Maximizing the treatment and prevention benefits of antiretroviral therapy for key populations: What additional evidence is required? Co-Conveners: WHO and IAS 29 June 2013 Dorsett Regency Kuala Lumpur, Malaysia Concept Paper Introduction The HPTN 052 trial demonstrated that antiretroviral drugs are important for preventing the transmission of HIV and for treatment of the individual. Recent cohort studies further suggest that increasing antiretroviral treatment coverage is important to decrease the risk of HIV acquisition at the population level. Following these results, the global HIV/AIDS community has aggressively mobilized to accelerate scale-up of antiretroviral therapy (ART) as both a treatment and a prevention strategy. Maximizing the treatment and prevention benefits of ART requires that clinical guidelines reflect earlier treatment, less toxic regimens, and service delivery approaches that improve engagement of people with HIV across the continuum of care. Implementation science (IS) plays a fundamental role in building the evidence-base for such policy and programme decision-making by systematically examining the challenges to treatment for prevention scale-up, developing and accessing different strategies, and evaluating the impact of antiretroviral treatment programmes. Dialogue on implementation science has been on-going since the results of the HPTN 052 trial were released. A stakeholders consultation in 2011 reviewed ongoing and planned research on prevention of ART in men who have sex with men and other populations who practice penile anal intercourse. In 2012, the WHO, the United States National Institutes of Health (NIH) and the network on Therapeutics Research, Education, and AIDS Training in Asia (TREAT Asia) hosted consultations in Asia to discuss current and future efforts in implementation science to inform treatment for prevention strategies in the region. WHO has also conducted regional consultations on the Strategic Use of Antiretrovirals with HIV programmes in Asia and Africa. The 2013 WHO Consolidated ARV Guidelines for HIV treatment and prevention raise questions around the strength of evidence on offering ART to key populations with CD4 counts above 500 cells/mm3. In 2013, the International AIDS Society (IAS) has co-organized two country level consultations in Zambia and France, lifting up economic, legal, regulatory, systemic and social and individual issues regarding treatment for prevention implementation. The impact on health care systems, health care providers, health care systems delivery and additional challenges or benefits from the implementation of maximizing the treatment and prevention benefits of ART were also analyzed. The experiences, opportunities, challenges and complexities of potential treatment for prevention implementation strategies were brought to the fore. The voices and experiences from communities and national stakeholders are also being channelled to the international forums and policy makers. We now have an opportunity to continue and further expand the dialogue on the role of implementation science to accelerate treatment for prevention research in key populations, addressing health systems, human rights, as well as, ethical issues. This concept paper proposes a global consultation titled “Maximizing the treatment and prevention benefits of ARVs for Key Populations: What Additional Evidence is Required?” on 29 June 2013. This will be held before the 7th IAS Conference on HIV Pathogenesis, Treatment and Prevention in Kuala Lumpur, Malaysia from 30 June - 3 July 2013. This one day pre-conference meeting will be co-convened by IAS and WHO and will bring together leading experts in HIV/AIDS and implementation research, public health and programme specialists, policymakers, and civil society groups to share information on current efforts and continuing challenges in using implementation science to inform treatment for prevention and key populations. Building on the advances outlined in the 2013 WHO Consolidated ARV Guidelines for Treatment and Prevention, the main outcome of this meeting will be to identify research domains and questions for maximizing the treatment and prevention benefits of ART in key populations. The audience for this meeting will be researchers and funders of research, policy makers and civil society. Objectives The purpose of the meeting is to begin developing a research agenda on maximizing the treatment and prevention benefits of ART for key populations. The objectives are: To present and discuss scientific evidence and programme experience across countries on maximizing the treatment and prevention benefits of ART for key populations To discuss human rights and ethical implications of maximizing the treatment and prevention benefits of ART for key populations Review Child Health and Nutrition Research Initiative methodology for developing research agenda To formulate research questions in the context of maximizing the treatment and prevention benefits of ART for key populations * Key populations are MSM, TG, PWID and SW (including adolescents in these populations) Time presenter CHAIRS 08:00-08:30 08:30-08:35 Potential Topics STEN VERMUND AND ANDREW HUNTER Registration Chris Lee, Malaysia MoH Welcoming remarks Time 08:35-08:50 presenter Meg Doherty, WHO Potential Topics Meeting objectives and rationale -Key population ART recommendations in 2013 guidelines -Role of implementation sciences to monitor and evaluate guidelines -Description of CHNRI process for creating HIV treatment research agenda 08:50-09:00 Chris Beyrer, JHU ART scientific landscape for key populations 09:00-09:10 Anna Zakowicz, IAS Outcomes of IAS country consultations 09:10-09:20 Emily Erbelding, NIH NIH scientific updates, funding opportunities and on-going collaboration 09:20-09:30 Cameron Wolf, USAID PEPFAR scientific updates, funding opportunities and on-going collaboration 09:30-09:45 Jerome Singh, Univ KZN Ethical and human rights issues related to offering ART to key populations irrespective of their CD4 count 09:45-09:55 Panusart (Midnight) Poonkasetwatana, APCOM Community perspectives on accessing ART irrespective of CD4 count in key populations 09:55-10:05 Nzansimana Sabin, Rwanda Implementation questions for maximizing the MoH treatment and prevention benefits of ART in KP in Rwanda 10:05-10:15 Beatriz Grinsztejn, FIOCRUZ Research on maximizing the treatment and prevention benefits of ART in MSM/TG in Brasil 10:15-10:30 ALL Tea Break CHAIRS SHIBA PHURAILATPAM AND MEG DOHERTY 10:30-10:40 Ying Ru-Lo, WHO Western Research on maximizing the treatment and Pacific Regional Office prevention benefits of ART in PWID in Asia 10:40-12:00 Kenneth Health Mayer, 12:00-13:00 Andrew Institute Grulich, Fenway Interventions to improve engagement of key populations as part of the ART cascade. 15 minute presentation followed by group discussion on research questions. Kirby Transmission dynamics in key populations (including acute infection, on-going research). 15 minute presentation followed by group Time presenter Potential Topics discussion on research questions. 13:00-14:00 ALL Lunch 14:00-15:20 Jens Lundgren, Copenhagen HIV Programme (Against) Julio Montaner, UBC (For) TBC ART should be offered to key populations irrespective of their CD4 count. 10 minute presentations followed by group discussion on research questions 15:20-16:30 Tim Mastro, FHI 360 Programmatic monitoring and evaluation of ART impact (incidence assays, community viral load, mortality, morbidity, and other key metrics). 15 minute presentation followed by group discussion on research questions 16:30-16:45 ALL Tea Break 16:45-16:55 Annette Sohn, AMFAR AMFAR scientific updates, funding opportunities and on-going collaboration 16:55-17:05 Chris Duncombe, Foundation TBC 17:05-17:15 Mohamed Osman, Elton John Elton John Foundation scientific updates, funding Foundation TBC opportunities and on-going collaboration 17:15-17:45 Sten Vermund, Vanderbilt Summary of discussions and the way forward University and Rachel Baggaley, WHO Gates Gates Foundation scientific updates, funding opportunities and on-going collaboration Meeting Participants Diverse Roles, Countries, and Organizations The meeting will have attendees representing a diverse group of researchers, technical experts, policymakers, civil society representatives.