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PARTICIPATION IN HIV CURE RESEARCH
HIV Cure Research Training CurriculumModule developed by:Karine Dubé, DrPH Candidate, The University of North Carolina at Chapel HillMatt Sharp, National Martin Delaney Community Advisory Board (CAB) Leader September 2015 with input from Sidaction
The HIV CURE research training curriculum is a collaborative project aimed at making HIV cure research science accessible to the community and the HIV research field.
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Module Objectives
• Describe HIV cure clinical research in the context of the broader HIV research agenda
• Discuss inclusion of people living with HIV in cure research, including under-representation of certain populations
• Provide overview of the various types of HIV cure-related studies enrolling participants
• Provide the patient perspective and explore considerations for participation in HIV cure-related research, such as managing expectations
• Start to understand factors that would facilitate or deter participation in HIV cure-related research
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HIV Cure Clinical Research
Why it matters Why it matters
• Clinical research is the gold standard for moving any kind of medical research forward
• HIV/AIDS clinical studies are not new but there are important differences with HIV cure-related research
• Clinical research is the gold standard for moving any kind of medical research forward
• HIV/AIDS clinical studies are not new but there are important differences with HIV cure-related research
Clinical researchClinical
research
• Essential to advancing medical discovery and reducing the burden of disease and illness
• 2.5 million new HIV/AIDS infections per year; > 34 million people living with HIV worldwide
• Rationale for finding a cure for HIV infection • Allows us to collect data and test hypotheses formulated from
observations and/or intuition
• Essential to advancing medical discovery and reducing the burden of disease and illness
• 2.5 million new HIV/AIDS infections per year; > 34 million people living with HIV worldwide
• Rationale for finding a cure for HIV infection • Allows us to collect data and test hypotheses formulated from
observations and/or intuition
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Definitions of HIV ‘Cure’
• Very small numbers of HIV infected cells persist below detectable levels while off treatment
• Very small numbers of HIV infected cells persist below detectable levels while off treatment
Functional Cure/RemissionFunctional Cure/Remission
• Complete eradication of virus from the body
• Complete eradication of virus from the body
Sterilizing CureSterilizing Cure
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HIV treatment, prevention and ‘cure’ researchResearch type Participant status Research goal Selected ethical
issuesHIV treatment HIV positive Effective
suppression of virus, boosting immune system
All phases; risk of drug side- effects; adherence problems
HIV prevention HIV negative Effective methods of preventing HIV acquisition
Seroconversion of participants during trial; behavioral disinhibition
HIV ‘cure’ HIV positive Interventions to permanently suppress or eradicate HIV
Early phase; risk of intervention side-effects; existence of known effective treatment
Slide Credit: Stuart Rennie, University of North Carolina at Chapel Hill
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Individuals Needed for HIV Cure-Related Studies• Will be as diverse as the HIV population itself
Johnston and Heitzeg, ‘Sex, Age, Race and Intervention Type in Clinical Studies of HIV Cure: A Systematic Review’, ARHR 2015
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Under-Represented Populations in HIV Cure-Related Research
Johnston and Heitzeg, ‘Sex, Age, Race and Intervention Type in Clinical Studies of HIV Cure: A Systematic Review’, ARHR 2015
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Under-Represented Populations in HIV Cure-Related Research• Women, older people and non-whites do not reflect
national or international burden of HIV infection • More data needed to determine associations between
demographic characteristics and safety/efficacy of HIV curative research strategies
• Study recommends that • Authors should report basic demographic data (sex, age, race)• Outcomes (safety and efficacy) should be analyzed by demographic
variables and results reported• If possible, studies should be powered to explore differences (but
difficult for early phase research)• To facilitate meta-analyses, standardized endpoints should be taken
Johnston and Heitzeg, ‘Sex, Age, Race and Intervention Type in Clinical Studies of HIV Cure: A Systematic Review’, ARHR 2015
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Minority Participation in Clinical Research
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Types of Studies Enrolling Participants
Strategies Adoptive immuno-therapyAntibodiesGene ‘therapies’ – including those for people with cancer Latency-reversing agentsStem cell transplantation‘Therapeutic’ vaccinesTreatment intensificationCombinations Observational studies or cell donations Treatment Action Group (TAG) Research Towards a Cure Trials
http://www.treatmentactiongroup.org/cure/trials
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Types of Studies Enrolling Participants
Treatment Action Group (TAG) Research Towards a Cure Trialshttp://www.treatmentactiongroup.org/cure/trials
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Finding a Clinical Study
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What would facilitate making decisions about whether to participate in HIV cure-related studies?
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Core Components of Clinical Studies
Entry (Inclusion/Exclusion)
Requirements
Entry (Inclusion/Exclusion)
Requirements
Informed Consent
Informed Consent
IRBApproved
Compensation
IRBApproved
Compensation
Voluntary EnrollmentVoluntary Enrollment
Study Procedures
Study Procedures
Time and Commitment
Needed
Time and Commitment
Needed
Expected Risks
and Benefits
Expected Risks
and Benefits
Ethical Considerations
Ethical Considerations
Can withdraw at any time
Can withdraw at any time
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HIV Cure-Related Clinical Studies
Main Procedures
(e.g. Biopsies)
Main Procedures
(e.g. Biopsies)PheresesPhereses
Analytical Treatment
Interruption?
Analytical Treatment
Interruption?
Side Effects(Expected vs. Unexpected)
Side Effects(Expected vs. Unexpected)
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Language and Terminology
• Patients vs. subjects vs. participants vs. volunteers (Bromley et al., AJPH 2015)
• Clinical studies vs. trials vs. experiments (Dubé et al., Trends in Microbiol, 2014)
• Impact of the word ‘cure’ when early-phase studies will not be curative (Rennie & Tucker)
• Use of the word ‘therapeutic’ (e.g. gene ‘therapy’ and ‘therapeutic’ vaccine) in the experimental stage (Henderson GE)
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Managing Expectations
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Motivators to participation• Difference between early phase studies vs. late phase trials • Emphasis on personal risks vs. personal benefits and social risks vs. social
benefits • Social motivators divided between microsocial, mesosocial and
macrosocialBarriers to participation • Divided between safety concerns, fear/mistrust, discrimination, pragmatic
obstacles • Difference between hypothetical and actual trial participation• Discrepancy between qualitative and quantitative studiesOriginal research articles:• Psychometric scale to assess facilitators and inhibitors of enrollment
Willingness to Participate in HIV Prevention Research
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Participation in HIV Treatment Trials
Main barriers to participation organized in terms of: 1) Safety concerns/side effects 2) Distrust of researchers 3) Concerns around research design 4) Logistical challenges and 5) Social discrimination
Decisions depended on: • Perceptions of trials • Knowledge about trials • Biases of physicians/researchers • Lived experiences and psychological context • One study (Slomka et al.) employed Health Belief Model: 1) impact of HIV
disease on decision; 2) benefits 3) barriers; 4) triggers/cues; and 5) self-efficacy towards involvement in research
• Risk-benefit ratios• Clinical contact factors (Worthington et al.) as largest confounder for
personal characteristics
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Cancer Literature
Factors promoting participation in cancer trials:1) Trusting relationship between researcher and patient 2) Communication processes and informed consent Reasons for not participating included: 3) Patients decisions4) Researchers choosing not to offer trial involvement5) Lack of knowledge6) Patients not meeting I/E criteria7) Concerns around profit-driven motives of pharmaceutical companies Other themes: • Tension between conflicting objectives of clinical care/treatment and
research • Role of support• Concerns around impact on health insurance • Hope for therapeutic benefit and altruism embedded • Entire therapeutic trajectory
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What would be some issues to consider to participate in HIV cure-related studies?
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Dutch HIV Association Survey (n = 458)
F. Verdult, with HIV Vereniging Nederland (Dutch HIV association)• Internet survey (2012)• 86% self-reported to be in good health• 94% on cART• 62% reported positive effects of HIV on their life• 72% said it was very important for them to be
cured of HIV
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Five top ten disadvantages are psycho-social related factors
Dutch HIV Association Survey (n = 458)
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A sterilizing cure is very desirable for most of respondents
Dutch HIV Association Survey (n = 458)
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• M.P. Arnold (Fred Hutchinson Cancer Research Center, Legacy project)
• Internet survey (2011-2012), n = 2262 PLWH
• 81% self-reported to be in good health
• 93% on cART• 87% viral load <50 copies/mL
• 55% CD4>500 cells/mm3
Arnold et al., J. Viral Eradication 2015
U.S. Survey (n = 2, 262)
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• Willingness to participate in HCRT including treatment interruptions• 63% for personal benefits• 55% for social benefits• 44% for scientific benefit
• Factors influencing participation (important/very important)• 77% current health• 58% financial compensation
U.S. Survey (n = 2, 262)
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• Focused on risks and benefits of HIV cure-related clinical studies
For more details, please contact: Jeff Taylor: [email protected] Co-Investigators: David Evans ([email protected]) and Paris Mullen ([email protected])Karine Dubé: [email protected]
New Survey
Objectives: • To better understand factors that act as motivators and/or deterrents of
participation in HIV cure-related studies• To explore how various stakeholders perceive risks and benefits of HIV cure-
related studies• To understand some of the practical and pragmatic issues that affect
participation in HIV cure-related studies to facilitate ethical conduct
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The Voice of the Patient FDA’s Patient-Focused Drug Development Initiative
Source: http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM389379.pdf
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Developing Country Considerations
• Research landscape • Funded research, capacity, implementation of research
• Health priorities and HIV cure-related research• Scalability • Informed consent, literacy and meaning of HIV cure • Treatment interruption• Risk determination• Partner involvement
Credit: Stuart Rennie, University of North Carolina at Chapel Hill
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Community Participation and Driving Principles
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Resources
Community Participation ResourcesDAIDS Learning Portal:• Community Advisory Boards (eLearning)• Introduction to Clinical Research and the Clinical Research Progress (eLearning) • CAB Workshop • Community Discussion Group (Social Learning Community)HANC:
AVAC:• Good Participatory Practice Guidelines (document, toolkit, workshops)
FHI 360:• Stakeholder Engagement Toolkit for HIV Prevention Trials CUREiculum:• http://www.avac.org/cureiculum
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Acknowledgements