Background: Several clinical trials have reported efficacy of three different ARV-based prevention strategies including vaginal microbicides (CAPRISA 004), PrEP (iPrEx, Partners PrEP, TDF 2), and HIV treatment (HPTN 052). Statistically significant P-values and strong confidence intervals are not sufficient for countries to make decisions on the potential deployment of any ARV-based prevention strategy. Stakeholder inputs from community, research, policy and governmental spheres are critical for mapping pathways to sound, evidence-based decision making.
Methods: Community organizations in India, South Africa and the United States collaborated with RAND to solicit community opinions and concerns regarding ARV-based prevention strategies through an online survey and individual interviews. The online survey ran for six months and was open to anyone interested in ARV-based prevention from the three countries. Interviews were conducted concurrently with specially selected stakeholders in the three target countries.
Results: Among the three countries, 1,069 individuals answered the survey, and 572 completed all questions. Most respondents were from urban settings and identified as advocates, AIDS service organization personnel, doctors, and/or people living with HIV. Survey respondents were most in favour of expanded treatment and microbicides, but all had concerns about accessibility, economics, health systems impacts, and stakeholder resistance to these strategies. Forty semi-structured stakeholder interviews were conducted concurrently (India = 9, South Africa = 13, United States = 18) revealing some convergent opinions across geographies and disciplines about the strength of the science for treatment as prevention, but also strongly divergent opinions on issues such as readiness and feasibility. PrEP was the most polarizing strategy with concerns including prohibitive resource costs, behavioural disinhibition and drug resistance. There were also concerns about the individuals who needed treatment in all three countries who were unable to access ARV drugs.
Conclusions: 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.
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Expanding the Evidence Base for ARV Prevention Strategies: Community Perspectives from India, South Africa, and the United States
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 1 AIDS Foundation of
Chataway2 (Cambridge, UK), Mark Chicago
Chataway3 (Wales, UK), Caroline Fry2 2 RAND
(Cambridge, UK) Anjali Gopalan4 (New 3 Baird’s CMC
Delhi, India), Daniella Mark5 (Cape 4 Naz India
Town, South Africa), William McColl6 5 Desmond Tutu HIV
Foundation
(Washington DC, USA) Molly Morgan
6 AIDS United
Jones2 (Cambridge, UK), James Swartz7 7 University of Illinois -
(Chicago, USA) Jessica Terlikowski6 Chicago
(Washington DC, USA)
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
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
What country are you from? (n=1069)
10.6% 9.4%
32.3%
47.7%
a) India b) South Africa c) United States d) Other
Microbicides 2012 – Sydney, Australia - 17 April, 2012
14. Respondents felt most positively about TLC+
Do you think that TLC+ should be an Microbicides
important part of the HIV prevention plan – 68% felt it should be
important
for your country? (n=687)
PrEP
– 45% felt it should be
1.0% a) No, not at all important and
should be given no attention
important
8.9% – 45% felt important, but
2.6% other things more
b) It is somewhat important, but
there are other things that are PEP
more important
– 25% very
87.5% c) Very important and should be important, should be
given lots of attention given more attention
– 26.3% not
d) No opinion 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
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)
1.7%
4.5%
a) Definitely
8.3% b) Probably
c) Probably not
d) Definitely not
53.2%
32.4% e) No opinion
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
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
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
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. [SOUTH AFRICA]
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. So what?
THIS ISN’T GOOD ENOUGH .
The only important
thing to know and
do is always wear a
condom.
- Larry Kramer
March, 2012
Microbicides 2012 – Sydney, Australia - 17 April, 2012
No significant differences in views across countriesPpl were skipped out if not from India, SA or USA – so actual numbers are in the 600 range as the rest came from other countries outside those threeMore information is needed on all ARV-based prevention strategies and the evidence base for themA majority would find the following information useful:Challenges to making the strategies a realityCosts of each ARV-based prevention strategy‘Other’ benefits which might come with the strategyWhat community leaders, experts and government members ‘think’
People were asked how important they felt that the individual strategies were. The majority of participants felt that TLC+ was the most important strategy, followed by microbicides. The views on PrEP were somewhat mixed, with some feeling that it was a very important strategy that should be given a lot of attention, and others feeling that other strategies were more important. Although there were not significant differences in views between the countries, particularly with regards to PrEP, respondents from South Africa felt that PEP was slightly more important than did respondents in other countries, and respondents from India viewed both TLC+ and microbicides as slightly less important than respondents in other countries.
We asked respondents what information they would find useful in their work. Respondents generally felt that education and awareness of the strategies needed to be improved, and also that information on resistance, side effects and how they were to be implemented and financed would be useful. A comparison on the cost-effectiveness and potential epidemiological effects would be appreciated. Finally, we asked respondents about their concerns. USA:Main concerns were about the cost of the strategies, the delivery conditions required for the strategies to succeed, and drug resistanceSouth Africa:Concerns included drug resistance, cost-effectiveness and affordability, and risk disinhibitionIndia:Major concerns were drug resistance and respondents felt that awareness of the strategies needed to increase
We asked respondents what information they would find useful in their work. Respondents generally felt that education and awareness of the strategies needed to be improved, and also that information on resistance, side effects and how they were to be implemented and financed would be useful. A comparison on the cost-effectiveness and potential epidemiological effects would be appreciated. Finally, we asked respondents about their concerns. USA:Main concerns were about the cost of the strategies, the delivery conditions required for the strategies to succeed, and drug resistanceSouth Africa:Concerns included drug resistance, cost-effectiveness and affordability, and risk disinhibitionIndia:Major concerns were drug resistance and respondents felt that awareness of the strategies needed to increase
One U.S. stakeholder provided the novel suggestion that because of adherence concerns over the long-term only people in high-risk groups who demonstrate adherence to shorter term treatment-as-prevention protocols such as PEP should be considered viable candidates for PrEP: Even before PrEP studies came out, we proposed a PEP program to the state. At what point does that turn into PrEP? I thought it would be an interesting avenue to explore. Suppose I had sex last night, the person wasn’t wearing a condom, and I get PEP. If I appear to be adherent to PEP, I might be a good candidate for PrEP. That’s different from what took place in the studies. There wasn’t a high level of adherence. How well people are voluntarily engaged in a level of adherence that would make PrEP more viable.
By country, the following is a sampling of the rationales for not changing existing prevention guidelines to accommodate the PrEP findings. Many, although stating they would not change existing guidelines, also stated they would be open to changing the guidelines in the future pending the results of further study: India: I did not think we are ready for it now. As for the future it will depend on how effective it is. It is important to give an option to a couple, and counseling is the better and safer option than ARV. South Africa: I am skeptical about how to use the PrEP results. I think the guidelines could be modified to include the examples above (abused women, sex workers, couples wanting to conceive, MSM who self-identify as high-risk) – but how do you put that in the guidelines – at the discretion of the clinician? United States: I don’t think so yet. There is still a lot we don’t know. What we do with heterosexual men and women and MSM, we have some tricky evidence right now. VOICE and FEM PREP—we don’t have good science to tell us what this means for heterosexual, HIV- negative women. We need to know a lot more. Until we do, we can’t make such decisions.
South Africa. The most pessimistic of all stakeholders regarding microbicides, South Africans expressed the most uncertainty about efficacy/effectiveness. Their pessimism about efficacy/effectiveness was based on a number of different factors and as a result is hard to characterize in a simple way. One effectiveness issue mentioned by at least several South African stakeholders were the disappointing results from the CAPRISA trial, believing that the infection rate among the women using the tenofovir gel in that trial was still too high even though it was significantly lower than in the placebo condition. [The stakeholder] is not convinced by the efficacy of microbicides. [The stakeholder thinks] the CAPRISA results showed the effect to wane with time. [The stakeholder] also thinks the CAPRISA interventional arm (who received active microbicides) received additional safe sex practices counselling and wonders ‘how much of an impact did THAT have?’CAPRISA stands for the Centre for the AIDS Program of Research in South Africa. Stakeholders concerns about microbicides were likely specifically referencing the results of the CAPRISA 004 trial whereby 889 HIV- women in KwaZulu Natal were randomly assigned to one of two conditions and received a tenofovir gel, the microbicide, or a placebo gel. The women were followed monthly for 30 months during which they were tested for HIV. Women in the group receiving the tenofovir gel had a 39% reduction in HIV incidence relative to controls overall. Women with high adherence to the recommended protocol had a 54% reduction, both of which were statistically significant. See Karim, et al. (2010) for further details.