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

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

What is community involvement? Department of Sustainability and Environment

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

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)

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 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

Expectations and Challenges facing CABS ExpectationsRealities? Represent community viewpoints Channel for communication between researchers and community Independent advice to researchers Voluntary commitment of members over time Provide input on trial design and protocol Oversight/watchdog for the research Co-opted or dominated by political or other agenda Role confusion: should CAB members and CLO’s help recruit? Ability to challenge the institution supporting the structure? Competing priorities in resource- limited settings? Power to influence research agenda? Accountability of CAB to community and research enterprise to CAB

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

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

Issues of Power 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.

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

Female Barrier - Diaphragm Male Circumcision - Susceptibility Microbicides - Carraguard Male Circumcision - Infectiousness Microbicides BG/Pro2000 CS – 1 CS – 2 Pro2000 TDF Oral PrEP - IDU HSV-2 Treatment - Infectiousness HSV-2 Treatment – Susceptibility Oral PrEP MSM Heterosexual 2012 Index Partner Treatment Vaccines - Adenovirus1 Adenovirus 2 Vaccines - Prime/Boost Community VCT and HIV Support Oral PrEP - West Africa Prevention Research Landscape, Micoribicides Saavy

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

Cameroon falls next

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

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

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

` The Revised Prevention Research Landscape November Female Barrier Diaphragm Male Circumcision – Susceptibility Microbicides – Carraguard Male Circumcision – Infectiousness Microbicides BG/Pro2000 Pro2000 TDF Oral PrEP – IDU HSV-2 Treatment – Infectiousness HSV-2 Treatment – Susceptibility Oral PrEP MSM Heterosexual Index Partner Treatment Vaccine – VRC PAVE 100 Vaccines – Prime/Boost Merck Adeno 1 Community VCT and HIV Support Oral PrEP – West Africa Microbicides – CS-1 CS-2 Vaccine – Merck Adeno 2 Micoribicides Saavy ?

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 Good Participatory Practice Guidelines

Normative DocumentsInstitutional/Internal Guidelines Resources/How To Normative Guidance, Institutional Guidelines & Operational Tools Each Has A Distinct Role

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) Stand Alone Sites: (Not part of a network) Family Health Int’l 6 site Truvada Study CAPRISA Tenofovir gel Population Council UCSF/CDC Prep Studies Lavalle-University (invisible condom study) Universe Microbicide Trial Players 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)

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