Nothing About Us Without Us! Community Engagement in HIV Research
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- Godwin Baldwin
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1 Nothing About Us Without Us! Community Engagement in HIV Research Judith D. Auerbach, Ph.D. Professor, Center for AIDS Prevention Studies School of Medicine University of California, San Francisco Engaging Patients, Families and Communities in all Phases of Translational Research to Improve Health Bethesda, Maryland August 21-22, 2014
2 Outline: Focus on Three Aspects Treatment/Research Advocacy Engagement in Clinical Trials Translation/Implementation
3 Global HIV Epidemic
4 Context
5 Trends in Annual Age-Adjusted* Rate of Death Due to HIV Infection, United States, Note: For comparison with data for 1999 and later years, data for were modified to account for ICD-10 rules instead of ICD-9 rules. *Standard: age distribution of 2000 US population
6 Trends in Annual Rates of Death due to the 9 Leading Causes among Persons Years Old, United States, Note: For comparison with data for 1999 and later years, data for were modified to account for ICD-10 rules instead of ICD-9 rules.
7 Hardest Hit Communities: Gay Men & PWID
8 San Francisco Gay Men s Chorus, 1993
9 Advocacy
10 Community Advocacy Education Memorialization Protest
11 Research Advocacy
12 Research Advocacy: ACT UP, TAG, GMHC
13 Creation of the NIH Office of AIDS Research DHHS/NIH/OD/OAR
14 $3,500, $3,000, $2,500, $2,000, $1,500, $1,000, $500, $ Source: NIH Office of AIDS Research
15 Levine Committee Report, 1996
16 Antiretroviral Therapy: pills; divided 3-4x/d 1 pill; once a day
17 Evolution of Combination Therapy
18 HIV Treatment approved drugs 7 preferred first-line regimens 3 approved one-pill once-daily regimens 4th at the FDA, 5th in phase 3 clinical trials Virologic response rates >85% with HIV RNA suppression Life expectancy close to that of the general population aidsinfo.nih.gov; Landovitz CROI 2014 #85; Samji PLoS One 2013
19 HIV Survival and Life Expectancy Life-Expectancy in HIV-Infected Individuals (20y) This is a life expectancy that approaches that of a 20-year old in the general population today. Samji et al. PLoS ONE, 2013; CDC HIV Surveillance Report, 2011;
20 Community Engagement in Clinical Trials
21 Community-Collaborative & Community-Based Participatory Research
22 Institutionalizing Community Engagement Denver Principles: 1983 Greater Involvement of People Living with AIDS (GIPA): 1994 Good Participatory Practices (GPP): 2007
23 Good Participatory Practice Guidelines for Biomedical HIV Prevention Trials Response to pre-exposure prophylaxis (PrEP) trial controversies in Cambodia and Cameroon in 2004/2005 Leadership from AVAC and UNAIDS First edition (2007) developed by international, multidisciplinary working group with input from stakeholders around the globe The second edition (2011) incorporates feedback gathered through global consultations and piloting Source: Kate MacQueen, AIDS 2014
24 Who is the community? 21 st Century global research includes: Multi-site trials Public-private partnerships Profit/non-profit sponsors/implementers Government/foundation/corporate funders Advocates: population, disease, social causes Policy: local, national, global
25 GPP Examples of Stakeholders
26 Stakeholder Engagement Toolkit for HIV Prevention Trials Printed copies of the Stakeholder Engagement Toolkit for HIV Prevention Trials are available by request Includes a CD with the 2014 Toolkit Quick Guide and additional resources Access a web version of the Toolkit Quick Guide at
27 Objectives of the SE Toolkit Provide step-by-step guidance to help HIV researchers engage stakeholders efficiently and transparently Provide tools to help staff document their plans and experiences as they implement a SE strategy Make it easier for research teams in different settings to compare methods and identify best practices
28 GPP-TB: extending the model Critical Path to TB Drug Regimens (CPTR) initiative Stakeholder & Community Engagement Workgroup (SCE-WG) 2011 mapping exercise by WG confirmed need for guidance In 2012 WG partnered with AVAC to adapt GPP-HIV to TB context
29 Community Engagement Post-Trial? Source: Pedro Goicochea, AIDS
30 The Ethics First PrEP trial to provide post-trial access of a successful intervention to study participants Facilitated resources to inform and educate communities and generate discussion with stakeholders at local level and national level FTC/TDF for tx is approved in all countries where the iprex study took place but one, Peru (an application is in process) However: How can investigators deliver access to a product over which they have limited control? 1 Source: Pedro Goicochea, AIDS Haire B, Jordens C. Mind the gap: An empirical study of post-trial access in HIV biomedical prevention trials. Developing world bioethics 2013
31 Translation/Implementation
32 Translation/Implementation HIV Care Continuum/Treatment Cascade
33 C
34 Conclusion
35 Acknowledgements Steven Epstein, Northwestern University Steve Gibson, Magnet/San Francisco AIDS Foundation Pedro Goicochea, Gladstone Institute, iprex OLE Roy Gulick, Cornell University Mark Harrington, Treatment Action Group (TAG) Jennifer Kates, Kaiser Family Foundation Kate MacQueen, FHI360 Richard Parker, Columbia University Kane Race, University of Sydney Ron Stall, University of Pittsburgh Rochelle Walensky, Harvard University
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