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

Jim Pickett, AIDS Foundation of Chicago º Microbicides 2012 º 17 April 2012

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

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)

Microbicides 2012 – Sydney, Australia - 17 April, 2012

1 AIDS Foundation of Chicago2 RAND 3 Baird’s CMC4 Naz India5 Desmond Tutu HIV Foundation6 AIDS United7 University of Illinois - Chicago

Our pathway for the next 12.5 min.


• What is Mapping Pathways?

• What did we do?• What will we focus on

today??

• So what?


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



What do we look like?

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.


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


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

What are we talking about today?

–Online survey –Stakeholder interviews


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


Online survey

• How important are each of the strategies?

• What information do you need to make decisions?

• What are your concerns?


Majority respondents U.S., no significant differences across countries

9.4%

32.3%

47.7%

10.6%

What country are you from? (n=1069)

a) India b) South Africa c) United States d) Other


And the survey said

1.0%8.9%

87.5%

2.6%

Do you think that TLC+ should be an important part of the HIV

prevention plan for your coun-try? (n=687)

a) No, not at all important and should be given no attention

b) It is somewhat important, but there are other things that are more important

c) Very important and should be given lots of attention

d) No opinion

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

Respondents felt most positively about TLC+


And the survey said

Most felt ARV-based prevention strategies worthwhile

53.2%

32.4%

8.3%

1.7% 4.5%

Would you be willing to give your time and/or your resources to help make people aware of these ARV-based HIV prevention strategies?

(n=664)

a) Definitely

b) Probably

c) Probably not

d) Definitely not

e) No opinion


And the survey said


And the survey said

• 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.

A bit of qualitative color

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



• 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?



Stakeholders and TLC+


Stakeholders and TLC+

… 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]


Stakeholders and HPTN 052



If you have cancer the doctor doesn’t say, let’s wait until you’re half-dead until we give you treatment. [SOUTH AFRICA]



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]



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]


Stakeholders and PrEP




Stakeholders and PrEPCost 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]



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]


Stakeholders and Microbicides

Figure 10. Likely Programmatic and Policy Impact of Microbicides



….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. [SOUTH AFRICA]



…. 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]


Stakeholders: All the above…. 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]


• 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


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.


So what?

The science isn’t conclusive for any of the strategies.


So what?

The evidence base is much more than P-values and statistical significance.


THIS ISN’T GOOD ENOUGH.


The only important thing to know and do is always wear acondom.- Larry Kramer March, 2012

So what?

Questions?


Contact


mappingpathways.blogspot.com

[email protected]

Documents

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