In response to recent news from the FDA regarding the use of the drug Truvada for prevention, Mapping Pathways U.S. partners AIDS United and AIDS Foundation of Chicago presented a webinar June 19 focusing on the ARV-based strategy PrEP (pre-exposure prophylaxis.) During the webinar, key findings from the Mapping Pathways online survey and stakeholder interviews were presented to help illuminate the wide-ranging perspectives of advocates, clinicians, people living with HIV, policy makers and others regarding PrEP. While the U.S. context was highlighted, comparisons/contrasts were drawn with the opinions of individuals in South Africa and India. These are the slides from that webinar.
2. Webinar Housekeeping
• All participants are in listen-only
mode
• We will open the call for
discussion after the presentation
• Use the chat feature at any time
during the webinar to submit
your questions
3. What We’re Going to Cover
• What Mapping Pathways Is
• Definition of Terms
• What Mapping Pathways Did
• U.S. Perspectives of ARV-
Based Strategies
• U.S. Advocacy
• What You Can Do
4. What is Mapping Pathways?
• Multinational project, began 2011
• Funding
– Merck 2011
– Merck and NIH (BTG Bridge) 2012
• AIDS Foundation of Chicago, AIDS United, Desmond Tutu
HIV Foundation, RAND, Baird’s CMC
• Review potential social, economic, and clinical impacts
of ARV-based prevention
• South Africa, India, U.S.
• Current partners include AIDS Foundation of Chicago,
AIDS United, Desmond Tutu HIV Foundation, RAND,
Baird’s CMC
5. Why Mapping Pathways?
• Critical to ask questions about
how, if, and where these
strategies fit on the prevention
maps of cities, states, and/or
countries
• Develop and nurture a research-
driven, community-led global
understanding of emerging
evidence around ARV-based
prevention strategies
6. Why Mapping Pathways?
• Provide research and analysis
communities and policymakers need
to formulate coherent, evidence-
based decisions for HIV/AIDS
treatment and prevention strategies
in the 21st century
• Explore different perspectives on the
evidence base and the implications
for decision making
7. What Mapping Pathways Is Not
• Mapping Pathways is not advocating for
any specific strategy in any specific context
• It is not trying to imply one strategy is
“better” than the other
• Nor is it trying to imply one strategy should
receive more/less resources
• It is not a “PrEP feasibility” study
8. What Mapping Pathways Did
• 2011 – Data collection
– Online survey (grassroots)
– Stakeholder interviews
(grasstops)
– Literature review (empirical
evidence base)
– ExpertLens (where are the fault
lines?)
• 2012 – Data dissemination
9. Community and Stakeholder Engagement
• Engaged diverse stakeholders and
community members from each partner
country
– Advocates
– Researchers
– Elected officials
– Government agency heads
– Industry
– People living with HIV
– Service providers
– Clinicians
– And others!
10. Definition of ARV-Based Strategy
Terms
• TLC+ (not “treatment as
prevention”)
• PrEP (not “treatment for
prevention”)
• ARV-based Microbicides
Everything
(not “topical PrEP”)
You Wanted
to Know about
• PEP (occupational, IDU,
ARVs, *But Were sexual exposure)
Afraid to Ask
12. PrEP
• Pre-Exposure Prophylaxis
• Provision of anti-retroviral drugs to people at risk
of HIV
• All trials to date have been on tenofovir & Truvada
• 3 trials = PrEP to reduce HIV infection risk
– i-PrEX (Truvada in gay men and trans women)
– Partners PrEP (Truvada and tenofovir in heterosexual
couples)
– TDF2 (Truvada heterosexual men & women)
• 2 trials = no benefit of PrEP as prevention
– FEM-PrEP (Truvada in women)
– VOICE* (tenofovir arm stopped, oral Truvada arm
continues in women)
13. PrEP
• Follow-up research is being
conducted on each of the
previously mentioned trials
• More research into real-world
applications is needed
• Demo projects in Miami and San
Francisco for gay men, MSM, and
transwomen
• Some physicians have been
prescribing PrEP for off label use,
particularly since the positive
outcomes of the i-PrEX trial
14. FDA Review of PrEP
• May 10 FDA advisory committee
recommended that the FDA
approve Truvada as PrEP for
high-risk individuals
• Recommendation is non-binding
• FDA pushed back review of
Gilead’s Truvada for prevention
to September 14
15. What is the FDA looking for?
• Risk Evaluation and Mitigation
Strategy (REMS)
• Medication guide
• Community education
• Provider training
• Implementation
16. What are we talking about today?
• Online survey
• Stakeholder interviews
Microbicides
PEP PrEP PEP
PEP
17. What We Asked
• How important are each of
the strategies in your
country?
• What information do you
need to make decisions?
• What are your concerns?
18. Online survey
• Grassroots
• May – November 2011; India, South Africa, United States
• 1,069 respondents, nearly 70% urban
• Majority were from U.S.
• Main professions/identities
– Advocates/activists
– ASO workers
– NGOs with AIDS services
– Doctors/clinicians
– People living with HIV
19. Online survey
Majority respondents U.S., no significant differences across countries
20. U.S. Online Survey Respondents
• 510 respondents
• Gender
– 61% male
– 37% female
• Sexuality
– 37% heterosexual
– 48% gay
• Age
– 25% 18-35 years old
– 23% 36-45 years old
– 31% 46-55 years old
• Location
– 72% urban
– 9% rural
21. U.S. Online Survey Results—Interest & Involvement
• The majority of people had thought about
and discussed these strategies, and were
willing to give time/resources to help make
people more aware of them
• 83% spent time thinking about ARV-based
prevention strategies
• 84% have been involved in formal and
casual discussions with colleagues and
advocates about ARV-based prevention
strategies
• 83% expressed willingness to help build
awareness of ARV-based prevention
strategies
23. U.S. Online Survey Results—Advocacy
• Most respondents felt that the
following information would be
useful in their advocacy efforts
– Cost of strategies
– Challenges of implementing
strategies
– Indirect outcomes of implementing
strategies, such as strengthening of
health care systems or identifying
new HIV infections
– Perspectives of community leaders,
government officials, and experts
24. U.S. Online Survey Results—Concerns
• Majority of concerns:
– Drug resistance
– Side effects
– Costs
– Risk disinhibition
– Re-directing resources
– Real-world applicability
• Other concerns:
– Profit motives of pharmaceutical industry
– Politics
– Stigma
25. U.S. Online Survey Results—Concerns
“I find it hard to “We don't have all
understand why the data on the
people will take an impact of the “Corporate profit
expensive, less medications in the over the health
effective pill than use long run” benefits of the
condoms” millions”
“Simply put, insurance “I am deeply concerned
companies are not going that the political
to fund these prevention opposition will succeed in
strategies because of its' keeping these options out
sexual nature” of peoples' hands”
26. U.S. Online Survey Results—Information Wanted
• Cost of strategies, funding
• Comparisons with other strategies
and cost-effectiveness comparisons
• Implementation information including
– Lessons learned from other
implementations
– Geographical information
– Political situation
• Opinions on the strategies from
decision makers, impacted
communities, and healthcare workers
27. U.S. Online Survey Results—Information Wanted
“Recommendations “What policy makers
on which approach and government
would be more useful officials think and
(PEP or PREP) in a vote on these issues”
particular country”
“I would like to see data
on the efficacy of the
“As the research various methods and
continues to also on side effects and
evolve, how the other possible negative
opinions change outcomes of utilizing
over time” each method”
28. Stakeholder Interviews
• To complement online survey, conducted 43
semi-structured interviews with selected
“grasstops”
• India=9
• South Africa=13
• U.S.=21* (19 individuals)
– * Two group discussions (6 individuals per) in U.S. –
each group counted as 1 individual for coding
purposes
29. 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
30. Stakeholder Interviews
• 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?
31. Stakeholders and PrEP
Figure 8. Likely Programmatic and Policy Impacts of PrEP
“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.”
35. Stakeholders and PrEP
It will be hard for an individual to accept that he or
she is “high-risk” and should take this treatment.
[INDIA]
I am skeptical about how to use the PrEP results…
the guidelines could be modified to include abused
women, sex workers, couples wanting to conceive,
MSM who self ID as high risk, but how do you put
that in … at the discretion of the clinician? [RSA]
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. [UNITED STATES]
36. A U.S. Pharmacist’s Perspective on PrEP
“Not knowing which customers are HIV+ and HIV-
leaves the pharmacist unable to provide the proper
consultation for the patient. If they are getting
Truvada do they need a protease inhibitor? It would
be useful if there were different names for Truvada
when it was used as prevention—Truvada 1 and
Truvada 2, for example.”
37. So, what does all of
this mean?
Many stakeholders believe that scientific results proving
the efficacy of vaginal microbicides, PrEP, and TLC+ are
not yet sufficient to successfully implement these
strategies in 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 in the U.S., India, or South Africa.
38. So, what does all of this mean?
• Evidence is more than P-values
and confidence intervals
• Community members and
stakeholders’ experiences,
perspectives, and collective
wisdom are part of the evidence
base, just as is the science is and
must be equally valued
39. What YOU Can Do
• Integrate these perspectives into
community conversations about ARV-based
prevention
• Seek out perspectives in your community
• Use the MP tools and outcomes to identify
YOUR community’s thoughts, concerns, etc.
• Educate your community
– Mapping Pathways factsheets
– Host MP community education session with
AIDS United’s Organizing Team
– Become a MP Media Advocate
40. What YOU Can Do
• Stay connected to Mapping Pathways
– www.mappingpathways.blogspot.com
– www.facebook.com/pages/Mapping-Pathways
• U.S. Conference on AIDS in Las Vegas this fall
• Stay tuned for monograph and articles!
41. Mapping Pathways at AIDS 2012
• July 22 11:15am – 1:15pm Satellite: Session Room 9
– “From Revolution to Reality: How Will New Science Impact the U.S.
National HIV/AIDS Strategy?”
• July 23 12:30pm – 2:30pm Poster Presentations
• "Mapping Pathways: Developing the evidence base for biomedical
prevention strategies“ (MOPE591)
• "Synthesizing the empirical evidence for ARV-based prevention strategies to
map pathways to sound HIV prevention planning” (M0PE590)
• July 24 6:30pm – 8:30pm Satellite: Mini Room 2
– “Microbicides: The Road Ahead”
• July 25 10:30am – 12:00pm MSM NWZ, Global Village
– “Is it Celebration Time? What needs to happen for gay men/MSM to
make the most of ARV-based prevention (PrEP, rectal microbicides and
treatment as prevention) around the world.”
42. U.S. Advocacy—Challenges, Opportunities, Activities
• FDA sNDA
• “Tea bag” science
• Cost
• Access
• Implementation
• Community stigma
• National PrEP working group led by AVAC
– www.prepwatch.org
• Demo projects
• Policy papers
43. Addressing Stigma with Real Voices and Experiences
Instead of denigrating people on
PrEP as willful, filthy whores,
what if we respected them as
people who were willing to
venture into uncharted territory
for their own health and the
good of the world?
myprepexperience.blogspot.com
44. Addressing Stigma with Real Voices and Experiences
PrEP didn’t make me stop using condoms.
Instead PrEP provided me with protection
that I would use consistently, rather than
protection that I was already rejecting.
What has angered me the most, is watching
and listening to doctors, politicians, and
experts decide what my choices and risks
should be. For most of them, it is their job.
But for me.... it is my life.
myprepexperience.blogspot.com
45. Discussion
• What conversations are taking place
in your community about PrEP?
• What information would be useful
to help your community, city, state,
etc. determine how and if to move
forward with PrEP?
• Do you think the findings of the
survey and stakeholder interviews
reflect the perspectives of your
community?
46. Resources
• AVAC www.avac.org
• MTN www.mtnstopshiv.org
• HPTN hptn.org/index.htm
• IRMA www.rectalmicrobicides.org
• Aidsmap www.aidsmap.com/
• PrEP Watch www.prepwatch.org
• My PrEP Experience
www.myprepexperience.blogspot.com
• AIDS United www.aidsunited.org
• AIDS Foundation of Chicago www.aidschicago.org
The dynamic nature of prevention science and the outcomes of recent clinical trials of ARV-based prevention options requires communities and policymakers to understand their implications and to develop sound, evidence-based decisions about HIV/AIDS treatment and prevention strategies. Cities, states, and countries need to determine how, if, where, and when these strategies fit on their respective prevention maps. The evidence base is comprised of more than scientific data derived from clinical research – it is more than p-values and confidence intervals. The perspectives, experiences, and collective wisdom of community members and key stakeholders must be valued as much as statistically significant trial results.
Mapping Pathways is a multi-national project to develop and nurture a research-driven community-led global understanding of the emerging evidence base around the adoption of antiretroviral-based (ARV) prevention strategies to end the HIV/AIDS epidemic. Mapping Pathways includes a thorough review of the social, economic, and clinical impacts of TLC+ (expanded testing, linkage to care, plus offer of treatment), vaginal and rectal microbicides, pre-exposure prophylaxis (PrEP), and post-exposure prophylaxis (PEP) in the contexts of the United States, South Africa, and India. The project’s aim is to provide the research and analysis that communities and policy makers need in order to formulate coherent, evidence-based decisions for HIV/AIDS treatment and prevention strategies in the 21st century.
In 2011, Mapping Pathways engaged HIV/AIDS stakeholders and grassroots communities in the United States, India, and South Africa to learn their thoughts, concerns, priorities, and questions about ARV-based prevention options. The project engaged “grassroots” community members in an online survey and conducted individual interviews with “grasstops” advocacy, research, policy, government, and industry stakeholders to learn their views on programmatic and policy implications of ARV-based prevention strategies. 2012 is focused on disseminating Mapping Pathways findings. Disseminating information through community education efforts, including this webinar, development of a book documenting the entire process and outcomes, creation of accessible factsheets that outline the various perspectives raised and considerations suggested by participants. AU is working with its MP partners to disseminate this information through community briefings and meetings. The goal is for these materials to be another tool for advocates and others in the HIV field to use while determining their jurisdiction’s path forward on ARV prevention options. The Mapping Pathways blog features articles on the latest ARV-based research as well as perspectives of advocates, researchers, and others on current and future prevention strategies. We will tell you how to sign up to receive all of the latest MP news in your inbox at the end of the presentation.
Community engagement is at the heart of the Mapping Pathways project. We solicited input from grassroots and grasstops constituents to learn their perspectives on the range of ARV-based strategies.
ARV-based prevention strategies refer to a category of methods that use HIV treatment drugs called antiretrovirals (ARVs) to prevent HIV transmission. These methods include TLC+ (testing, linkage to care, plus treatment), vaginal and rectal microbicides, pre-exposure prophylaxis (PrEP), and post-exposure prophylaxis (PEP). TLC+: Provision of ARV treatment and care to HIV-positive people with the aims of preserving the health of people living with HIV and reducing the likelihood of transmitting the virus to others by reducing the amount of virus in their blood. TLC+ involves expanding testing and treatment efforts. It also requires offering treatment to people as soon as they test positive for HIV, regardless of their T cell count. This strategy is also known as Treatment as Prevention (TASP) and Treatment for Prevention (T4P). PrEP: Provision of ARV drugs to an HIV-negative person with the aim of reducing the risk of contracting HIV. All trials to date have tested Truvada and tenofovir. This approach is also known as oral prevention, oral PrEP. ARV-Based Microbicides: Substances that can be applied to the vagina or rectum to reduce sexual transmission of HIV. Formulations could include gels, vaginal rings, films, enemas. The majority of compounds currently in trials are ARV-based. PEP: Provision of ARVs after to person after HIV exposure. The drugs must be taken within 72 hours of exposure and for 28 days. The term n-PEP is used to describe non-occupational use.
There are a number of terms being used to describe the same interventions mentioned on the previous slide. Additionally, some of the terms are being used interchangeably. This confusion happens often between treatment as prevention and PrEP. To minimize confusion and ensure we are all speaking the same language, Mapping Pathways only uses the names that are at the top of this slide.
VOICE – Vaginal and Oral Interventions to Control the Epidemic – is a major HIV prevention trial designed to evaluate whether antiretroviral (ARV) medicines commonly used to treat people with HIV are safe and effective for preventing sexual transmission of HIV in women. The study has focused on two ARV-based approaches: daily use of an ARV tablet –PrEP – and daily use of a vaginal microbicide containing an ARV in gel form. VOICE stopped tenofovir arms because it failed to reduce women’s risk. However, the oral Truvada arm continues. Results are expected in 2013.
The extended review time enables the FDA to ensure the proper measures are put in place to protect people who would be taking PrEP.
FDA is thinking through these items to ensure safe and proper implementation of PrEP would be possible. They are asking what kind of community education efforts will be needed, what information will be necessary on the medication guide, the information and methods for ensuring providers have the necessary knowledge on prescribing PrEP.
No significant differences in views across countries Ppl 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 three More information is needed on all ARV-based prevention strategies and the evidence base for them A majority would find the following information useful: Challenges to making the strategies a reality Costs of each ARV-based prevention strategy ‘ Other’ benefits which might come with the strategy What community leaders, experts and government members ‘think’
The majority of survey respondents expressed that PrEP was either very important and should be given lots of attention or that it was important, but other are more important.
Survey respondents were asked two open-ended questions. The first one was what concerns do you have about ARV-based prevention strategies. Main concerns of US participants were about the cost of the strategies, the delivery conditions required for the strategies to succeed, and drug resistance.
Here is a sampling of those responses.
We also asked respondents what other type of information would be useful in their advocacy efforts and what else would they like to see/know regarding these topics. 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 resistance
These are a few of the quotes of respondents stating what other information would be useful to them.
Diverse group of grasstops individuals who were diverse in their disciplines and highly engaged and influential.
Who are the stakeholders? Due to many stakeholders playing many roles advocate, clinician, and researcher for example, it was difficult to classify responses as being representative of a single discipline. Therefore, we did not make any interpretations based on a person’s profession.
US stakeholders expressed that PrEP might be most useful for specific high risk populations. They also expressed significant skepticism for implementation because of the costs and resources necessary. US stakeholders reacted differently when faced with the evidence as opposed to when asked about the policy and programmatic impacts of that evidence 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.
Compared with the South Africa and India, U.S. stakeholders expressed the fewest positive feelings about the likely programmatic and policy impacts of PrEP. Compared to the U.S. and South Africa, India had the largest numbers of both positive and skeptical feelings about the likely programmatic and policy impacts of PrEP.
While many U.S. stakeholders expressed excitement about positive new data regarding strategies such as PrEP and their potential implications for HIV prevention, they also expressed concern about the actual, “real world” implementation of any of these strategies. Cost and resource concerns were the highest among U.S. stakeholders in comparison to the other countries and rank highest among concerns. However, the areas which received the greatest positive responses had to do with how useful PrEP would be for high-risk populations and that PrEP had demonstrated efficacy and effectiveness.
As you can see, 13% of U.S. stakeholders responded that the evidence supports changing treatment guidelines. However, 100% of stakeholders in South Africa and India responded with skepticism to the idea that the evidence supports changing guidelines.
If a pharmacy were to fill the prescription for prevention purposes, (for someone who is HIV-negative) it wouldn’t get reimbursed for providing the medication. It is already important for pharmacists to understand the complexities of HIV treatment. The availability of these new strategies makes it even more important for them to understand all of these new strategies, how they work, and what they mean for patients. Pharmacists have to know what is going on with the patient in order to provide the necessary care and guidance. Pharmacists aren’t just about dispensing. It is likely that PrEP would be considered a “vanity” drug—meaning a drug that would improve one’s life or lifestyle, but isn’t a necessity to save one’s life like it is for those who are really sick and need the medications.
The evidence is more than P-values and confidence intervals. The experiences, perspectives, and collective wisdom of community members and stakeholders are just as much a part of the evidence base as the science is, and should be valued as much as we value the science. Clearly, even with strong scientific results – the perspectives on the ground, and the REALITIES, are really important to consider.
Even with strong scientific results – the perspectives on the ground, and the REALITIES, are really important to consider as decisions are made regarding if, how, and when PrEP would be implemented.
We share the latest information in research and advocacy on the Mapping Pathways blog. Sign up to have them the blogs delivered right to your inbox. Friend us on Facebook. In 2012 the broader MP team is also doing presentations at conferences and publishing papers, and a monograph documenting the whole Mapping Pathways process.
If you are in DC for AIDS 2012, please be sure to attend any of the sessions!
AIDS United and AFC participate in the National PrEP working group.