require for funding
National governments – can make part of national guidelines
Ethics Committees or IRBs – can make part of trial review/approval
NGOs/civil society – can advocate for adoption; speak out if not
Research teams - can decide to adopt and implement them on their own; may experience benefits from putting practices in place
Community stakeholders can require that guidelines be followed when research is conducted in their area.
Finally, it may be that GPP becomes a standard just because stakeholders begin to view GPP as the reference document for stakeholder engagement and expect that they will be followed, even if they are not explicitly required by any particular body.

36. Thank you! www.avac.org/gpp
The GPP guidelines are available for download on the AVAC and UNAIDS websites.
Hard copies can be ordered from both websites as well.
Visit the GPP page on the AVAC website to access tools for GPP understanding, implementation, and monitoring.