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What is Good
Participatory Practice?
Stacey Hannah
Jessica Handibode
14 June 2014
What is GPP?
• Unique set of guidelines
around stakeholders’ roles in
research
• First normative framework
• Builds on existing programs
• 2007 – guidelines established
• 2011 – publication of 2nd
edition
Why were the GPP guidelines developed?
• In response to PrEP trial government shut-downs in Cambodia
and Cameroon in 2004 and 2005. (PrEP trials in four of five
countries prematurely closed)
 To facilitate the building of effective partnerships among all
research stakeholders including “community” to ensure
successful trials
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.
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.
Contents of the GPP Guidelines, Second Edition
Sections of the GPP Guidelines
GPP topic areas
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
Section 3 of GPP guidelines
What GPP Is NOT
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Not recruitment
Not retention
Not a CAB
Not participant-trial site interactions
Not about a single trial
Not a “nice to have”
It IS core to the research and development
process
Did You Say GCP?
GCP ≠ GPP
Research
Investigator
GCP
Trial
participants
Stakeholders
Research
teams
(and trial
sponsors and
funders)
GPP
Stakeholders
Stakeholders
Stakeholders
Stakeholders
Stakeholders
Not Just a CAB
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.
It’s a Process
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
They must be adopted and implemented
Adoption of
guidelines
Ethics,
principles,
expectations
Development
of guidelines
and
Establishment
of resources
and support for
participatory
practices
Implementation
of participatory
practices
Monitoring
Evaluation
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.
Ensuring GPP uptake
Evaluate:

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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.
GPP in the News
GPP Implementation
National level
• IRB training
• Incorporation into national
policies/regulations
• National stakeholder
advisory boards
Trial level
• Staff, community trainings
• Site evaluations/assessments
• Implementation in trials
• Tools, template development and use
International level
• Endorsement by funders, networks
• Broader adaptation
• Community of practice
• International conference highlights,
sessions, presentations
Where Are We Now?
National level
• National GPP plan and N-CAB in
Thailand
• National framework,
incorporation into ethics review
processes in South Africa
• Incorporation into ethics
guidelines in Uganda
Trial site level
• FACTS 001
• iPrEX
• ASPIRE
• IAVI partner research centers
International level
• Adaptation to other fields, e.g., TB
and fetal distress
• Endorsement by Presidential
Bioethics Commission
• Global consultations, e.g.,
proposed ECHO trial, MTN-017
• Reconstitution of Stakeholder
Engagement CoP
Recommendations and Adaptations
• Adapted for TB drug trials
• CPTR request to AVAC
• Adapted topic areas to be
relevant to TB drug trials
• Published in 2012
• Ongoing collaboration
through CoP, etc.
• US Presidential Bioethics
Commission recommendation
• Interest in adaptation/
application for HIV cure, fetal
distress research
Supplementary GPP Tools
• Understand
– Training curricula for trial sites, community, and
other stakeholders
• Implement
– Tools for community mapping, how to identify
stakeholders, formative research activities,
templates
• Monitor & evaluate
– Tools to develop indicators for measuring
process and impact for research and community,
e.g. checklists, matrices, interview guides
Online Training Curriculum
• Being developed for
multiple audiences
• Primary focus on trial
implementers – key
objective to develop
strategies, workplans
• Interactive
asynchronous content
• Moderated courses
• Will launch Oct. 2014
GPP Blueprint
• Influenced and aligned
with the research agenda
• Guides user through the
creation of goals and
objectives for stakeholder
engagement
• Creates benchmarks that
can be used for
monitoring & evaluation
Tools
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Circle Diagram
Participatory Community Mapping
Listing, Scoring Ranking
Stakeholder Interview Questions
GPP Strengths and Gaps
GPP Summary Sheets
Circles Diagram
• Prioritize and connect key issues, concerns and
community perceptions of proposed or
ongoing research
• Determine community perceptions of GPP
Circles Diagram
• Can be used with the Listing, Ranking, Scoring
document or other tools that capture
perceptions and issues of trials.
• Facilitate a deeper conversation about one or
two issues
Participatory Community Mapping
• Facilitate community participation in the
research process
• Creates visual representation of “community”
boarders
Participatory Community Mapping
• Can be used to create recruitment hot spots or
map safe zones
• Facilitates in the definition of “community” by
allowing communities to determine their own
borders
Listing, Scoring, Ranking
• Identify key issues, concerns and community
perceptions of proposed or ongoing research
• Facilitate community participation in the
research process
Listing, Scoring, Ranking
• Gauge community impressions on specific
events such as protocol design or results
dissemination
• Help determine engagement priorities
Stakeholder Interview Questions
• Set of questions that can be used to assess
adherence to the GPP guidelines
• Can be used as one component to monitor
engagement strategies being conducted at
research sites
GPP Strengths & Gaps
• Can be used as one component to monitor
engagement strategies being conducted at
research sites
• Can be used throughout the lifecycle of a trial
to assess the effectiveness of a site’s
stakeholder engagement plan
GPP Summary Sheets
• An at-a-glance summary of the GPP guidelines
• Provide specific stakeholder considerations for
each stage of the trial lifecycle
GPP Summary Sheets
• Can be distributed to stakeholders who should
be aware of guidelines but are not directly
involved with implementation
Other Resources
• HANC/Community Partners
Recommendations for Community
Involvement
• DAIDS Learning Portal
• DAIDS Learning Management System
• DAIDS Social Learning Community
• FHI360 Stakeholder Engagement Toolkit
• Stakeholder Engagement Community of
Practice
Who is AVAC?
Deliver proven tools for immediate impact
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Testing
Treatment
Voluntary Medical Male Circumcision
Female and male condoms
Prevention of pediatric infection
Syringe exchange programs
C O M B I N E
• End confusion about “combination
prevention”
• Narrow gaps in treatment cascade
• Prepare for new non-surgical male
circumcision devices
Demonstrate proven tools for immediate impact
• Define and initiate the “core
package” of PrEP demonstration
projects
• Daily oral TDF/FTC as PrEP
• 1% tenofovir gel
Develop long-term solutions to end the epidemic
• Safeguard HIV Prevention Research
Funding
Years to Impact
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GOAL: A sustained
decline in HIV
infections (now at
2.5 million/year)
AIDS vaccines (px and tx)
Multi-purpose prevention technologies
Next generation ARV-based prevention
Rectal microbicides
Non-ARV-based microbicides
Cure
Zero to 5
AVAC Report 2012: Achieving the End – One year and counting. www.avac.org/report2012.
5 to 10
10 to End
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Contact Information
• GPP
– Avac.org/gpp
• Stacey Hannah
– [email protected]
• Jessica Handibode
– [email protected]

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