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 f ID: 611636
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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. Slide2
Session Goals
What is stakeholder engagement
Why is engagement important for cure research
Lessons learned from other HIV fieldsSlide3
Job security
Stigma
Personal Health
Gender Based Violence
HIV-positive Diagonosis
Treatment Access
Discrimination
Criminalization
Racial Stigma
Homophobia
poverty
Food security
Housing securitySlide4
Defining Community
Individual’s community is fluid
Multiple memberships
Establish a working definitionSlide5
Defining Community
“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)Slide6
The Denver Principles
Community involvement in HIV research began with the Denver Principles in 1983 when PLWHIV demanded a place at the table.Slide7
Where Engagement Fits
Stakeholder Engagement
WHO
CIOMS
UNAIDS
Good Clinical Practice
Human Rights ConsiderationsSlide8
Lesson Learned From HIV Prevention
PrEP
Research trial controversy
2004- Cambodia trials were not initiated
2005- Camaroon and Nigeria trials discontinuedSlide9
Guiding Principles of Engagement
Good Participatory Practices
Respect
Mutual Understanding
Integrity
Community Stakeholder Autonomy
Transparency
Effective Stakeholder Engagement
AccountabilitySlide10
How can we define stakeholders?Slide11
Global Stakeholders
National
Global
Broader
Community
Participants
International NGOs, Trial sponsors, WHO/UNAIDS, International Foundations, FundersSlide12
National Stakeholders
National
Global
Broader
Community
Participants
National NGOs, Ministries of Health, Regulatory Bodies, Ethical Review CommitteesSlide13
Broader Stakeholders
National
Global
Broader
Community
Participants
NGOs, Local Policymakers, Local Media, Medical ProfessionalsSlide14
Community Stakeholders
National
Global
Broader
Community
Participants
CBOs, participant family, friends, schools, peers, trial site staff, local health service providers, community advisory boards, traditional leadersSlide15
Good Participatory Practices: HIV Prevention vs Cure
Formative Research Activities
Stakeholder Engagement Plan
Stakeholder advisory mechanisms
Communications Plan
Issues Management Plan
Site Selection
Stakeholder Education Plan
Protocol Development
Informed Consent Process
Standard HIV Prevention
Access to HIV Care and Treatment
Non HIV-Related Care
Policies on Trial-Related Harms
Trial Accrual, follow-Up, and Exit
Trial Closure and Results DisseminationPost-trial Access to Trial Products or Procedures.Formative Research Activities
Stakeholder Engagement Plan
Issues Management PlanProtocol DevelopmentInformed Consent Process
Access to HIV Care and Treatment Policies on Trial-Related HarmsTrial Closure and Results DisseminationSlide16
Formative Research Activities
Allows the research team to:
gain informed understanding of local populations
socio cultural norms
local power dynamicslocal perceptionschannels of communicationSlide17
Stakeholder Engagement Plan1
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 relationshipsSlide18
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 agentsSlide19
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. Slide20
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 inputSlide21
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
Risk
BenefitSlide22
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 researchParticipant talks to physician about study
Participant first sees informed consent documents
Participant talks to partner, friends, family
Participant signs documents. Enrolls in trial Participant receives 1st comprehension examSlide23
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 consideredlong term logistics planning should be consideredAccess guidelines should be updated with national guidelinesSlide24
Policies on Trial Related Harm
How research teams will treat and compensate trial participants
Physical harms-
include any negative physical event
Social harms- non medical consequences such asSocial isolationStigma or discriminationEmployment or housing lossDifficulties in personal relationshipsSlide25
Meaningful EngagementSlide26
Engagement in Early Phase Research
Engaging around ideas
Building trust
Establishing cultural competency and dialogueSlide27
It’s a Process
The road to cure is long
Early engagement is key to ethical
research
One trial impacts anotherSlide28
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