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Expanding the Evidence Base for ARV Prevention Strategies: Community Perspectives from India, South Africa, and the United States. Authors.

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  1. Expanding the Evidence Base for ARV Prevention Strategies: Community Perspectives from India, South Africa, and the United States

  2. Authors • Jim Pickett1(Chicago, USA), Joanna Chataway2 (Cambridge, UK), Mark Chataway3 (Wales, UK), Caroline Fry2 (Cambridge, UK) Anjali Gopalan4 (New Delhi, India), Daniella Mark5 (Cape Town, South Africa), William McColl6 (Washington DC, USA) Molly Morgan Jones2 (Cambridge, UK), James Swartz7 (Chicago, USA) Jessica Terlikowski6 (Washington DC, USA) 1 AIDS Foundation of Chicago 2 RAND 3 Baird’s CMC 4 Naz India 5 Desmond Tutu HIV Foundation 6 AIDS United 7 University of Illinois - Chicago Microbicides 2012 – Sydney, Australia - 17 April, 2012

  3. Our pathway for the next 12.5 min. • What is Mapping Pathways? • What did we do? • What will we focus on today?? • So what? Microbicides 2012 – Sydney, Australia - 17 April, 2012

  4. Microbicides 2012 – Sydney, Australia - 17 April, 2012

  5. What is Mapping Pathways? • Multinational project, began 2011 • Funding • Merck 2011 • Merck and NIH (BTG Bridge) 2012 • Review potential social, economic and clinical impacts of ARV-based prevention • South Africa, India, U.S. • AIDS Foundation of Chicago, AIDS United, Desmond Tutu HIV Foundation, Naz India, RAND, Baird’s CMC Microbicides 2012 – Sydney, Australia - 17 April, 2012

  6. What do we look like? Microbicides 2012 – Sydney, Australia - 17 April, 2012

  7. Why Mapping Pathways? • The project’s aim is to provide the research and analysis that communities and policymakers need in order to formulate coherent, evidence-based decisions for HIV/AIDS treatment and prevention strategies in the 21st century. Microbicides 2012 – Sydney, Australia - 17 April, 2012

  8. What did Mapping Pathways do? • 2011 – Data collection • Online survey (grassroots) • Stakeholder interviews (grasstops) • Literature review (empirical evidence base) • ExpertLens (where are the fault lines?) • 2012 – Data dissemination Microbicides 2012 – Sydney, Australia - 17 April, 2012

  9. Our glossary • Microbicides (not “topical PrEP”) • PrEP (not “treatment for prevention”) • TLC+ (not “treatment as prevention”) • PEP (occupational, IDU, sexual exposure) Microbicides 2012 – Sydney, Australia - 17 April, 2012

  10. What are we talking about today? • Online survey • Stakeholder interviews Microbicides 2012 – Sydney, Australia - 17 April, 2012

  11. Online survey • May – November 2011; India, SA, U.S. • 1,069 respondents, nearly 70% urban • Main professions/identities • Advocates/activists • ASO workers • NGO’s with AIDS services • Doctors/clinicians • People living with HIV Microbicides 2012 – Sydney, Australia - 17 April, 2012

  12. Online survey • How important are each of the strategies? • What information do you need to make decisions? • What are your concerns? Microbicides 2012 – Sydney, Australia - 17 April, 2012

  13. Majority respondents U.S., no significant differences across countries Microbicides 2012 – Sydney, Australia - 17 April, 2012

  14. Respondents felt most positively about TLC+ Microbicides • 68% felt it should be important PrEP • 45% felt it should be important • 45% felt important, but other things more PEP • 25% very important, should be given more attention • 26.3% not important, but needs to be • 9% felt not important and didn’t need to be Microbicides 2012 – Sydney, Australia - 17 April, 2012

  15. Most felt ARV-based prevention strategies worthwhile Microbicides 2012 – Sydney, Australia - 17 April, 2012

  16. A bit of qualitative color • United States • I am deeply concerned that the political opposition will succeed in keeping these options out of peoples' hands. • India • While you mention "voluntary testing and treatment", the danger is that this easily gets converted to "compulsory" or "opt-out" testing and possibly forcible treatment. It's a fine line in many places. • South Africa • Both PreP and microbicides need more evidence before any implementation. More research is needed with other drugs that are safe and have high barrier to resistance. Microbicides 2012 – Sydney, Australia - 17 April, 2012

  17. Stakeholder Interviews • To complement online survey, conducted 43 semi-structured interviews with selected “grasstops” • India=9, SA=13, US=21* (19 individuals) • * two group discussions (6 individuals per) in U.S. – each group counted as 1 individual for coding purposes Microbicides 2012 – Sydney, Australia - 17 April, 2012

  18. Stakeholder Interviews • All had ability to exert some degree of influence on policy, but disciplines varied considerably • Clinical, advocacy, research/academia, political, administrative • Many wore multiple hats - not easy to classify • Assess views of policy implications of new ARV prevention science • What are your existing perceptions about ARV-based prevention strategies? • What are your perceptions about the evidence base for these strategies? • What evidence would be useful? Microbicides 2012 – Sydney, Australia - 17 April, 2012

  19. Microbicides 2012 – Sydney, Australia - 17 April, 2012

  20. … enormous challenges and enormous benefits. Are people willing to be tested? Do they want drugs? What is adherence like? What impact does stigma have? What are side effects like? Is there viral rebound? It would be irresponsible to just roll it out as we need to consider (operational) issues before going out there.We need to do it well – the only thing worse than not doing it would be to do it badly. [SOUTH AFRICA] Microbicides 2012 – Sydney, Australia - 17 April, 2012

  21. Microbicides 2012 – Sydney, Australia - 17 April, 2012

  22. If you have cancer the doctor doesn’t say, let’s wait until you’re half-dead until we give you treatment. [SOUTH AFRICA] Microbicides 2012 – Sydney, Australia - 17 April, 2012

  23. Currently, guidelines define parameters for when people are put on ARVs depending on viral loads and CD4 counts. However, this evidence would imply that all people should be put on ARVs. If there were a large decrease in transmission rates, the stigma towards HIV could be reduced. [INDIA] Microbicides 2012 – Sydney, Australia - 17 April, 2012

  24. We need to be clear that HPTN 052 doesn’t necessarily provide evidence for a treatment benefit but rather as a public health benefit. That is something that people with HIV want. We need to be clear about the benefits and risks involved particularly in early stages of treatment. [UNITED STATES] Microbicides 2012 – Sydney, Australia - 17 April, 2012

  25. Microbicides 2012 – Sydney, Australia - 17 April, 2012

  26. Microbicides 2012 – Sydney, Australia - 17 April, 2012

  27. Cost effectiveness is important. Realistically there are way too many couples to put all negative partners on treatment. We need to reach the people who are so vulnerable they can’t negotiate condom usage regularly. We need to know if they could take medication regularly enough to be effective. It’s a great tool, but how to use it as sparingly as possible and how many resources should we devote to it. [UNITED STATES] Microbicides 2012 – Sydney, Australia - 17 April, 2012

  28. In an Indian culture that still struggles to accept condoms, it would be difficult to get the general population to accept PrEP. While risk categories based on global norms are feasible to define and accept, it will be hard for an individual to accept that he or she is “high-risk” and should take this treatment. [INDIA] Microbicides 2012 – Sydney, Australia - 17 April, 2012

  29. Figure 10. Likely Programmatic and Policy Impact of Microbicides Microbicides 2012 – Sydney, Australia - 17 April, 2012

  30. ….there is clear evidence of efficacy. However, the incidence in the CAPRISA trial was mind-boggling …[I am] concerned about risk compensation and the sociological consequences of a gel that people are told is protective. I wonder how the efficacy result could be translated into guidance and policy. [SOUTHAFRICA] Microbicides 2012 – Sydney, Australia - 17 April, 2012

  31. …. The only way there will be more of a chance of them ever being taken up by communities is if they are marketed as a sex toy or lubricant. If you call them microbicides, you’ll sell 3 in 20 years; if you call them applicators, you’ll sell 2 in 20 years… they now need to be handed over to a marketing company to consider how to advertise them as a sex toy. But [could this] ever be done in practice? Grumpy old nurses are funny about condoms so [they] would struggle with marketing a product as sex enhancing. [SOUTH AFRICA] Microbicides 2012 – Sydney, Australia - 17 April, 2012

  32. …. we know less about microbicides… It’s not as high efficacy … but it’s definitely worth supporting further exploration before policy is changed… We know that vaginal microbicides have been effective, not a lot of information on rectal microbicides. The issue with TLC+, PrEP, and microbicides is they don’t exist in isolation from each other. They are three new powerful tools, but you can’t think about them alone. How do they work in the real world, individually and together? There is more that needs to be assessed.. [UNITED STATES] Microbicides 2012 – Sydney, Australia - 17 April, 2012

  33. Stakeholder Interviews • In general, large cultural differences between the three countries • Enthusiasm for the various approaches were different for each approach, and each country • U.S. – very positive about 052, India very skeptical, South Africa pretty evenly distributed between positive/mixed/skeptical • U.S. and India more positive about microbicides compared to South Africa Microbicides 2012 – Sydney, Australia - 17 April, 2012

  34. So what? Scientific results proving the efficacy of vaginal microbicides, PrEP, and TLC+ are not sufficient to successfully implement these strategies in India, South Africa, and the United States. Funders and policy makers must understand and address stakeholder support as well as stakeholder resistance when deciding whether or not to implement any ARV-based prevention strategy. Microbicides 2012 – Sydney, Australia - 17 April, 2012

  35. So what? The science isn’t conclusive for any of the strategies. Microbicides 2012 – Sydney, Australia - 17 April, 2012

  36. So what? The evidence base is much more than P-values and statistical significance. Microbicides 2012 – Sydney, Australia - 17 April, 2012

  37. THISISN’T GOOD ENOUGH. So what? • The only important thing to know and do is always wear a • condom. • Larry Kramer • March, 2012 Microbicides 2012 – Sydney, Australia - 17 April, 2012

  38. Questions? Microbicides 2012 – Sydney, Australia - 17 April, 2012

  39. Contact mappingpathways.blogspot.comjpickett@aidschicago.org Microbicides 2012 – Sydney, Australia - 17 April, 2012

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