Global and Regional Processes Relevant for PrEP Scale-Up: The PrEP Task Force Carlos F. Cáceres, MD, MPH, PhD Centro de Estudios Interdisciplinarios en Sexualidad, Sida y Sociedad Universidad Peruana Cayetano Heredia PI for ImPrEP in Peru Member, LAC Task Force on PrEP and Global PrEP Coalition

PrEP in LAC Implemented or planned as public health policy: Bahamas, Brazil, Barbados Serodiscordant couples by MOH: Costa Rica, St. Lucia, Suriname, Grenada and Guatemala 9 demonstration projects (UNITAID, PEPFAR, GF, or MOH): Brazil, Mexico, Peru, Chile (planned), Guatemala Haiti, Jamaica, Paraguay, Dominican Republic Initiatives from civil society: Guatemala, Paraguay, Dominican Rep, Ecuador (planned) PrEP “on demand”?? Argentina, Barbados, Chile, Peru (maybe more) PrEP “in the wild”

WHO Recommendations for HIV Prevention and care among MSM/TW PAHO Blueprints for MSM and TW WHO Recommendations for HIV Prevention and care among MSM/TW Guidance and tools WHO: Guidelines for MSM/TW (2011); updates PAHO: Blueprint for MSM (2012); blueprint for Trans Others: Additional guidance How to get this implemented? Dissemination (need for collaboration) Advocacy for concerted work Activists, UN partners, funders Operations research for contextualized adaptation Implementation tools (e.g. PrEP) Needs appraisal for tailored plans Training tools and training Political commitment

WHO recommendation for PrEP (2015) Oral PrEP (containing TDF) should be offered as an additional prevention choice for people at substantial risk of HIV infection as part of combination prevention approaches. strong recommendation high quality evidence

What is this recommendation all about? Enabling recommendation Not population specific For people at substantial HIV risk (provisionally defined as HIV incidence > 3 per 100 person–years in the absence of PrEP) Offer as an additional prevention choice within combination prevention Condoms and lube - Harm reduction HIV testing and links to ART - PEP Provide PrEP with comprehensive support Adherence counselling - Legal and social support Mental health and emotional support - Contraception and RH services

WHO PrEP recommendation included in 2016 ARV update 2015 recommendation incorporated into update of the Consolidated guidelines (2016) Some changes to text for implementation considerations http://apps.who.int/iris/bitstream/10665/208825/1/9789241549684_eng.pdf?ua=1

Australia: real-life, public health impact of combination prevention Newly diagnosed HIV cases in New South Wales (including Sydney) Educated community and built demand for PrEP among MSM PrEP demonstration project at scale 25% reduction in the average number of new cases compared to the previous five years. PrEP starts March 2016 Australia is an early success story in terms of PrEP as a public health intervention. There’s been an ambitious plan towards elimination of HIV out to 2020 in that country. That plan has clear targets on reduction of new HIV cases. And as part of that plan, PrEP is an important intervention in combination prevention. Australia has a concentrated HIV epidemic in men who have sex with men (MSM). In this slide, you can see the blue line at the top which represents the new HIV diagnoses reported for MSM in New South Wales. PrEP started being offered in March 2016, under an implementation project. Sydney like other big cities in Australia also had established solid infrastructure on HIV testing, linkages to care for those newly diagnosed already, but then in March of 2016, PrEP became accessible to MSM. As you can from the graph, by the end of 2016 and into 2017, there has been a decline in new HIV cases being diagnosed for MSM, which is the target population for PrEP in Australia. http://www.health.nsw.gov.au/endinghiv/Documents/q2-2017-nsw-hiv-data-report.pdf Source: http://www.health.nsw.gov.au/endinghiv/Documents/q2-2017-nsw-hiv-data-report.pdf

WHO PrEP Implementation Tool (2017) The tool, which is available online, is split into chapters, what we call modules, and currently available in .pdf format. Each module is aimed at a different stakeholder in PrEP implementation, including those who are interested in taking PrEP or are actually on PrEP, or have taken PrEP at some point.

Here we have the cover of the clinical module Here we have the cover of the clinical module. It’s helpful to mention that we at WHO are in partnership with Jhpiego to transform the clinical and pharmacists modules into online training sessions.

The back side of the card lists some basic messages on PrEP effectiveness, and it makes clear that PrEP does not prevent pregnancy or STIs. Whether you are a provider, or someone who is going to swallow a pill, you want to know what the side effect profile is for any given drug, and so that is noted. The three key side effects are the well known start-up syndrome of nausea which typically resolves after a month, for the kidney, the impact on creatinine elevation, and also loss of bone mineral density which has been reported from clinical trials. There are a series of suggested tests that need to be done before PrEP is taken, with the most critical one being the HIV test of course to ensure the individual is negative. And then we suggest that while someone is on PrEP, that they come in every 3 months for

PrEP is part of combination prevention How do we implement strategically? Start with highest incidence groups KPs (e.g. MSM) Serodiscordant couples Other populations (e.g. AGYW) Safer conception Part of enhanced eMTCT Integration and linkages to existing services Some key considerations: Not for EVERYONE Uptake and continuation is variable Not for ALWAYS Seasons of HIV risk Adherence is critical for PrEP effectiveness Other services beneficial, valued and necessary Many benefits beyond PrEP itself So as my final slide, I think I just want to emphasize to everyone who is listening that PrEP is really part of having good combination prevention at the country level. For those who want to provide PrEP, it is important to recognize that PrEP is not for everyone (e.g. not all gay men are at risk for HIV). It is also important to recognize as a provider that people themselves are not risk, but engage in periods of risk when PrEP can be considered. In the literature, you may see this term come up, where we talk about ‘seasons of risk’. Of course, taking your PrEP drug consistently will ensure effectiveness in preventing HIV acquision, and therefore adherence is incredibly critical. And as I mentioned earlier, other services are beneficial when offering PrEP, including the provision of quality STI management and opportunities to offer hepatitis B vaccination to those who have not. And so I want to conclude, by making the case, that when PrEP is offered as a service, you can have benefits beyond PrEP itself. Source: WHO PrEP implementation tool

Creation of LAC PrEP Task Force Based on the context described, resulting from a joint initiative of PAHO and NEMUS, the LAC PrEP Task Force was formed in late 2016 as: “A regional resource bringing together expertise, knowledge and public health perspectives to provide qualified technical assistance to countries engaged or interested in initiating the challenging provision of PrEP services.”

LAC PrEP TF: Mandate Promote PrEP awareness and provide expert guidance and technical support: for the development and implementation of PrEP policies, within the context of HIV/STI combination prevention, with a focus on most-affected populations.

LAC PrEP TF: Membership Representatives from multilateral and bilateral agencies involved in normative guidance development and technical cooperation on PrEP: PAHO (proposed coordinating agency of the Task Force); UNICEF (to lead PrEP work with adolescents); UNAIDS; UNFPA; UN women; UNDP; PEPFAR/CDC/USAID; and others. Regional experts from universities and research institutions with recognized experience and leaders in PrEP research:. Representatives from National HIV Programs/ National Health Institutes of countries with experience in developing PrEP-related policies and implementing PrEP programs. Civil society and community members with recognized experience in PrEP-related research and/or leaders in advocacy for access to PrEP.

LAC PrEP Task Force: Functions Promote awareness and build knowledge on PrEP among policy makers, health providers and civil society. Support the dissemination and regional adaptation of global guidance and tools related to PrEP and combination HIV prevention (including assessment tools, estimates, implementation tool kits, etc.) Facilitate sharing of experiences and tools (best practices of PrEP scale up, including regulatory processes and drug procurement) among countries, and promote horizontal cooperation, including interregional partnerships. Conduct regional assessments and build models for south-south cooperation. Provide on-demand technical assistance to interested National Programs. Promote collaborative work in the field of implementation research to address key knowledge gaps and inform/facilitate programmatic implementation.

PrEP Task force: proposed Activities Regular virtual meetings (quarterly, as needed) Seminars and debates via virtual platform (NEMUS, PAHO, etc.) Face-to-face meetings (at regional and global conferences) Provision of technical assistance to countries (on demand) Monitoring progress PrEP implementation and scale up Collaborative multi-country operational/implementation research Develop tools to support PrEP implementation Creation of a web based platform Development of a virtual course on PrEP delivery

PrEP Repository Task Force DropBox: Task force documents Guidelines Articles Communication material Drug regulation and procurement Forms and data collection tools Tools Power point Responsibility by topic according of expertise and interest

PrEP tools Development of modeling tools to support planning for PrEP implementation (with UNAIDS) methods and tool for projecting expected PrEP needs based on estimates, bio-behavioral survey and programmatic data, including from HIV case reporting systems, focusing specific key populations (MSM and TGW). costing tool for program managers and planners to project estimated costs of implementing PrEP in the context of existing health facility- and community-based services.

Technical cooperation Communication to NAPs managers about the existence of the Task Force Virtual seminar with Central American countries and the Dominican Republic (2016) with representatives from national programs, health providers and civil society from 6 countries Caribbean countries (pending in 2017) PrEP protocol/project review (Paraguay in 2017) Recommendations to Chile (2017) Technical cooperation (on demand)

Acknowledgements Giovanni Ravasi (PAHO) Maeve de Mello (PAHO) Ioannis Mameletzis (WHO) Robert Grant (UCSF) LAC PrEP Task Force WHO and PAHO Thank you!