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Public Engagement with HIV Science Melbourne, 22 of July, 2014

The Continuum of Participation in Research From HIV Prevention to Care: Seven Years of the iPrEx Trial. Public Engagement with HIV Science Melbourne, 22 of July, 2014. “There is no other area of medicine where activism has been so strong and has accomplished so much as in the

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Public Engagement with HIV Science Melbourne, 22 of July, 2014

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  1. The Continuum of Participation in Research From HIV Prevention to Care: Seven Years of the iPrEx Trial Public Engagement with HIV Science Melbourne, 22 of July, 2014

  2. “There is no other area of medicine where activism has been so strong and has accomplished so much as in the HIV/AIDS field. Let’s be just a little brave, and stand up to protect that legacy.”

  3. Chicago San Francisco Boston Chiang Mai Guayaquil Iquitos Sao Paulo Lima Rio de Janeiro Cape Town New England Journal of Medicine, online Nov 23, 2010

  4. Formative work in iPrEx • Qualitative formative work throughout the duration of the study with participants • In-depth interviews • Discussion groups • Inquiring on • Information needs • Motivations to participate • Adherence • Perception of study services

  5. Motivations to participate in iPrEx in the Andes Global iPrEx • Health care benefits • Altruism • Commitment • Other: • Socializing opportunities • Reimbursement • Condoms and other goods iPrEx OLE • Health care benefits • PrEP • Other: • Reimbursement • Condoms and other goods • Socializing opportunities

  6. PrEP is not for everybody Insights from off-PrEP OLE participants in the Andes “I use condoms, so I did not want to take the medication.” (Lima OLE participant, off-PrEP) “I did not want to be on PrEP because the study was going to end, and then what…?” (Lima OLE participant, off-PrEP) “I was taking Truvada in iPrEx [blinded] and had adverse events, so I decided to enroll off-PrEP in OLE.” (Guayaquil OLE participant, off-PrEP)

  7. I can benefit from PrEP Insights from on-PrEP OLE participants in the Andes “I learned about the results and chose to be on PrEP.” (Iquitos OLE participant, on-PrEP) “I decided to choose PrEP because I was going to be protected by the pills, the counselors and the physician [at the study site].” (Guayaquil OLE participant, on-PrEP) “Now [that the study has ended] I will start using condoms that I get from my sisters who get them at the family planning services.” (Lima OLE participant, on-PrEP)

  8. The Ethics in iPrEx • Constant consultation with community and stakeholders before, during and after the study • Provision of post-trial access of a PrEP intervention to study participants. • Provided standard of prevention and ancillary care that are acknowledged by trial participants. • FTC/TDF for treatment is approved in all countries where the iPrEx study took place but one, Peru (an application is in process). • However: • How can investigators deliver access to a product over which they have limited control?1 1Haire B, Jordens C. Mind the gap: An empirical study of post-trial access in HIV biomedical prevention trials. Developing world bioethics 2013

  9. 2010 - 2014 In the US • Concerns about PrEP • Cost: Tx. vs. Px. • Medicalization of prevention • Behavioral desinhibition • Efficacy → adherence • PrEP activism in the US • AVAC, Project Inform, SFAF, AFC, etc. • Approval of FTC/TDF by the FDA • Access • Demo projects • > 150 US organizations and individuals endorse their support of CDC guidelines Regulatory paths • 2011: CDC Guidance on PrEP • 2012: South African Guidelines for PrEP for MSM • 2012: FDA approves FTC/TDF for PrEP • 2012: WHO Guidance for demo projects • 2014: CDC Guidelines for PrEP • 2014: WHO Consolidated Guidelines

  10. 2011: PrEP Stakeholder Consultations in Peru and Ecuador From policy makers and regulatory authorities point of view: • Pilot studies (demonstration projects) • Results from trials in women • Mathematical modeling: Cost-benefit analyses • Priority populations: Serodiscordant couples and women • Improve the existing HIV prevention services in the countries

  11. 2011: PrEP Stakeholder Consultations From a few activists point of view: • To ensure that PLWHA have access to TDF/FTC in the country • Advocacy to make PrEP an HIV prevention policy • Focus on one population and generate interest in this population • Develop a sense of ownership of PrEP as part of a combination prevention package

  12. Advocacy for Better HIV Prevention Tools: What is next? • Providers and stakeholders need to be educated on new HIV prevention strategies • PrEP is not for everyone, but should be a tool in the toolbox, accessible, and affordable • Communities need to demand effective HIV prevention strategies that reduce their risk of HIV • Speed up regulatory processes for approval of FTC/TDF for prevention

  13. Thanks to the 2499 iPrEx participants who made it possible to learn that daily oral PrEP is effective in preventing HIV acquisition in gay men, transgender women and other men who have sex with men.

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