1. HIV i-Base: Community outreach MRC April 2006 Community outreach in MRC national and international trials Simon Collins HIV i-Base, London UK-CAB and ECAB

2. HIV i-Base: Community outreach MRC April 2006 Community outreach Involvement at all levels of our care Individual treatment decisions Community education Trial design International networks Resourcing and development Questions throughout

3. HIV i-Base: Community outreach MRC April 2006 Community Advisory Boards (CABs) Specialise in scientific training Trial review and design Representation on Steering and Executive Cttees, DSMB, Guidelines cttes High involvement of HIV+ advocates Network for 2-way communication: to advise the trial and to report through community networks

4. HIV i-Base: Community outreach MRC April 2006 CAB networks National CABs: UK-CAB; France (TRT-5); Italy; Spain (FEAT); Germany; Portugal European CAB (ECAB) - Pan European advocacy group - working group of European AIDS Treatment Group ‘World CAB’ - global access and pharmaceutical pricing (generic and brand), and part of International Treatment Preparedness network (>600 members, >120 countries

5. HIV i-Base: Community outreach MRC April 2006 UK-CAB.1 4 yrs old, ~ 130 members from UK Broad representation of affected communities: approx 50% African, 50% men/women; 70% HIV+ and includes haemophilia and IDU networks Includes all main ASOs - ie producers of community publications plus individuals 4 meetings/year (~30 people) - at MRC: training and strengthening support network

6. HIV i-Base: Community outreach MRC April 2006 UK-CAB.2 Linked by email list: treatment discussion, including related policy issues: administration for meetings and reports Chooses community reps for trial cttees (national, Optima, Esprit, Silcaat, SMART, INSIGHT, PENTA) and guidelines (BHIVA) Forum for communication out from trials and research networks Accountable to the wider community

7. HIV i-Base: Community outreach MRC April 2006 European CAB (ECAB) Pan-European CAB: Approx 35 members from 20 countries 5-6 meetings annually, each 3 days Meets all major companies running international trials, and works closely with networks of independent investigators Includes Protocol Review Group All national CABs are represented

8. HIV i-Base: Community outreach MRC April 2006 European CAB (ECAB).2 Choosing community representatives for international steering cttes, treatment guidelines panels (resistance, adherence, treatment, coinfection) and often for involvement in scientific meetings Advocates are active in their own countries and well connected to those community networks

9. HIV i-Base: Community outreach MRC April 2006 MRC trials As with all trials, community representation is expected on scientific and steering committees, and sometimes on DSMBs Help focus trial design that will continue to be relevant from community perspective Helps faster enrollment, and greater publicity in the community Can raise and communicate problems to wider community

10. HIV i-Base: Community outreach MRC April 2006 Example: Esprit/Silcaat Community represented in trial design and at investigator meetings, including presenting issues form community perspective Raise safety concerns over management (ie issue of dose reduction) Raise trial profile (UK enrolled highest number of patients) Advocate for Silcaat to continue after Chiron withdrew funding

11. HIV i-Base: Community outreach MRC April 2006 Example: SMART Community involved in initial discussions (>5 years ago) Community reps on each of 4 regions organising and investigator committees High community profile of trial contributed to rapid enrollment Working with community representatives, helped communicate difficult and sensitive results following DSMB-recommended discontinuation in January 2006

12. HIV i-Base: Community outreach MRC April 2006 Conclusions Community partnership is essential in trial networks Requires resourcing when planned: most advocates volunteer for CAB work Significant community training required for representatives to be actively involved Resources are especially important for international trials (where one advocate may represent several countries)