Emily Bass AIDS Vaccine Advocacy Coalition (AVAC) 2 July 2007

1. HIV Prevention Research and Implementation: Challenges and Opportunities on the Horizon Emily Bass AIDS Vaccine Advocacy Coalition (AVAC) 2 July 2007

2. The Next Frontiers: 2007 and beyond • AVAC is a non-profit advocacy group based in New York and working internationally, dedicated to advancing ethical research on and implementation of new prevention technologies • The future is now! The next several years will bring a variety of scenarios that we must not encounter unprepared.

3. May you live in interesting times More funding—in some settings—for existing prevention Low coverage and uptake of these proven strategies More new prevention technologies moving through large-scale clinical trials than ever before More answers about potential tools to add to the tool kit of existing prevention More challenges about how to communicate those answers and how to act on them

4. Overview • Prevention research – what does the future hold • Prevention trials – what are we learning? • Preparing for access: opportunities to learn today

5. New strategies • Treatment of HSV-2 • Pre-exposure prophylaxis • Male circumcision (with unanswered questions) • Microbicides • Vaccines • Behavorial interventions

6. New types of information • Success • Failure • Indeterminate results

7. I read the news today, oh boy… • Vaccine for AIDS appears to work; Blacks, Asians receive the most protection • USA Today, February 24, 2003 • Large Trial Finds AIDS Vaccine Fails To Stop Infection • New York Times, February 24, 2003 • Firm vows to push for OK on AIDS vaccine; inoculation may help some minority groups • San Francisco Chronicle, February 25, 2003 • AIDS Vaccine Trial Produces Disappointment and Confusion • Science, February 28, 2003

8. Success is… • A clinical trial that produces a scientifically precise result. • It may not be the result we had hoped for, but it answers questions that help the field move forward. • These trials need to be designed so that whether or not any particular trial finds efficacy, it at least produces clear results. • At the very least we will know what doesn't work, and perhaps be able to analyze results to understand why.

9. Failure is/can be of the… • Product/candidate • Concept • Trial • Field • Communications

10. 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 Research that Could Re-define Prevention, 9/06 See also http://www.avac.org/timeline-website/index.htm

11. HSV-2 Treatment - Infectiousness Female Barrier - Diaphragm Oral PrEP - IDU Vaccines - Adenovirus1 Adenovirus 2 Community VCT and HIV Support Male Circumcision - Susceptibility Vaccines - Prime/Boost Microbicides - Carraguard • 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 Research that Could Re-define Prevention, 12/06 See also http://www.avac.org/timeline-website/index.htm

12. Microbicides – CS-1 CS-21 Microbicides – Carraguard HSV-2 Treatment - Infectiousness Vaccines - Adenovirus-1 Adenovirus-2 Community VCT and HIV Support Male Circumcision - Susceptibility Vaccines - Prime/Boost Female Barrier- Diaphragm Oral PrEP - IDU • Microbicides • BG/Pro2000 • 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 Research that Could Re-define Prevention, 7/07 See also http://www.avac.org/timeline-website/index.htm

14. Community is key • Advising – trial sites and staff through community advisory mechanisms • Advocating – for proven prevention and existing strategies • Translating – what do research results mean; what are implications of findings in one arena on activity in another • Assessing – what are priorities in your community?

15. Media Headlines

16. Media Articles isiZulu Press informed by English speaking press

17. Acting on research results The Marathon: What do we still need to learn? Maintaining momentum and support for next generation studies and operational research • The Triathlon: What else is happening? Ongoing analysis of the broader context of prevention research and implementation • The Relay: What needs to happen next? Swiftly and effectively translating results into action when there is a positive finding

18. New promises, new challenges • How good is good enough? • Who will get new prevention tools – and when? • Who will pay for them? • What will the new standard of prevention & care be generally and in the context of other clinical trials? • Will we still be able to develop other new technologies? • Blurring lines

19. Passing the baton: Opportunities to learn today • HPV vaccine • Delays in clarity around access: One year after licensure, no clear statement on cost in developing countries • Pharma companies identify need for clearer ‘demand’ • Is this a priority for communities? • Can we make make ties between different fields? • How do we build platforms that reach our adolescent girls?

20. Passing the baton: Opportunities to learn today • Male circumcision • Do communities and key leaders “believe” the results? • Do activists, advocates, policy makers and others feel the new intervention is a priority that “fits” within their agendas? • Is the new strategy seen as a threat: to human and financial resources for other proven prevention; to specific groups’ needs (women versus men, eg); to paradigms (biomedical, structural, behavioral)

21. I am surprised there is no action on male circumcision. Where are the male activists? -- South African AIDS Researcher, 2007

22. When there is a new biomedical prevention technology for use by women … will we be asking “Where are the women activists?”

23. Where we must go… • Innovative programming • Walking the walk of comprehensive prevention • Leadership from developing country governments, policy makers and communities

24. Leadership can mean • Advocating for proven prevention • Sharing information about experimental options • Volunteering for a trial • Serving on a community advisory board • Talking to your neighbor or your health provider or your MP or your daughter, son, mother, aunt • Advocacy to research entities, local and national government, NGOs, and other key decision makers

25. Challenges Beyond the Horizon • Managing expectations • Under promise • Over deliver • Delivering what we have today • Striving for more and better options for tomorrow • It’s not the result – it is what we do with it!

26. Thank you