Download Effective Stakeholder Engagement - AVAC: Global Advocacy for HIV

STAKEHOLDER ENGAGEMENT
IN CURE RESEARCH
HIV Cure Research Training Curriculum
Stakeholder Engagement in Cure Research Module by:
Jessica Handibode, AVAC
February 2015
The HIV CURE training curriculum is a collaborative project aimed at making HIV
cure research science accessible to the community and the HIV research field.
Session Goals
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What is stakeholder engagement
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Why is engagement important for cure
research
•
Lessons learned from other HIV fields
Racial Stigma
Homophobia
Stigma
Personal
Health
Gender Based
Violence
HIV-positive
Diagonosis
Food security
Treatment
Access
Job security
Discrimination
Criminalization
Housing
security
poverty
Defining Community
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Individual’s community is fluid
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Multiple memberships
•
Establish a working definition
Defining Community
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“A group of people with diverse
characteristics who are linked by social ties,
share common perspectives, and engage in
joint action in geographical locations or
settings.” (McQueen, 2001)
“who is included and who is excluded from
membership” (IOM, 1995)
The Denver Principles
Community involvement in HIV research
began with the Denver Principles in 1983
when PLWHIV demanded a place at the
table.
Where Engagement Fits
Lesson Learned From HIV Prevention
PrEP Research trial controversy
2004- Cambodia trials were not initiated
2005- Camaroon and Nigeria trials discontinued
Guiding Principles of Engagement
Integrity
Transparency
Mutual
Understanding
Accountability
Good Participatory Practices
Respect
Effective Stakeholder Engagement
Community
Stakeholder
Autonomy
How can we define stakeholders?
Global Stakeholders
International
NGOs, Trial
sponsors,
WHO/UNAIDS,
International
Foundations,
Funders
Participants
National Stakeholders
Participants
National NGOs,
Ministries of
Health,
Regulatory
Bodies, Ethical
Review
Committees
Broader Stakeholders
Participants
NGOs, Local
Policymakers,
Local Media,
Medical
Professionals
Community Stakeholders
Participants
CBOs, participant
family, friends,
schools, peers, trial
site staff, local health
service providers,
community advisory
boards, traditional
leaders
Good Participatory Practices: HIV Prevention vs Cure
Formative Research Activities
Formative Research
Activities
Stakeholder advisory mechanisms
Stakeholder Engagement Plan
Stakeholder Engagement
Plan
Stakeholder Education Plan
Communications Plan
Issues Management Plan
Issues Management Plan
Site Selection
Protocol Development
Protocol Development
Informed Consent Process
Standard HIV Prevention
Informed Consent Process
Access to HIV Care and Treatment
Non HIV-Related Care
Access to HIV Care and
Treatment
Policies on Trial-Related Harms
Trial Accrual, follow-Up, and Exit
Trial Closure and Results
Dissemination
Post-trial Access to Trial Products or
Procedures.
Policies on Trial-Related
Harms
Trial Closure and Results
Dissemination
Formative Research Activities
Allows the research team to:
•
•
•
•
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gain informed understanding of local populations
socio cultural norms
local power dynamics
local perceptions
channels of communication
Stakeholder Engagement Plan1
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•
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Describes strategies and mechanisms for
building and sustaining a broad range of
local, national and international
stakeholders
Lays the foundation for supportive research
environment
Familiar and receptive to the changing
needs of a dynamic community and shifting
stakeholder relationships
Stakeholder Engagement Plan2
•
Communication component
• Policies and strategies to increase broad
awareness of the trial and facilitate accurate
dissemination of research
•
Education component
• Key to building research literacy and empowering
community stakeholders as decision-making
agents
Issues Management Plan
•
•
Describes how research teams intend to
manage points of concern or unexpected
developments
Stakeholder input can help mitigate the risk
of negative developments. It will increase
potential support for the trial.
Protocol Development
•
•
Stakeholder input can provide insight to
protocol design and procedures are locally
appropriate
Multisite or multicounty trials may be
largely centralized
• Develop mechanisms early in the process for
local stakeholder input
Informed Consent Process
•
The cornerstone of ethical research
•
The process can be influenced by
community stakeholders but is implemented
confidentially between the research staff an
individual
Informed Consent Process
•
Comprehension should be assessed throughout
the research process
•
Forms, materials and techniques to assess
understanding should be locally appropriate
•
Partner consent process
•
Strategies to pilot tools of consent
Participant first
hears about the
research
Participant talks to
physician about study
Participant first sees
informed consent
documents
Participant signs
documents. Enrolls in
trial
Participant talks to partner,
friends, family
Participant receives 1st
comprehension exam
Access to HIV Care
•
HIV care includes all psychosocial,
psychological and clinical components of HIV
care
• Alternative regimens
• Counseling –e.g. identity
•
HIV care and treatment guidelines vary by
country and should be considered
• long term logistics planning should be considered
• Access guidelines should be updated with national
guidelines
Policies on Trial Related Harm
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•
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How research teams will treat and
compensate trial participants
Physical harms- include any negative
physical event
Social harms- non medical consequences
such as
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Social isolation
Stigma or discrimination
Employment or housing loss
Difficulties in personal relationships
Meaningful Engagement
Engagement in Early Phase Research
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Engaging around ideas
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Building trust
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Establishing cultural competency and
dialogue
It’s a Process
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The road to cure is long
•
Early engagement is key to ethical research
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One trial impacts another
PreTrial
PostTrial
Trial
Conduct
Conclusions
•
Genuine and effective engagement has
benefits for both the HIV and research
community
•
Research has a direct impact on lives
•
Community can have an input even on basic
research