Mapping Pathways - Community Perspectives on PrEP


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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.

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  • 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.
  • Mapping Pathways - Community Perspectives on PrEP

    1. 1. Mapping Pathways Community Perspectives on PrEP
    2. 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. 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. 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. 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. 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. 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. 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. 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. 10. Definition of ARV-Based StrategyTerms • 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
    11. 11. Other Terms in Use
    12. 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. 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. 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. 15. What is the FDA looking for?• Risk Evaluation and Mitigation Strategy (REMS)• Medication guide• Community education• Provider training• Implementation
    16. 16. What are we talking about today?• Online survey• Stakeholder interviews Microbicides PEP PrEP PEP PEP
    17. 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. 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. 19. Online survey Majority respondents U.S., no significant differences across countries
    20. 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. 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
    22. 22. U.S. Online Survey Results—PrEP
    23. 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. 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. 25. U.S. Online Survey Results—Concerns “I find it hard to “We dont 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. 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. 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. 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. 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. 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. 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 thepeople 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.”
    32. 32. Stakeholders and PrEP Figure 8. Likely Programmatic and Policy Impacts of PrEP
    33. 33. Stakeholders and PrEP Likely Programmatic and Policy Impacts in Detail
    34. 34. Stakeholders and PrEP Does the evidence support changing guidelines?
    35. 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. 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. 37. So, what does all of this mean?Many stakeholders believe that scientific results provingthe efficacy of vaginal microbicides, PrEP, and TLC+ arenot yet sufficient to successfully implement thesestrategies in the United States. Funders and policymakers must understand and address stakeholdersupport as well as stakeholder resistance whendeciding whether or not to implement any ARV-basedprevention strategy in the U.S., India, or South Africa.
    38. 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. 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. 40. What YOU Can Do• Stay connected to Mapping Pathways – –• U.S. Conference on AIDS in Las Vegas this fall• Stay tuned for monograph and articles!
    41. 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. 42. U.S. Advocacy—Challenges, Opportunities, Activities• FDA sNDA• “Tea bag” science• Cost• Access• Implementation• Community stigma• National PrEP working group led by AVAC –• Demo projects• Policy papers
    43. 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?
    44. 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 watchingand listening to doctors, politicians, andexperts decide what my choices and risksshould be. For most of them, it is their job.But for me.... it is my life.
    45. 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. 46. Resources• AVAC• MTN• HPTN• IRMA• Aidsmap• PrEP Watch• My PrEP Experience• AIDS United• AIDS Foundation of Chicago
    47. 47. Thank You!• Caressa Cameron –• Jim Pickett –• Jessica Terlikowski –