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Evolution in Community Involvement : The Changing Landscape

Explore the history and shifts in community involvement in HIV research, from activist-led trials to researcher/donor-led prevention trials. Learn about the importance of community involvement, power dynamics, and the challenges facing Community Advisory Boards (CABs).

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Evolution in Community Involvement : The Changing Landscape

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  1. Evolution in Community Involvement:The Changing Landscape Lori Heise Global Campaign for Microbicides

  2. Overview • A short (and undoubtedly) incomplete history of community involvement • Re-consideration of the CAB/CAG model • Seismic shifts in the prevention trials landscape • An introduction to on-going and planned initiatives

  3. Department of Sustainability and Environment www.dpi.vic.gov.au What is community involvement?

  4. History of Community Involvement in HIV Research • US AIDS activists pushed for a advocate role in early days of HIV treatment research • Community Advisory Boards (CABs) emerged in response; European treatment activists (TR5, EATG) and Big Pharma follow suit • CAB model becomes institutionalized and is exported via NIH, ANRS, etc. to international research sites

  5. GCM Community Involvement Dialogue Meeting, 2003 “It may be difficult to meet the diverse and complex challenges of community involvement through a single mechanism like a CAB or CAG.” “Sites have begun to use other mechanisms to help educate, respond to, protect, collaborate with and seek ongoing input from communities.” (Mobilization for Community Involvement in Microbicide Trials, SAMRI and GCM,’03)

  6. Then... Activist-led Treatment trials- individual urgency Individuals educated, empowered, motivated to learn more Clearer understanding of community Community “PUSHED” researchers for involvement, defined parameters In 2003... Researcher/Donor-led Prevention trials- less chance of immediate benefit Individuals marginalized, less powerful, less educated Less clear understanding of who is included in “community” Researchers “PULL” community into involvement, define parameters

  7. Expectations and Challenges facing CABS

  8. Where should the efforts in CI be leading us to? London Councils – Local Government

  9. Why Community Involvement? • Improve ethical and scientific integrity of trials • Increase transparency and accountability of the research to the community • Maximize benefits and minimize risks for participants and for host community • Strengthen local capacity and infrastructure

  10. Issues ofPower • Power imbalances exist across multiple lines: PIs versus field staff, Northern researchers versus Southern; community versus research enterprise; within communities and CABs • One goal of community involvement and microbicide advocacy is to work towards reduced power disparities. • Pretending that power imbalances do not exist, however, breeds the worst form of tokenism.

  11. Why Community Involvement? (RHRU, 2003) • To inform community about the study • To enable and increase recruitment into the study • To maintain enrollment levels • To develop strategies for the referral and support of women who test positive for HIV • To solve problems arising from the study

  12. Female Barrier - Diaphragm HSV-2 Treatment - Infectiousness Microbicides - Carraguard Oral PrEP - IDU Vaccines - Adenovirus1 Adenovirus 2 Male Circumcision - Susceptibility Community VCT and HIV Support Vaccines - Prime/Boost • Microbicides • BG/Pro2000 • CS – 1 • CS – 2 • Pro2000 • TDF Male Circumcision - Infectiousness HSV-2 Treatment – Susceptibility • Oral PrEP • MSM • Heterosexual Index Partner Treatment Oral PrEP - West Africa 2012 2010 2006 2008 2009 2007 Prevention Research Landscape, 2005 Micoribicides Saavy http://www.avac.org/timeline-website/index.htm

  13. “We will not let Cambodians be used as guinea pigs…”Cambodian prime minister r

  14. Cameroon falls next

  15. SOC Ethical Debate Research literacy Consultations & Searching self-reflection • Gates Foundation • Stakeholder consultation on oral tenofovir trials • UNAIDS • 3 regional consultations • Global meeting in Geneva community

  16. GCM Work plan & Response • Case studies • Cambodia • Cameroon • Manual and CI Tool Kit • Shift to “community involvement plans” • Field Test and Demonstration Project • In collaboration with EDCTP project

  17. Lessons Learned:Community Consultation • Must extend beyond local trial community to include NGOs and other opinion leaders and stakeholders • Requires adequate lead time and a specialized skill set; • Must begin early when input can still effect change • Demands separate line item in the budget • Formative research cannot substitute for a consultative process

  18. The Revised Prevention Research Landscape November 2007 Micoribicides Saavy ` Vaccines – Prime/Boost Merck Adeno 1 Female Barrier Diaphragm Microbicides – Carraguard HSV-2 Treatment – Infectiousness ? Microbicides – CS-1 CS-2 Community VCT and HIV Support Male Circumcision – Susceptibility Oral PrEP – IDU Vaccine – Merck Adeno 2 Vaccine – VRC PAVE 100 • Microbicides • BG/Pro2000 • Pro2000 • TDF Male Circumcision – Infectiousness HSV-2 Treatment – Susceptibility • Oral PrEP • MSM • Heterosexual Index Partner Treatment Oral PrEP – West Africa 2011+ 2010 2006 2008 2009 2007 http://www.avac.org/timeline-website/index.htm

  19. Good ParticipatoryPractice Guidelines • Grew out of2005 UNAIDS Global Consultation: “Creating Effective Partnerships for HIV Prevention Trials” • Process jointly convened by UNAIDS and AVAC • Objectives • Establish clear, global standards for community participation and input in HIV prevention trials • Publish guidelines with the intent of seeking eventual endorsement by ICH

  20. Normative Guidance, Institutional Guidelines & Operational Tools Normative Documents Institutional/Internal Guidelines Resources/How To GLP HPTN Operating Policies GCP GMP GPP GCM Community Tool Kit HPTN CAB Guidelines Site SOPs Each Has A Distinct Role

  21. Universe Microbicide Trial Players • NIH Division of AIDS(DAIDS) • AIDS Clinical Trials Group (ACTG) • HIV Prevention Trials Network (HPTN) • HIV Vaccine Trials Network (HVTN) • Adolescent AIDS Clinical Trials group (IMPAACT) • Int’l Network for Strategic Initiatives in Global HIV Trials (INSIGHT) • Microbicides Trials Network (MTN) Int’l Partnership for Microbicides (IPM) (Up to 20 sites planned) • Microbicide Development Programme (MDP) • University Teaching Hospital (Lusaka, Zambia) • SA MRC & University of Natal (Durban, SA) • RHRU/University of Witwatersrand (Johannesburg, SA) • AMREF/NIMR/LSHTM (Mwanza, Tanzania) • Imperial College at St. Mary’s Hospital (London, UK) • MRC/Uganda Virus Research Institute (Entebbe, Uganda) • Africa Centre for Health & Population Studies (Mtubatuba, SA) • Stand Alone Sites:(Not part of a network) • Family Health Int’l 6 site Truvada Study • CAPRISATenofovir gel • Population Council • UCSF/CDC Prep Studies • Lavalle-University (invisible condom study)

  22. Other initiatives • ICASO Voices Project • GCM Digital Stories Project • Ethics, Society and Culture Gates Global Challenges Project • MDS Civil Society Project

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