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WWW.ICAD-CISD.COM New Prevention Technologies Workshop Module 5: State of NPT Research STATUS OF RESEARCH What happened with these trials? Nonoxynol 9 Savvy Circumcision Cellulose Sulphate Merck vaccine CAPRISA 004 (tenofovir gel) iPrEx AIDSVAX AIDSVAX/ALVAC MIRA (Diaphragm) PRO 2000 BufferGel Carraguard FEM-PrEP Treatment as prevention Outcomes of past studies Safe Tend towards harm Signs of efficacy Circumcision AIDSVAX/ALVAC CAPRISA 004 (tenofovir gel) iPrEx Treatment as prevention No efficacy Carraguard BufferGel PRO 2000 AIDSVAX MIRA (diaphragm) FEM-PrEP Nonoxynol-9 Savvy Cellulose sulphate Merck vaccine NPT late-stage trials: When will we know? 2012+ PrEP Injection drug users PrEP Serodiscordant couples PrEP/Microbicides Women Vaccine* Men who have sex with men PrEP: When will we know? Where Who What When Thailand (CDC) Injection drug users tenofovir 2012 Uganda, Kenya (Partners PrEP) Serodiscordant couples (men and women) tenofovir, Truvada 2012 South Africa, Uganda, Zambia, Zimbabwe (VOICE) Women tenofovir (pill & gel), Truvada 2013 Microbicides: When will we know? Product Trial sponsor Tenofovir gel MTN (VOICE) Phase 2b Location(s) South Africa, Uganda, Zambia, Zimbabwe Results expected 2013 Vaccines: When will we know? Phase 2 Where Who What When US (HVTN/NIH) Men who have sex with men Prime/boost (DNA/Ad5) 2012 2009-10 discovery of new “broadly neutralizing antibodies” – possibly good target for further research SOCIAL AND BEHAVIOURAL ISSUES Social and Behavioural Issues Perceptions of “risk” Risk compensation (e.g., condom substitution?) Gender implications Stigma Community preparedness Social and Behavioural Questions o How would the introduction of NPTs impact the risk, negotiation, and autonomy of receptive sexual partners who generally have low control over condom use by their insertive partners? o How best can CBOs be supported for NPT preparedness and communications at the community level? o What are the social mechanisms by which NPTs could serve as a catalyst for broader structural changes in gender norms? ACCESS TO NPTs Who will have access? Who decides? The general public? How will decisions be made? Most « at-risk » groups? Who is that in the national context? What factors will influence this? How will it be available? Will it require a prescription? Is it available now? Will testing be a condition? Who will pay? What practical questions are raised? Will receptive partners (male or female) who use a partially effective NPT find it harder to get their partner to use a condom? What if I use this differently than how it was tested in trials? How will our healthcare system deal with the increase in testing? What ethical questions are raised? What are the implications of limiting access to prevention options only to certain groups? How do we deal with access inequality within our country? Between countries? How do we deal with the stigma of associating some prevention tools with high-risk populations? The elephant in the room…. Is it ethical to supply ARVs to HIV-negative people for prevention even though most HIVpositive people who need ARVs to prolong their lives do not get them? What research questions are raised? What if someone uses this when they are HIV+? Do trial results in one population translate to other populations? Can I take this when I’m pregnant? Will it hurt my baby? What about breastfeeding? Exercise What are some of the key considerations to keep in mind when thinking about access to NPTs for: Women in African countries Women in Canada Gay men in developing countries Gay men in Canada Canadians of African or Caribbean descent Persons who inject drugs Aboriginal people Public Funding is Essential Why aren’t large pharmaceutical companies investing? Perceived low profitability Liability concerns Lack of in-house expertise Uncertain regulatory environment Global Annual Microbicides R&D Investment 2009 in USD$ millions Source: HIV Vaccines and Microbicides Resource Tracking Working Group “Sure, you know about [all types of existing and new prevention options]... We need you to unravel the secrets of the science, to make all of that elusive and mysterious information accessible to the untutored rest of us… Somehow, along with the science, we need the activism. They are inseparable.” Stephen Lewis Co-Director, AIDS-Free World, and Former United Nations Secretary-General’s Special Envoy for HIV/AIDS in Africa (2001–2006) July 19, 2009 International AIDS Society Conference Cape Town, South Africa © Nick Wiebe 2006